Clinical Trial Results:
A Phase II, Single Centre, Open-label, Randomized Study to Investigate Meningococcal Serogroup A, C, W-135 and Y Saccharide Specific B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants

Due to a system error, the data reported in v1 is not correct and has been removed from public view.

Summary
EudraCT number	2006-003476-35
Trial protocol	GB
Global end of trial date	19 Jun 2009

Results information
Results version number	v2(current)
This version publication date	03 Jun 2016
First version publication date	14 Jun 2015
Other versions	v1 (removed from public view)
Version creation reason	Correction of full data set re-QC of the study needed because of EudraCT system glitch and updates are required.

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

Top of page

Sponsor protocol code

V59P16

ISRCTN number

US NCT number

NCT00488683

WHO universal trial number (UTN)

Sponsor organisation name

Novartis Vaccines and Diagnostics S.r.l.

Sponsor organisation address

Via Fiorentina 1, Siena, Italy, 53100

Public contact

Posting Director, Novartis Vaccines and Diagnostics S.r.l. , RegistryContactVaccinesUS@novartis.com

Scientific contact

Posting Director, Novartis Vaccines and Diagnostics S.r.l. , RegistryContactVaccinesUS@novartis.com

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-000032-PIP01-07

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

17 Sep 2012

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

19 Jun 2009

Was the trial ended prematurely?

Main objective of the trial

To assess whether the frequency of meningococcal serogroup A, C, W-135 and Y specific memory B cells, measured 1 month after a 2, 4-month course of Novartis MenACWY vaccine, predicts the specific serum bactericidal activity using human complement (hSBA) of (respectively) serogroup A, C, W-135 and Y at 12 months of age.

Protection of trial subjects

This clinical study was designed, implemented and reported in accordance with the International Conference on Harmonisation (ICH) Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations, including the European Directive 2001/20/EC, the US CFR Title 21, Novartis codes on the protection of human rights, and with the ethical principles laid down in the Declaration of Helsinki.

Background therapy

Evidence for comparator

Actual start date of recruitment

09 Jul 2007

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United Kingdom: 216

Worldwide total number of subjects

216

EEA total number of subjects

216

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

216

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Participants were enrolled from one study center in UK.

Screening details

All enrolled subjects were included in study.

Period 1 title

Overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

MenACWY-CRM and Routine Vaccines (Group 1)

Arm description

Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.

Arm type

Experimental

Investigational medicinal product name

Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2-, 4-, and 12-months as IM injections in the anterolateral area of the right thigh.

Investigational medicinal product name

DTaP-Hib-IPV

Investigational medicinal product code

Other name

Combined diphtheria, tetanus toxoid, acellular pertussis, Haemophilus influenzae type B and inactivated polio vaccine, Pediacel

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Three doses (0.5 mL each) were administered at 2-, 3-, and 4-months in the anterolateral area of the left thigh.

Investigational medicinal product name

PCV

Investigational medicinal product code

Other name

Heptavalent Streptoccus pneumonia, Prevnar

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Three doses (0.5 mL each) were administered at 2-, 4-, 13-months in the anterolateral area of the left thigh.

Investigational medicinal product name

Hib

Investigational medicinal product code

Other name

Vaxem Hib

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

One dose (0.5 mL) was administered at 13 months in the anterolateral area of the right thigh.

Investigational medicinal product name

MMR

Investigational medicinal product code

Other name

Measles, mumps, and rubella vaccine, Priorix

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose (0.5 mL) was administered at 13 months in the anterolateral area of the left thigh.

MenACWY-CRM and Routine Vaccines (Group 2)

Arm description

Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months. This group had an additional blood draw at the time of enrollment.

Arm type

Experimental

Investigational medicinal product name

Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Investigational medicinal product name

DTaP-Hib-IPV

Investigational medicinal product code

Other name

Combined diphtheria, tetanus toxoid, acellular pertussis, Haemophilus influenzae type B and inactivated polio vaccine, Pediacel

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Three doses (0.5 mL each) were administered at 2-, 3-, and 4-months in the anterolateral area of the left thigh.

Investigational medicinal product name

PCV

Investigational medicinal product code

Other name

Heptavalent Streptoccus pneumonia, Prevnar

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Three doses (0.5 mL each) were administered at 2-, 4-, 12-months in the anterolateral area of the left thigh.

Investigational medicinal product name

MMR

Investigational medicinal product code

Other name

Measles, mumps, and rubella vaccine, Priorix

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose (0.5 mL) was administered at 13 months in the anterolateral area of the left thigh.

Investigational medicinal product name

Hib

Investigational medicinal product code

Other name

Vaxem Hib

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

One dose (0.5 mL) was administered at 13 months in the anterolateral area of the right thigh.

MenACWY-CRM and Routine Vaccines (Group 3)

Arm description

Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age. This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM.

Arm type

Experimental

Investigational medicinal product name

Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solution for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Investigational medicinal product name

DTaP-Hib-IPV

Investigational medicinal product code

Other name

Combined diphtheria, tetanus toxoid, acellular pertussis, Haemophilus influenzae type B and inactivated polio vaccine, Pediacel

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Three doses (0.5 mL each) were administered at 2-, 3-, and 4-months in the anterolateral area of the left thigh.

Investigational medicinal product name

PCV

Investigational medicinal product code

Other name

Heptavalent Streptoccus pneumonia, Prevnar

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

Three doses (0.5 mL each) were administered at 2-, 4-, 12-months in the anterolateral area of the left thigh

Investigational medicinal product name

MMR

Investigational medicinal product code

Other name

Measles, mumps, and rubella vaccine, Priorix

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose (0.5 mL) was administered at 13 months in the anterolateral area of the left thigh.

Investigational medicinal product name

Hib

Investigational medicinal product code

Other name

Vaxem Hib

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

One dose (0.5 mL) was administered at 13 months in the anterolateral area of the right thigh.

Number of subjects in period 1	MenACWY-CRM and Routine Vaccines (Group 1)	MenACWY-CRM and Routine Vaccines (Group 2)	MenACWY-CRM and Routine Vaccines (Group 3)
Started	108	54	54
Completed	96	48	52
Not completed	12	6	2
Consent withdrawn by subject	1	2	2
Unable to classify	1	-	-
Lost to follow-up	5	3	-
Protocol deviation	5	1	-

Baseline characteristics

Top of page

Reporting group title

MenACWY-CRM and Routine Vaccines (Group 1)

Reporting group description

Reporting group title

MenACWY-CRM and Routine Vaccines (Group 2)

Reporting group description

Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months. This group had an additional blood draw at the time of enrollment.

Reporting group title

MenACWY-CRM and Routine Vaccines (Group 3)

Reporting group description

Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age. This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM.

Reporting group values	MenACWY-CRM and Routine Vaccines (Group 1)	MenACWY-CRM and Routine Vaccines (Group 2)	MenACWY-CRM and Routine Vaccines (Group 3)	Total
Number of subjects	108	54	54	216
Age categorical
Units: Subjects
Age continuous
Analysis was done on all enrolled subjects.
Units: days
arithmetic mean (standard deviation)	60.5 ( 3.7 )	59.8 ( 3.6 )	59.8 ( 3.6 )	-
Gender categorical
Analysis was done on all enrolled subjects.
Units: Subjects
Female	48	28	25	101
Male	60	26	29	115

End points

Top of page

Reporting group title

MenACWY-CRM and Routine Vaccines (Group 1)

Reporting group description

Reporting group title

MenACWY-CRM and Routine Vaccines (Group 2)

Reporting group description

Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months. This group had an additional blood draw at the time of enrollment.

Reporting group title

MenACWY-CRM and Routine Vaccines (Group 3)

Reporting group description

Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age. This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM.

Subject analysis set title

All enrolled population

Subject analysis set type

Full analysis

Subject analysis set description

All subjects enrolled/randomized in the study, i.e., with a record in DEMOG. This population was used for the analysis of demographics.

Subject analysis set title

Modified Intention-to-treat (ITT) population, Immunogenicity

Subject analysis set type

Modified intention-to-treat

Subject analysis set description

All randomized subjects who received a dose of MenACWY, and provided at least one evaluable blood sample after vaccination.

Subject analysis set title

Per protocol (PP) population, Immunogenicity

Subject analysis set type

Per protocol

Subject analysis set description

All subjects in the enrolled population who received all the relevant doses of vaccine correctly, and - provided evaluable blood samples at the relevant time points, and - had no major protocol violation as defined prior to analysis.

Subject analysis set title

Safety population

Subject analysis set type

Safety analysis

Subject analysis set description

All subjects who received a dose of MenACWY and some post-baseline safety data.

Subject analysis set title

Plasma cells at 7 Days after booster vacc. (Group 3)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of Plasma cells per 2x10E5 PBMCs at 7 Days After Booster Vaccination of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 3).

Subject analysis set title

Specific IgG GMC 7 Days after booster vacc. (Group 3)

Subject analysis set type

Per protocol

Subject analysis set description

Serogroup Specific IgG Geometric Mean Concentration at 1 week after booster vaccination of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 3).

Subject analysis set title

Specific Memory B cells at 7 days after booster vacc (Group 3)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of Memory B cells per 2x10E5 Lymphocytes Obtained from Culture (LOC) at 7 Days After Booster Vaccination of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 3).

Subject analysis set title

Human SBA GMTs at 7 days after booster vacc. (Group 3)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of Human SBA GMTs at 7 Days After Booster Vaccination of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 3).

Subject analysis set title

Human SBA GMTs at 12 Months of Age (Group 1)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of Human SBA GMTs at 12 Months of Age of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 1).

Subject analysis set title

Human SBA GMTs at 12 Months of Age (Group 2)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of Human SBA GMTs at 12 Months of Age of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 2).

Subject analysis set title

Human SBA GMTs at 12 Months of Age (Group 3)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of Human SBA GMTs at 12 Months of Age of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 3).

Subject analysis set title

Specific Memory B Cells at 12 Months of Age (Group 1)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of Memory B cells at 12 Months of Age of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 1).

Subject analysis set title

Specific Memory B Cells at 12 Months of Age (Group 2)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of Memory B cells at 12 Months of Age f subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 2).

Subject analysis set title

Specific Memory B Cells at 12 Months of Age (Group 3)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of Memory B cells at 12 Months of Age f subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 3).

Subject analysis set title

Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of IgG Geometric Mean Concentrations at 12 Months of Age of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 1).

Subject analysis set title

Specific IgG Geometric Mean Conc at 12 Months of Age (Group 2)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of IgG Geometric Mean Concentrations at 12 Months of Age of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 2).

Subject analysis set title

Specific IgG Geometric Mean Conc at 12 Months of Age (Group 3)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of IgG Geometric Mean Concentrations at 12 Months of Age of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 3).

Subject analysis set title

Human SBA GMTs at 13 Months of Age (Group 1)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of Human SBA GMTs at 13 Months of Age of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 1).

Subject analysis set title

Human SBA GMTs at 13 Months of Age (Group 2)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of Human SBA GMTs at 13 Months of Age of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 2).

Subject analysis set title

Human SBA GMTs at 13 Months of Age (Group 3)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of Human SBA GMTs at 13 Months of Age of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 3).

Subject analysis set title

Specific Memory B Cells at 13 Months of Age (Group 1)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of Memory B cells at 13 Months of Age of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 1).

Subject analysis set title

Specific Memory B Cells at 13 Months of Age (Group 2)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of Memory B cells at 13 Months of Age of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 2).

Subject analysis set title

Specific Memory B Cells at 13 Months of Age (Group 3)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of Memory B cells at 13 Months of Age of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 3).

Subject analysis set title

Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of IgG Geometric Mean Concentrations at 13 Months of Age of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 1).

Subject analysis set title

Specific IgG Geometric Mean Conc at 13 Months of Age (Group 2)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of IgG Geometric Mean Concentrations at 13 Months of Age of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 2).

Subject analysis set title

Specific IgG Geometric Mean Conc at 13 Months of Age (Group 3)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of IgG Geometric Mean Concentrations at 13 Months of Age of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 3).

Subject analysis set title

Specific IgG Geometric Mean Conc at Day 1 in mothers (Group 1)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of IgG Geometric Mean Concentrations at Day 1 in mothers of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 1).

Subject analysis set title

Specific IgG Geometric Mean Conc at Day 1 in mothers (Group 2)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of IgG Geometric Mean Concentrations at Day 1 in mothers of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 2).

Subject analysis set title

Specific IgG Geometric Mean Conc at Day 1 in mothers (Group 3)

Subject analysis set type

Per protocol

Subject analysis set description

Summary of IgG Geometric Mean Concentrations at Day 1 in mothers of subjects that belongs to MenACWY-CRM and Routine Vaccines (Group 3).

Primary: 1. Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135, and Y Specific Memory B Cells at 5 Months of Age and hSBA Titers at 12 Months of Age by Serogroup A, C, W-135 and Y

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End point title

1. Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135, and Y Specific Memory B Cells at 5 Months of Age and hSBA Titers at 12 Months of Age by Serogroup A, C, W-135 and Y

End point description

The memory B cell response at one month after primary vaccinations (5 months of age) was defined as the mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells, measured in vitro by ELISpot assay per 2x10^5 lymphocytes obtained from culture (LOC) of peripheral blood mononuclear cells (PBMC) circulating in blood incubated for 5.5 days in the presence of polyclonal B cell activators. Serogroup A, C, W-135 and Y geometric mean titers (GMTs) were measured by serum bactericidal assay using human complement (hSBA) at 12 months of age (before third dose). Correlation and linear regression coefficients were determined between memory B cells at 1 month after primary vaccinations with MenACWY-CRM (5 months of age) and hSBA titers at 12 months of age (before third dose) for the serogroups A, C, W-135 and Y. Analysis was performed on per-protocol (PP) dataset of primary vaccination. Note: hSBA GMTs dispersion was reported as confidence intervals (see table notes)

End point type

Primary

End point timeframe

1 month after primary vaccination and 12 months of age

End point values	MenACWY-CRM and Routine Vaccines (Group 1)	MenACWY-CRM and Routine Vaccines (Group 2)	MenACWY-CRM and Routine Vaccines (Group 3)	Human SBA GMTs at 12 Months of Age (Group 1)	Human SBA GMTs at 12 Months of Age (Group 2)	Human SBA GMTs at 12 Months of Age (Group 3)
Number of subjects analysed	71 ^[1]	31 ^[2]	43 ^[3]	85 ^[4]	40 ^[5]	42 ^[6]
Units: B cells per 2x10^5 lymphocytes
arithmetic mean (standard deviation)
Serogroup A	2.1 ( 2.03 )	1.8 ( 1.27 )	1.72 ( 1.89 )	2.2 ( 0 )	2 ( 0 )	2.14 ( 0 )
Serogroup C	2.57 ( 2.73 )	1.71 ( 1.12 )	2.43 ( 2.32 )	5.56 ( 0 )	4.83 ( 0 )	5.61 ( 0 )
Serogroup W-135	2.39 ( 4.69 )	1.5 ( 0.72 )	1.57 ( 1.47 )	8.4 ( 0 )	12 ( 0 )	10 ( 0 )
Serogroup Y	2.91 ( 8.36 )	1.43 ( 0.71 )	1.78 ( 1.67 )	8.71 ( 0 )	9.9 ( 0 )	9.15 ( 0 )

Notes
[1] - N= Serogroup A=50, C=71, W-135=62, Y=54
[2] - N= Serogroup A=25, C=31, W-135=26, Y=25
[3] - N= Serogroup A=30, C=43, W-135=40, Y=30
[4] - N= Serogroup A=85, C=83, W-135=67, Y=43; 95%CI= A=2.05-2.36, C=4.23-7.3,W-135=6.03-12,Y=5.82-13
[5] - N= Serogroup A=40, C=39, W-135=37, Y=25; 95%CI= A=2-2, C=3.28-7.09, W-135=8.05-17, Y=5.39-18
[6] - N= Serogroup A=42, C=40, W-135=34, Y=16; 95%CI= A=1.93-2.37, C=3.78-8.33, W-135=6.73-15, Y=4.95-17

Statistical Analysis 1

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup A.

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 12 Months of Age (Group 1) v Human SBA GMTs at 12 Months of Age (Group 2) v Human SBA GMTs at 12 Months of Age (Group 3)

Number of subjects included in analysis

312

Analysis specification

Pre-specified

Analysis type

other ^[7]

P-value

= 0.69 ^[8]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.06

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[7] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[8] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 2

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 12 Months of Age (Group 1) v Human SBA GMTs at 12 Months of Age (Group 2) v Human SBA GMTs at 12 Months of Age (Group 3)

Number of subjects included in analysis

312

Analysis specification

Pre-specified

Analysis type

other ^[9]

P-value

= 0.3 ^[10]

Method

parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.14

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[9] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[10] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 3

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup W-135

Comparison groups

Number of subjects included in analysis

312

Analysis specification

Pre-specified

Analysis type

other ^[11]

P-value

< 0.0001 ^[12]

Method

parametric correlation

Parameter type

pearson correlation coefficient

Point estimate

0.81

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[11] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[12] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 4

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup Y

Comparison groups

Number of subjects included in analysis

312

Analysis specification

Pre-specified

Analysis type

other ^[13]

P-value

= 0.0012 ^[14]

Method

parametric correlation

Parameter type

pearson correlation coefficient

Point estimate

0.67

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[13] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[14] - Values from Groups 1, 2 and 3 were combined for this analysis.

Statistical Analysis 5

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup A

Comparison groups

Number of subjects included in analysis

312

Analysis specification

Pre-specified

Analysis type

other ^[15]

P-value

= 0.61 ^[16]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

-0.08

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[15] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[16] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 6

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup C

Comparison groups

Number of subjects included in analysis

312

Analysis specification

Pre-specified

Analysis type

other ^[17]

P-value

= 0.02 ^[18]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.31

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[17] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[18] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 7

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup W-135

Comparison groups

Number of subjects included in analysis

312

Analysis specification

Pre-specified

Analysis type

other ^[19]

P-value

= 0.0018 ^[20]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.45

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[19] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[20] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 8

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup Y

Comparison groups

Number of subjects included in analysis

312

Analysis specification

Pre-specified

Analysis type

other ^[21]

P-value

= 0.08 ^[22]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[21] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[22] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 9

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup A

Comparison groups

Number of subjects included in analysis

312

Analysis specification

Pre-specified

Analysis type

other ^[23]

Method

Regression, Linear

Parameter type

R-square

Point estimate

0.0041

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[23] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 10

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup C

Comparison groups

Number of subjects included in analysis

312

Analysis specification

Pre-specified

Analysis type

other ^[24]

Method

Regression, Linear

Parameter type

R-square

Point estimate

0.02

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[24] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 11

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup W - 135

Comparison groups

Number of subjects included in analysis

312

Analysis specification

Pre-specified

Analysis type

other ^[25]

Method

Regression, Linear

Parameter type

R-square

Point estimate

0.66

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[25] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 12

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup Y

Comparison groups

Number of subjects included in analysis

312

Analysis specification

Pre-specified

Analysis type

other ^[26]

Method

Regression, Linear

Parameter type

R-square

Point estimate

0.45

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[26] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Secondary: 2. Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135 and Y Specific Memory B Cells at 1 Month After MenACWY-CRM Primary Vaccination and Serogroup A, C, W-135 and Y Specific Memory B Cells and IgG Concentration at 12 Months Age

Top of page

End point title

2. Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135 and Y Specific Memory B Cells at 1 Month After MenACWY-CRM Primary Vaccination and Serogroup A, C, W-135 and Y Specific Memory B Cells and IgG Concentration at 12 Months Age

End point description

Memory B cell response at 1 month after primary vaccination and immediately before third dose at 12 months of age was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x10^5 LOC. The meningococcal serogroup A, C, W-135 and Y specific IgG concentrations immediately before third dose at 12 months of age were measured by ELISA and reported as μg/mL. Note: Specific IgG GMCs dispersion was reported as confidence intervals (see table notes)

End point type

Secondary

End point timeframe

1 month after primary vaccination (B cells) and at 12 months of age (B cells and IgG concentration)

End point values	MenACWY-CRM and Routine Vaccines (Group 1)	MenACWY-CRM and Routine Vaccines (Group 2)	MenACWY-CRM and Routine Vaccines (Group 3)	Specific Memory B Cells at 12 Months of Age (Group 1)	Specific Memory B Cells at 12 Months of Age (Group 2)	Specific Memory B Cells at 12 Months of Age (Group 3)	Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)	Specific IgG Geometric Mean Conc at 12 Months of Age (Group 2)	Specific IgG Geometric Mean Conc at 12 Months of Age (Group 3)
Number of subjects analysed	71 ^[27]	31 ^[28]	43 ^[29]	75 ^[30]	35 ^[31]	38 ^[32]	55 ^[33]	25 ^[34]	26 ^[35]
Units: Mean of memory B cells
arithmetic mean (standard deviation)
Serogroup A	2.1 ( 2.03 )	1.8 ( 1.27 )	1.72 ( 1.89 )	1.811 ( 1.935 )	1.988 ( 1.881 )	1.692 ( 1.398 )	0.37 ( 0 )	0.33 ( 0 )	0.31 ( 0 )
Serogroup C	2.57 ( 2.73 )	1.71 ( 1.12 )	2.43 ( 2.32 )	2.076 ( 1.926 )	1.983 ( 1.482 )	2.188 ( 2.004 )	0.19 ( 0 )	0.18 ( 0 )	0.2 ( 0 )
Serogroup W-135	2.39 ( 4.69 )	1.5 ( 0.721 )	1.57 ( 1.47 )	1.783 ( 2.189 )	1.793 ( 1.531 )	2.067 ( 2.716 )	0.31 ( 0 )	0.35 ( 0 )	0.29 ( 0 )
Serogroup Y	2.91 ( 8.36 )	1.43 ( 0.71 )	1.78 ( 1.67 )	2.172 ( 2.934 )	1.556 ( 0.898 )	1.749 ( 1.797 )	0.43 ( 0 )	0.47 ( 0 )	0.37 ( 0 )

Notes
[27] - N= Serogroup A=50, C=71, W-135=62, Y=54
[28] - N= Serogroup A=25, C=31, W-135=26, Y=25
[29] - N= Serogroup A=30, C=43, W-135=40, Y=30
[30] - N= Serogroup A=58, C=75, W-135=75, Y=67
[31] - N= Serogroup A=29, C=35, W-135=34, Y=33
[32] - N= Serogroup A=31, C=38, W-135=38, Y=34
[33] - N= Serogroup A=49, C=55, W-135=55, Y=49; 95%CI= A=0.27-0.49, C=0.16-0.23,W-135=0.25-0.38,Y=0.34-0.55
[34] - N= Serogroup A=23, C=25, W-135=21, Y=21; 95%CI= A=0.23-0.46, C=0.14-0.22,W-135=0.25-0.48,Y=0.33-0.67
[35] - N= Serogroup A=24, C=26, W-135=26, Y=24; 95%CI= A=0.23-0.42, C=0.15-0.28,W-135=0.2-0.43,Y=0.25-0.55

Statistical Analysis 1

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 12 Months of Age (Group 1) v Specific Memory B Cells at 12 Months of Age (Group 2) v Specific Memory B Cells at 12 Months of Age (Group 3)

Number of subjects included in analysis

293

Analysis specification

Pre-specified

Analysis type

other ^[36]

P-value

= 0.7 ^[37]

Method

Parametric correlation

Parameter type

pearson correlation coefficient

Point estimate

-0.07

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[36] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[37] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 2

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C

Comparison groups

Number of subjects included in analysis

293

Analysis specification

Pre-specified

Analysis type

other ^[38]

P-value

= 0.37 ^[39]

Method

Parametric correlation

Parameter type

pearson correlation coefficient

Point estimate

-0.13

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[38] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[39] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 3

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135

Comparison groups

Number of subjects included in analysis

293

Analysis specification

Pre-specified

Analysis type

other ^[40]

P-value

< 0.0001 ^[41]

Method

Parametric correlation

Parameter type

pearson correlation coefficient

Point estimate

0.66

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[40] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[41] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 4

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y

Comparison groups

Number of subjects included in analysis

293

Analysis specification

Pre-specified

Analysis type

other ^[42]

P-value

< 0.0001 ^[43]

Method

Parametric correlation

Parameter type

pearson correlation coefficient

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[42] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[43] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 5

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A

Comparison groups

Number of subjects included in analysis

293

Analysis specification

Pre-specified

Analysis type

other ^[44]

P-value

= 0.94 ^[45]

Method

Non-parametric correlation

Parameter type

spearman correlation coefficient

Point estimate

0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[44] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[45] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 6

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C

Comparison groups

Number of subjects included in analysis

293

Analysis specification

Pre-specified

Analysis type

other ^[46]

P-value

= 0.7 ^[47]

Method

Non-parametric correlation

Parameter type

spearman correlation coefficient

Point estimate

-0.05

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[46] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[47] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 7

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135

Comparison groups

Number of subjects included in analysis

293

Analysis specification

Pre-specified

Analysis type

other ^[48]

P-value

= 0.04 ^[49]

Method

Non-parametric correlation

Parameter type

spearman correlation coefficient

Point estimate

0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[48] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[49] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 8

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y

Comparison groups

Number of subjects included in analysis

293

Analysis specification

Pre-specified

Analysis type

other ^[50]

P-value

= 0.0043 ^[51]

Method

Non-parametric correlation

Parameter type

spearman correlation coefficient

Point estimate

0.46

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[50] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[51] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 9

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A

Comparison groups

Number of subjects included in analysis

293

Analysis specification

Pre-specified

Analysis type

other ^[52]

Method

Parameter type

R-square

Point estimate

0.0053

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[52] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 10

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C

Comparison groups

Number of subjects included in analysis

293

Analysis specification

Pre-specified

Analysis type

other ^[53]

Method

Parameter type

R-square

Point estimate

0.02

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[53] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 11

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135

Comparison groups

Number of subjects included in analysis

293

Analysis specification

Pre-specified

Analysis type

other ^[54]

Method

Parameter type

R-square

Point estimate

0.43

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[54] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 12

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y

Comparison groups

Number of subjects included in analysis

293

Analysis specification

Pre-specified

Analysis type

other ^[55]

Method

Parameter type

R-square

Point estimate

0.82

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[55] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 13

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 2) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 3)

Number of subjects included in analysis

251

Analysis specification

Pre-specified

Analysis type

other ^[56]

P-value

= 0.68 ^[57]

Method

Parametric correlation

Parameter type

pearson correlation coefficient

Point estimate

0.05

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[56] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[57] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 14

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C

Comparison groups

Number of subjects included in analysis

251

Analysis specification

Pre-specified

Analysis type

other ^[58]

P-value

= 0.46 ^[59]

Method

Parametric correlation

Parameter type

pearson correlation coefficient

Point estimate

0.08

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[58] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[59] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 15

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135

Comparison groups

Number of subjects included in analysis

251

Analysis specification

Pre-specified

Analysis type

other ^[60]

P-value

= 0.08 ^[61]

Method

Parametric correlation

Parameter type

pearson correlation coefficient

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[60] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[61] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 16

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y

Comparison groups

Number of subjects included in analysis

251

Analysis specification

Pre-specified

Analysis type

other ^[62]

P-value

= 0.000145 ^[63]

Method

Parametric correlation

Parameter type

pearson correlation coefficient

Point estimate

0.45

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[62] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[63] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 17

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A

Comparison groups

Number of subjects included in analysis

251

Analysis specification

Pre-specified

Analysis type

other ^[64]

P-value

= 0.75 ^[65]

Method

Non-parametric correlation

Parameter type

spearman correlation coefficient

Point estimate

-0.04

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[64] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[65] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 18

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C

Comparison groups

Number of subjects included in analysis

251

Analysis specification

Pre-specified

Analysis type

other ^[66]

P-value

= 0.27 ^[67]

Method

Non-parametric correlation

Parameter type

spearman correlation coefficient

Point estimate

0.11

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[66] - Confidence Intervals were not calculated for the purpose of this study.
[67] - Non-parametric correlation Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 19

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135

Comparison groups

Number of subjects included in analysis

251

Analysis specification

Pre-specified

Analysis type

other ^[68]

P-value

= 0.07 ^[69]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[68] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[69] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 20

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y

Comparison groups

Number of subjects included in analysis

251

Analysis specification

Pre-specified

Analysis type

other ^[70]

P-value

= 0.06 ^[71]

Method

Non-parametric correlation

Parameter type

spearman correlation coefficient

Point estimate

0.23

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[70] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[71] - Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 21

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A

Comparison groups

Number of subjects included in analysis

251

Analysis specification

Pre-specified

Analysis type

other ^[72]

Method

Parameter type

R-square

Point estimate

0.0029

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[72] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 22

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C

Comparison groups

Number of subjects included in analysis

251

Analysis specification

Pre-specified

Analysis type

other ^[73]

Method

Parameter type

R-square

Point estimate

0.0059

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[73] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 23

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135

Comparison groups

Number of subjects included in analysis

251

Analysis specification

Pre-specified

Analysis type

other ^[74]

Method

Parameter type

R-square

Point estimate

0.04

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[74] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 24

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y

Comparison groups

Number of subjects included in analysis

251

Analysis specification

Pre-specified

Analysis type

other ^[75]

Method

Parameter type

R-square

Point estimate

0.21

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[75] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Secondary: 3. Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135 and Y Specific Memory B Cells 1 Month After MenACWY-CRM Primary Vaccination and Memory B Cells and hSBA Titers and IgG Conc. 1 Month Post MenACWY-CRM Booster Vaccination

Top of page

End point title

3. Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135 and Y Specific Memory B Cells 1 Month After MenACWY-CRM Primary Vaccination and Memory B Cells and hSBA Titers and IgG Conc. 1 Month Post MenACWY-CRM Booster Vaccination

End point description

Memory B cell response at 1 month after MenACWY-CRM primary and booster vaccinations was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC. hSBA geometric mean titers (GMTs) for the serogroup A, C, W-135 and Y were measured one month after the third MenACWY-CRM vaccination. The meningococcal serogroup A, C, W-135 and Y specific IgG concentrations one month after third MenACWY-CRM vaccination were measured by ELISA and reported as μg/mL. Values from Group 1 were analyzed separately. Values from Group 2 and 3 were combined for the analysis. Groups 2 and 3 received PCV at 12 months while Group 1 received PCV at 13 months. Analysis was performed on PP booster population. Note: Specific IgG GMCs and hSBA GMTs dispersion was reported as confidence intervals (see table notes)

End point type

Secondary

End point timeframe

1 month after primary vaccination and 1 month after third vaccination

End point values	MenACWY-CRM and Routine Vaccines (Group 1)	MenACWY-CRM and Routine Vaccines (Group 2)	MenACWY-CRM and Routine Vaccines (Group 3)	Human SBA GMTs at 13 Months of Age (Group 1)	Human SBA GMTs at 13 Months of Age (Group 2)	Human SBA GMTs at 13 Months of Age (Group 3)	Specific Memory B Cells at 13 Months of Age (Group 1)	Specific Memory B Cells at 13 Months of Age (Group 2)	Specific Memory B Cells at 13 Months of Age (Group 3)	Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)	Specific IgG Geometric Mean Conc at 13 Months of Age (Group 2)	Specific IgG Geometric Mean Conc at 13 Months of Age (Group 3)
Number of subjects analysed	71 ^[76]	31 ^[77]	43 ^[78]	85 ^[79]	40 ^[80]	42 ^[81]	73 ^[82]	37 ^[83]	40 ^[84]	66 ^[85]	34 ^[86]	38 ^[87]
Units: Mean of memory B cells
arithmetic mean (standard deviation)
Serogroup A	2.1 ( 2.03 )	1.8 ( 1.27 )	1.72 ( 1.89 )	65 ( 0 )	48 ( 0 )	67 ( 0 )	6.429 ( 6.365 )	6.527 ( 5.957 )	7.488 ( 12.512 )	4.59 ( 0 )	3.5 ( 0 )	5.18 ( 0 )
Serogroup C	2.57 ( 2.73 )	1.71 ( 1.12 )	2.43 ( 2.32 )	315 ( 0 )	217 ( 0 )	308 ( 0 )	9.437 ( 10.861 )	8.907 ( 9.791 )	8.915 ( 10.83 )	1.83 ( 0 )	1.67 ( 0 )	2.63 ( 0 )
Serogroup W-135	2.39 ( 4.69 )	1.5 ( 0.72 )	1.57 ( 1.47 )	889 ( 0 )	649 ( 0 )	602 ( 0 )	6.205 ( 6.776 )	4.43 ( 5.939 )	5.201 ( 6.648 )	5.97 ( 0 )	5.37 ( 0 )	5.12 ( 0 )
Serogroup Y	2.91 ( 8.36 )	1.43 ( 0.71 )	1.78 ( 1.67 )	492 ( 0 )	480 ( 0 )	475 ( 0 )	6.95 ( 9.122 )	6.603 ( 8.198 )	5.746 ( 12.624 )	6.2 ( 0 )	5.58 ( 0 )	5.75 ( 0 )

Notes
[76] - N= Serogroup A=50, C=71, W-135=62, Y=54
[77] - N= Serogroup A=25, C=31, W-135=26, Y=25
[78] - N= Serogroup A=30, C=43, W-135=40, Y=30
[79] - N= Serogroup A=85, C=78, W-135=59, Y=32; 95%CI= A=47-89, C=239-417,W-135=622-1271,Y=305-793
[80] - N= Serogroup A=40, C=39, W-135=35, Y=20; 95%CI= A=32-72, C=138-341,W-135=419-1004,Y=269-857
[81] - N= Serogroup A=42, C=40, W-135=33, Y=15; 95%CI= A=44-102, C=214-445,W-135=343-1057,Y=220-1025
[82] - N= Serogroup A=54, C=73, W-135=73, Y=64
[83] - N= Serogroup A=26, C=37, W-135=37, Y=32
[84] - N= Serogroup A=33, C=40, W-135=39, Y=34
[85] - N= Serogroup A=66, C=59, W-135=56, Y=56; 95%CI= A=3.63-5.81, C=1.43-2.35,W-135=4.67-7.64,Y=4.77-8.05
[86] - N= Serogroup A=34, C=33, W-135=32, Y=31; 95%CI= A=2.6-4.73, C=1.18-2.36,W-135=4.06-7.1,Y=4.06-7.67
[87] - N= Serogroup A=38, C=37, W-135=32, Y=33; 95%CI= A=3.48-6.99, C=1.87-3.7,W-135=3.5-7.5,Y=3.93-8.42

Statistical Analysis 1

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[88]

P-value

= 0.46

Method

Parametric correlation

Parameter type

pearson correlation coefficient

Point estimate

-0.26

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[88] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 2

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2) v Specific Memory B Cells at 13 Months of Age (Group 3)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[89]

P-value

= 0.59 ^[90]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.14

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[89] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[90] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 3

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[91]

P-value

= 0.98

Method

parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.006

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[91] - parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 4

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[92]

P-value

= 0.2 ^[93]

Method

Parametric correlation

Parameter type

pearson correlation coefficient

Point estimate

0.24

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[92] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[93] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 5

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[94]

P-value

= 0.08

Method

Parametric correlation

Parameter type

pearson correlation coefficient

Point estimate

0.43

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[94] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 6

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[95]

P-value

= 0.68 ^[96]

Method

Parametric correlation

Parameter type

pearson correlation coefficient

Point estimate

-0.08

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[95] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[96] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 7

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[97]

P-value

= 0.006

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.77

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[97] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 8

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[98]

P-value

= 0.48 ^[99]

Method

Parametric correlation

Parameter type

pearson correlation coefficient

Point estimate

0.16

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[98] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[99] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 9

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[100]

P-value

= 0.46

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

-0.26

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[100] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 10

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[101]

P-value

= 0.4 ^[102]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

-0.21

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[101] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[102] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 11

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[103]

P-value

= 0.6

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.12

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[103] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 12

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v MenACWY-CRM and Routine Vaccines (Group 2) v Specific Memory B Cells at 13 Months of Age (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[104]

P-value

= 0.03 ^[105]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[104] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[105] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 13

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[106]

P-value

= 0.001

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.72

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[106] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 14

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[107]

P-value

= 1 ^[108]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[107] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[108] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 15

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[109]

P-value

= 0.24

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.39

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[109] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 16

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2) v Specific Memory B Cells at 13 Months of Age (Group 3)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[110]

P-value

= 0.34 ^[111]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.22

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[110] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[111] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 17

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[112]

Method

Parameter type

Regression, Linear

Point estimate

0.07

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[112] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 18

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2) v Specific Memory B Cells at 13 Months of Age (Group 3)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[113]

Method

Parameter type

R-square

Point estimate

0.02

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[113] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 19

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[114]

Method

Parameter type

Regression, Linear

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[114] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 20

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[115]

Method

Parameter type

Regression, Linear

Point estimate

0.06

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[115] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 21

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[116]

Method

Parameter type

R-square

Point estimate

0.19

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[116] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 22

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2) v Specific Memory B Cells at 13 Months of Age (Group 3)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[117]

Method

Parameter type

R-square

Point estimate

0.0068

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[117] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 23

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[118]

Method

Parameter type

R-square

Point estimate

0.59

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[118] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 24

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[119]

Method

Parameter type

R-square

Point estimate

0.03

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[119] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 25

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[120]

P-value

= 0.0002

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.77

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[120] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 26

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[121]

P-value

= 0.9 ^[122]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.03

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[121] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[122] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 27

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[123]

P-value

= 0.02

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.47

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[123] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 28

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[124]

P-value

= 0.12 ^[125]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.29

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[124] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[125] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 29

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[126]

P-value

= 0.22

Method

Parametric correlation

Parameter type

[Pearson correlation coefficient

Point estimate

0.31

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[126] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 30

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[127]

P-value

< 0.0001 ^[128]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.81

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[127] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[128] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 31

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[129]

P-value

= 0.82

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.15

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[129] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 32

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[130]

P-value

= 0.66 ^[131]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.15

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[130] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[131] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 33

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[132]

P-value

= 0.03

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.51

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[132] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 34

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[133]

P-value

= 0.53 ^[134]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.14

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[133] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[134] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 35

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[135]

P-value

= 0.35

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[135] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 36

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[136]

P-value

= 0.09 ^[137]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.47

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[136] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[137] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 37

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[138]

P-value

= 0.04

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.51

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[138] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 38

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[139]

P-value

= 0.1 ^[140]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.35

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[139] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[140] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 39

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[141]

P-value

= 0.56

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.35

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[141] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 40

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[142]

P-value

= 0.84 ^[143]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

-0.07

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[142] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[143] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 41

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[144]

Method

Parameter type

R-square

Point estimate

0.59

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[144] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 42

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[145]

Method

Parameter type

R-square

Point estimate

0.0007

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[145] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 43

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[146]

Method

Parameter type

R-square

Point estimate

0.22

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[146] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 44

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[147]

Method

Parameter type

R-square

Point estimate

0.08

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[147] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 45

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[148]

Method

Parameter type

R-square

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[148] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 46

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[149]

Method

Parameter type

R-square

Point estimate

0.66

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[149] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 47

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[150]

Method

Parameter type

R-square

Point estimate

0.02

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[150] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 48

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[151]

Method

Parameter type

R-square

Point estimate

0.02

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[151] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 49

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[152]

P-value

= 0.08

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.29

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[152] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 50

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 2) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 3)

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[153]

P-value

= 0.74 ^[154]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.05

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[153] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[154] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 51

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[155]

P-value

= 0.94

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[155] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 52

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[156]

P-value

= 0.51 ^[157]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.09

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[156] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[157] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 53

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[158]

P-value

= 0.12

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.27

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[158] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 54

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[159]

P-value

= 0.09 ^[160]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.25

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[159] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[160] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 55

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[161]

P-value

= 0.81

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.05

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[161] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 56

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[162]

P-value

= 0.07 ^[163]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.28

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[162] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[163] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 57

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[164]

P-value

= 0.02

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.36

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[164] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 58

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[165]

P-value

= 0.59 ^[166]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.08

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[165] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[166] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 59

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[167]

P-value

= 0.51

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

-0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[167] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 60

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[168]

P-value

= 0.9 ^[169]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.02

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[168] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[169] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 61

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[170]

P-value

= 0.02

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.39

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[170] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 62

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[171]

P-value

= 0.2 ^[172]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.19

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[171] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[172] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 63

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[173]

P-value

= 0.34

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.18

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[173] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 64

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[174]

P-value

= 0.04 ^[175]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.33

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[174] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[175] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 65

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[176]

Method

Parameter type

R-square

Point estimate

0.08

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[176] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 66

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[177]

Method

Parameter type

R-square

Point estimate

0.0027

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[177] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 67

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[178]

Method

Parameter type

R-square

Point estimate

0.0002

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[178] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 68

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[179]

Method

Parameter type

R-square

Point estimate

0.0077

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[179] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 69

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[180]

Method

Parameter type

R-square

Point estimate

0.07

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[180] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 70

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[181]

Method

Parameter type

R-square

Point estimate

0.06

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[181] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 71

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[182]

Method

Parameter type

R-square

Point estimate

0.0023

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[182] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 72

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[183]

Method

Parameter type

R-square

Point estimate

0.08

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[183] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Secondary: 4. Correlation and Regression Coefficients Between Memory B Cells 1 Month After Primary Vaccination and Rise From Prebooster Levels in Serogroup Specific Memory B Cells and IgG Concentration and hSBA Titers 1 Month After MenACWY -CRM Booster Vaccination

Top of page

End point title

4. Correlation and Regression Coefficients Between Memory B Cells 1 Month After Primary Vaccination and Rise From Prebooster Levels in Serogroup Specific Memory B Cells and IgG Concentration and hSBA Titers 1 Month After MenACWY -CRM Booster Vaccination

End point description

Memory B cell response at 1 month after MenACWY-CRM primary and booster vaccination was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC. The serogroup A, C, W-135 and Y specific IgG concentrations at 1 month after MenACWY-CRM booster were measured by ELISA and reported as μg/mL.. hSBA GMTs were measured by hSBA assay one month after MenACWY-CRM booster vaccination.The rise in serogroup specific IgG, memory B cells and hSBA was calculated by pre/post third dose geometric mean ratios, calculated by the difference in the log10 of the concentrations/titers measured at 13 months to the log10 of the concentrations at 12 months: (i.e. rise = log10(x) at 13 months minus log10(x) at 12 months) where x is the serogroup specific IgG or memory B cell concentrations or SBA titers. Analysis was performed on PP booster population. Note: Specific IgG GMCs and hSBA GMTs dispersion was reported as confidence intervals (see table notes).

End point type

Secondary

End point timeframe

1 month after primary and booster vaccination

End point values	MenACWY-CRM and Routine Vaccines (Group 1)	MenACWY-CRM and Routine Vaccines (Group 2)	MenACWY-CRM and Routine Vaccines (Group 3)	Human SBA GMTs at 13 Months of Age (Group 1)	Human SBA GMTs at 13 Months of Age (Group 2)	Human SBA GMTs at 13 Months of Age (Group 3)	Specific Memory B Cells at 13 Months of Age (Group 1)	Specific Memory B Cells at 13 Months of Age (Group 2)	Specific Memory B Cells at 13 Months of Age (Group 3)	Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)	Specific IgG Geometric Mean Conc at 13 Months of Age (Group 2)	Specific IgG Geometric Mean Conc at 13 Months of Age (Group 3)
Number of subjects analysed	71 ^[184]	31 ^[185]	43 ^[186]	85 ^[187]	40 ^[188]	42 ^[189]	73 ^[190]	37 ^[191]	40 ^[192]	66 ^[193]	34 ^[194]	38 ^[195]
Units: Mean of memory B cells
arithmetic mean (standard deviation)
Serogroup A	2.1 ( 2.03 )	1.8 ( 1.27 )	1.72 ( 1.89 )	65 ( 0 )	48 ( 0 )	67 ( 0 )	6.429 ( 6.365 )	6.527 ( 5.957 )	7.488 ( 12.512 )	4.59 ( 0 )	3.5 ( 0 )	5.18 ( 0 )
Serogroup C	2.57 ( 2.73 )	1.71 ( 1.12 )	2.43 ( 2.32 )	315 ( 0 )	217 ( 0 )	308 ( 0 )	9.437 ( 10.861 )	8.907 ( 9.791 )	8.915 ( 10.83 )	1.83 ( 0 )	1.67 ( 0 )	2.63 ( 0 )
Serogroup W-135	2.39 ( 4.69 )	1.5 ( 0.72 )	1.57 ( 1.47 )	889 ( 0 )	649 ( 0 )	602 ( 0 )	6.205 ( 6.776 )	4.43 ( 5.939 )	5.201 ( 6.648 )	5.97 ( 0 )	5.37 ( 0 )	5.12 ( 0 )
Serogroup Y	2.91 ( 8.36 )	1.43 ( 0.71 )	1.78 ( 1.67 )	492 ( 0 )	480 ( 0 )	475 ( 0 )	6.95 ( 9.122 )	6.603 ( 8.198 )	5.746 ( 12.624 )	6.2 ( 0 )	5.58 ( 0 )	5.75 ( 0 )

Notes
[184] - N= Serogroup A=50, C=71, W-135=62, Y=54
[185] - N= Serogroup A=25, C=31, W-135=26, Y=25
[186] - N= Serogroup A=30, C=43, W-135=40, Y=30
[187] - N= Serogroup A=85, C=78, W-135=59, Y=32; 95%CI= A=47-89, C=239-417,W-135=622-1271,Y=305-793
[188] - N= Serogroup A=40, C=39, W-135=35, Y=20; 95%CI= A=32-72, C=138-341,W-135=419-1004,Y=269-857
[189] - N= Serogroup A=42, C=40, W-135=33, Y=15; 95%CI= A=44-102, C=214-445,W-135=343-1057,Y=220-1025
[190] - N= Serogroup A=54, C=73, W-135=73, Y=64
[191] - N= Serogroup A=26, C=37, W-135=37, Y=32
[192] - N= Serogroup A=33, C=40, W-135=39, Y=34
[193] - N= Serogroup A=66, C=59, W-135=56, Y=56; 95%CI= A=3.63-5.81, C=1.43-2.35,W-135=4.67-7.64,Y=4.77-8.05
[194] - N= Serogroup A=34, C=33, W-135=32, Y=31; 95%CI= A=2.6-4.73, C=1.18-2.36,W-135=4.06-7.1,Y=4.06-7.67
[195] - N= Serogroup A=38, C=37, W-135=32, Y=33; 95%CI= A=3.48-6.99, C=1.87-3.7,W-135=3.5-7.5,Y=3.93-8.42

Statistical Analysis 1

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A.

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[196]

P-value

= 0.59

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.25

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[196] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 2

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2) v Specific Memory B Cells at 13 Months of Age (Group 3)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[197]

P-value

= 0.68 ^[198]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.12

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[197] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[198] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 3

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[199]

P-value

= 0.12

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.36

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[199] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 4

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2) v Specific Memory B Cells at 13 Months of Age (Group 3)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[200]

P-value

= 0.26 ^[201]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.22

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[200] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[201] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 5

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[202]

P-value

= 0.08

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.43

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[202] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 6

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2) v Specific Memory B Cells at 13 Months of Age (Group 3)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[203]

P-value

= 0.42 ^[204]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.17

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[203] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[204] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 7

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[205]

P-value

= 0.01

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.77

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[205] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 8

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2) v Specific Memory B Cells at 13 Months of Age (Group 3)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[206]

P-value

= 0.65 ^[207]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.12

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[206] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[207] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 9

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[208]

P-value

= 0.58

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

-0.25

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[208] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 10

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2) v Specific Memory B Cells at 13 Months of Age (Group 3)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[209]

P-value

= 0.51 ^[210]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

-0.19

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[209] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[210] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 11

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[211]

P-value

= 0.24

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.28

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[211] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 12

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2) v Specific Memory B Cells at 13 Months of Age (Group 3)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[212]

P-value

= 0.06 ^[213]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.36

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[212] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[213] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 13

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[214]

P-value

= 0.001

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.72

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[214] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 14

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2) v Specific Memory B Cells at 13 Months of Age (Group 3)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[215]

P-value

= 0.12 ^[216]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

-0.32

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[215] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[216] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 15

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[217]

P-value

= 0.18

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.49

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[217] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 16

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2) v Specific Memory B Cells at 13 Months of Age (Group 3)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[218]

P-value

= 0.34 ^[219]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

-0.25

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[218] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[219] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 17

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[220]

Method

Parameter type

R-square

Point estimate

0.06

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[220] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 18

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2) v Specific Memory B Cells at 13 Months of Age (Group 3)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[221]

Method

Parameter type

R-square

Point estimate

0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[221] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 19

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[222]

Method

Parameter type

R-square

Point estimate

0.13

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[222] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 20

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2) v Specific Memory B Cells at 13 Months of Age (Group 3)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[223]

Method

Parameter type

R-square

Point estimate

0.05

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[223] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 21

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[224]

Method

Parameter type

R-square

Point estimate

0.19

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[224] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 22

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2) v Specific Memory B Cells at 13 Months of Age (Group 3)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[225]

Method

Parameter type

R-square

Point estimate

0.03

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[225] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 23

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[226]

Method

Parameter type

R-square

Point estimate

0.6

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[226] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 24

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2) v Specific Memory B Cells at 13 Months of Age (Group 3)

Number of subjects included in analysis

151

Analysis specification

Pre-specified

Analysis type

other ^[227]

Method

Parameter type

R-square

Point estimate

0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[227] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis. Specific number of subjects for serogroup Y is 121.

Statistical Analysis 25

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[228]

P-value

= 0.0008

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.83

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[228] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 26

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[229]

P-value

= 0.57 ^[230]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.14

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[229] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[230] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 27

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[231]

P-value

= 0.001

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.65

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[231] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 28

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[232]

P-value

= 0.11 ^[233]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.31

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[232] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[233] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 29

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[234]

P-value

= 0.94

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.02

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[234] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 30

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[235]

P-value

= 1 ^[236]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.0003

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[235] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[236] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 31

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[237]

P-value

= 1

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.004

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[237] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 32

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[238]

P-value

= 0.37 ^[239]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[238] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[239] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 33

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[240]

P-value

= 0.09

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.52

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[240] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 34

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[241]

P-value

= 0.4 ^[242]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.21

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[241] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[242] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 35

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[243]

P-value

= 0.2

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.28

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[243] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 36

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[244]

P-value

= 0.03 ^[245]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.41

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[244] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[245] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 37

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[246]

P-value

= 0.07

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.48

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[246] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 38

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[247]

P-value

= 0.3 ^[248]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.22

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[247] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[248] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 39

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[249]

P-value

= 0.74

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.26

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[249] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 40

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[250]

P-value

= 0.25 ^[251]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

-0.38

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[250] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[251] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 41

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[252]

Method

Parameter type

R-square

Point estimate

0.69

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[252] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 42

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[253]

Method

Parameter type

R-square

Point estimate

0.02

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[253] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 43

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[254]

Method

Parameter type

R-square

Point estimate

0.42

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[254] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 44

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[255]

Method

Parameter type

R-square

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[255] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 45

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[256]

Method

Parameter type

R-square

Point estimate

0.0004

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[256] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 46

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[257]

Method

Parameter type

R-square

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[257] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 47

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 13 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[258]

Method

Parameter type

R-square

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[258] - Regression, Linea Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 48

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 13 Months of Age (Group 2) v Human SBA GMTs at 13 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[259]

Method

Parameter type

R-square

Point estimate

0.09

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[259] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 49

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[260]

P-value

= 0.86

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.04

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[260] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 50

Statistical analysis description

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[261]

P-value

= 0.7 ^[262]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.08

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[261] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[262] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 51

Statistical analysis description

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[263]

P-value

= 0.58

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.11

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[263] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 52

Statistical analysis description

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[264]

P-value

= 0.44 ^[265]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.13

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[264] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[265] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 53

Statistical analysis description

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[266]

P-value

= 0.75

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.07

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[266] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 54

Statistical analysis description

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[267]

P-value

= 0.84 ^[268]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.04

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[267] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[268] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 55

Statistical analysis description

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[269]

P-value

= 0.67

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.11

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[269] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 56

Statistical analysis description

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[270]

P-value

= 0.99 ^[271]

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.002

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[270] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[271] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 57

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[272]

P-value

= 0.62

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.11

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[272] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 58

Statistical analysis description

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[273]

P-value

= 0.36 ^[274]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.17

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[273] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[274] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 59

Statistical analysis description

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[275]

P-value

= 0.99

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

-0.003

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[275] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 60

Statistical analysis description

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[276]

P-value

= 0.24 ^[277]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

-0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[276] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[277] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 61

Statistical analysis description

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[278]

P-value

= 0.62

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.11

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[278] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 62

Statistical analysis description

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[279]

P-value

= 0.69 ^[280]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.08

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[279] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[280] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 63

Statistical analysis description

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[281]

P-value

= 0.6

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

-0.13

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[281] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 64

Statistical analysis description

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[282]

P-value

= 0.95 ^[283]

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

-0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[282] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.
[283] - Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 65

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[284]

Method

Parameter type

R-square

Point estimate

0.0015

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[284] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 66

Statistical analysis description

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[285]

Method

Parameter type

R-square

Point estimate

0.0057

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[285] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 67

Statistical analysis description

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[286]

Method

Parameter type

R-square

Point estimate

0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[286] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 68

Statistical analysis description

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[287]

Method

Parameter type

R-square

Point estimate

0.02

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[287] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 69

Statistical analysis description

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[288]

Method

Parameter type

R-square

Point estimate

0.0048

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[288] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 70

Statistical analysis description

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[289]

Method

Parameter type

R-square

Point estimate

0.0018

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[289] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 71

Statistical analysis description

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

other ^[290]

Method

Parameter type

R-square

Point estimate

0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[290] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 72

Statistical analysis description

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[291]

Method

Parameter type

R-square

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[291] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Secondary: 5. Correlation and Linear Regression Coefficients Between Memory B Cells 1 Month After Primary Vaccination and Serogroup A, C, W-135 and Y Specific Plasma Cells and Memory B Cells and IgG Concentration and hSBA Titers 1 Week After MenACWY-CRM Booster

Top of page

End point title

5. Correlation and Linear Regression Coefficients Between Memory B Cells 1 Month After Primary Vaccination and Serogroup A, C, W-135 and Y Specific Plasma Cells and Memory B Cells and IgG Concentration and hSBA Titers 1 Week After MenACWY-CRM Booster ^[292]

End point description

Memory B cell response at 1 month after primary vaccination and at 1 week after booster vaccination was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC. Plasma B cell response at 1 week after vaccination was measured as the mean number of cells secreting antibodies specific for meningococcal serogroup A, C, W-135 and Y, measured by ELISpot assay, per 2x100000 PBMC. Serogroup A, C, W-135 and Y specific IgG were measured by ELISA and reported as μg/mL and hSBA titers (GMTs) were measured at 1 week after booster vaccination. This outcome was assessed in Group 3 subjects only as they provided a blood draw at 1 week following the MenACWY-CRM booster vaccination. Analysis was performed on PP booster population. Note: Specific IgG GMCs and hSBA GMTs dispersion was reported as confidence intervals (see table notes)

End point type

Secondary

End point timeframe

One month after primary and 1 week after booster

Notes
[292] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: statistical analyses not applicable for this endpoint.

End point values	MenACWY-CRM and Routine Vaccines (Group 3)	Plasma cells at 7 Days after booster vacc. (Group 3)	Specific IgG GMC 7 Days after booster vacc. (Group 3)	Specific Memory B cells at 7 days after booster vacc (Group 3)	Human SBA GMTs at 7 days after booster vacc. (Group 3)
Number of subjects analysed	43 ^[293]	41 ^[294]	32 ^[295]	7 ^[296]	43 ^[297]
Units: Mean of memory B cells
arithmetic mean (standard deviation)
Serogroup A	1.72 ( 1.89 )	15.511 ( 22.96 )	9.28 ( 0 )	19.85 ( 9.12 )	97 ( 0 )
Serogroup C	2.43 ( 2.32 )	7.373 ( 9.002 )	4.16 ( 0 )	39.41 ( 43.16 )	657 ( 0 )
Serogroup W-135	1.57 ( 1.47 )	10.894 ( 13.229 )	7.3 ( 0 )	71.88 ( 67.59 )	1063 ( 0 )
Serogroup Y	1.78 ( 1.67 )	13.626 ( 19.535 )	11 ( 0 )	85.46 ( 86.23 )	435 ( 0 )

Notes
[293] - N= Serogroup A=30, C=43, W-135=40, Y=30
[294] - N= Serogroup A=40, C=41, W-135=41, Y=41
[295] - N= Serogroup A=32, C=31, W-135=31, Y=31; 95%CI= A=6.49-13, C=2.9-5.96,W-135=4.86-11,Y=7.27-16
[296] - N= Serogroup A=2, C=7, W-135=5, Y=5
[297] - N= Serogroup A=43, C=41, W-135=31, Y=16; 95%CI= A=67-139, C=466-927,W-135=628-1802,Y=199-954

Statistical Analysis 1

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Plasma cells at 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[298]

P-value

= 0.68

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.14

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[298] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 2

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Plasma cells at 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[299]

P-value

= 0.09

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.44

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[299] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 3

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Plasma cells at 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[300]

P-value

= 0.69

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.11

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[300] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 4

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Plasma cells at 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[301]

P-value

= 0.2

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.38

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[301] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 5

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Plasma cells at 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[302]

P-value

= 0.88

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

-0.05

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[302] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 6

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Plasma cells at 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[303]

P-value

= 0.12

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.41

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[303] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 7

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Plasma cells at 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[304]

P-value

= 0.37

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.25

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[304] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 8

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Plasma cells at 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[305]

P-value

= 0.36

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.28

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[305] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 9

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Plasma cells at 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[306]

Method

Parameter type

R-square

Point estimate

0.02

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[306] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 10

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Plasma cells at 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[307]

Method

Parameter type

R-square

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[307] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 11

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Plasma cells at 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[308]

Method

Parameter type

R-square

Point estimate

0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[308] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 12

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Plasma cells at 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[309]

Method

Parameter type

R-square

Point estimate

0.15

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[309] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 13

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B cells at 7 days after booster vacc (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[310]

Method

Parameter type

Pearson correlation coefficient

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[310] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 14

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B cells at 7 days after booster vacc (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[311]

Method

Parameter type

Spearman correlation coefficient

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[311] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 15

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B cells at 7 days after booster vacc (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[312]

Method

Parameter type

R-square

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[312] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 16

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B cells at 7 days after booster vacc (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[313]

Method

Parameter type

R-square

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[313] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 17

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B cells at 7 days after booster vacc (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[314]

Method

Parameter type

R-square

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[314] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 18

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 7 days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[315]

P-value

= 0.79

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.08

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[315] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 19

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 7 days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[316]

P-value

= 0.16

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.35

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[316] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 20

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 7 days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[317]

P-value

= 0.1

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.48

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[317] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 21

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 7 days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[318]

P-value

= 0.0033

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.98

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[318] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 22

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 7 days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[319]

P-value

= 0.91

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

-0.03

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[319] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 23

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 7 days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[320]

P-value

= 0.01

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.57

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[320] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 24

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 7 days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[321]

P-value

= 0.19

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.39

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[321] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 25

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 7 days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[322]

P-value

= 0.04

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.89

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[322] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 26

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 7 days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[323]

Method

Parameter type

R-square

Point estimate

0.006

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[323] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 27

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 7 days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[324]

Method

Parameter type

R-square

Point estimate

0.12

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[324] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 28

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 7 days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[325]

Method

Parameter type

R-square

Point estimate

0.23

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[325] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 29

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 7 days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[326]

Method

Parameter type

R-square

Point estimate

0.96

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[326] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 30

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Specific IgG GMC 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[327]

P-value

= 0.46

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.18

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[327] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 31

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Specific IgG GMC 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[328]

P-value

= 0.9

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.03

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[328] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 32

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Specific IgG GMC 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[329]

P-value

= 0.00844

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.51

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[329] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 33

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Specific IgG GMC 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[330]

P-value

= 0.08

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.42

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[330] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 34

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Specific IgG GMC 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[331]

P-value

= 0.52

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.15

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[331] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 35

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Specific IgG GMC 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[332]

P-value

= 0.18

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.27

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[332] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 36

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Specific IgG GMC 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[333]

P-value

= 0.07

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.37

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[333] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 37

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Specific IgG GMC 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[334]

P-value

= 0.55

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.14

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[334] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 38

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Specific IgG GMC 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[335]

Method

Parameter type

R-square

Point estimate

0.03

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[335] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 39

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Specific IgG GMC 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[336]

Method

Parameter type

R-square

Point estimate

0.0007

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[336] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 40

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Specific IgG GMC 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[337]

Method

Parameter type

R-square

Point estimate

0.27

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[337] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 41

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 3) v Specific IgG GMC 7 Days after booster vacc. (Group 3)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[338]

Method

Parameter type

R-square

Point estimate

0.17

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[338] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Secondary: 6. Correlation and Linear Regression Coefficients Between CRM197 Specific Memory B Cells 1 Month After Primary Vaccination and CRM197 Specific Memory B Cells and IgG Concentration at 12 Months of Age and One Month After MenACWYCRM Booster Vaccination

Top of page

End point title

6. Correlation and Linear Regression Coefficients Between CRM197 Specific Memory B Cells 1 Month After Primary Vaccination and CRM197 Specific Memory B Cells and IgG Concentration at 12 Months of Age and One Month After MenACWYCRM Booster Vaccination

End point description

CRM197 specific memory B cell response at each time point was measured as mean number of CRM197 specific memory B cells by ELISpot assay per 2x100000 LOC. CRM197 specific IgG concentration was measured by ELISA reported as μg/mL at 12 months of age and one month after MenACWY-CRM booster vaccination. Analysis was done on the PP primary population and PP booster population. Specific IgG GMCs dispersion was reported as confidence intervals (see table notes)

End point type

Secondary

End point timeframe

5 months (memory B cells), 12 months, and 13 months (memory B cells and IgG) of age

End point values	MenACWY-CRM and Routine Vaccines (Group 1)	MenACWY-CRM and Routine Vaccines (Group 2)	MenACWY-CRM and Routine Vaccines (Group 3)	Specific Memory B Cells at 12 Months of Age (Group 1)	Specific Memory B Cells at 12 Months of Age (Group 2)	Specific Memory B Cells at 12 Months of Age (Group 3)	Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)	Specific IgG Geometric Mean Conc at 12 Months of Age (Group 2)	Specific IgG Geometric Mean Conc at 12 Months of Age (Group 3)	Specific Memory B Cells at 13 Months of Age (Group 1)	Specific Memory B Cells at 13 Months of Age (Group 2)	Specific Memory B Cells at 13 Months of Age (Group 3)	Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)	Specific IgG Geometric Mean Conc at 13 Months of Age (Group 2)	Specific IgG Geometric Mean Conc at 13 Months of Age (Group 3)
Number of subjects analysed	71	30	43	75	35	38	85 ^[339]	37 ^[340]	40 ^[341]	73	37	40	81 ^[342]	39 ^[343]	46 ^[344]
Units: Mean of CRM197 Specific B cells
arithmetic mean (standard deviation)
CRM197	6.942 ( 8.379 )	4.317 ( 4.589 )	6.063 ( 7.244 )	11.252 ( 10.883 )	8.143 ( 8.81 )	10.112 ( 9.997 )	0.26 ( 0 )	0.23 ( 0 )	0.28 ( 0 )	25.64 ( 17.527 )	19.978 ( 12.454 )	22.953 ( 13.325 )	2.84 ( 0 )	2.81 ( 0 )	3.34 ( 0 )

Notes
[339] - 95%CI = 0.22-0.3
[340] - 95%CI =0.18-0.29
[341] - 95%CI = 0.22-0.35
[342] - 95%CI = 2.43-3.32
[343] - 95%CI = 2.24-3.52
[344] - 95%CI = 2.71-4.11

Statistical Analysis 1

Statistical analysis description

Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age

Comparison groups

Number of subjects included in analysis

292

Analysis specification

Pre-specified

Analysis type

other ^[345]

P-value

= 0.0006

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.45

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[345] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study. Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 2

Statistical analysis description

Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age

Comparison groups

Number of subjects included in analysis

292

Analysis specification

Pre-specified

Analysis type

other ^[346]

P-value

= 0.0021

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.41

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[346] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study. Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 3

Statistical analysis description

Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age

Comparison groups

Number of subjects included in analysis

292

Analysis specification

Pre-specified

Analysis type

other ^[347]

Method

Parameter type

R-square

Point estimate

0.21

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[347] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 4

Statistical analysis description

Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells 1 month after booster vaccination

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[348]

P-value

= 0.53

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.15

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[348] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 5

Statistical analysis description

Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 2) v Specific Memory B Cells at 13 Months of Age (Group 3)

Number of subjects included in analysis

294

Analysis specification

Pre-specified

Analysis type

other ^[349]

P-value

= 0.26

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.21

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[349] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study. Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 6

Statistical analysis description

Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[350]

P-value

= 0.84

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

-0.05

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[350] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 7

Statistical analysis description

Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2) v Specific Memory B Cells at 13 Months of Age (Group 3)

Number of subjects included in analysis

150

Analysis specification

Pre-specified

Analysis type

other ^[351]

P-value

= 0.26

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.22

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[351] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 8

Statistical analysis description

Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific Memory B Cells at 13 Months of Age (Group 1)

Number of subjects included in analysis

144

Analysis specification

Pre-specified

Analysis type

other ^[352]

Method

Parameter type

R-square

Point estimate

0.02

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[352] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 9

Statistical analysis description

Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific Memory B Cells at 13 Months of Age (Group 2) v Specific Memory B Cells at 13 Months of Age (Group 3)

Number of subjects included in analysis

150

Analysis specification

Pre-specified

Analysis type

other ^[353]

Method

Parameter type

R-square

Point estimate

0.05

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[353] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 10

Statistical analysis description

Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 2) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 3) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

other ^[354]

P-value

= 0.00012

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.33

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[354] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study. Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 11

Statistical analysis description

Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 2) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 3)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

other ^[355]

P-value

< 0.001

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.46

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[355] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study. Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 12

Statistical analysis description

Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 2) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 3)

Number of subjects included in analysis

306

Analysis specification

Pre-specified

Analysis type

other ^[356]

P-value

< 0.001

Method

Regression, Linear

Parameter type

R-square

Point estimate

0.11

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[356] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 1, 2 and 3 were combined for this analysis.

Statistical Analysis 13

Statistical analysis description

Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

152

Analysis specification

Pre-specified

Analysis type

other ^[357]

P-value

= 0.06

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.24

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[357] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 14

Statistical analysis description

Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination

Comparison groups

Number of subjects included in analysis

158

Analysis specification

Pre-specified

Analysis type

other ^[358]

P-value

< 0.001

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.5

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[358] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 15

Statistical analysis description

Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

152

Analysis specification

Pre-specified

Analysis type

other ^[359]

P-value

= 0.01

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.31

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[359] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 16

Statistical analysis description

Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination

Comparison groups

Number of subjects included in analysis

158

Analysis specification

Pre-specified

Analysis type

other ^[360]

P-value

= 0.1

Method

Non-parametric correlation

Parameter type

Spearman correlation coefficient

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[360] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 17

Statistical analysis description

Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 13 Months of Age (Group 1)

Number of subjects included in analysis

152

Analysis specification

Pre-specified

Analysis type

other ^[361]

Method

Parameter type

R-square

Point estimate

0.06

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[361] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 18

Statistical analysis description

Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination

Comparison groups

Number of subjects included in analysis

158

Analysis specification

Pre-specified

Analysis type

other ^[362]

Method

Parameter type

R-square

Point estimate

0.25

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[362] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Secondary: 7. Increase in Serogroup A, C, W-135 and Y Specific Memory B Cells Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone

Top of page

End point title

7. Increase in Serogroup A, C, W-135 and Y Specific Memory B Cells Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone

End point description

Memory B cell response before and one month after MenACWY-CRM booster vaccination at 12 months of age was measured as mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells by ELISpot assay per 2x10^5 LOC.

End point type

Secondary

End point timeframe

Before and one month after booster vaccination

End point values	MenACWY-CRM and Routine Vaccines (Group 1)	MenACWY-CRM and Routine Vaccines (Group 2)	MenACWY-CRM and Routine Vaccines (Group 3)
Number of subjects analysed	75	37	40
Units: Mean of memory B cells
arithmetic mean (standard deviation)
Serogroup A specific B cells (N=58,29,31) month 12	1.811 ( 1.935 )	1.988 ( 1.881 )	1.692 ( 1.398 )
Serogroup A specific B cells (N=54,26,33) month 13	6.429 ( 6.365 )	6.527 ( 5.957 )	7.488 ( 12.512 )
Serogroup C specific B cells (N=75,35,38) month 12	2.076 ( 1.926 )	1.983 ( 1.482 )	2.188 ( 2.004 )
Serogroup C specific B cells (N=73,37,40)month 13	9.437 ( 10.861 )	8.907 ( 9.791 )	8.915 ( 10.83 )
Serogroup W specific B cells (N=75,34,38) month 12	1.783 ( 2.189 )	1.793 ( 1.531 )	2.067 ( 2.716 )
Serogroup W specific B cells(N=73,37,39) month 13	6.205 ( 6.776 )	4.43 ( 5.939 )	5.201 ( 6.648 )
Serogroup Y specific B cells (N=67,33,34) month 12	2.172 ( 2.934 )	1.556 ( 0.898 )	1.749 ( 1.797 )
Serogroup Y specific B cells (N=64,32,34) month 13	6.95 ( 9.122 )	6.603 ( 8.198 )	5.746 ( 12.624 )

No statistical analyses for this end point

Secondary: 8. Increase in Serogroup A, C, W-135 and Y Specific IgG Concentrations Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone

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End point title

8. Increase in Serogroup A, C, W-135 and Y Specific IgG Concentrations Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone

End point description

Serogroup A, C, W-135 and Y specific IgG concentrations were measured before and one month after MenACWY-CRM booster vaccination by ELISA.

End point type

Secondary

End point timeframe

Before and one month after booster vaccination

End point values	MenACWY-CRM and Routine Vaccines (Group 1)	MenACWY-CRM and Routine Vaccines (Group 2)	MenACWY-CRM and Routine Vaccines (Group 3)
Number of subjects analysed	66	34	38
Units: μg/mL
geometric mean (confidence interval 95%)
Serogroup A specific IgG (N=49,23,47) before	0.37 (0.27 to 0.49)	0.33 (0.23 to 0.46)	0.31 (0.23 to 0.42)
Serogroup A specific IgG (N=66,34,38) after	4.59 (3.63 to 5.81)	3.5 (2.6 to 4.73)	5.18 (3.84 to 6.99)
Serogroup C specific IgG (N=55,25,26) before	0.19 (0.16 to 0.23)	0.18 (0.14 to 0.22)	0.2 (0.15 to 0.28)
Serogroup C specific IgG (N=59,33,37) after	1.83 (1.43 to 2.35)	1.67 (1.18 to 2.36)	2.63 (1.87 to 3.7)
Serogroup W specific IgG (N=55,21,26) before	0.31 (0.25 to 0.38)	0.35 (0.25 to 0.48)	0.29 (0.2 to 0.43)
Serogroup W specific IgG (N=56,32,32) after	5.97 (4.67 to 7.64)	5.37 (4.06 to 7.1)	5.12 (3.5 to 7.5)
Serogroup Y specific IgG (N=49,21,24) before	0.43 (0.34 to 0.55)	0.47 (0.33 to 0.67)	0.37 (0.25 to 0.55)
Serogroup Y specific IgG (N=56,31,33) after	6.2 (4.77 to 8.05)	5.58 (4.06 to 7.67)	5.75 (3.93 to 8.42)

No statistical analyses for this end point

Secondary: 9. Increase in Serogroup A, C, W-135 and Y hSBA Titers Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone

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End point title

9. Increase in Serogroup A, C, W-135 and Y hSBA Titers Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone

End point description

hSBA GMTs were measured before and one month after MenACWY-CRM booster vaccination at 12 months of age.

End point type

Secondary

End point timeframe

Before and one month after booster vaccination

End point values	MenACWY-CRM and Routine Vaccines (Group 1)	MenACWY-CRM and Routine Vaccines (Group 2)	MenACWY-CRM and Routine Vaccines (Group 3)
Number of subjects analysed	85	40	42
Units: Geometric mean of titers
geometric mean (confidence interval 95%)
Serogroup A - hSBA GMT - before	2.2 (2.05 to 2.36)	2 (2 to 2)	2.14 (1.93 to 2.37)
Serogroup A - hSBA GMT - after	65 (47 to 89)	48 (32 to 72)	67 (44 to 102)
Serogroup C - hSBA GMT (N=83,39,40) - before	5.56 (4.23 to 7.3)	4.83 (3.28 to 7.09)	5.61 (3.78 to 8.33)
Serogroup C - hSBA GMT (N=78,39,40)- after	315 (239 to 417)	217 (138 to 341)	308 (214 to 445)
Serogroup W - hSBA GMT (N=67,37,34)- before	8.4 (6.03 to 12)	12 (8.05 to 17)	10 (6.73 to 15)
Serogroup W - hSBA GMT (N=59,35,33)	889 (622 to 1271)	649 (419 to 1004)	602 (343 to 1057)
Serogroup Y - hSBA GMT (N=43,25,16)- before	8.71 (5.82 to 13)	9.9 (5.39 to 18)	9.15 (4.95 to 17)
Serogroup Y - hSBA GMT (N=32,20,15)- after	492 (305 to 793)	480 (269 to 857)	475 (220 to 1025)

No statistical analyses for this end point

Secondary: 10. Serogroups A, C, W-135 and Y Specific Memory B Cell Response in Children Lacking a hSBA Titer of ≥1:8 One Month After MenACWY-CRM Primary Vaccination

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End point title

10. Serogroups A, C, W-135 and Y Specific Memory B Cell Response in Children Lacking a hSBA Titer of ≥1:8 One Month After MenACWY-CRM Primary Vaccination

End point description

The memory B cell response in children lacking a hSBA titer ≥1:8 one month after MenACWY-CRM primary vaccination was calculated as the mean number of meningococcal serogroup specific memory B cells, measured by ELISpot assay per 2x100000 LOC. - Serogroup C specific memory B cells (N=6,2,1)/ Group 3: Analysis was done on one subject only - Serogroup W-135 specific memory B cells (N=3,0,1)/ Group 2: None of the subject had hSBA titer <1:8 - Serogroup W-135 specific memory B cells (N=3,0,1)/ Group 3: Analysis was done on one subject only - Serogroup Y specific memory B cells (N=0,1,1)/ Group 1: None of the subject had hSBA titer <1:8

End point type

Secondary

End point timeframe

One month after primary vaccination

End point values	MenACWY-CRM and Routine Vaccines (Group 1)	MenACWY-CRM and Routine Vaccines (Group 2)	MenACWY-CRM and Routine Vaccines (Group 3)
Number of subjects analysed	24	11	8
Units: Mean of memory B cells
arithmetic mean (standard deviation)
Serogroup A specific memory B cells (N=24,11,8)	1.533 ( 1.028 )	1.391 ( 0.467 )	1.25 ( 0 )
Serogroup C specific memory B cells (N=6,2,1)	2.667 ( 2.444 )	1.25 ( 0 )	1.25 ( 0 )
Serogroup W-135 specific memory B cells (N=3,0,1)	1.25 ( 0 )	0 ( 0 )	1.25 ( 0 )
Serogroup Y specific memory B cells (N=0,1,1)	0 ( 0 )	1.25 ( 0 )	1.25 ( 0 )

No statistical analyses for this end point

Secondary: 11. Kinetics of Serogroup A, C, W-135 and Y Specific Memory B Cells and Plasma B Cells After MenACWY-CRM Primary Vaccination

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End point title

11. Kinetics of Serogroup A, C, W-135 and Y Specific Memory B Cells and Plasma B Cells After MenACWY-CRM Primary Vaccination ^[363]

End point description

To assess the kinetics of serogroup A, C, W-135 and Y specific memory B cells and plasma B cells were measured on days 0, 7, 14, 49, 90, and 120 following vaccination with MenACWY-CRM vaccination at month 4 of the study

End point type

Secondary

End point timeframe

Day 0, 7, 14, 49, 90, and 120 after MenACWY-CRM vaccination at month 4

Notes
[363] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: statistical analyses not applicable for this endpoint.

End point values	MenACWY-CRM and Routine Vaccines (Group 1)
Number of subjects analysed	88
Units: Mean
arithmetic mean (standard deviation)
Serogroup A sp. memory B cell (N=4)- Day 0	1.25 ( 0 )
Serogroup A sp. memory B cell (N=14)- Day 7	3.889 ( 5.07 )
Serogroup A sp. memory B cell (N=7)- Day 14	2.343 ( 2.891 )
Serogroup A sp. memory B cell (N=10)- Day 49	1.97 ( 1.533 )
Serogroup A sp. memory B cell (N=9)- Day 90	1.25 ( 0 )
Serogroup A sp. memory B cell (N=11)- Day 120	1.845 ( 1.14 )
Serogroup C sp. memory B cell (N=6)- Day 0	1.558 ( 0.775 )
Serogroup C sp. memory B cell (N=16)- Day 7	2.856 ( 2.974 )
Serogroup C sp. memory B cell (N=12)- Day 14	5.183 ( 5.723 )
Serogroup C sp. memory B cell (N=13)- Day 49	2.323 ( 2.044 )
Serogroup C sp. memory B cell (N=16)- Day 90	2.469 ( 1.865 )
Serogroup C sp. memory B cell (N=14)- Day 120	1.561 ( 1.163 )
Serogroup W-135 sp. memory B cell (N=4)- Day 0	1.25 ( 0 )
Serogroup W-135 sp. memory B cell (N=15)- Day 7	3.737 ( 6.68 )
Serogroup W-135 sp. memory B cell (N=12)- Day 14	2.754 ( 2.245 )
Serogroup W-135 sp. memory B cell (N=13)- Day 49	2.735 ( 2.4 )
Serogroup W-135 sp. memory B cell (N=14)- Day 90	1.404 ( 0.575 )
Serogroup W-135 sp. memory B cell (N=14)- Day 120	1.25 ( 0 )
Serogroup Y sp. memory B cell (N=3)- Day 0	1.25 ( 0 )
Serogroup Y sp. memory B cell (N=15)- Day 7	4.847 ( 9.043 )
Serogroup Y sp. memory B cell (N=7)- Day 14	1.471 ( 0.586 )
Serogroup Y sp. memory B cell (N=11)- Day 49	1.482 ( 0.769 )
Serogroup Y sp. memory B cell (N=12)- Day 90	1.567 ( 0.74 )
Serogroup Y sp. memory B cell (N=13)- Day 120	1.527 ( 0.684 )
Serogroup A sp. plasma B cell (N=3)- Day 0	1.25 ( 0 )
Serogroup A sp. plasma B cell (N=1)- Day 7	1.25 ( 0 )
Serogroup A sp. plasma B cell (N=1)- Day 14	1.25 ( 0 )
Serogroup A sp. plasma B cell (N=2)- Day 49	1.25 ( 0 )
Serogroup A sp. plasma B cell (N=2)- Day 90	1.25 ( 0 )
Serogroup A sp. plasma B cell (N=2)- Day 120	1.25 ( 0 )
Serogroup C sp. plasma B cell (N=3)- Day 0	1.25 ( 0 )
Serogroup C sp. plasma B cell (N=2)- Day 7	2.025 ( 1.096 )
Serogroup C sp. plasma B cell (N=1)- Day 14	1.25 ( 0 )
Serogroup C sp. plasma B cell (N=2)- Day 49	1.25 ( 0 )
Serogroup C sp. plasma B cell (N=2)- Day 90	1.25 ( 0 )
Serogroup C sp. plasma B cell (N=3)- Day 120	1.25 ( 0 )
Serogroup W-135 sp. plasma B cell (N=3)- Day 0	1.25 ( 0 )
Serogroup W-135 sp. plasma B cell (N=1)- Day 7	1.25 ( 0 )
Serogroup W-135 sp. plasma B cell (N=1)- Day 14	1.25 ( 0 )
Serogroup W-135 sp. plasma B cell (N=2)- Day 49	1.25 ( 0 )
Serogroup W-135 sp. plasma B cell (N=2)- Day 90	1.25 ( 0 )
Serogroup W-135 sp. plasma B cell (N=3)- Day 120	1.25 ( 0 )
Serogroup Y sp. plasma B cell (N=3)- Day 0	1.25 ( 0 )
Serogroup Y sp. plasma B cell (N=1)- Day 7	1.25 ( 0 )
Serogroup Y sp. plasma B cell (N=1)- Day 14	1.25 ( 0 )
Serogroup Y sp. plasma B cell (N=2)- Day 49	1.25 ( 0 )
Serogroup Y sp. plasma B cell (N=2)- Day 90	1.25 ( 0 )
Serogroup Y sp. plasma B cell (N=2)- Day 120	1.25 ( 0 )

No statistical analyses for this end point

Secondary: 12. Kinetics of Serogroup A, C, W-135 and Y Specific IgG Concentrations After MenACWY-CRM Primary Vaccination

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End point title

12. Kinetics of Serogroup A, C, W-135 and Y Specific IgG Concentrations After MenACWY-CRM Primary Vaccination ^[364]

End point description

To assess the kinetics of serogroup A, C, W-135 and Y specific IgG concentrations, the geometric means was measured on day 0, 7, 14, 30, 49, 90, and 120 following vaccination with MenACWY-CRM vaccination at month 4 of the study. Note: Confidence Interval was not calculated for Serogroup A specific IgG (N=1)- Day 120 because only one subject was analyzed.

End point type

Secondary

End point timeframe

Day 0, 7, 14, 30, 49, 90,120 after MenACWY-CRM vaccination at month 4

Notes
[364] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: statistical analyses not applicable for this endpoint.

End point values	MenACWY-CRM and Routine Vaccines (Group 1)
Number of subjects analysed	60
Units: Geometric mean of Concentrations
geometric mean (confidence interval 95%)
Serogroup A specific IgG (N=3)- Day 0	0.98 (0.0094 to 101)
Serogroup A specific IgG (N=9)- Day 7	2.23 (1.02 to 4.87)
Serogroup A specific IgG (N=7)- Day 14	2.27 (0.75 to 6.9)
Serogroup A specific IgG (N=45)- Day 30	1.29 (1.01 to 1.65)
Serogroup A specific IgG (N=5)- Day 49	1.39 (0.47 to 4.14)
Serogroup A specific IgG (N=5)- Day 90	0.94 (0.62 to 1.43)
Serogroup A specific IgG (N=1)- Day 120	1.03 (-9999 to 9999)
Serogroup C specific IgG (N=4)- Day 0	0.92 (0.19 to 4.35)
Serogroup C specific IgG (N=14)- Day 7	1.4 (0.85 to 2.28)
Serogroup C specific IgG (N=8)- Day 14	1.43 (0.76 to 2.7)
Serogroup C specific IgG (N=60)- Day 30	0.94 (0.77 to 1.14)
Serogroup C specific IgG (N=5)- Day 49	1.02 (0.28 to 3.69)
Serogroup C specific IgG (N=7)- Day 90	0.75 (0.46 to 1.23)
Serogroup C specific IgG (N=5)- Day 120	0.85 (0.26 to 2.75)
Serogroup W-135 specific IgG (N=3)- Day 0	0.43 (0.0096 to 19)
Serogroup W-135 specific IgG (N=10)- Day 7	3.75 (1.76 to 8)
Serogroup W-135 specific IgG (N=8)- Day 14	3.77 (1.82 to 7.84)
Serogroup W-135 specific IgG (N=39)- Day 30	1.53 (1.14 to 2.05)
Serogroup W-135 specific IgG (N=6)- Day 49	2.58 (0.83 to 8.05)
Serogroup W-135 specific IgG (N=9)- Day 90	0.81 (0.59 to 1.13)
Serogroup W-135 specific IgG (N=2)- Day 120	0.57 (0.0011 to 305)
Serogroup Y specific IgG (N=3)- Day 0	0.82 (0.039 to 18)
Serogroup Y specific IgG (N=4)- Day 7	1.46 (0.24 to 8.99)
Serogroup Y specific IgG (N=3)- Day 14	5.04 (0.58 to 44)
Serogroup Y specific IgG (N=33)- Day 30	1.34 (1.01 to 1.79)
Serogroup Y specific IgG (N=3)- Day 49	2.47 (0.24 to 26)
Serogroup Y specific IgG (N=2)- Day 90	0.57 (0.039 to 8.17)

No statistical analyses for this end point

Secondary: 13. Kinetics of Serogroup A, C, W-135 and Y hSBA Titers After MenACWY-CRM Primary Vaccination

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End point title

13. Kinetics of Serogroup A, C, W-135 and Y hSBA Titers After MenACWY-CRM Primary Vaccination ^[365]

End point description

To assess the kinetics of serogroup A, C, W-135 and Y hSBA titers, the geometric means was measured on day 0, 7, 14, 30, 49, 90, and 120 following vaccination with MenACWY-CRM vaccination at month 4 of the study. Note: Confidence Interval was not calculated for Serogroup Y - hSBA GMTs (N=1)- Day 0 because only one subject was analyzed.

End point type

Secondary

End point timeframe

Day 0, 7, 14, 30, 49, 90,120 after MenACWY-CRM vaccination at month 4

Notes
[365] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: statistical analyses not applicable for this endpoint.

End point values	MenACWY-CRM and Routine Vaccines (Group 1)
Number of subjects analysed	61
Units: Geometric mean of titers
geometric mean (confidence interval 95%)
Serogroup A - hSBA GMTs (N=7)- Day 0	2 (2 to 2)
Serogroup A - hSBA GMTs (N=18)- Day 7	13 (7.15 to 25)
Serogroup A - hSBA GMTs (N=16)- Day 14	26 (10 to 63)
Serogroup A - hSBA GMTs - Day 30	9.79 (7.22 to 13)
Serogroup A - hSBA GMTs (N=16)- Day 49	9.53 (4.49 to 20)
Serogroup A - hSBA GMTs (N=18)- Day 90	2.63 (1.77 to 3.91)
Serogroup A - hSBA GMTs (N=16) Day 120	4.45 (2.25 to 8.83)
Serogroup C - hSBA GMTs (N=5)- Day 0	7.19 (1.33 to 39)
Serogroup C - hSBA GMTs (N=16)- Day 7	138 (43 to 439)
Serogroup C - hSBA GMTs (N=12)- Day 14	180 (55 to 596)
Serogroup C - hSBA GMTs (N=31)- Day 30	105 (73 to 151)
Serogroup C - hSBA GMTs (N=16)- Day 49	104 (50 to 219)
Serogroup C - hSBA GMTs (N=18)- Day 90	31 (18 to 53)
Serogroup C - hSBA GMTs (N=16)- Day 120	15 (6.5 to 36)
Serogroup W-135 - hSBA GMTs (N=5)- Day 0	4.43 (1.48 to 13)
Serogroup W-135 - hSBA GMTs (N=12)- Day 7	99 (42 to 232)
Serogroup W-135 - hSBA GMTs (N=9)- Day 14	144 (42 to 497)
Serogroup W-135 - hSBA GMTs (N=61)- Day 30	60 (44 to 83)
Serogroup W-135 - hSBA GMTs (N=11)- Day 49	35 (18 to 69)
Serogroup W-135 - hSBA GMTs (N=15)- Day 90	20 (11 to 35)
Serogroup W-135 - hSBA GMTs (N=4)- Day 120	12 (7.58 to 20)
Serogroup Y - hSBA GMTs (N=1)- Day 0	2 (-9999 to 9999)
Serogroup Y - hSBA GMTs (N=8)- Day 7	32 (8.06 to 123)
Serogroup Y - hSBA GMTs (N=4)- Day 14	95 (8 to 1131)
Serogroup Y - hSBA GMTs (N=20)- Day 30	24 (16 to 38)
Serogroup Y - hSBA GMTs (N=8)- Day 49	33 (11 to 101)
Serogroup Y - hSBA GMTs (N=9)- Day 90	12 (4.62 to 29)
Serogroup Y - hSBA GMTs (N=8)- Day 120	8.15 (3.77 to 18)

No statistical analyses for this end point

Secondary: 14. Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135 and Y Specific Memory B Cells 1 Month After MenACWY-CRM Primary Vaccination and IgG Concentration at Day 1 in the Serum of Mothers of Infants

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End point title

14. Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135 and Y Specific Memory B Cells 1 Month After MenACWY-CRM Primary Vaccination and IgG Concentration at Day 1 in the Serum of Mothers of Infants

End point description

The serogroup A, C, W-135 and Y specific IgG concentrations were measured in the serum of mothers at the time of their enrollment into the study (Day 1) by ELISA and reported as μg/mL. Analysis was done on the PP primary population and PP booster population. Specific IgG GMCs dispersion was reported as confidence intervals (see table notes)

End point type

Secondary

End point timeframe

Day 1 (IgG) and one month after primary vaccination (B cells)

End point values	MenACWY-CRM and Routine Vaccines (Group 1)	MenACWY-CRM and Routine Vaccines (Group 2)	MenACWY-CRM and Routine Vaccines (Group 3)	Specific IgG Geometric Mean Conc at Day 1 in mothers (Group 1)	Specific IgG Geometric Mean Conc at Day 1 in mothers (Group 2)	Specific IgG Geometric Mean Conc at Day 1 in mothers (Group 3)
Number of subjects analysed	71 ^[366]	31 ^[367]	43 ^[368]	101 ^[369]	41 ^[370]	52 ^[371]
Units: Mean of memory B cells
arithmetic mean (standard deviation)
Serogroup A	2.1 ( 2.03 )	1.8 ( 1.27 )	1.72 ( 1.89 )	4.14 ( 0 )	6.11 ( 0 )	3.28 ( 0 )
Serogroup C	2.57 ( 2.73 )	1.71 ( 1.12 )	2.43 ( 2.32 )	0.54 ( 0 )	1.59 ( 0 )	0.61 ( 0 )
Serogroup W-135	2.39 ( 4.69 )	1.5 ( 0.72 )	1.57 ( 1.47 )	0.48 ( 0 )	0.75 ( 0 )	0.62 ( 0 )
Serogroup Y	2.91 ( 8.36 )	1.43 ( 0.71 )	1.78 ( 1.67 )	0.64 ( 0 )	0.96 ( 0 )	0.69 ( 0 )

Notes
[366] - N= Serogroup A=50, C=71, W-135=62, Y=54
[367] - N= Serogroup A=25, C=31, W-135=26, Y=25
[368] - N= Serogroup A=30, C=43, W-135=40, Y=30
[369] - N= Serogroup A,C,Y =101, W-135=98; 95%CI= A=3.18-5.4, C=0.38-0.75,W-135=0.37-0.61,Y=0.48-0.84
[370] - 95%CI= A=4.03-9.27, C=0.94-2.7,W-135=0.5-1.11,Y=0.62-1.49
[371] - N= Serogroup A,C,Y=52, W-135=51; 95%CI= A=2.27-4.75, C=0.38-0.98, W-135=0.43-0.88,Y=0.47-1.02

Statistical Analysis 1

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific IgG Geometric Mean Conc at Day 1 in mothers (Group 1) v Specific IgG Geometric Mean Conc at Day 1 in mothers (Group 2) v Specific IgG Geometric Mean Conc at Day 1 in mothers (Group 3)

Number of subjects included in analysis

339

Analysis specification

Pre-specified

Analysis type

other ^[372]

P-value

= 0.7

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

0.04

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[372] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 2

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C

Comparison groups

Number of subjects included in analysis

339

Analysis specification

Pre-specified

Analysis type

other ^[373]

P-value

= 0.63

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.04

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[373] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 3

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135

Comparison groups

Number of subjects included in analysis

339

Analysis specification

Pre-specified

Analysis type

other ^[374]

P-value

= 0.74

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.03

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[374] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 4

Statistical analysis description

Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y

Comparison groups

Number of subjects included in analysis

339

Analysis specification

Pre-specified

Analysis type

other ^[375]

P-value

= 0.74

Method

Parametric correlation

Parameter type

Pearson correlation coefficient

Point estimate

-0.03

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[375] - Parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 5

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A

Comparison groups

Number of subjects included in analysis

339

Analysis specification

Pre-specified

Analysis type

other ^[376]

P-value

= 0.05

Method

Non-parametric correlation]

Parameter type

Spearman correlation coefficient

Point estimate

0.18

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[376] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 6

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C

Comparison groups

Number of subjects included in analysis

339

Analysis specification

Pre-specified

Analysis type

other ^[377]

P-value

= 0.36

Method

Non-parametric correlation]

Parameter type

Spearman correlation coefficient

Point estimate

-0.07

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[377] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 7

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135

Comparison groups

Number of subjects included in analysis

339

Analysis specification

Pre-specified

Analysis type

other ^[378]

P-value

= 0.18

Method

Non-parametric correlation]

Parameter type

Spearman correlation coefficient

Point estimate

-0.11

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[378] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 8

Statistical analysis description

Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y

Comparison groups

Number of subjects included in analysis

339

Analysis specification

Pre-specified

Analysis type

other ^[379]

P-value

= 0.82

Method

Non-parametric correlation]

Parameter type

Spearman correlation coefficient

Point estimate

0.02

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[379] - Non-parametric correlation Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 9

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A

Comparison groups

Number of subjects included in analysis

339

Analysis specification

Pre-specified

Analysis type

other ^[380]

Method

Parameter type

R-square

Point estimate

0.0013

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[380] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 10

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C

Comparison groups

Number of subjects included in analysis

339

Analysis specification

Pre-specified

Analysis type

other ^[381]

Method

Parameter type

R-square

Point estimate

0.0014

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[381] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 11

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135

Comparison groups

Number of subjects included in analysis

339

Analysis specification

Pre-specified

Analysis type

other ^[382]

Method

Parameter type

R-square

Point estimate

0.0008

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[382] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 12

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y

Comparison groups

Number of subjects included in analysis

339

Analysis specification

Pre-specified

Analysis type

other ^[383]

Method

Parameter type

R-square

Point estimate

0.0009

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[383] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Secondary: 15. Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and hSBA Titers at 12 Months, (2) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and IgG at 12 Months, After a 2-Dose Primary Course of MenACWY-CRM

Top of page

End point title

15. Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and hSBA Titers at 12 Months, (2) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and IgG at 12 Months, After a 2-Dose Primary Course of MenACWY-CRM

End point description

Linear regression analysis between memory B cells at 5 months of age and hSBA titers and IgG at 12 months of age was performed with and without inclusion of demographic factors (subject's household smoking status, number of older children living in subject's household, attendance at daycare and total duration of breast feeding) in the model. Analysis was performed on the PP dataset of persistence population. Note: Specific IgG GMCs and hSBA GMTs dispersion was reported as confidence intervals (see table notes)

End point type

Secondary

End point timeframe

1 month post primary vaccination (B cells) and 12 months (hSBA titers and IgG)

End point values	MenACWY-CRM and Routine Vaccines (Group 1)	MenACWY-CRM and Routine Vaccines (Group 2)	MenACWY-CRM and Routine Vaccines (Group 3)	Human SBA GMTs at 12 Months of Age (Group 1)	Human SBA GMTs at 12 Months of Age (Group 2)	Human SBA GMTs at 12 Months of Age (Group 3)	Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)	Specific IgG Geometric Mean Conc at 12 Months of Age (Group 2)	Specific IgG Geometric Mean Conc at 12 Months of Age (Group 3)
Number of subjects analysed	71 ^[384]	31 ^[385]	43 ^[386]	85 ^[387]	40 ^[388]	42 ^[389]	55 ^[390]	25 ^[391]	26 ^[392]
Units: Mean of memory B cells
arithmetic mean (standard deviation)
Serogroup A	2.1 ( 2.03 )	1.8 ( 1.27 )	1.72 ( 1.89 )	2.2 ( 0 )	2 ( 0 )	2.14 ( 0 )	0.37 ( 0 )	0.33 ( 0 )	0.31 ( 0 )
Serogroup C	2.57 ( 2.73 )	1.71 ( 1.12 )	2.43 ( 2.32 )	5.56 ( 0 )	4.83 ( 0 )	5.61 ( 0 )	0.19 ( 0 )	0.18 ( 0 )	0.2 ( 0 )
Serogroup W-135	2.39 ( 4.69 )	1.5 ( 0.721 )	1.57 ( 1.47 )	8.4 ( 0 )	12 ( 0 )	10 ( 0 )	0.31 ( 0 )	0.35 ( 0 )	0.29 ( 0 )
Serogroup Y	2.91 ( 8.36 )	1.43 ( 0.71 )	1.78 ( 1.67 )	8.71 ( 0 )	9.9 ( 0 )	9.15 ( 0 )	0.43 ( 0 )	0.47 ( 0 )	0.37 ( 0 )

Notes
[384] - N= Serogroup A=50, C=71, W-135=62, Y=54
[385] - N= Serogroup A=25, C=31, W-135=26, Y=25
[386] - N= Serogroup A=30, C=43, W-135=40, Y=30
[387] - N= Serogroup A=85, C=83, W-135=67, Y=43; 95%CI= A=2.05-2.36, C=4.23-7.3,W-135=6.03-12,Y=5.82-13
[388] - N= Serogroup A=40, C=39, W-135=37, Y=25; 95%CI= A=2-2, C=3.28-7.09, W-135=8.05-17, Y=5.39-18
[389] - N= Serogroup A=42, C=40, W-135=34, Y=16; 95%CI= A=1.93-2.37, C=3.78-8.33, W-135=6.73-15, Y=4.95-17
[390] - N= Serogroup A=49, C=55, W-135=55, Y=49; 95%CI= A=0.27-0.49, C=0.16-0.23,W-135=0.25-0.38,Y=0.34-0.55
[391] - N= Serogroup A=23, C=25, W-135=21, Y=21; 95%CI= A=0.23-0.46, C=0.14-0.22,W-135=0.25-0.48,Y=0.33-0.67
[392] - N= Serogroup A=24, C=26, W-135=26, Y=24; 95%CI= A=0.23-0.42, C=0.15-0.28,W-135=0.2-0.43,Y=0.25-0.55

Statistical Analysis 1

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 12 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[393]

Method

Parameter type

R-square

Point estimate

0.34

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[393] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 2

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 12 Months of Age (Group 2) v Human SBA GMTs at 12 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[394]

Method

Parameter type

R-square

Point estimate

0.14

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[394] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 3

Statistical analysis description

Linear regression coefficient between demographic factors, memory B cells at 5 months of age and hSBA titers at 12 months of age after a 2, 4-month course of MenACWY-CRM vaccination for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 12 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[395]

Method

Parameter type

R-square

Point estimate

0.09

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[395] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 4

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 12 Months of Age (Group 2) v Human SBA GMTs at 12 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[396]

Method

Parameter type

R-square

Point estimate

0.16

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[396] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 5

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 12 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[397]

Method

Parameter type

R-square

Point estimate

0.22

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[397] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 6

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 12 Months of Age (Group 2) v Human SBA GMTs at 12 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[398]

Method

Parameter type

R-square

Point estimate

0.33

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[398] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 7

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 12 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[399]

Method

Parameter type

R-square

Point estimate

0.74

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[399] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 8

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 12 Months of Age (Group 2) v Human SBA GMTs at 12 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[400]

Method

Parameter type

R-square

Point estimate

0.53

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[400] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 9

Statistical analysis description

Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 12 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[401]

Method

Parameter type

R-square

Point estimate

0.37

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[401] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 10

Statistical analysis description

Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 12 Months of Age (Group 2) v Human SBA GMTs at 12 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[402]

Method

Parameter type

R-square

Point estimate

0.14

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[402] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 11

Statistical analysis description

Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 12 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[403]

Method

Parameter type

R-square

Point estimate

0.13

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[403] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 12

Statistical analysis description

Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 12 Months of Age (Group 2) v Human SBA GMTs at 12 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[404]

Method

Parameter type

R-square

Point estimate

0.17

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[404] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 13

Statistical analysis description

Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 12 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[405]

Method

Parameter type

R-square

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[405] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 14

Statistical analysis description

Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 12 Months of Age (Group 2) v Human SBA GMTs at 12 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[406]

Method

Parameter type

R-square

Point estimate

0.78

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[406] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 15

Statistical analysis description

Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 12 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[407]

Method

Parameter type

R-square

Point estimate

0.94

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[407] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 16

Statistical analysis description

Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 12 Months of Age (Group 2) v Human SBA GMTs at 12 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[408]

Method

Parameter type

R-square

Point estimate

0.85

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[408] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 17

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)

Number of subjects included in analysis

126

Analysis specification

Pre-specified

Analysis type

other ^[409]

Method

Parameter type

R-square

Point estimate

0.03

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[409] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 18

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 2) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 3)

Number of subjects included in analysis

125

Analysis specification

Pre-specified

Analysis type

other ^[410]

Method

Parameter type

R-square

Point estimate

0.02

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[410] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 19

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)

Number of subjects included in analysis

126

Analysis specification

Pre-specified

Analysis type

other ^[411]

Method

Parameter type

R-square

Point estimate

0.007

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[411] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 20

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C

Comparison groups

Number of subjects included in analysis

125

Analysis specification

Pre-specified

Analysis type

other ^[412]

Method

Parameter type

R-square

Point estimate

0.04

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[412] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 21

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)

Number of subjects included in analysis

126

Analysis specification

Pre-specified

Analysis type

other ^[413]

Method

Parameter type

R-square

Point estimate

0.02

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[413] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 22

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135

Comparison groups

Number of subjects included in analysis

125

Analysis specification

Pre-specified

Analysis type

other ^[414]

Method

Parameter type

R-square

Point estimate

0.08

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[414] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 23

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)

Number of subjects included in analysis

126

Analysis specification

Pre-specified

Analysis type

other ^[415]

Method

Parameter type

R-square

Point estimate

0.13

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[415] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 24

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y

Comparison groups

Number of subjects included in analysis

125

Analysis specification

Pre-specified

Analysis type

other ^[416]

Method

Parameter type

R-square

Point estimate

0.28

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[416] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 25

Statistical analysis description

Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)

Number of subjects included in analysis

126

Analysis specification

Pre-specified

Analysis type

other ^[417]

Method

Parameter type

R-square

Point estimate

0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[417] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 26

Statistical analysis description

Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A

Comparison groups

Number of subjects included in analysis

125

Analysis specification

Pre-specified

Analysis type

other ^[418]

Method

Parameter type

R-square

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[418] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 27

Statistical analysis description

Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)

Number of subjects included in analysis

126

Analysis specification

Pre-specified

Analysis type

other ^[419]

Method

Parameter type

R-square

Point estimate

0.11

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[419] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 28

Statistical analysis description

Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C

Comparison groups

Number of subjects included in analysis

125

Analysis specification

Pre-specified

Analysis type

other ^[420]

Method

Parameter type

R-square

Point estimate

0.06

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[420] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 29

Statistical analysis description

Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)

Number of subjects included in analysis

126

Analysis specification

Pre-specified

Analysis type

other ^[421]

Method

Parameter type

R-square

Point estimate

0.17

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[421] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 30

Statistical analysis description

Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135

Comparison groups

Number of subjects included in analysis

125

Analysis specification

Pre-specified

Analysis type

other ^[422]

Method

Parameter type

R-square

Point estimate

0.21

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[422] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 31

Statistical analysis description

Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)

Number of subjects included in analysis

126

Analysis specification

Pre-specified

Analysis type

other ^[423]

Method

Parameter type

R-square

Point estimate

0.39

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[423] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 32

Statistical analysis description

Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y

Comparison groups

Number of subjects included in analysis

125

Analysis specification

Pre-specified

Analysis type

other ^[424]

Method

Parameter type

R-square

Point estimate

0.33

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[424] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Secondary: 16. Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in hSBA Titers, (2) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in IgG, After Third Dose of MenACWY-CRM at 12 Months

Top of page

End point title

16. Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in hSBA Titers, (2) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in IgG, After Third Dose of MenACWY-CRM at 12 Months

End point description

The rise in serogroup-specific hSBA and IgG was calculated by pre/post third dose geometric mean ratios, calculated by the difference in the log10 of the concentrations/titers measured at 13 months to the log10 of the concentrations at 12 months: i.e. rise = log10(x) at 13 months minus log10(x) at 12 months where x is the serogroup specific IgG or SBA titers. Linear regression analysis between memory B cells at 5 months of age and rise in hSBA titers or IgG at 12 months of age was performed with and without inclusion of demographic factors (subject's household smoking status, number of older children living in subject's household, attendance at daycare and total duration of breast feeding) in the model. Analysis was performed on the PP dataset after booster vaccination. Note: Specific IgG GMCs and hSBA GMTs dispersion was reported as confidence intervals (see table notes)

End point type

Secondary

End point timeframe

1 month post primary vaccination (B cells) and 12 months (hSBA titers and IgG)

End point values	MenACWY-CRM and Routine Vaccines (Group 1)	MenACWY-CRM and Routine Vaccines (Group 2)	MenACWY-CRM and Routine Vaccines (Group 3)	Human SBA GMTs at 12 Months of Age (Group 1)	Human SBA GMTs at 12 Months of Age (Group 2)	Human SBA GMTs at 12 Months of Age (Group 3)	Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)	Specific IgG Geometric Mean Conc at 12 Months of Age (Group 2)	Specific IgG Geometric Mean Conc at 12 Months of Age (Group 3)
Number of subjects analysed	71 ^[425]	31 ^[426]	43 ^[427]	85 ^[428]	40 ^[429]	42 ^[430]	55 ^[431]	25 ^[432]	47 ^[433]
Units: Mean of memory B cells
arithmetic mean (standard deviation)
Serogroup A	2.1 ( 2.03 )	1.8 ( 1.27 )	1.72 ( 1.89 )	2.2 ( 0 )	2 ( 0 )	2.14 ( 0 )	0.37 ( 0 )	0.33 ( 0 )	0.31 ( 0 )
Serogroup C	2.57 ( 2.73 )	1.71 ( 1.12 )	2.43 ( 2.32 )	5.56 ( 0 )	4.83 ( 0 )	5.61 ( 0 )	0.19 ( 0 )	0.18 ( 0 )	0.2 ( 0 )
Serogroup W-135	2.39 ( 4.69 )	1.5 ( 0.721 )	1.57 ( 1.47 )	8.4 ( 0 )	12 ( 0 )	10 ( 0 )	0.31 ( 0 )	0.35 ( 0 )	0.29 ( 0 )
Serogroup Y	2.91 ( 8.36 )	1.43 ( 0.71 )	1.78 ( 1.67 )	8.71 ( 0 )	9.9 ( 0 )	9.15 ( 0 )	0.43 ( 0 )	0.47 ( 0 )	0.37 ( 0 )

Notes
[425] - N= Serogroup A=50, C=71, W-135=62, Y=54
[426] - N= Serogroup A=25, C=31, W-135=26, Y=25
[427] - N= Serogroup A=30, C=43, W-135=40, Y=30
[428] - N= Serogroup A=85, C=83, W-135=67, Y=43; 95%CI= A=2.05-2.36, C=4.23-7.3,W-135=6.03-12,Y=5.82-13
[429] - N= Serogroup A=40, C=39, W-135=37, Y=25; 95%CI= A=2-2, C=3.28-7.09, W-135=8.05-17, Y=5.39-18
[430] - N= Serogroup A=42, C=40, W-135=34, Y=16; 95%CI= A=1.93-2.37, C=3.78-8.33, W-135=6.73-15, Y=4.95-17
[431] - N= Serogroup A=49, C=55, W-135=55, Y=49; 95%CI= A=0.27-0.49, C=0.16-0.23,W-135=0.25-0.38,Y=0.34-0.55
[432] - N= Serogroup A=23, C=25, W-135=21, Y=21; 95%CI= A=0.23-0.46, C=0.14-0.22,W-135=0.25-0.48,Y=0.33-0.67
[433] - N= Serogroup A=47, C=26, W-135=26, Y=24; 95%CI= A=0.23-0.42, C=0.15-0.28,W-135=0.2-0.43,Y=0.25-0.55

Statistical Analysis 1

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 12 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[434]

Method

Parameter type

R-square

Point estimate

0.21

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[434] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 2

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 12 Months of Age (Group 2) v Human SBA GMTs at 12 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[435]

Method

Parameter type

R-square

Point estimate

0.19

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[435] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 3

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 12 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[436]

Method

Parameter type

R-square

Point estimate

0.24

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[436] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 4

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 12 Months of Age (Group 2) v Human SBA GMTs at 12 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[437]

Method

Parameter type

R-square

Point estimate

0.07

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[437] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 5

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 12 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[438]

Method

Parameter type

R-square

Point estimate

0.52

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[438] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 6

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 12 Months of Age (Group 2) v Human SBA GMTs at 12 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[439]

Method

Parameter type

R-square

Point estimate

0.29

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[439] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 7

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 12 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[440]

Method

Parameter type

R-square

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[440] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 8

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 12 Months of Age (Group 2) v Human SBA GMTs at 12 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[441]

Method

Parameter type

R-square

Point estimate

0.05

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[441] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 9

Statistical analysis description

Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 12 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[442]

Method

Parameter type

R-square

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[442] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 10

Statistical analysis description

Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 12 Months of Age (Group 2) v Human SBA GMTs at 12 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[443]

Method

Parameter type

R-square

Point estimate

0.21

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[443] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 11

Statistical analysis description

Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 12 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[444]

Method

Parameter type

R-square

Point estimate

0.5

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[444] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 12

Statistical analysis description

Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 12 Months of Age (Group 2) v Human SBA GMTs at 12 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[445]

Method

Parameter type

R-square

Point estimate

0.16

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[445] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 13

Statistical analysis description

Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 12 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[446]

Method

Parameter type

R-square

Point estimate

0.93

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[446] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 14

Statistical analysis description

Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 12 Months of Age (Group 2) v Human SBA GMTs at 12 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[447]

Method

Parameter type

R-square

Point estimate

0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[447] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 15

Statistical analysis description

Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Human SBA GMTs at 12 Months of Age (Group 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[448]

Method

Parameter type

R-square

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[448] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 16

Statistical analysis description

Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 2) v MenACWY-CRM and Routine Vaccines (Group 3) v Human SBA GMTs at 12 Months of Age (Group 2) v Human SBA GMTs at 12 Months of Age (Group 3)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

other ^[449]

Method

Parameter type

R-square

Point estimate

0.12

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[449] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 17

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)

Number of subjects included in analysis

126

Analysis specification

Pre-specified

Analysis type

other ^[450]

Method

Parameter type

R-square

Point estimate

0.0015

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[450] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 18

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[451]

Method

Parameter type

R-square

Point estimate

0.0057

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[451] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 19

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)

Number of subjects included in analysis

126

Analysis specification

Pre-specified

Analysis type

other ^[452]

Method

Parameter type

R-square

Point estimate

0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[452] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 20

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[453]

Method

Parameter type

R-square

Point estimate

0.02

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[453] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 21

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)

Number of subjects included in analysis

126

Analysis specification

Pre-specified

Analysis type

other ^[454]

Method

Parameter type

R-square

Point estimate

0.0048

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[454] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 22

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[455]

Method

Parameter type

R-square

Point estimate

0.0018

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[455] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 23

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)

Number of subjects included in analysis

126

Analysis specification

Pre-specified

Analysis type

other ^[456]

Method

Parameter type

R-square

Point estimate

0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[456] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 24

Statistical analysis description

Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[457]

Method

Parameter type

R-square

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[457] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 25

Statistical analysis description

Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)

Number of subjects included in analysis

126

Analysis specification

Pre-specified

Analysis type

other ^[458]

Method

Parameter type

R-square

Point estimate

0.27

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[458] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 26

Statistical analysis description

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[459]

Method

Parameter type

R-square

Point estimate

0.19

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[459] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 27

Statistical analysis description

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)

Number of subjects included in analysis

126

Analysis specification

Pre-specified

Analysis type

other ^[460]

Method

Parameter type

R-square

Point estimate

0.08

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[460] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 28

Statistical analysis description

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[461]

Method

Parameter type

R-square

Point estimate

0.08

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[461] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 29

Statistical analysis description

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)

Number of subjects included in analysis

126

Analysis specification

Pre-specified

Analysis type

other ^[462]

Method

Parameter type

R-square

Point estimate

0.45

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[462] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 30

Statistical analysis description

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[463]

Method

Parameter type

R-square

Point estimate

0.17

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[463] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Statistical Analysis 31

Statistical analysis description

Comparison groups

MenACWY-CRM and Routine Vaccines (Group 1) v Specific IgG Geometric Mean Conc at 12 Months of Age (Group 1)

Number of subjects included in analysis

126

Analysis specification

Pre-specified

Analysis type

other ^[464]

Method

Parameter type

R-square

Point estimate

0.37

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[464] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study.

Statistical Analysis 32

Statistical analysis description

Comparison groups

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

other ^[465]

Method

Parameter type

R-square

Point estimate

0.07

Confidence interval

level

95%

sides

2-sided

lower limit

-9999

upper limit

9999

Notes
[465] - Regression, Linear Confidence Intervals were not calculated for the purpose of this study. Values from Group 2 and 3 were combined for this analysis.

Secondary: 17. Percentage of Subjects Who Reported Injection Site Local Reactions After Each MenACWY-CRM and Routine Infant Vaccinations.

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End point title

17. Percentage of Subjects Who Reported Injection Site Local Reactions After Each MenACWY-CRM and Routine Infant Vaccinations.

End point description

Safety was assessed as the percentage of subjects who reported injection site local reactions during 7-day follow-up period after each MenACWY-CRM and routine infant vaccination administered as a primary course of vaccination.

End point type

Secondary

End point timeframe

7 days post primary MenACWY-CRM and routine infant vaccination

End point values	MenACWY-CRM and Routine Vaccines (Group 1)	MenACWY-CRM and Routine Vaccines (Group 2)	MenACWY-CRM and Routine Vaccines (Group 3)
Number of subjects analysed	108	54	54
Units: Percentage of subjects
Tenderness - MenACWY-CRM (Vaccination 1)	35	19	12
Tenderness - MenACWY-CRM (Vaccination 2)	21	15	9
Erythema - MenACWY-CRM (Vaccination 1)	101	52	51
Erythema - MenACWY-CRM (Vaccination 2)	104	52	54
Induration - MenACWY-CRM (Vaccination 1)	38	20	21
Induration - MenACWY-CRM (Vaccination 2)	48	27	29
Tenderness - DTaP-IPV-Hib (Vaccination 1)	43	23	15
Tenderness - DTaP-IPV-Hib (Vaccination 2)	33	19	17
Tenderness - DTaP-IPV-Hib (Vaccination 3)	29	18	13
Erythema - DTaP-IPV-Hib (Vaccination 1)	105	53	49
Erythema - DTaP-IPV-Hib (Vaccination 2)	102	50	54
Erythema - DTaP-IPV-Hib (Vaccination 3)	105	53	53
Induration - DTaP-IPV-Hib (Vaccination 1)	53	27	29
Induration - DTaP-IPV-Hib (Vaccination 2)	57	35	29
Induration - DTaP-IPV-Hib (Vaccination 3)	71	39	38
Tenderness - PCV (Vaccination 1)	43	21	18
Tenderness - PCV (Vaccination 2)	29	21	14
Erythema - PCV (Vaccination 1)	103	53	50
Erythema - PCV (Vaccination 2)	105	52	54
Induration - PCV (Vaccination 1)	41	24	27
Induration - PCV (Vaccination 2)	57	33	35

No statistical analyses for this end point

Secondary: 18. Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and Routine Infants Primary Vaccinations

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End point title

18. Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and Routine Infants Primary Vaccinations

End point description

Safety was assessed as the percentage of subjects who reported systemic reactions during 7-day follow-up period after MenACWY-CRM (2 and 4 months) and routine infant primary vaccinations (2, 3 and 4 months).

End point type

Secondary

End point timeframe

7 days post vaccination at 2, 3, and 4 months of age

End point values	MenACWY-CRM and Routine Vaccines (Group 1)	MenACWY-CRM and Routine Vaccines (Group 2)	MenACWY-CRM and Routine Vaccines (Group 3)
Number of subjects analysed	108	54	54
Units: Percentage of subjects
Change in eat. habits (N=106,54,54)- Vaccination 1	20	11	16
Change in eat. habits (N=107,53,54)- Vaccination 2	19	8	9
Change in eat. habits (N=106,54,53)- Vaccination 3	20	14	16
Sleepiness (Vaccination 1)	63	29	32
Sleepiness (Vaccination 2)	42	18	28
Sleepiness (Vaccination 3)	38	18	20
Vomiting (Vaccination 1)	26	6	9
Vomiting (Vaccination 2)	15	7	3
Vomiting (Vaccination 3)	16	6	8
Diarrhea (Vaccination 1)	22	11	8
Diarrhea (Vaccination 2)	18	5	7
Diarrhea (Vaccination 3)	10	9	7
Irritability (Vaccination 1)	71	37	33
Irritability (Vaccination 2)	51	41	27
Irritability (Vaccination 3)	55	30	31
Unusual crying (Vaccination 1)	29	11	8
Unusual crying (Vaccination 2)	18	15	10
Unusual crying (Vaccination 3)	23	8	14
Fever (≥38 °C) - Vaccination 1	4	2	0
Fever (≥38 °C) - Vaccination 2	6	3	0
Fever (≥38 °C) - Vaccination 3	6	5	2
Analg. Antipyr. Med. Used (Vaccination 1)	43	14	15
Analg. Antipyr. Med. Used (Vaccination 2)	28	24	21
Analg. Antipyr. Med. Used (Vaccination 3)	44	18	30

No statistical analyses for this end point

Secondary: 19. Percentage of Subjects Who Reported Injection Site Local Reactions After MenACWY-CRM and PCV Vaccinations at 12 Months of Age

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End point title

19. Percentage of Subjects Who Reported Injection Site Local Reactions After MenACWY-CRM and PCV Vaccinations at 12 Months of Age

End point description

Safety was assessed as the percentage of subjects who reported injection site local reactions during 7-day follow-up period after MenACWY-CRM and PCV vaccinations at 12 months of age.

End point type

Secondary

End point timeframe

7 days post 12 month vaccination

End point values	MenACWY-CRM and Routine Vaccines (Group 1)	MenACWY-CRM and Routine Vaccines (Group 2)	MenACWY-CRM and Routine Vaccines (Group 3)
Number of subjects analysed	103	50	52
Units: Percentage of subjects
Tenderness - MenACWY-CRM	29	14	10
Erythema - MenACWY-CRM	102	46	49
Induration - MenACWY-CRM	54	25	29
Tenderness - PCV	15	15	11
Erythema - PCV	43	43	49
Induration - PCV	24	24	33

No statistical analyses for this end point

Secondary: 20. Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and PCV Vaccination at 12 Months of Age

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End point title

20. Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and PCV Vaccination at 12 Months of Age

End point description

Safety was assessed as the percentage of subjects who reported systemic reactions during 7-day follow-up period after MenACWY-CRM and PCV vaccination at 12 months of age.

End point type

Secondary

End point timeframe

7 days post 12 months vaccination

End point values	MenACWY-CRM and Routine Vaccines (Group 1)	MenACWY-CRM and Routine Vaccines (Group 2)	MenACWY-CRM and Routine Vaccines (Group 3)
Number of subjects analysed	103	50	52
Units: Percentage of subjects
Change in eating habits (N=97,48,52)	22	11	16
Sleepiness	21	12	13
Vomiting	3	5	6
Diarrhea	14	8	8
Irritability	26	23	21
Unusual crying	12	10	8
Fever (≥38 °C)	8	3	3
Analgesics Antipyretics Medicine Used	33	22	24

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

All the serious adverse events were collected throughout the study (day 1 to 18 months).

Adverse event reporting additional description

Other adverse events included solicited local and systemic reactions and non-serious unsolicited adverse events. Solicited local and systemic reactions were collected from day 1 to day 7 after each vaccination. Non-serious unsolicited adverse events were collected from 7 days after each vaccination to the next visit.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

12.1

Reporting group title

MenACWY-CRM and Routine Vaccines (Group 1)

Reporting group description

Reporting group title

MenACWY-CRM and Routine Vaccines (Group 2)

Reporting group description

Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months. This group had an additional blood draw at the time of enrollment.

Reporting group title

MenACWY-CRM and Routine Vaccines (Group 3)

Reporting group description

Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age. This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM.

Serious adverse events	MenACWY-CRM and Routine Vaccines (Group 1)	MenACWY-CRM and Routine Vaccines (Group 2)	MenACWY-CRM and Routine Vaccines (Group 3)
Total subjects affected by serious adverse events
subjects affected / exposed	7 / 108 (6.48%)	4 / 54 (7.41%)	6 / 54 (11.11%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0
Injury, poisoning and procedural complications
Head injury
subjects affected / exposed	0 / 108 (0.00%)	0 / 54 (0.00%)	1 / 54 (1.85%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
Febrile convulsion
subjects affected / exposed	0 / 108 (0.00%)	1 / 54 (1.85%)	0 / 54 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	0 / 108 (0.00%)	0 / 54 (0.00%)	1 / 54 (1.85%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Eosinophilic colitis
subjects affected / exposed	0 / 108 (0.00%)	0 / 54 (0.00%)	1 / 54 (1.85%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrooesophageal Reflux Disease
subjects affected / exposed	1 / 108 (0.93%)	0 / 54 (0.00%)	0 / 54 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Wheezing
subjects affected / exposed	1 / 108 (0.93%)	0 / 54 (0.00%)	0 / 54 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Bronchiolitis
subjects affected / exposed	2 / 108 (1.85%)	1 / 54 (1.85%)	0 / 54 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	0 / 108 (0.00%)	1 / 54 (1.85%)	0 / 54 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 108 (0.00%)	0 / 54 (0.00%)	2 / 54 (3.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	1 / 108 (0.93%)	1 / 54 (1.85%)	0 / 54 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Viral infection
subjects affected / exposed	3 / 108 (2.78%)	0 / 54 (0.00%)	2 / 54 (3.70%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Viral upper respiratory tract infection
subjects affected / exposed	0 / 108 (0.00%)	1 / 54 (1.85%)	0 / 54 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	MenACWY-CRM and Routine Vaccines (Group 1)	MenACWY-CRM and Routine Vaccines (Group 2)	MenACWY-CRM and Routine Vaccines (Group 3)
Total subjects affected by non serious adverse events
subjects affected / exposed	108 / 108 (100.00%)	54 / 54 (100.00%)	54 / 54 (100.00%)
Nervous system disorders
Somnolence
subjects affected / exposed	81 / 108 (75.00%)	40 / 54 (74.07%)	42 / 54 (77.78%)
occurrences all number	184	82	108
General disorders and administration site conditions
Injection site erythema
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	108 / 108 (100.00%)	53 / 54 (98.15%)	54 / 54 (100.00%)
occurrences all number	859	475	486
Injection site induration
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	91 / 108 (84.26%)	50 / 54 (92.59%)	50 / 54 (92.59%)
occurrences all number	437	271	283
Injection site pain
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	74 / 108 (68.52%)	42 / 54 (77.78%)	38 / 54 (70.37%)
occurrences all number	265	172	121
Pyrexia
subjects affected / exposed	25 / 108 (23.15%)	12 / 54 (22.22%)	9 / 54 (16.67%)
occurrences all number	36	19	10
Crying
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	49 / 108 (45.37%)	29 / 54 (53.70%)	29 / 54 (53.70%)
occurrences all number	98	57	47
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	45 / 108 (41.67%)	23 / 54 (42.59%)	19 / 54 (35.19%)
occurrences all number	77	43	40
Gastrooesophageal reflux disease
subjects affected / exposed	3 / 108 (2.78%)	4 / 54 (7.41%)	2 / 54 (3.70%)
occurrences all number	3	4	2
Teething
subjects affected / exposed	14 / 108 (12.96%)	8 / 54 (14.81%)	5 / 54 (9.26%)
occurrences all number	15	10	7
Vomiting
subjects affected / exposed	43 / 108 (39.81%)	20 / 54 (37.04%)	19 / 54 (35.19%)
occurrences all number	75	31	34
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	14 / 108 (12.96%)	6 / 54 (11.11%)	3 / 54 (5.56%)
occurrences all number	15	9	3
Skin and subcutaneous tissue disorders
Eczema
subjects affected / exposed	7 / 108 (6.48%)	4 / 54 (7.41%)	4 / 54 (7.41%)
occurrences all number	8	4	4
Rash
subjects affected / exposed	10 / 108 (9.26%)	4 / 54 (7.41%)	1 / 54 (1.85%)
occurrences all number	10	4	2
Psychiatric disorders
Irritability
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	93 / 108 (86.11%)	53 / 54 (98.15%)	47 / 54 (87.04%)
occurrences all number	248	163	145
Eating disorder
subjects affected / exposed	55 / 108 (50.93%)	30 / 54 (55.56%)	31 / 54 (57.41%)
occurrences all number	100	52	80
Infections and infestations
Conjunctivitis
alternative dictionary used: MedDRA 17.1
subjects affected / exposed	7 / 108 (6.48%)	3 / 54 (5.56%)	5 / 54 (9.26%)
occurrences all number	9	3	6
Ear infection
subjects affected / exposed	7 / 108 (6.48%)	5 / 54 (9.26%)	1 / 54 (1.85%)
occurrences all number	7	5	1
Lower respiratory tract infection
subjects affected / exposed	10 / 108 (9.26%)	11 / 54 (20.37%)	5 / 54 (9.26%)
occurrences all number	12	13	5
Nasopharyngitis
subjects affected / exposed	1 / 108 (0.93%)	3 / 54 (5.56%)	0 / 54 (0.00%)
occurrences all number	1	4	0
Rhinitis
subjects affected / exposed	21 / 108 (19.44%)	15 / 54 (27.78%)	13 / 54 (24.07%)
occurrences all number	26	20	15
Upper respiratory tract infection
subjects affected / exposed	7 / 108 (6.48%)	2 / 54 (3.70%)	6 / 54 (11.11%)
occurrences all number	7	2	6

More information

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Were there any global substantial amendments to the protocol? Yes

13 Jun 2008

Amendment No. 1: The main reason for this amendment was to insert a new secondary objective due to the addition of an optional genetic analysis. Moreover also the Sponsor Study personnel have been updated. Finally some changes have been implemented throughout the protocol for consistency and to better clarify the text.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

http://www.ncbi.nlm.nih.gov/pubmed/23538521
http://www.ncbi.nlm.nih.gov/pubmed/23566945

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Clinical trials

Clinical Trial Results: A Phase II, Single Centre, Open-label, Randomized Study to Investigate Meningococcal Serogroup A, C, W-135 and Y Saccharide Specific B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: 1. Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135, and Y Specific Memory B Cells at 5 Months of Age and hSBA Titers at 12 Months of Age by Serogroup A, C, W-135 and Y

Primary: 1. Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135, and Y Specific Memory B Cells at 5 Months of Age and hSBA Titers at 12 Months of Age by Serogroup A, C, W-135 and Y

Secondary: 2. Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135 and Y Specific Memory B Cells at 1 Month After MenACWY-CRM Primary Vaccination and Serogroup A, C, W-135 and Y Specific Memory B Cells and IgG Concentration at 12 Months Age

Secondary: 2. Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135 and Y Specific Memory B Cells at 1 Month After MenACWY-CRM Primary Vaccination and Serogroup A, C, W-135 and Y Specific Memory B Cells and IgG Concentration at 12 Months Age

Secondary: 3. Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135 and Y Specific Memory B Cells 1 Month After MenACWY-CRM Primary Vaccination and Memory B Cells and hSBA Titers and IgG Conc. 1 Month Post MenACWY-CRM Booster Vaccination

Secondary: 3. Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135 and Y Specific Memory B Cells 1 Month After MenACWY-CRM Primary Vaccination and Memory B Cells and hSBA Titers and IgG Conc. 1 Month Post MenACWY-CRM Booster Vaccination

Secondary: 4. Correlation and Regression Coefficients Between Memory B Cells 1 Month After Primary Vaccination and Rise From Prebooster Levels in Serogroup Specific Memory B Cells and IgG Concentration and hSBA Titers 1 Month After MenACWY -CRM Booster Vaccination

Secondary: 4. Correlation and Regression Coefficients Between Memory B Cells 1 Month After Primary Vaccination and Rise From Prebooster Levels in Serogroup Specific Memory B Cells and IgG Concentration and hSBA Titers 1 Month After MenACWY -CRM Booster Vaccination

Secondary: 5. Correlation and Linear Regression Coefficients Between Memory B Cells 1 Month After Primary Vaccination and Serogroup A, C, W-135 and Y Specific Plasma Cells and Memory B Cells and IgG Concentration and hSBA Titers 1 Week After MenACWY-CRM Booster

Secondary: 5. Correlation and Linear Regression Coefficients Between Memory B Cells 1 Month After Primary Vaccination and Serogroup A, C, W-135 and Y Specific Plasma Cells and Memory B Cells and IgG Concentration and hSBA Titers 1 Week After MenACWY-CRM Booster

Secondary: 6. Correlation and Linear Regression Coefficients Between CRM197 Specific Memory B Cells 1 Month After Primary Vaccination and CRM197 Specific Memory B Cells and IgG Concentration at 12 Months of Age and One Month After MenACWYCRM Booster Vaccination

Secondary: 6. Correlation and Linear Regression Coefficients Between CRM197 Specific Memory B Cells 1 Month After Primary Vaccination and CRM197 Specific Memory B Cells and IgG Concentration at 12 Months of Age and One Month After MenACWYCRM Booster Vaccination

Secondary: 7. Increase in Serogroup A, C, W-135 and Y Specific Memory B Cells Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone

Secondary: 7. Increase in Serogroup A, C, W-135 and Y Specific Memory B Cells Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone

Secondary: 8. Increase in Serogroup A, C, W-135 and Y Specific IgG Concentrations Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone

Secondary: 8. Increase in Serogroup A, C, W-135 and Y Specific IgG Concentrations Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone

Secondary: 9. Increase in Serogroup A, C, W-135 and Y hSBA Titers Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone

Secondary: 9. Increase in Serogroup A, C, W-135 and Y hSBA Titers Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone

Secondary: 10. Serogroups A, C, W-135 and Y Specific Memory B Cell Response in Children Lacking a hSBA Titer of ≥1:8 One Month After MenACWY-CRM Primary Vaccination

Secondary: 10. Serogroups A, C, W-135 and Y Specific Memory B Cell Response in Children Lacking a hSBA Titer of ≥1:8 One Month After MenACWY-CRM Primary Vaccination

Secondary: 11. Kinetics of Serogroup A, C, W-135 and Y Specific Memory B Cells and Plasma B Cells After MenACWY-CRM Primary Vaccination

Secondary: 11. Kinetics of Serogroup A, C, W-135 and Y Specific Memory B Cells and Plasma B Cells After MenACWY-CRM Primary Vaccination

Secondary: 12. Kinetics of Serogroup A, C, W-135 and Y Specific IgG Concentrations After MenACWY-CRM Primary Vaccination

Secondary: 12. Kinetics of Serogroup A, C, W-135 and Y Specific IgG Concentrations After MenACWY-CRM Primary Vaccination

Secondary: 13. Kinetics of Serogroup A, C, W-135 and Y hSBA Titers After MenACWY-CRM Primary Vaccination

Secondary: 13. Kinetics of Serogroup A, C, W-135 and Y hSBA Titers After MenACWY-CRM Primary Vaccination

Secondary: 14. Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135 and Y Specific Memory B Cells 1 Month After MenACWY-CRM Primary Vaccination and IgG Concentration at Day 1 in the Serum of Mothers of Infants

Secondary: 14. Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135 and Y Specific Memory B Cells 1 Month After MenACWY-CRM Primary Vaccination and IgG Concentration at Day 1 in the Serum of Mothers of Infants

Secondary: 15. Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and hSBA Titers at 12 Months, (2) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and IgG at 12 Months, After a 2-Dose Primary Course of MenACWY-CRM

Secondary: 15. Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and hSBA Titers at 12 Months, (2) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and IgG at 12 Months, After a 2-Dose Primary Course of MenACWY-CRM

Secondary: 16. Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in hSBA Titers, (2) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in IgG, After Third Dose of MenACWY-CRM at 12 Months

Secondary: 16. Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in hSBA Titers, (2) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in IgG, After Third Dose of MenACWY-CRM at 12 Months

Secondary: 17. Percentage of Subjects Who Reported Injection Site Local Reactions After Each MenACWY-CRM and Routine Infant Vaccinations.

Secondary: 17. Percentage of Subjects Who Reported Injection Site Local Reactions After Each MenACWY-CRM and Routine Infant Vaccinations.

Secondary: 18. Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and Routine Infants Primary Vaccinations

Secondary: 18. Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and Routine Infants Primary Vaccinations

Secondary: 19. Percentage of Subjects Who Reported Injection Site Local Reactions After MenACWY-CRM and PCV Vaccinations at 12 Months of Age

Secondary: 19. Percentage of Subjects Who Reported Injection Site Local Reactions After MenACWY-CRM and PCV Vaccinations at 12 Months of Age

Secondary: 20. Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and PCV Vaccination at 12 Months of Age

Secondary: 20. Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and PCV Vaccination at 12 Months of Age

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

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Clinical Trial Results:
A Phase II, Single Centre, Open-label, Randomized Study to Investigate Meningococcal Serogroup A, C, W-135 and Y Saccharide Specific B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants