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Clinical Trial Results:
A Phase II, open (partially double-blind), randomized, controlled dose-range study to evaluate the immunogenicity, reactogenicity and safety of four different formulations of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine versus MenC-CRM197 conjugate vaccine or MENCEVAX ACWY when given as one dose to children aged 12 to 14 months and 3 to 5 years old.

Summary
EudraCT number	2004-003768-32
Trial protocol	AT
Global end of trial date	16 Feb 2007

Results information
Results version number	v4(current)
This version publication date	17 Oct 2020
First version publication date	15 Feb 2015
Other versions	v1 (removed from public view) , v2 , v3
Version creation reason	Correction of full data set Correction of errors in safety section.

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

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Trial information

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Sponsor protocol code

103533, 103534

ISRCTN number

US NCT number

NCT00196976

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline Biologicals

Sponsor organisation address

Rue de l’Institut 89, Rixensart, Belgium, B-1330

Public contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com

Scientific contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com

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

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

21 Nov 2007

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

16 Feb 2007

Was the trial ended prematurely?

Main objective of the trial

Based on the immune response induced one month post vaccination, to select the best of four different formulations of GSK Biologicals’ MenACWY-TT conjugate vaccine when given as one single dose to healthy children aged 12-14 months and 3-5 years.

Protection of trial subjects

Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.

Background therapy

Evidence for comparator

Actual start date of recruitment

24 Mar 2005

Long term follow-up planned

Yes

Long term follow-up rationale

Efficacy

Long term follow-up duration

12 Months

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Greece: 358

Country: Number of subjects enrolled

Austria: 103

Worldwide total number of subjects

461

EEA total number of subjects

461

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)

201

Children (2-11 years)

260

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

Screening details

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Period 1 title

Primary Study

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Blinding implementation details

The primary study was a partially double-blind, randomized (1:1:1:1:1), controlled multi-centre study with 5 groups with balanced allocation. The Formulations 1, 2 & 3 of the candidate Nimenrix vaccine (Forms 1, 2 and 3) were administered in a double-blind manner with respect to each other, while Formulation 4 was administered in a single-blind manner.

Are arms mutually exclusive

Yes

12-14 months of age Formulation 1 Group

Arm description

Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the Nimenrix conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphteria, tetanus and acellular pertussis (Infanrix or Infanrix Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT, GSK134612A, GSK Biologicals’ meningococcal serogroups A, C, W-135, Y-tetanus toxoid conjugate vaccine

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Nimenrix vaccine formulations were administered by intramuscular injection into the left deltoid region.

Investigational medicinal product name

Infanrix

Investigational medicinal product code

Other name

DTPa-IPV/Hib, GSK Biologicals` combined diphteria, tetanus, acellular pertusis, inactivated poliomyelitis and conjugated Haemophilus influenzae type b vaccine

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Infanrix vaccine was administered by intramuscular injection into the left thigh.

Investigational medicinal product name

Infanrix Hexa

Investigational medicinal product code

Other name

DTPa-HBV-IPV/Hib, GSK Biologicals` combined diphteria,tetanus,acellular pertussis,inactivated poliomyelitis,hepatitis B and conjugated Haem. influenzae type b

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Infanrix Hexa vaccine was administered by intramuscular injection into the left thigh.

12-14 months of age Formulation 2 Group

Arm description

Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the Nimenrix conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphteria, tetanus and acellular pertusis (Infanrix or Infanrix Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT, GSK134612A, GSK Biologicals’ meningococcal serogroups A, C, W-135, Y-tetanus toxoid conjugate vaccine

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Nimenrix vaccine formulations were administered by intramuscular injection into the left deltoid region.

Investigational medicinal product name

Infanrix

Investigational medicinal product code

Other name

DTPa-IPV/Hib, GSK Biologicals` combined diphteria, tetanus, acellular pertusis, inactivated poliomyelitis and conjugated Haemophilus influenzae type b vaccine

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Infanrix vaccine was administered by intramuscular injection into the left thigh.

Investigational medicinal product name

Infanrix Hexa

Investigational medicinal product code

Other name

DTPa-HBV-IPV/Hib, GSK Biologicals` combined diphteria,tetanus,acellular pertussis,inactivated poliomyelitis,hepatitis B and conjugated Haem. influenzae type b

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Infanrix Hexa vaccine was administered by intramuscular injection into the left thigh.

12-14 months of age Formulation 3 Group

Arm description

Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form 3) of the Nimenrix conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix or Infanrix Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT, GSK134612A, GSK Biologicals’ meningococcal serogroups A, C, W-135, Y-tetanus toxoid conjugate vaccine

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Nimenrix vaccine formulations were administered by intramuscular injection into the left deltoid region.

Investigational medicinal product name

Infanrix

Investigational medicinal product code

Other name

DTPa-IPV/Hib, GSK Biologicals` combined diphteria, tetanus, acellular pertusis, inactivated poliomyelitis and conjugated Haemophilus influenzae type b vaccine

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Infanrix vaccine was administered by intramuscular injection into the left thigh.

Investigational medicinal product name

Infanrix Hexa

Investigational medicinal product code

Other name

DTPa-HBV-IPV/Hib, GSK Biologicals` combined diphteria,tetanus,acellular pertussis,inactivated poliomyelitis,hepatitis B and conjugated Haem. influenzae type b

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Infanrix Hexa vaccine was administered by intramuscular injection into the left thigh.

12-14 months of age Formulation 4 Group

Arm description

Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the Nimenrix conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix or Infanrix Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT, GSK134612A, GSK Biologicals’ meningococcal serogroups A, C, W-135, Y-tetanus toxoid conjugate vaccine

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Nimenrix vaccine formulations were administered by intramuscular injection into the left deltoid region.

Investigational medicinal product name

Infanrix

Investigational medicinal product code

Other name

DTPa-IPV/Hib, GSK Biologicals` combined diphteria, tetanus, acellular pertusis, inactivated poliomyelitis and conjugated Haemophilus influenzae type b vaccine

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Infanrix vaccine was administered by intramuscular injection into the left thigh.

Investigational medicinal product name

Infanrix Hexa

Investigational medicinal product code

Other name

DTPa-HBV-IPV/Hib, GSK Biologicals` combined diphteria,tetanus,acellular pertussis,inactivated poliomyelitis,hepatitis B and conjugated Haem. influenzae type b

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Infanrix Hexa vaccine was administered by intramuscular injection into the left thigh.

12-14 months of age Control Group

Arm description

Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer`s Meningitec conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphteria, tetanus and acellular pertusis (Infanrix or Infanrix Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.

Arm type

Active comparator

Investigational medicinal product name

Meningitec

Investigational medicinal product code

Other name

MenC, Pfizer`s (formerly Wyeth) MenC-CRM197 conjugate vaccine

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Meningitec vaccine was administered intramuscularly into the left deltoid region.

Investigational medicinal product name

Infanrix

Investigational medicinal product code

Other name

DTPa-IPV/Hib, GSK Biologicals` combined diphteria, tetanus, acellular pertusis, inactivated poliomyelitis and conjugated Haemophilus influenzae type b vaccine

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Infanrix vaccine was administered by intramuscular injection into the left thigh.

Investigational medicinal product name

Infanrix Hexa

Investigational medicinal product code

Other name

DTPa-HBV-IPV/Hib, GSK Biologicals` combined diphteria,tetanus,acellular pertussis,inactivated poliomyelitis,hepatitis B and conjugated Haem. influenzae type b

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Infanrix Hexa vaccine was administered by intramuscular injection into the left thigh.

3-5 years of age Formulation 1 Group

Arm description

Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the Nimenrix conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT, GSK134612A, GSK Biologicals’ meningococcal serogroups A, C, W-135, Y-tetanus toxoid conjugate vaccine

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Nimenrix vaccine formulations were administered by intramuscular injection into the left deltoid region.

3-5 years of age Formulation 2 Group

Arm description

Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the Nimenrix conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT, GSK134612A, GSK Biologicals’ meningococcal serogroups A, C, W-135, Y-tetanus toxoid conjugate vaccine

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Nimenrix vaccine formulations were administered by intramuscular injection into the left deltoid region.

3-5 years of age Formulation 3 Group

Arm description

Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the Nimenrix conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT, GSK134612A, GSK Biologicals’ meningococcal serogroups A, C, W-135, Y-tetanus toxoid conjugate vaccine

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Nimenrix vaccine formulations were administered by intramuscular injection into the left deltoid region.

3-5 years of age Formulation 4 Group

Arm description

Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the Nimenrix conjugate vaccine, intramuscularly into the left arm`s deltoid region, during this primary vaccination study (103533).

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT, GSK134612A, GSK Biologicals’ meningococcal serogroups A, C, W-135, Y-tetanus toxoid conjugate vaccine

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Nimenrix vaccine formulations were administered by intramuscular injection into the left deltoid region.

3-5 years of age Control Group

Arm description

Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).

Arm type

Active comparator

Investigational medicinal product name

Mencevax ACWY

Investigational medicinal product code

Other name

MenACWY, GSK Biologicals` meningococcal A, C, W-135, Y plain polysachharide vaccine

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Mencevax ACWY vaccine was administered subcutaneously into the left upper arm.

Number of subjects in period 1	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Started	39	41	41	40	40	54	50	52	52	52
Completed	38	40	37	39	37	52	50	49	52	51
Not completed	1	1	4	1	3	2	0	3	0	1
Consent withdrawn by subject	1	-	1	1	2	1	-	-	-	1
Others	-	-	2	-	-	-	-	-	-	-
Protocol violation	-	1	1	-	-	-	-	-	-	-
Migrated from study area	-	-	-	-	-	-	-	1	-	-
Lost to follow-up	-	-	-	-	1	1	-	2	-	-

Period 2 title

Booster Study

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

12-14 months of age Booster Group

Arm description

Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the Nimenrix conjugate vaccine, additionally received 1/5 dose of Mencevax ACWY vaccine intramuscularly into the left deltoid region, during the booster study (103534).

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT, GSK134612A, GSK Biologicals’ meningococcal serogroups A, C, W-135, Y-tetanus toxoid conjugate vaccine

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Nimenrix vaccine formulations were administered by intramuscular injection into the left deltoid region.

Investigational medicinal product name

Mencevax ACWY

Investigational medicinal product code

Other name

MenACWY, GSK Biologicals` meningococcal A, C, W-135, Y plain polysachharide vaccine

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

1/5 dose of Mencevax ACWY vaccine was administered intramuscularly into the left deltoid region.

12-14 months of age Booster Control Group

Arm description

Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec conjugate vaccine, additionally received 1/5 dose of Mencevax ACWY vaccine intramuscularly into the left deltoid region, during the booster study (103534).

Arm type

Active comparator

Investigational medicinal product name

Meningitec

Investigational medicinal product code

Other name

MenC, Pfizer`s (formerly Wyeth) MenC-CRM197 conjugate vaccine

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Meningitec vaccine was administered intramuscularly into the left deltoid region.

Investigational medicinal product name

Mencevax ACWY

Investigational medicinal product code

Other name

MenACWY, GSK Biologicals` meningococcal A, C, W-135, Y plain polysachharide vaccine

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

1/5 dose of Mencevax ACWY vaccine was administered intramuscularly into the left deltoid region.

3-5 years of age Booster Group

Arm description

Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the Nimenrix conjugate vaccine, did not receive any booster vaccination.

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT, GSK134612A, GSK Biologicals’ meningococcal serogroups A, C, W-135, Y-tetanus toxoid conjugate vaccine

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Nimenrix vaccine formulations were administered by intramuscular injection into the left deltoid region.

3-5 years of age Booster Control Group

Arm description

Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer`s Meningitec conjugate vaccine, did not receive any booster vaccination.

Arm type

Active comparator

Investigational medicinal product name

Meningitec

Investigational medicinal product code

Other name

MenC, Pfizer`s (formerly Wyeth) MenC-CRM197 conjugate vaccine

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Meningitec vaccine was administered intramuscularly into the left deltoid region.

Number of subjects in period 2 ^[1]	12-14 months of age Booster Group	12-14 months of age Booster Control Group	3-5 years of age Booster Group	3-5 years of age Booster Control Group
Started	33	32	45	43
Completed	31	30	45	43
Not completed	2	2	0	0
Consent withdrawn by subject	1	-	-	-
Lost to follow-up	1	2	-	-

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Not all the subjects completing the Primary study came back for the Booster phase follow-up.

Baseline characteristics

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Reporting group title

12-14 months of age Formulation 1 Group

Reporting group description

Reporting group title

12-14 months of age Formulation 2 Group

Reporting group description

Reporting group title

12-14 months of age Formulation 3 Group

Reporting group description

Reporting group title

12-14 months of age Formulation 4 Group

Reporting group description

Reporting group title

12-14 months of age Control Group

Reporting group description

Reporting group title

3-5 years of age Formulation 1 Group

Reporting group description

Reporting group title

3-5 years of age Formulation 2 Group

Reporting group description

Reporting group title

3-5 years of age Formulation 3 Group

Reporting group description

Reporting group title

3-5 years of age Formulation 4 Group

Reporting group description

Reporting group title

3-5 years of age Control Group

Reporting group description

Reporting group values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group	Total
Number of subjects	39	41	41	40	40	54	50	52	52	52	461
Age categorical
Units: Subjects
In utero											0
Preterm newborn infants (gestational age < 37 wks)											0
Newborns (0-27 days)											0
Infants and toddlers (28 days-23 months)											0
Children (2-11 years)											0
Adolescents (12-17 years)											0
Adults (18-64 years)											0
From 65-84 years											0
85 years and over											0
Age continuous
Units: months
arithmetic mean (standard deviation)	12.5 ( 0.82 )	12.8 ( 0.86 )	12.8 ( 0.86 )	12.9 ( 0.83 )	12.8 ( 0.79 )	48.1 ( 7.12 )	48 ( 7.22 )	47.8 ( 7.01 )	48 ( 7.78 )	47.7 ( 7.15 )	-
Gender categorical
Units: Subjects
Female	15	15	17	24	19	21	16	23	27	27	204
Male	24	26	24	16	21	33	34	29	25	25	257
Race
Units: Subjects
White/Caucasian	38	40	40	38	39	53	50	50	50	51	449
Arabic/north african	1	0	1	0	1	1	0	2	1	0	7
East/south east asian	0	1	0	1	0	0	0	0	0	0	2
Black	0	0	0	1	0	0	0	0	1	1	3

End points

Top of page

Reporting group title

12-14 months of age Formulation 1 Group

Reporting group description

Reporting group title

12-14 months of age Formulation 2 Group

Reporting group description

Reporting group title

12-14 months of age Formulation 3 Group

Reporting group description

Reporting group title

12-14 months of age Formulation 4 Group

Reporting group description

Reporting group title

12-14 months of age Control Group

Reporting group description

Reporting group title

3-5 years of age Formulation 1 Group

Reporting group description

Reporting group title

3-5 years of age Formulation 2 Group

Reporting group description

Reporting group title

3-5 years of age Formulation 3 Group

Reporting group description

Reporting group title

3-5 years of age Formulation 4 Group

Reporting group description

Reporting group title

3-5 years of age Control Group

Reporting group description

Reporting group title

12-14 months of age Booster Group

Reporting group description

Reporting group title

12-14 months of age Booster Control Group

Reporting group description

Reporting group title

3-5 years of age Booster Group

Reporting group description

Reporting group title

3-5 years of age Booster Control Group

Reporting group description

Primary: Number of subjects with an immune response to the serum bactericidal assay meningococcal serogroup A using rabbit complement (rSBA-MenA), rSBA-MenC, rSBA-MenW-135, rSBA-MenY

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End point title

Number of subjects with an immune response to the serum bactericidal assay meningococcal serogroup A using rabbit complement (rSBA-MenA), rSBA-MenC, rSBA-MenW-135, rSBA-MenY ^[1]

End point description

A responder to serum bactericidal assay meningococcal serogroups A, C, W and Y, using rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) was defined as follows: -for initially seronegative subjects (antibody titres < 1:8 for rSBA-Men), a subject achieving a post-vaccination rSBA-Men antibody titre of ≥ 1:32; - for initially seropositive subjects (antibody titres ≥ 1:8 for rSBA-Men), a subject having a ≥ 4-fold increase in rSBA-Men antibody titre from pre to post vaccination.

End point type

Primary

End point timeframe

One month after the first vaccine dose

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis was only performed on all subjects of the Control groups and all subjects part of the group with the selected MenACWY-TT formulation (Formulation 1).

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	36	36	29	35	33	50	48	46	50	43
Units: Subjects
rSBA-MenA (N=33,34,26,31,31,45,45,44,50,40)	30	32	26	27	6	41	38	41	42	36
rSBA-MenC (N=32,34,29,34,32,50,48,46,49,42)	30	32	26	33	30	45	44	44	46	34
rSBA-MenW-135 (N=35,36,28,35,33,47,47,46,48,43)	34	36	27	35	3	46	44	46	48	36
rSBA-MenY (N=36,35,29,34,33,48,48,46,50,43)	33	34	26	34	3	46	47	45	47	34

No statistical analyses for this end point

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:8

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End point title

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:8

End point description

A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titres greater than or equal to (≥) 1:8.

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after (M1) the first vaccine dose

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	36	38	30	35	35	51	48	48	50	44
Units: Subjects
rSBA-MenA, PRE (N=33,34,27,32,34,46,46,44,50,41)	23	22	19	21	20	41	42	40	47	39
rSBA-MenC, PRE (N=32,34,30,34,32,50,48,47,49,42)	5	2	2	5	3	16	8	17	12	14
rSBA-MenW-135,PRE(N=35,36,29,35,34,47,47,46,48,43)	17	19	12	13	15	34	24	25	36	27
rSBA-MenY, PRE (N=36,35,30,34,34,48,48,46,50,43)	23	17	16	19	22	37	42	39	42	36
rSBA-MenA, M1 (N=36,38,30,34,32,50,47,48,50,43)	36	38	30	34	23	50	47	48	50	43
rSBA-MenC, M1 (N=36,38,29,35,35,51,48,47,50,44)	36	38	28	35	34	50	47	47	49	43
rSBA-MenW-135, M1(N=36,38,30,35,34,51,48,48,50,44)	35	38	30	35	15	50	48	48	50	44
rSBA-MenY, M1 (N=36,38,30,35,34,51,48,48,50,44)	35	38	29	35	25	51	48	48	50	44

No statistical analyses for this end point

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:128.

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End point title

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:128.

End point description

A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titres greater than or equal to (≥) 1:128.

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after (M1) the first vaccine dose

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	36	38	30	35	35	51	48	48	50	44
Units: Sbjects
rSBA-MenA, PRE (N=33,34,27,32,34,46,46,44,50,41)	19	19	13	19	17	41	39	40	46	37
rSBA-MenC, PRE (N=32,34,30,34,32,50,48,47,49,42)	3	0	0	3	1	9	4	5	7	5
rSBA-MenW-135,PRE(N=35,36,29,35,34,47,47,46,48,43)	8	9	4	4	8	19	11	9	15	12
rSBA-MenY, PRE (N=36,35,30,34,34,48,48,46,50,43)	17	11	9	12	17	29	37	32	33	30
rSBA-MenA, M1 (N=36,38,30,34,32,50,47,48,50,43)	36	38	29	34	20	49	47	48	50	43
rSBA-MenC, M1 (N=36,38,29,35,35,51,48,47,50,44)	35	34	26	31	27	49	46	45	48	39
rSBA-MenW-135, M1(N=36,38,30,35,34,51,48,48,50,44)	35	38	29	35	9	50	48	48	49	42
rSBA-MenY, M1 (N=36,38,30,35,34,51,48,48,50,44)	35	37	29	34	18	51	48	48	50	43

No statistical analyses for this end point

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres

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End point title

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres

End point description

Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titres (GMTs).

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after (M1) the first vaccine dose

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	36	38	30	35	35	51	48	48	50	44
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA, PRE (N=33,34,27,32,34,46,46,44,50,41)	84.2 (39.3 to 180.1)	77.3 (32.9 to 181.6)	68.4 (30.1 to 155.3)	76 (33.8 to 170.8)	69.1 (28.1 to 169.9)	359.7 (212 to 610.4)	367.2 (222.1 to 607)	375.9 (227.4 to 621.2)	465.2 (307.2 to 704.4)	427.4 (280.3 to 651.7)
rSBA-MenC, PRE (N=32,34,30,34,32,50,48,47,49,42)	6.9 (4.1 to 11.5)	4.5 (3.8 to 5.2)	4.6 (3.8 to 5.7)	6.6 (4.2 to 10.2)	5.3 (3.8 to 7.3)	12.5 (7.6 to 20.5)	7.4 (4.7 to 11.6)	11.8 (7.5 to 18.5)	8.9 (5.7 to 14.1)	11.9 (7 to 20.2)
rSBA-MenW-135,PRE(N=35,36,29,35,34,47,47,46,48,43)	19.8 (10.7 to 36.9)	21.1 (11.5 to 38.6)	14.5 (7.7 to 27.3)	12.1 (7.1 to 20.6)	18 (9.7 to 33.6)	45.8 (27.9 to 75.2)	22.3 (12.7 to 39)	23.7 (14.2 to 39.7)	44.6 (28.1 to 71)	31.5 (18 to 55)
rSBA-MenY, PRE (N=36,35,30,34,34,48,48,46,50,43)	57.7 (27.5 to 121.3)	24.4 (12 to 49.7)	32.4 (14.3 to 73)	32.9 (15.9 to 68.3)	52.8 (25.5 to 109.5)	98.7 (54.9 to 177.5)	181.9 (112.1 to 295.3)	146.8 (86.2 to 250.1)	140.6 (82.8 to 238.9)	123.6 (73.3 to 208.6)
rSBA-MenA, M1 (N=36,38,30,34,32,50,47,48,50,43)	6648 (4787.3 to 9231.9)	5406.8 (3961.5 to 7379.4)	6225.2 (3510.2 to 11040.2)	3928.6 (2851.5 to 5412.4)	125.9 (53.1 to 298.3)	7469.5 (5468.8 to 10202.1)	7569.7 (6044 to 9480.6)	13668.3 (11274.3 to 16570.6)	4878 (4002.5 to 5944.9)	4556.8 (3598 to 5771.1)
rSBA-MenC, M1 (N=36,38,29,35,35,51,48,47,50,44)	656.4 (483 to 892)	495.7 (334.6 to 734.4)	477.2 (245.1 to 929.4)	464.3 (324.4 to 664.5)	404.5 (222.5 to 735.4)	967.6 (672 to 1393.3)	1115 (746.4 to 1665.7)	1738.8 (1159.7 to 2607)	1197.6 (765 to 1874.7)	378.3 (257.2 to 556.5)
rSBA-MenW-135, M1(N=36,38,30,35,34,51,48,48,50,44)	2781.4 (1647 to 4697.2)	3447.5 (2484.8 to 4783.3)	2545 (1522.2 to 4254.9)	3260.8 (2342.1 to 4539.8)	21.7 (10.5 to 44.9)	4317.4 (3114.8 to 5984.3)	3856.5 (3153.4 to 4716.4)	5262.1 (4417.8 to 6267.7)	4556.1 (3576.6 to 5803.7)	912.7 (659.1 to 1264.1)
rSBA-MenY, M1 (N=36,38,30,35,34,51,48,48,50,44)	2599.9 (1531.8 to 4412.7)	2150.9 (1486.2 to 3112.9)	1920.9 (1014.2 to 3638.2)	3544.7 (2480.2 to 5065.9)	75.6 (38.1 to 150.1)	5249.1 (4107.9 to 6707.4)	5150.5 (4149.8 to 6392.6)	5896.3 (4686.4 to 7418.5)	7548.4 (6116.1 to 9316.2)	1527.3 (1110.8 to 2099.9)

No statistical analyses for this end point

Secondary: Number of subjects with anti-polysaccharide A (PSA), anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ≥ 0.3 μg/mL

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End point title

Number of subjects with anti-polysaccharide A (PSA), anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ≥ 0.3 μg/mL

End point description

A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per millilitre (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after (M1) the first vaccine dose

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	36	38	31	35	34	51	47	48	50	44
Units: Number
Anti-PSA, PRE (N=33,32,30,27,31,51,46,47,49,43)	1	2	0	1	0	10	4	6	9	10
Anti-PSC, PRE (N=32,33,30,30,29,51,46,47,50,43)	1	1	0	1	1	3	4	1	1	2
Anti-PSW-135, PRE(N=34,35,30,33,33,51,47,48,50,44)	1	0	1	1	0	1	4	2	0	1
Anti-PSY, PRE (N=34,36,30,32,34,51,47,48,50,44)	2	0	2	1	1	2	4	2	1	1
Anti-PSA, M1 (N=36,36,31,34,30,48,46,48,49,44)	35	36	30	34	2	48	45	48	48	44
Anti-PSC, M1 (N=34,38,31,35,34,49,46,48,49,44)	33	38	30	35	34	49	45	48	48	44
Anti-PSW-135, M1 (N=35,37,31,35,34,50,46,48,49,44)	34	36	30	35	0	48	45	48	48	44
Anti-PSY, M1 (N=35,37,31,34,32,50,46,46,49,44)	34	37	30	34	2	49	45	46	48	44

No statistical analyses for this end point

Secondary: Number of subjects with anti-polysaccharide A (PSA), anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ≥ 2.0 μg/mL

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End point title

Number of subjects with anti-polysaccharide A (PSA), anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ≥ 2.0 μg/mL

End point description

A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per millilitre (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after (M1) the first vaccine dose

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	36	38	31	35	34	51	47	48	50	44
Units: Subjects
Anti-PSA, PRE (N=33,32,30,27,31,51,46,47,49,43)	0	0	0	0	0	1	1	0	2	5
Anti-PSC, PRE (N=32,33,30,30,29,51,46,47,50,43)	0	0	0	0	0	2	2	0	0	2
Anti-PSW-135, PRE(N=34,35,30,33,33,51,47,48,50,44)	0	0	0	0	0	0	1	0	0	0
Anti-PSY, PRE (N=34,36,30,32,34,51,47,48,50,44)	0	0	0	1	0	1	2	0	0	0
Anti-PSA, M1 (N=36,36,31,34,30,48,46,48,49,44)	35	35	30	25	0	48	44	47	34	40
Anti-PSC, M1 (N=34,38,31,35,34,49,46,48,49,44)	33	37	29	34	33	44	45	45	47	44
Anti-PSW-135, M1 (N=35,37,31,35,34,50,46,48,49,44)	33	27	23	32	0	41	31	41	39	39
Anti-PSY, M1 (N=35,37,31,34,32,50,46,46,49,44)	34	34	27	33	0	46	40	39	47	42

No statistical analyses for this end point

Secondary: Anti-polysaccharide A (PSA), anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations

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End point title

Anti-polysaccharide A (PSA), anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations

End point description

The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per millilitre (μg/mL).

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after (M1) the first vaccine dose

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	36	38	31	35	34	51	47	48	50	44
Units: μg/mL
geometric mean (confidence interval 95%)
Anti-PSA, PRE (N=33,32,30,27,31,51,46,47,49,43)	0.16 (0.14 to 0.18)	0.16 (0.14 to 0.19)	0.15 (0.15 to 0.15)	0.16 (0.14 to 0.17)	0.15 (0.15 to 0.15)	0.2 (0.17 to 0.25)	0.17 (0.15 to 0.2)	0.17 (0.15 to 0.19)	0.21 (0.17 to 0.26)	0.25 (0.18 to 0.35)
Anti-PSC, PRE (N=32,33,30,30,29,51,46,47,50,43)	0.16 (0.14 to 0.17)	0.16 (0.14 to 0.17)	0.15 (0.15 to 0.15)	0.15 (0.15 to 0.16)	0.16 (0.14 to 0.17)	0.18 (0.15 to 0.22)	0.18 (0.15 to 0.23)	0.16 (0.14 to 0.17)	0.15 (0.15 to 0.16)	0.18 (0.14 to 0.22)
Anti-PSW-135, PRE(N=34,35,30,33,33,51,47,48,50,44)	0.15 (0.15 to 0.16)	0.15 (0.15 to 0.15)	0.16 (0.14 to 0.17)	0.15 (0.15 to 0.16)	0.15 (0.15 to 0.15)	0.15 (0.15 to 0.16)	0.17 (0.15 to 0.2)	0.16 (0.15 to 0.17)	0.15 (0.15 to 0.15)	0.16 (0.14 to 0.17)
Anti-PSY, PRE (N=34,36,30,32,34,51,47,48,50,44)	0.16 (0.14 to 0.18)	0.15 (0.15 to 0.15)	0.16 (0.15 to 0.17)	0.16 (0.14 to 0.2)	0.15 (0.15 to 0.16)	0.16 (0.14 to 0.18)	0.19 (0.15 to 0.24)	0.16 (0.15 to 0.17)	0.15 (0.15 to 0.16)	0.15 (0.15 to 0.16)
Anti-PSA, M1 (N=36,36,31,34,30,48,46,48,49,44)	30.65 (19.83 to 47.38)	22.09 (16.35 to 29.84)	34.68 (21.7 to 55.42)	4.03 (2.72 to 5.98)	0.17 (0.14 to 0.2)	20.01 (14.53 to 27.56)	12.62 (8.74 to 18.22)	24.69 (19.14 to 31.85)	3.63 (2.62 to 5.04)	13.79 (9.04 to 21.02)
Anti-PSC, M1 (N=34,38,31,35,34,49,46,48,49,44)	10.67 (7.47 to 15.23)	11.23 (8.75 to 14.4)	12.91 (8.83 to 18.88)	10.74 (8.43 to 13.68)	11.99 (9.26 to 15.53)	6.33 (4.81 to 8.34)	7.76 (5.76 to 10.44)	7.71 (6.05 to 9.83)	7.78 (5.83 to 10.38)	14.44 (11.32 to 18.42)
Anti-PSW-135, M1 (N=35,37,31,35,34,50,46,48,49,44)	7.52 (4.97 to 11.36)	3.12 (2.3 to 4.22)	3.62 (2.31 to 5.68)	7.09 (5.19 to 9.7)	0.15 (0.15 to 0.15)	4.76 (3.4 to 6.66)	3.2 (2.33 to 4.39)	3.85 (2.85 to 5.21)	4.99 (3.7 to 6.73)	7.93 (5.39 to 11.66)
Anti-PSY, M1 (N=35,37,31,34,32,50,46,46,49,44)	10.86 (7.41 to 15.92)	6.71 (5.12 to 8.8)	6.01 (4 to 9.03)	13.38 (9.48 to 18.89)	0.16 (0.15 to 0.17)	9.41 (6.66 to 13.31)	6.59 (4.7 to 9.25)	5.75 (4.23 to 7.81)	11.7 (8.39 to 16.32)	18.96 (13.68 to 26.29)

No statistical analyses for this end point

Secondary: Number of subjects with anti-tetanus (anti-T) antibody concentrations ≥ 0.1 IU/mL

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End point title

Number of subjects with anti-tetanus (anti-T) antibody concentrations ≥ 0.1 IU/mL

End point description

A seropositive subject for anti-tetanus was defined as having antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units per millilitre (IU/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after (M1) the first vaccine dose

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	36	37	30	35	35	51	48	48	50	44
Units: Subjects
Anti-T, PRE (N=35,36,30,33,34,51,48,48,50,44)	34	36	30	32	33	49	47	46	48	43
Anti-T, M1 (N=36,37,30,35,35,49,47,48,50,44)	36	37	30	35	34	48	47	48	50	43

No statistical analyses for this end point

Secondary: Anti-T antibody concentrations

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End point title

Anti-T antibody concentrations

End point description

Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) method, presented as geometric mean concentrations (GMCs) and expressed in international units per millilitre (IU/mL).

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after (M1) the first vaccine dose

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	36	37	30	35	35	51	48	48	50	44
Units: IU/mL
geometric mean (confidence interval 95%)
Anti-T, PRE (N=35,36,30,33,34,51,48,48,50,44)	1.007 (0.671 to 1.51)	1.159 (0.814 to 1.65)	1.203 (0.871 to 1.662)	1.293 (0.826 to 2.023)	0.792 (0.578 to 1.084)	1.426 (0.94 to 2.164)	1.312 (0.935 to 1.841)	1.232 (0.849 to 1.788)	1.18 (0.823 to 1.694)	1.083 (0.742 to 1.58)
Anti-T, M1 (N=36,37,30,35,35,49,47,48,50,44)	7.559 (5.04 to 11.335)	5.353 (3.832 to 7.477)	8.094 (4.855 to 13.492)	7.675 (4.783 to 12.315)	0.696 (0.52 to 0.932)	17.284 (11.812 to 25.292)	15.823 (11.728 to 21.348)	19.369 (13.226 to 28.363)	15.957 (11.767 to 21.639)	1.231 (0.833 to 1.82)

No statistical analyses for this end point

Secondary: Number of toddlers with solicited local symptoms

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End point title

Number of toddlers with solicited local symptoms ^[2]

End point description

The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine (Men) and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine (DTPa). Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

End point type

Secondary

End point timeframe

During the 8-day (Days 0-7) post-vaccination period following each study vaccine

Notes
[2] - 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: The analysis was only performed on subjects aged between 12 to 14 months of age.

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group
Number of subjects analysed	38	41	39	40	39
Units: Subjects
Pain, Men Vacc (N=38,41,39,40,39)	4	8	3	6	4
Redness, Men Vacc (N=38,41,39,40,39)	9	12	10	9	11
Swelling, Men Vacc (N=38,41,39,40,39)	1	6	7	6	4
Pain, DTPA (N=38,39,37,39,37)	3	10	6	7	6
Redness, DTPA (N=38,39,37,39,37)	7	13	9	8	7
Swelling, DTPA (N=38,39,37,39,37)	3	7	9	7	3

No statistical analyses for this end point

Secondary: Number of children with solicited local symptoms

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End point title

Number of children with solicited local symptoms ^[3]

End point description

The children subgroup received one dose of the meningococcal vaccine. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

End point type

Secondary

End point timeframe

During the 8-day (Days 0-7) post-vaccination period

Notes
[3] - 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: The analysis was only performed on subjects aged between 3 to 5 years of age.

End point values	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	52	50	50	52	51
Units: Subjects
Pain	10	11	9	11	13
Redness	9	11	10	9	7
Swelling	7	9	8	10	4

No statistical analyses for this end point

Secondary: Number of toddlers with solicited general symptoms

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End point title

Number of toddlers with solicited general symptoms ^[4]

End point description

The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine (Men) and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine (DTPa). Assessed solicited general symptoms included drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.

End point type

Secondary

End point timeframe

During the 8-day (Days 0-7) post-vaccination period following each study vaccine

Notes
[4] - 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: The analysis was only performed on subjects aged between 12 to 14 months of age.

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group
Number of subjects analysed	38	41	39	40	39
Units: Subjects
Drowsiness, Men Vacc (N=38;41;39;40;39)	1	5	4	4	5
Fever (Rectal), Men Vacc (N=38;41;39;40;39)	5	8	8	3	5
Irritability, Men Vacc (N=38;41;39;40;39)	4	9	6	5	5
Loss of appetite, Men Vacc (N=38;41;39;40;39)	1	6	5	3	6
Drowsiness, DTPA (N=38;39;37;39;37)	2	2	3	7	3
Fever (Rectal), DTPA (N=38;39;37;39;37)	4	5	5	5	8
Irritability, DTPA (N=38;39;37;39;37)	6	7	3	9	5
Loss of appetite, DTPA (N=38;39;37;39;37)	4	3	2	6	2

No statistical analyses for this end point

Secondary: Number of children with solicited general symptoms

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End point title

Number of children with solicited general symptoms ^[5]

End point description

The children subgroup received one primary meningococcal vaccine dose. Assessed solicited general symptoms included drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.

End point type

Secondary

End point timeframe

During the 8-day (Days 0-7) post-vaccination period

Notes
[5] - 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: The analysis was only performed on subjects aged between 3 to 5 years of age.

End point values	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	52	50	50	52	51
Units: Subjects
Drowsiness	4	2	0	5	4
Fever (Rectal)	4	4	3	3	3
Irritability	2	4	2	4	7
Loss of appetite	2	3	2	6	3

No statistical analyses for this end point

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:8

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End point title

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:8 ^[6]

End point description

A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titres greater than or equal to (≥) 1:8.

End point type

Secondary

End point timeframe

At one month (M1) and 12 months (M12) post primary vaccination

Notes
[6] - 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: The analysis was only performed on all subjects of the Control groups and all subjects part of the group with the selected MenACWY-TT formulation (Formulation 1).

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Control Group
Number of subjects analysed	31	30	44	37
Units: Subjects
rSBA-MenA, M1 (N=31,27,43,36)	31	18	43	36
rSBA-MenC, M1 (N=31,30,44,37)	31	29	43	36
rSBA-MenW-135, M1 (N=31,29,44,37)	30	11	43	37
rSBA-MenY, M1 (N=31,29,44,37)	30	20	44	37
rSBA-MenA, M12 (N=23,25,39,33)	23	20	39	33
rSBA-MenC, M12 (N=31,29,41,32)	29	25	40	22
rSBA-MenW-135, M12 (N=31,27,41,35)	30	11	41	31
rSBA-MenY, M12 (N=31,29,41,37)	31	23	41	36

No statistical analyses for this end point

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:128.

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End point title

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:128. ^[7]

End point description

A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titres greater than or equal to (≥) 1:128.

End point type

Secondary

End point timeframe

At one month (M1) and 12 months (M12) post primary vaccination

Notes
[7] - 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: The analysis was only performed on all subjects of the Control groups and all subjects part of the group with the selected MenACWY-TT formulation (Formulation 1).

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Control Group
Number of subjects analysed	31	30	44	37
Units: Subjects
rSBA-MenA, M1 (N=31,27,43,36)	31	14	42	36
rSBA-MenC, M1 (N=31,30,44,37)	31	23	42	34
rSBA-MenW-135, M1 (N=31,29,44,37)	30	6	43	35
rSBA-MenY, M1 (N=31,29,44,37)	30	13	44	36
rSBA-MenA, M12 (N=23,25,39,33)	23	19	39	32
rSBA-MenC, M12 (N=31,29,41,32)	13	15	27	10
rSBA-MenW-135, M12 (N=31,27,41,35)	27	6	41	27
rSBA-MenY, M12 (N=31,29,41,37)	30	17	40	32

No statistical analyses for this end point

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres

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End point title

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres ^[8]

End point description

Antibody titres against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titres (GMTs).

End point type

Secondary

End point timeframe

At one month (M1) and 12 months (M12) post primary vaccination

Notes
[8] - 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: The analysis was only performed on all subjects of the Control groups and all subjects part of the group with the selected MenACWY-TT formulation (Fromulation 1).

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Control Group
Number of subjects analysed	31	30	44	37
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA, M1 (N=31,27,43,36)	6577.8 (4606.7 to 9392.4)	84.9 (32.4 to 222.8)	6565.3 (4616.3 to 9337.2)	4649.5 (3572.8 to 6050.8)
rSBA-MenC, M1 (N=31,30,44,37)	660.4 (484.4 to 900.3)	440.2 (227.1 to 853.1)	893.6 (600.3 to 1330.3)	416.2 (270.5 to 640.5)
rSBA-MenW-135, M1 (N=31,29,44,37)	2523.5 (1433.1 to 4443.7)	17.2 (7.9 to 37.8)	3893.6 (2671.2 to 5675.6)	1004.4 (690.4 to 1461.2)
rSBA-MenY, M1 (N=31,29,44,37)	2483.9 (1363.8 to 4524.1)	57.7 (27.1 to 123.2)	4808.5 (3653 to 6329.6)	1641.1 (1131.2 to 2380.9)
rSBA-MenA, M12 (N=23,25,39,33)	2369.1 (1642 to 3418.2)	179.3 (76.1 to 422.9)	2356.7 (1786.7 to 3108.4)	1134.3 (767.8 to 1675.5)
rSBA-MenC, M12 (N=31,29,41,32)	110.2 (60.6 to 200.7)	122 (59 to 252.2)	172.5 (117.7 to 252.9)	41.7 (22 to 79.2)
rSBA-MenW-135, M12 (N=31,27,41,35)	541.8 (305.5 to 961)	18.9 (8.4 to 42.9)	1322.2 (978.3 to 1786.8)	181.7 (104.6 to 315.8)
rSBA-MenY, M12 (N=31,29,41,37)	740.3 (493.4 to 1110.9)	110.6 (51.6 to 237.1)	1400.8 (1008.8 to 1945.1)	347.2 (228.2 to 528.5)

No statistical analyses for this end point

Secondary: Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ≥ 0.3 μg/mL

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End point title

Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ≥ 0.3 μg/mL ^[9]

End point description

End point type

Secondary

End point timeframe

At one month (M1) and 12 months (M12) post primary vaccination

Notes
[9] - 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: The analysis was only performed on all subjects of the Control groups and all subjects part of the group with the selected MenACWY-TT formulation (Fromulation 1).

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Control Group
Number of subjects analysed	31	30	43	37
Units: Subjects
Anti-PSA, M1 (N=31,25,41,37)	30	1	41	37
Anti-PSC, M1 (N=29,30,42,37)	28	30	42	37
Anti-PSW-135, M1 (N=30,29,43,37)	29	0	41	37
Anti-PSY, M1 (N=30,27,43,37)	29	2	42	37
Anti-PSA, M12 (N=27,22,38,36)	22	2	34	34
Anti-PSC, M12 (N=27,27,39,37)	13	18	18	36
Anti-PSW-135, M12 (N=25,21,37,34)	25	3	34	32
Anti-PSY, M12 (N=26,21,37,35)	26	3	34	35

No statistical analyses for this end point

Secondary: Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ≥ 2.0 μg/mL

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End point title

Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ≥ 2.0 μg/mL ^[10]

End point description

End point type

Secondary

End point timeframe

At one month (M1) and 12 months (M12) post primary vaccination

Notes
[10] - 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: The analysis was only performed on all subjects of the Control groups and all subjects part of the group with the selected MenACWY-TT formulation (Fromulation 1).

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Control Group
Number of subjects analysed	31	30	43	37
Units: Subjects
Anti-PSA, M1 (N=31,25,41,37)	30	0	41	33
Anti-PSC, M1 (N=29,30,42,37)	28	29	37	37
Anti-PSW-135, M1 (N=30,29,43,37)	28	0	34	32
Anti-PSY, M1 (N=30,27,43,37)	29	0	39	35
Anti-PSA, M12 (N=27,22,38,36)	10	0	12	22
Anti-PSC, M12 (N=27,27,39,37)	2	4	0	24
Anti-PSW-135, M12 (N=25,21,37,34)	6	2	10	23
Anti-PSY, M12 (N=26,21,37,35)	15	1	19	30

No statistical analyses for this end point

Secondary: Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations

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End point title

Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ^[11]

End point description

End point type

Secondary

End point timeframe

At one month (M1) and 12 months (M12) post primary vaccination

Notes
[11] - 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: The analysis was only performed on all subjects of the Control groups and all subjects part of the group with the selected MenACWY-TT formulation (Fromulation 1).

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Control Group
Number of subjects analysed	31	30	43	37
Units: µg/mL
geometric mean (confidence interval 95%)
Anti-PSA, M1 (N=31,25,41,37)	32.72 (20.12 to 53.22)	0.17 (0.14 to 0.2)	18.29 (12.86 to 26.01)	13 (8.19 to 20.63)
Anti-PSC, M1 (N=29,30,42,37)	11.25 (7.48 to 16.93)	12.43 (9.28 to 16.65)	5.64 (4.21 to 7.57)	14.5 (11.01 to 19.1)
Anti-PSW-135, M1 (N=30,29,43,37)	6.65 (4.29 to 10.3)	0.15 (0.15 to 0.15)	4.23 (2.94 to 6.09)	8.17 (5.19 to 12.86)
Anti-PSY, M1 (N=30,27,43,37)	10.37 (6.74 to 15.94)	0.16 (0.15 to 0.17)	8.07 (5.79 to 11.24)	18.12 (12.41 to 26.46)
Anti-PSA, M12 (N=27,22,38,36)	1.25 (0.68 to 2.3)	0.17 (0.14 to 0.21)	1.32 (0.9 to 1.95)	4.43 (2.55 to 7.7)
Anti-PSC, M12 (N=27,27,39,37)	0.39 (0.23 to 0.66)	0.54 (0.34 to 0.86)	0.28 (0.22 to 0.36)	2.9 (1.94 to 4.35)
Anti-PSW-135, M12 (N=25,21,37,34)	1.36 (1.06 to 1.74)	0.21 (0.14 to 0.32)	1.11 (0.79 to 1.57)	3.16 (1.87 to 5.34)
Anti-PSY, M12 (N=26,21,37,35)	2.36 (1.75 to 3.18)	0.21 (0.14 to 0.33)	1.84 (1.2 to 2.82)	6.9 (4.51 to 10.54)

No statistical analyses for this end point

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:8 and ≥ 1:128

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End point title

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:8 and ≥ 1:128

End point description

A seropositive subject for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY was defined as a vaccinated subject with antibody titres greater than or equal to (≥) 1:128, while for a seroprotected subject, titres were ≥1:8.

End point type

Secondary

End point timeframe

Before (PRE = at Month 12) and post (M13 = at Month 13) booster vaccination.

End point values	12-14 months of age Booster Group	12-14 months of age Booster Control Group
Number of subjects analysed	27	24
Units: Subjects
rSBA-MenA ≥ 1:8, PRE (N=20,21)	20	17
rSBA-MenC ≥ 1:8, PRE (N=27,24)	25	20
rSBA-MenW-135 ≥ 1:8, PRE (N=27,23)	26	9
rSBA-MenY ≥ 1:8, PRE (N=27,24)	27	18
rSBA-MenA ≥ 1:128, PRE (N=20,21)	20	16
rSBA-MenC ≥ 1:128, PRE (N=27,24)	10	12
rSBA-MenW-135 ≥ 1:128, PRE (N=27,23)	23	4
rSBA-MenY ≥ 1:128, PRE (N=27,24)	26	14
rSBA-MenA ≥ 1:8, M13 (N=6,20)	6	19
rSBA-MenC ≥ 1:8, M13 (N=25,24)	25	24
rSBA-MenW-135 ≥ 1:8, M13 (N=25,24)	25	21
rSBA-MenY ≥ 1:8, M13 (N=25,24)	25	22
rSBA-MenA ≥ 1:128, M13 (N=6,20)	6	19
rSBA-MenC ≥ 1:128, M13 (N=25,24)	24	24
rSBA-MenW-135 ≥ 1:128, M13 (N=25,24)	25	18
rSBA-MenY ≥ 1:128, M13 (N=25,24)	25	20

No statistical analyses for this end point

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers

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End point title

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers

End point description

Antibody titres against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titres (GMTs).

End point type

Secondary

End point timeframe

Before (PRE = at Month 12) and post (M13 = at Month 13) booster vaccination.

End point values	12-14 months of age Booster Group	12-14 months of age Booster Control Group
Number of subjects analysed	27	24
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA, PRE (N=20,21)	2163.4 (1436.6 to 3257.9)	175.7 (70.5 to 437.8)
rSBA-MenC, PRE (N=27,24)	82.5 (50.3 to 135.4)	102.5 (47.7 to 220.3)
rSBA-MenW-135, PRE (N=27,23)	436 (243.7 to 780.2)	15.5 (7 to 34.3)
rSBA-MenY, PRE (N=27,24)	634.5 (420 to 958.3)	93.6 (38.4 to 228.1)
rSBA-MenA, M13 (N=6,20)	3695.2 (1535.2 to 8894.7)	984.6 (479.7 to 2021.2)
rSBA-MenC, M13 (N=25,24)	7067.4 (4070.7 to 12270.3)	9209.3 (5153.4 to 16457.5)
rSBA-MenW-135, M13 (N=25,24)	5642.4 (3360 to 9475.4)	255.6 (110.1 to 593.6)
rSBA-MenY, M13 (N=25,24)	3337.7 (2013.7 to 5532.1)	323.8 (153.6 to 682.7)

No statistical analyses for this end point

Secondary: Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ≥ 0.3 μg/mL and ≥ 2.0 μg/mL

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End point title

Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ≥ 0.3 μg/mL and ≥ 2.0 μg/mL

End point description

A seropositive subject for anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY was defined as a vaccinated subject with antibody concentrations greater than or equal to (≥) 0.3 micrograms per millilitre (μg/mL), while for a seroprotected subject, antibody concentrations were ≥ 2.0 μg/mL.

End point type

Secondary

End point timeframe

Before (PRE) and 1 Month post (M13) booster vaccination

End point values	12-14 months of age Booster Group	12-14 months of age Booster Control Group
Number of subjects analysed	26	23
Units: Subjects
Anti-PSA ≥ 0.3 μg/mL, PRE (N=24,19)	19	1
Anti-PSC ≥ 0.3 μg/mL, PRE (N=24,23)	11	15
Anti-PSW-135 ≥ 0.3 μg/mL, PRE (N=23,18)	23	2
Anti-PSY ≥ 0.3 μg/mL, PRE (N=24,18)	24	2
Anti-PSA ≥ 2.0 μg/mL, PRE(N=24,19)	7	0
Anti-PSC ≥ 2.0 μg/mL, PRE (N=24,23)	1	3
Anti-PSW-135 ≥ 2.0 μg/mL, PRE (N=23,18)	5	1
Anti-PSY ≥ 2.0 μg/mL, PRE (N=24,18)	14	0
Anti-PSA ≥ 0.3 μg/mL, M13 (N=26,21)	26	19
Anti-PSC ≥ 0.3 μg/mL, M13 (N=26,22)	25	22
Anti-PSW-135 ≥ 0.3 μg/mL, M13 (N=25,21)	25	18
Anti-PSY ≥ 0.3 μg/mL, M13 (N=25,21)	25	20
Anti-PSA ≥ 2.0 μg/mL, M13 (N=26,21)	25	13
Anti-PSC ≥ 2.0 μg/mL, M13 (N=26,22)	25	22
Anti-PSW-135 ≥ 2.0 μg/mL, M13 (N=25,21)	24	9
Anti-PSY ≥ 2.0 μg/mL, M13 (N=25,21)	24	12

No statistical analyses for this end point

Secondary: Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations

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End point title

Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations

End point description

End point type

Secondary

End point timeframe

Before (PRE) and 1 Month post (M13) booster vaccination

End point values	12-14 months of age Booster Group	12-14 months of age Booster Control Group
Number of subjects analysed	26	23
Units: μg/mL
geometric mean (confidence interval 95%)
Anti-PSA, PRE (N=24,19)	0.98 (0.56 to 1.69)	0.16 (0.14 to 0.18)
Anti-PSA, POST (N=26,21)	0.32 (0.22 to 0.48)	0.5 (0.31 to 0.8)
Anti-PSC, PRE (N=24,23)	1.33 (1.02 to 1.72)	0.19 (0.13 to 0.27)
Anti-PSC, POST (N=26,22)	2.34 (1.69 to 3.24)	0.19 (0.13 to 0.26)
Anti-PSW-135, PRE (N=23,18)	25.67 (17.39 to 37.91)	3.1 (1.34 to 7.2)
Anti-PSW-135, POST (N=25,21)	11.63 (7.73 to 17.5)	15.23 (10.66 to 21.77)
Anti-PSY, PRE (N=24,18)	56.94 (35.87 to 90.38)	1.34 (0.63 to 2.88)
Anti-PSY, POST (N=25,21)	79.03 (52.06 to 119.97)	4.19 (2 to 8.78)

No statistical analyses for this end point

Secondary: Number of subjects with solicited local symptoms

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End point title

Number of subjects with solicited local symptoms

End point description

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

End point type

Secondary

End point timeframe

During the 8-day (Days 0-7) post-vaccination period following booster dose

End point values	12-14 months of age Booster Group	12-14 months of age Booster Control Group
Number of subjects analysed	31	30
Units: Subjects
Pain	1	0
Redness	3	3
Swelling	1	1

No statistical analyses for this end point

Secondary: Number of subjects with solicited general symptoms

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End point title

Number of subjects with solicited general symptoms

End point description

Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.

End point type

Secondary

End point timeframe

During the 8-day (Days 0-7) post-vaccination period following booster dose

End point values	12-14 months of age Booster Group	12-14 months of age Booster Control Group
Number of subjects analysed	31	30
Units: Subjects
Any Drowsiness	3	5
Any Fever (Rectally)	5	3
Any Irritability	4	5
Any Loss of appetite	2	2

No statistical analyses for this end point

Secondary: Number of subjects with unsolicited Adverse Events (AEs) after primary meningococcal vaccination

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End point title

Number of subjects with unsolicited Adverse Events (AEs) after primary meningococcal vaccination

End point description

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

End point type

Secondary

End point timeframe

Within 31 days (Days 0-30) after the primary meningococcal vaccination

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	39	41	41	40	40	54	50	52	52	52
Units: Subjects
Any AEs	11	16	5	8	14	6	12	7	5	6

No statistical analyses for this end point

Secondary: Number of subjects with unsolicited AEs after DTPa primary vaccination

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End point title

Number of subjects with unsolicited AEs after DTPa primary vaccination ^[12]

End point description

End point type

Secondary

End point timeframe

Within 31 days (Days 0-30) post-vaccination with diphteria, tetanus and acellular pertusis-containing vaccine, during the primary vaccination

Notes
[12] - 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: The analysis was only performed on subjects who had received DTPA vaccination (Infanrix or Infanrix hexa vaccines).

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group
Number of subjects analysed	38	40	37	40	39
Units: Subjects
Any AEs	5	8	5	5	7

No statistical analyses for this end point

Secondary: Number of subjects with unsolicited AEs

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End point title

Number of subjects with unsolicited AEs

End point description

End point type

Secondary

End point timeframe

Within 31 days (Days 0-30) after the booster vaccination

End point values	12-14 months of age Booster Group	12-14 months of age Booster Control Group
Number of subjects analysed	33	32
Units: Subjects
Any AEs	3	5

No statistical analyses for this end point

Secondary: Number of subjects with Serious Adverse Events (SAEs)

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End point title

Number of subjects with Serious Adverse Events (SAEs)

End point description

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

End point type

Secondary

End point timeframe

During the primary vaccination study (Month 0 up to Month 2)

End point values	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Number of subjects analysed	39	41	41	40	40	54	50	52	52	52
Units: Subjects
Any SAEs	1	1	1	1	1	0	0	0	0	0

No statistical analyses for this end point

Secondary: Number of subjects with SAEs

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End point title

Number of subjects with SAEs

End point description

End point type

Secondary

End point timeframe

Since the last study contact in the primary study to the end of the booster study (Month 2 up to Month 13)

End point values	12-14 months of age Booster Group	12-14 months of age Booster Control Group	3-5 years of age Booster Group	3-5 years of age Booster Control Group
Number of subjects analysed	33	32	45	43
Units: Subjects
Any SAEs	0	0	0	0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Solicited symptoms reported during the 8-day and unsolicited AEs during the 31-day follow-up period after primary vaccination. SAEs reported during the primary course of the study (Month 0 up to 2). For booster data, refer to the specific endpoints.

Adverse event reporting additional description

The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets. Except for the 5 toddlers (T) primary groups, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) is currently populated by the highest value of #Participants affected within other AE’s table.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

9.0

Reporting group title

12-14 months of age Formulation 1 Group

Reporting group description

Reporting group title

12-14 months of age Formulation 2 Group

Reporting group description

Reporting group title

12-14 months of age Formulation 3 Group

Reporting group description

Reporting group title

12-14 months of age Formulation 4 Group

Reporting group description

Reporting group title

12-14 months of age Control Group

Reporting group description

Reporting group title

3-5 years of age Formulation 1 Group

Reporting group description

Reporting group title

3-5 years of age Formulation 2 Group

Reporting group description

Reporting group title

3-5 years of age Formulation 3 Group

Reporting group description

Reporting group title

3-5 years of age Formulation 4 Group

Reporting group description

Reporting group title

3-5 years of age Control Group

Reporting group description

Serious adverse events	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 39 (2.56%)	1 / 41 (2.44%)	1 / 41 (2.44%)	1 / 40 (2.50%)	1 / 40 (2.50%)	0 / 54 (0.00%)	0 / 50 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)
number of deaths (all causes)	0	0	0	0	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0	0	0	0	0
Skin and subcutaneous tissue disorders
Maculo-papular rash
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 39 (0.00%)	0 / 41 (0.00%)	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 40 (2.50%)	0 / 54 (0.00%)	0 / 50 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Laryngitis
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 39 (0.00%)	0 / 41 (0.00%)	1 / 41 (2.44%)	1 / 40 (2.50%)	0 / 40 (0.00%)	0 / 54 (0.00%)	0 / 50 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Acute bronchitis
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 39 (0.00%)	1 / 41 (2.44%)	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 40 (0.00%)	0 / 54 (0.00%)	0 / 50 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bronchiolitis
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 39 (2.56%)	0 / 41 (0.00%)	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 40 (0.00%)	0 / 54 (0.00%)	0 / 50 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	12-14 months of age Formulation 1 Group	12-14 months of age Formulation 2 Group	12-14 months of age Formulation 3 Group	12-14 months of age Formulation 4 Group	12-14 months of age Control Group	3-5 years of age Formulation 1 Group	3-5 years of age Formulation 2 Group	3-5 years of age Formulation 3 Group	3-5 years of age Formulation 4 Group	3-5 years of age Control Group
Total subjects affected by non serious adverse events
subjects affected / exposed	20 / 39 (51.28%)	27 / 41 (65.85%)	23 / 41 (56.10%)	24 / 40 (60.00%)	25 / 40 (62.50%)	10 / 54 (18.52%)	11 / 50 (22.00%)	10 / 52 (19.23%)	11 / 52 (21.15%)	13 / 52 (25.00%)
General disorders and administration site conditions
Pain
subjects affected / exposed ^[1]	5 / 38 (13.16%)	13 / 41 (31.71%)	8 / 39 (20.51%)	10 / 40 (25.00%)	9 / 39 (23.08%)	10 / 54 (18.52%)	11 / 50 (22.00%)	9 / 52 (17.31%)	11 / 52 (21.15%)	13 / 52 (25.00%)
occurrences all number	5	13	8	10	9	10	11	9	11	13
Redness
subjects affected / exposed ^[2]	12 / 38 (31.58%)	15 / 41 (36.59%)	11 / 39 (28.21%)	11 / 40 (27.50%)	13 / 39 (33.33%)	9 / 54 (16.67%)	11 / 50 (22.00%)	10 / 52 (19.23%)	9 / 52 (17.31%)	7 / 52 (13.46%)
occurrences all number	12	15	11	11	13	9	11	10	9	7
Swelling
subjects affected / exposed ^[3]	4 / 38 (10.53%)	8 / 41 (19.51%)	9 / 39 (23.08%)	9 / 40 (22.50%)	6 / 39 (15.38%)	7 / 54 (12.96%)	9 / 50 (18.00%)	8 / 52 (15.38%)	10 / 52 (19.23%)	4 / 52 (7.69%)
occurrences all number	4	8	9	9	6	7	9	8	10	4
Drowsiness
subjects affected / exposed ^[4]	2 / 38 (5.26%)	6 / 41 (14.63%)	4 / 39 (10.26%)	9 / 40 (22.50%)	7 / 39 (17.95%)	4 / 54 (7.41%)	2 / 50 (4.00%)	0 / 52 (0.00%)	5 / 52 (9.62%)	4 / 52 (7.69%)
occurrences all number	2	6	4	9	7	4	2	0	5	4
Fever
subjects affected / exposed ^[5]	8 / 38 (21.05%)	10 / 41 (24.39%)	10 / 39 (25.64%)	8 / 40 (20.00%)	11 / 39 (28.21%)	4 / 54 (7.41%)	4 / 50 (8.00%)	3 / 52 (5.77%)	3 / 52 (5.77%)	3 / 52 (5.77%)
occurrences all number	8	10	10	8	11	4	4	3	3	3
Irritability
subjects affected / exposed ^[6]	8 / 38 (21.05%)	13 / 41 (31.71%)	6 / 39 (15.38%)	10 / 40 (25.00%)	8 / 39 (20.51%)	2 / 54 (3.70%)	4 / 50 (8.00%)	2 / 52 (3.85%)	4 / 52 (7.69%)	7 / 52 (13.46%)
occurrences all number	8	13	6	10	8	2	4	2	4	7
Loss of appetite
subjects affected / exposed ^[7]	4 / 38 (10.53%)	9 / 41 (21.95%)	5 / 39 (12.82%)	8 / 40 (20.00%)	7 / 39 (17.95%)	2 / 54 (3.70%)	3 / 50 (6.00%)	2 / 52 (3.85%)	6 / 52 (11.54%)	3 / 52 (5.77%)
occurrences all number	4	9	5	8	7	2	3	2	6	3
Pyrexia
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 39 (2.56%)	0 / 41 (0.00%)	0 / 41 (0.00%)	0 / 40 (0.00%)	2 / 40 (5.00%)	1 / 54 (1.85%)	0 / 50 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)
occurrences all number	1	0	0	0	2	1	0	0	0	0
Gastrointestinal disorders
Diarrhea
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 39 (0.00%)	1 / 41 (2.44%)	0 / 41 (0.00%)	2 / 40 (5.00%)	0 / 40 (0.00%)	0 / 54 (0.00%)	1 / 50 (2.00%)	0 / 52 (0.00%)	1 / 52 (1.92%)	0 / 52 (0.00%)
occurrences all number	0	1	0	2	0	0	1	0	1	0
Respiratory, thoracic and mediastinal disorders
Cough
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 39 (0.00%)	3 / 41 (7.32%)	0 / 41 (0.00%)	0 / 40 (0.00%)	1 / 40 (2.50%)	1 / 54 (1.85%)	0 / 50 (0.00%)	1 / 52 (1.92%)	0 / 52 (0.00%)	0 / 52 (0.00%)
occurrences all number	0	3	0	0	1	1	0	1	0	0
Skin and subcutaneous tissue disorders
Rash
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 39 (0.00%)	3 / 41 (7.32%)	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 40 (0.00%)	0 / 54 (0.00%)	0 / 50 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)
occurrences all number	0	3	0	0	0	0	0	0	0	0
Infections and infestations
Rhinitis
alternative assessment type: Non-systematic
subjects affected / exposed	3 / 39 (7.69%)	2 / 41 (4.88%)	0 / 41 (0.00%)	1 / 40 (2.50%)	3 / 40 (7.50%)	0 / 54 (0.00%)	0 / 50 (0.00%)	1 / 52 (1.92%)	0 / 52 (0.00%)	1 / 52 (1.92%)
occurrences all number	3	2	0	1	3	0	0	1	0	1
Pharyngitis
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 39 (2.56%)	0 / 41 (0.00%)	0 / 41 (0.00%)	0 / 40 (0.00%)	2 / 40 (5.00%)	0 / 54 (0.00%)	1 / 50 (2.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)
occurrences all number	1	0	0	0	2	0	1	0	0	0
Gastroenteritis viral
alternative assessment type: Non-systematic
subjects affected / exposed	2 / 39 (5.13%)	0 / 41 (0.00%)	0 / 41 (0.00%)	0 / 40 (0.00%)	0 / 40 (0.00%)	0 / 54 (0.00%)	0 / 50 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0	0
Bronchitis
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 39 (0.00%)	0 / 41 (0.00%)	0 / 41 (0.00%)	1 / 40 (2.50%)	2 / 40 (5.00%)	1 / 54 (1.85%)	1 / 50 (2.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)
occurrences all number	0	0	0	1	2	1	1	0	0	0

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Solicited local/general symptoms were tabulated only for subjects with a symptom sheet completed.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Solicited local/general symptoms were tabulated only for subjects with a symptom sheet completed.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Solicited local/general symptoms were tabulated only for subjects with a symptom sheet completed.
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Solicited local/general symptoms were tabulated only for subjects with a symptom sheet completed.
[5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Solicited local/general symptoms were tabulated only for subjects with a symptom sheet completed.
[6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Solicited local/general symptoms were tabulated only for subjects with a symptom sheet completed.
[7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Solicited local/general symptoms were tabulated only for subjects with a symptom sheet completed.

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Were there any global substantial amendments to the protocol? Yes

14 Feb 2005

Due to logistic changes, the vial containing the formulation without spacer of the candidate MenACWY-TT vaccine differs slightly in appearance from the vials containing the 3 different formulations with spacer. Therefore the three different formulations with spacer of the candidate MenACWY-TT vaccine (F1, F2 and F3) will be administered in a double-blind manner with respect to each other, however they will be single-blinded with respect to the formulation without spacer (F4). The requirements for regulatory reporting of SAEs have been changed to comply with new regulations following the European Union Clinical Trial Directive, and to align with GSK Biologicals’ standard operating procedures.

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.

For safety results after booster vaccination (not included in this summary due to a technical limitation), please refer to the respective endpoints or to the safety section detailed at https://www.clinicaltrials.gov/ct2/show/results/NCT00196976.

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of subjects with an immune response to the serum bactericidal assay meningococcal serogroup A using rabbit complement (rSBA-MenA), rSBA-MenC, rSBA-MenW-135, rSBA-MenY

Primary: Number of subjects with an immune response to the serum bactericidal assay meningococcal serogroup A using rabbit complement (rSBA-MenA), rSBA-MenC, rSBA-MenW-135, rSBA-MenY

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:8

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:8

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:128.

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:128.

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres

Secondary: Number of subjects with anti-polysaccharide A (PSA), anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ≥ 0.3 μg/mL

Secondary: Number of subjects with anti-polysaccharide A (PSA), anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ≥ 0.3 μg/mL

Secondary: Number of subjects with anti-polysaccharide A (PSA), anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ≥ 2.0 μg/mL

Secondary: Number of subjects with anti-polysaccharide A (PSA), anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ≥ 2.0 μg/mL

Secondary: Anti-polysaccharide A (PSA), anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations

Secondary: Anti-polysaccharide A (PSA), anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations

Secondary: Number of subjects with anti-tetanus (anti-T) antibody concentrations ≥ 0.1 IU/mL

Secondary: Number of subjects with anti-tetanus (anti-T) antibody concentrations ≥ 0.1 IU/mL

Secondary: Anti-T antibody concentrations

Secondary: Anti-T antibody concentrations

Secondary: Number of toddlers with solicited local symptoms

Secondary: Number of toddlers with solicited local symptoms

Secondary: Number of children with solicited local symptoms

Secondary: Number of children with solicited local symptoms

Secondary: Number of toddlers with solicited general symptoms

Secondary: Number of toddlers with solicited general symptoms

Secondary: Number of children with solicited general symptoms

Secondary: Number of children with solicited general symptoms

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:8

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:8

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:128.

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:128.

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres

Secondary: Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ≥ 0.3 μg/mL

Secondary: Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ≥ 0.3 μg/mL

Secondary: Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ≥ 2.0 μg/mL

Secondary: Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ≥ 2.0 μg/mL

Secondary: Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations

Secondary: Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:8 and ≥ 1:128

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥ 1:8 and ≥ 1:128

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers

Secondary: Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ≥ 0.3 μg/mL and ≥ 2.0 μg/mL

Secondary: Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ≥ 0.3 μg/mL and ≥ 2.0 μg/mL

Secondary: Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations

Secondary: Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations

Secondary: Number of subjects with solicited local symptoms

Secondary: Number of subjects with solicited local symptoms

Secondary: Number of subjects with solicited general symptoms

Secondary: Number of subjects with solicited general symptoms

Secondary: Number of subjects with unsolicited Adverse Events (AEs) after primary meningococcal vaccination

Secondary: Number of subjects with unsolicited Adverse Events (AEs) after primary meningococcal vaccination

Secondary: Number of subjects with unsolicited AEs after DTPa primary vaccination

Secondary: Number of subjects with unsolicited AEs after DTPa primary vaccination

Secondary: Number of subjects with unsolicited AEs

Secondary: Number of subjects with unsolicited AEs

Secondary: Number of subjects with Serious Adverse Events (SAEs)

Secondary: Number of subjects with Serious Adverse Events (SAEs)

Secondary: Number of subjects with SAEs

Secondary: Number of subjects with SAEs

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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