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Clinical Trial Results:
A phase IIb, open, randomized, controlled primary vaccination study to evaluate the non-inferiority and the persistence of the immune response of GSK Biologicals’ meningococcal serogroup ACWY conjugate vaccine given intramuscularly versus Meningitec or Mencevax ACWY to healthy subjects aged 1 through 10 years of age.

Summary
EudraCT number	2006-004236-70
Trial protocol	FI
Global end of trial date	24 May 2012

Results information
Results version number	v3(current)
This version publication date	19 Apr 2023
First version publication date	17 Jun 2015
Other versions	v1 (removed from public view) , v2
Version creation reason	Correction of full data set Correction of full data set and alignment between registries.

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

108658-60-61-63-65-68

ISRCTN number

US NCT number

NCT00427908

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

24 May 2012

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

24 May 2012

Was the trial ended prematurely?

Main objective of the trial

One month after vaccination: For Subjects of 2 years of age and above •To evaluate the non-inferiority of MenACWY-TT conjugate vaccine compared to MenACWY plain polysaccharide vaccine in terms of the vaccine response$ to MenA, MenC, MenY, and MenW-135. For Subjects below 2 years of age •To evaluate the non-inferiority of the vaccine response induced by MenACWY-TT conjugate vaccine when compared to the licensed MenC-CRM vaccine for MenC as measured by rSBA. •To evaluate the immunogenicity induced by MenACWY-TT conjugate vaccine for MenA, MenW-135, and MenY as measured by rSBA.

Protection of trial subjects

All subjects were supervised for 30 min after vaccination/product administration with appropriate medical treatment readily available. Vaccines/products were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines/products. Subjects were followed-up for 30 days after the last vaccination/product administration.

Background therapy

Evidence for comparator

Actual start date of recruitment

07 Feb 2007

Long term follow-up planned

Yes

Long term follow-up rationale

Efficacy

Long term follow-up duration

5 Years

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Finland: 613

Worldwide total number of subjects

613

EEA total number of subjects

613

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)

304

Children (2-11 years)

309

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 phase

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Nimenrix 1-2 years of age Group

Arm description

Subjects from 1 to 2 years of age who received one dose of Nimenrix vaccine administrated intramuscularly (IM) by injection in the non-dominant deltoid or the thigh region.

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered intramuscularly in the non-dominant deltoid or thigh region.

Nimenrix 2-6 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered intramuscularly in the non-dominant deltoid or thigh region.

Nimenrix 6-11 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered intramuscularly in the non-dominant deltoid or thigh region.

Meningitec 1-2 years of age Group

Arm description

Subjects from 1 to 2 years of age who received one dose of Meningitec vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.

Arm type

Active comparator

Investigational medicinal product name

Meningitec

Investigational medicinal product code

Other name

MenC-CRM

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered intramuscularly in the non-dominant deltoid or thigh region.

Mencevax 2-6 years of age Group

Arm description

Arm type

Active comparator

Investigational medicinal product name

Mencevax

Investigational medicinal product code

Other name

MenACWY

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered subcutaneously in the non-dominant upper arm.

Mencevax 6-11 years of age Group

Arm description

Arm type

Active comparator

Investigational medicinal product name

Mencevax

Investigational medicinal product code

Other name

MenACWY

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered subcutaneously in the non-dominant upper arm.

Number of subjects in period 1	Nimenrix 1-2 years of age Group	Nimenrix 2-6 years of age Group	Nimenrix 6-11 years of age Group	Meningitec 1-2 years of age Group	Mencevax 2-6 years of age Group	Mencevax 6-11 years of age Group
Started	229	114	117	75	39	39
Completed	224	110	112	72	39	39
Not completed	5	4	5	3	0	0
Consent withdrawn by subject	1	3	-	1	-	-
Lost to follow-up (complete vaccination)	4	1	-	2	-	-
Lost to follow-up (completed vaccination)	-	-	5	-	-	-

Period 2 title

Persistence Phase Year 1

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Nimenrix 1-2 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered intramuscularly in the non-dominant deltoid or thigh region.

Nimenrix 2-11 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered intramuscularly in the non-dominant deltoid or thigh region

Meningitec 1-2 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Meningitec

Investigational medicinal product code

Other name

MenC-CRM

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered intramuscularly in the non-dominant deltoid or thigh region

Mencevax 2-11 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Mencevax

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered subcutaneously in the non-dominant upper arm.

Number of subjects in period 2 ^[1]	Nimenrix 1-2 years of age Group	Nimenrix 2-11 years of age Group	Meningitec 1-2 years of age Group	Mencevax 2-11 years of age Group
Started	222	221	71	78
Completed	222	221	71	78

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 study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.

Period 3 title

Persistence Phase Year 2

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Nimenrix 1-2 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered intramuscularly in the non-dominant deltoid or thigh region

Nimenrix 2-11 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered intramuscularly in the non-dominant deltoid or thigh region

Meningitec 1-2 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Meningitec

Investigational medicinal product code

Other name

MenC-CRM

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered intramuscularly in the non-dominant deltoid or thigh region

Mencevax 2-11 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Mencevax

Investigational medicinal product code

Other name

MenACWY

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered subcutaneously in the non-dominant upper arm.

Number of subjects in period 3 ^[2]	Nimenrix 1-2 years of age Group	Nimenrix 2-11 years of age Group	Meningitec 1-2 years of age Group	Mencevax 2-11 years of age Group
Started	208	215	53	61
Completed	208	215	53	61

Notes
[2] - 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 study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.

Period 4 title

Persistence Phase Year 3

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Nimenrix™ 1-2 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Nimenrix™

Investigational medicinal product code

Other name

MenACWY-TT

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered intramuscularly in the non-dominant deltoid or thigh region

Nimenrix™ 2-11 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Nimenrix™

Investigational medicinal product code

Other name

MenACWY-TT

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered intramuscularly in the non-dominant deltoid or thigh region

Meningitec™ 1-2 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Meningitec™

Investigational medicinal product code

Other name

MenC-CRM

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered intramuscularly in the non-dominant deltoid or thigh region

Mencevax™ 2-11 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Meningitec™

Investigational medicinal product code

Other name

MenACWY

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered intramuscularly in the non-dominant deltoid or thigh region

Number of subjects in period 4 ^[3]	Nimenrix™ 1-2 years of age Group	Nimenrix™ 2-11 years of age Group	Meningitec™ 1-2 years of age Group	Mencevax™ 2-11 years of age Group
Started	185	201	38	38
Completed	185	201	38	38

Notes
[3] - 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 study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.

Period 5 title

Persistence Phase Year 4

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Nimenrix 1-2 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered intramuscularly in the non-dominant deltoid or thigh region

Nimenrix 2-11 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered intramuscularly in the non-dominant deltoid or thigh region

Meningitec 1-2 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Meningitec

Investigational medicinal product code

Other name

MenC-CRM

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered intramuscularly in the non-dominant deltoid or thigh region

Mencevax 2-11 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Mencevax

Investigational medicinal product code

Other name

MenACWY

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered subcutaneously in the non-dominant upper arm.

Number of subjects in period 5 ^[4]	Nimenrix 1-2 years of age Group	Nimenrix 2-11 years of age Group	Meningitec 1-2 years of age Group	Mencevax 2-11 years of age Group
Started	165	192	34	32
Completed	165	192	34	32

Notes
[4] - 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 study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.

Period 6 title

Persistence Phase Year 5

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Nimenrix 1-2 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered intramuscularly in the non-dominant deltoid or thigh region

Nimenrix 2-11 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered intramuscularly in the non-dominant deltoid or thigh region

Meningitec 1-2 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Meningitec

Investigational medicinal product code

Other name

MenC-CRM

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered intramuscularly in the non-dominant deltoid or thigh region

Mencevax 2-11 years of age Group

Arm description

Arm type

Experimental

Investigational medicinal product name

Mencevax

Investigational medicinal product code

Other name

MenACWY

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

One dose administered subcutaneously in the non-dominant upper arm.

Number of subjects in period 6 ^[5]	Nimenrix 1-2 years of age Group	Nimenrix 2-11 years of age Group	Meningitec 1-2 years of age Group	Mencevax 2-11 years of age Group
Started	52	99	12	13
Completed	52	99	12	13

Notes
[5] - 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 study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.

Baseline characteristics

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Reporting group title

Nimenrix 1-2 years of age Group

Reporting group description

Subjects from 1 to 2 years of age who received one dose of Nimenrix vaccine administrated intramuscularly (IM) by injection in the non-dominant deltoid or the thigh region.

Reporting group title

Nimenrix 2-6 years of age Group

Reporting group description

Reporting group title

Nimenrix 6-11 years of age Group

Reporting group description

Reporting group title

Meningitec 1-2 years of age Group

Reporting group description

Subjects from 1 to 2 years of age who received one dose of Meningitec vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.

Reporting group title

Mencevax 2-6 years of age Group

Reporting group description

Reporting group title

Mencevax 6-11 years of age Group

Reporting group description

Reporting group values	Nimenrix 1-2 years of age Group	Nimenrix 2-6 years of age Group	Nimenrix 6-11 years of age Group	Meningitec 1-2 years of age Group	Mencevax 2-6 years of age Group	Mencevax 6-11 years of age Group	Total
Number of subjects	229	114	117	75	39	39	613
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)	19.1 ( 2.96 )	44.1 ( 12.97 )	99 ( 16.27 )	19.3 ( 3.07 )	44.8 ( 12.51 )	98.3 ( 15.06 )	-
Gender categorical
Units: Subjects
Female	116	60	55	39	18	19	307
Male	113	54	62	36	21	20	306

Subject analysis set title

Nimenrix 2-11 years of age Primary Phase Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Pooled group of subjects above 2 years of age, participating in the Primary Phase.

Subject analysis set title

Mencevax 2-11 years of age Primary Phase Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Pooled group of subjects above 2 years of age, participating in the Primary phase.

Subject analysis sets values	Nimenrix 2-11 years of age Primary Phase Group	Mencevax 2-11 years of age Primary Phase Group
Number of subjects	231	78
Age categorical
Units: Subjects
In utero
Preterm newborn infants (gestational age < 37 wks)
Newborns (0-27 days)
Infants and toddlers (28 days-23 months)
Children (2-11 years)
Adolescents (12-17 years)
Adults (18-64 years)
From 65-84 years
85 years and over
Age continuous
Units: months
arithmetic mean (standard deviation)	71.91 ( 31.19 )	71.55 ( 30.23 )
Gender categorical
Units: Subjects
Female	115	37
Male	116	41

End points

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Reporting group title

Nimenrix 1-2 years of age Group

Reporting group description

Subjects from 1 to 2 years of age who received one dose of Nimenrix vaccine administrated intramuscularly (IM) by injection in the non-dominant deltoid or the thigh region.

Reporting group title

Nimenrix 2-6 years of age Group

Reporting group description

Reporting group title

Nimenrix 6-11 years of age Group

Reporting group description

Reporting group title

Meningitec 1-2 years of age Group

Reporting group description

Subjects from 1 to 2 years of age who received one dose of Meningitec vaccine administrated IM by injection in the non-dominant deltoid or the thigh region.

Reporting group title

Mencevax 2-6 years of age Group

Reporting group description

Reporting group title

Mencevax 6-11 years of age Group

Reporting group description

Reporting group title

Nimenrix 1-2 years of age Group

Reporting group description

Reporting group title

Nimenrix 2-11 years of age Group

Reporting group description

Reporting group title

Meningitec 1-2 years of age Group

Reporting group description

Reporting group title

Mencevax 2-11 years of age Group

Reporting group description

Reporting group title

Nimenrix 1-2 years of age Group

Reporting group description

Reporting group title

Nimenrix 2-11 years of age Group

Reporting group description

Reporting group title

Meningitec 1-2 years of age Group

Reporting group description

Reporting group title

Mencevax 2-11 years of age Group

Reporting group description

Reporting group title

Nimenrix™ 1-2 years of age Group

Reporting group description

Reporting group title

Nimenrix™ 2-11 years of age Group

Reporting group description

Reporting group title

Meningitec™ 1-2 years of age Group

Reporting group description

Reporting group title

Mencevax™ 2-11 years of age Group

Reporting group description

Reporting group title

Nimenrix 1-2 years of age Group

Reporting group description

Reporting group title

Nimenrix 2-11 years of age Group

Reporting group description

Reporting group title

Meningitec 1-2 years of age Group

Reporting group description

Reporting group title

Mencevax 2-11 years of age Group

Reporting group description

Reporting group title

Nimenrix 1-2 years of age Group

Reporting group description

Reporting group title

Nimenrix 2-11 years of age Group

Reporting group description

Reporting group title

Meningitec 1-2 years of age Group

Reporting group description

Reporting group title

Mencevax 2-11 years of age Group

Reporting group description

Subject analysis set title

Nimenrix 2-11 years of age Primary Phase Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Pooled group of subjects above 2 years of age, participating in the Primary Phase.

Subject analysis set title

Mencevax 2-11 years of age Primary Phase Group

Subject analysis set type

Sub-group analysis

Subject analysis set description

Pooled group of subjects above 2 years of age, participating in the Primary phase.

Primary: Number of subjects with rSBA antibodies vaccine response

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End point title

Number of subjects with rSBA antibodies vaccine response

End point description

End point type

Primary

End point timeframe

One Month after vaccination

End point values	Nimenrix 2-11 years of age Primary Phase Group	Mencevax 2-11 years of age Primary Phase Group
Number of subjects analysed	219	70
Units: Subjects
rSBA-MenA [N= 185;62]	182	57
rSBA-MenC [N= 212;69]	200	56
rSBA-MenW-135 [N= 199;68]	199	65
rSBA-MenY [N=219;70]	217	58

Difference in VRR to rSBA-MenA

Statistical analysis description

To evaluate the non-inferiority of MenACWY-TT conjugate vaccine compared to MenACWY plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenA. Response to a vaccine antigen component was defined as: - For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32; - For initially seropositive subject, at least 4-fold increase in rSBA titer from pre- to post-vaccination.

Comparison groups

Nimenrix 2-11 years of age Primary Phase Group v Mencevax 2-11 years of age Primary Phase Group

Number of subjects included in analysis

289

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[1]

Method

Parameter type

Difference in percentage

Point estimate

6.44

Confidence interval

level

95%

sides

2-sided

lower limit

1.15

upper limit

16.04

Notes
[1] - Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (MenACWY-TT minus MenACWY) in the percentage of subjects with bactericidal vaccine response to be greater than or equal to -15% for each of the four antigens.

Difference in VRR to rSBA-MenC

Statistical analysis description

To evaluate the non-inferiority of MenACWY-TT conjugate vaccine compared to MenACWY plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenC. Response to a vaccine antigen component was defined as: - For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32; - For initially seropositive subject, at least 4-fold increase in rSBA titer from pre- to post-vaccination.

Comparison groups

Mencevax 2-11 years of age Primary Phase Group v Nimenrix 2-11 years of age Primary Phase Group

Number of subjects included in analysis

289

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[2]

Method

Parameter type

Difference in percentage

Point estimate

13.18

Confidence interval

level

95%

sides

2-sided

lower limit

4.79

upper limit

24.32

Notes
[2] - Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (MenACWY-TT minus MenACWY) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for each of the four antigens.

Difference in VRR to rSBA-MenW-135

Statistical analysis description

To evaluate the non-inferiority of MenACWY-TT conjugate vaccine compared to MenACWY plain polysaccharide vaccine in terms of the vaccine response to MenW-135. Response to a vaccine antigen component was defined as: - For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32; - For initially seropositive subject, at least 4-fold increase in rSBA titer from pre- to post-vaccination.

Comparison groups

Nimenrix 2-11 years of age Primary Phase Group v Mencevax 2-11 years of age Primary Phase Group

Number of subjects included in analysis

289

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[3]

Method

Parameter type

Difference in percentage

Point estimate

4.41

Confidence interval

level

95%

sides

2-sided

lower limit

1.51

upper limit

12.21

Notes
[3] - Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (MenACWY-TT minus MenACWY) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for each of the four antigens.

Difference in VRR to rSBA-MenY

Statistical analysis description

To evaluate the non-inferiority of MenACWY-TT conjugate vaccine compared to MenACWY plain polysaccharide vaccine in terms of the vaccine response to MenY. Response to a vaccine antigen component was defined as: - For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32; - For initially seropositive subject, at least 4-fold increase in rSBA titer from pre- to post-vaccination.

Comparison groups

Nimenrix 2-11 years of age Primary Phase Group v Mencevax 2-11 years of age Primary Phase Group

Number of subjects included in analysis

289

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[4]

Method

Parameter type

Difference in percentage

Point estimate

16.23

Confidence interval

level

95%

sides

2-sided

lower limit

8.99

upper limit

26.78

Notes
[4] - Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (MenACWY-TT minus MenACWY) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for each of the four antigens.

Primary: Number of subjects with rSBA antibodies titers ≥ 1:8

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End point title

Number of subjects with rSBA antibodies titers ≥ 1:8 ^[5]

End point description

End point type

Primary

End point timeframe

Prior to (PRE) and one month after vaccination [PI(M1)]

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 results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	222	68
Units: Subjects
rSBA-MenA (PRE) [N= 191;65]	81	26
rSBA-MenA (PI[M1]) [N= 222;63]	222	22
rSBA-MenC (PRE) [N= 203;61]	80	19
rSBA-MenC (PI[M1]) [N= 220;68]	220	67
rSBA-MenW-135 (PRE) [N=208;62]	59	24
rSBA-MenW-135 (PI[M1]) [N=222;63]	222	27
rSBA-MenY (PRE) [N=208;67]	115	41
rSBA-MenY (PI[M1]) [N=222;66]	222	49

Difference in VRR to rSBA-MenC

Statistical analysis description

To evaluate the non-inferiority of the vaccine response induced by MenACWY-TT conjugate vaccine when compared to the licensed MenC-CRM vaccine for MenC as measured by rSBA.

Comparison groups

Meningitec 1-2 years of age Group v Nimenrix 1-2 years of age Group

Number of subjects included in analysis

290

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[6]

Method

Parameter type

Difference in percentage

Point estimate

1.47

Confidence interval

level

95%

sides

2-sided

lower limit

-0.27

upper limit

7.89

Notes
[6] - Criterion indicative of non-inferiority (serogroup C only): one month after vaccination, the lower limit of the 2-sided standardized asymptotic 95% CI for the group difference (MenACWY-TT minus MenC-CRM) in the percentage of subjects with rSBA titer ≥ 1:8 is greater than or equal to the pre-defined clinical limit of -15%.

Primary: Percentage of subjects with rSBA antibodies titers ≥ 1:8

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End point title

Percentage of subjects with rSBA antibodies titers ≥ 1:8 ^[7] ^[8]

End point description

End point type

Primary

End point timeframe

Prior to (PRE) and one month after vaccination [PI(M1)]

Notes
[7] - 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 results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
[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 results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	Nimenrix 1-2 years of age Group
Number of subjects analysed	222
Units: Percentage
number (confidence interval 95%)
rSBA-MenA (PRE) [N=191]	42.4 (35.3 to 49.8)
rSBA-MenA [PI(M1)] [N=222]	100 (98.4 to 100)
rSBA-MenC (PRE) [N=203]	39.4 (32.6 to 46.5)
rSBA-MenC [PI(M1)] [N=220]	100 (98.3 to 100)
rSBA-MenW-135 (PRE) [N=208]	28.4 (22.3 to 35)
rSBA-MenW-135 [PI(M1)] [N=222]	100 (98.4 to 100)
rSBA-MenY (PRE) [N=208]	55.3 (48.3 to 62.2)
rSBA-MenY [PI(M1)] [N=222]	100 (98.4 to 100)

No statistical analyses for this end point

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8 and ≥ 1:128

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End point title

Number of subjects with rSBA antibodies titers ≥ 1:8 and ≥ 1:128

End point description

These analyses were performed by the GSK Biologicals’ laboratory.

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after vaccination [PI(M1)]

End point values	Nimenrix 2-11 years of age Primary Phase Group	Mencevax 2-11 years of age Primary Phase Group
Number of subjects analysed	225	75
Units: Subjects
rSBA-MenA (PRE) ≥ 1:8 [N=185;62]	124	40
rSBA-MenA (PRE) ≥ 1:128 [N=185;62]	96	32
rSBA-MenA (PI[M1]) ≥ 1:8 [N=225;75]	225	75
rSBA-MenA (PI[M1]) ≥ 1:128 [N=225;75]	224	75
rSBA-MenC (PRE) ≥ 1:8 [N=212;70]	133	36
rSBA-MenC (PRE) ≥ 1:128 [N=212;70]	59	19
rSBA-MenC (PI[M1]) ≥ 1:8 [N=225;74]	225	74
rSBA-MenC (PI[M1]) ≥ 1:128 [N=225;74]	224	70
rSBA-MenW-135 (PRE) ≥ 1:8 [N=199;68]	120	39
rSBA-MenW-135 (PRE) ≥ 1:128 [N=199;68]	90	24
rSBA-MenW-135 (PI[M1]) ≥ 1:8 [N=225;75]	225	75
rSBA-MenW-135 (PI[M1]) ≥ 1:128 [N=225;75]	225	75
rSBA-MenY (PRE) ≥ 1:8 [N=219;70]	147	42
rSBA-MenY (PRE) ≥ 1:128 [N=219;70]	98	28
rSBA-MenY (PI[M1]) ≥ 1:8 [N=225;75]	225	75
rSBA-MenY (PI[M1]) ≥ 1:128 [N=225;75]	224	73

No statistical analyses for this end point

Secondary: rSBA antibodies titers

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End point title

rSBA antibodies titers

End point description

These analyses were performed by the GSK Biologicals’ laboratory.

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after vaccination [PI(M1)]

End point values	Nimenrix 2-11 years of age Primary Phase Group	Mencevax 2-11 years of age Primary Phase Group
Number of subjects analysed	225	75
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA (PRE) [N=185;62]	57.9 (43.3 to 77.5)	58.2 (33.8 to 100.1)
rSBA-MenA (PI[M1]) [N=225;75]	7300.9 (6586 to 8093.4)	2033.4 (1667.1 to 2480.2)
rSBA-MenC (PRE) [N=212;70]	33.5 (26 to 43.1)	24.1 (15.2 to 38.2)
rSBA-MenC (PI[M1]) [N=225;74]	2435.3 (2105.8 to 2816.3)	750.2 (555.2 to 1013.7)
rSBA-MenW-135 (PRE) [N=199;68]	43.1 (32.4 to 57.4)	40.1 (23.9 to 67.3)
rSBA-MenW-135 (PI[M1]) [N=225;75]	11777 (10666.2 to 13003.5)	2186.3 (1723.1 to 2773.9)
rSBA-MenY (PRE) [N=219;70]	57.3 (43.7 to 75.2)	45.5 (26.8 to 77)
rSBA-MenY (PI[M1]) [N=225;75]	6641.4 (6044.3 to 7297.4)	1409.9 (1085.9 to 1830.5)

No statistical analyses for this end point

Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL and ≥ 2.0 µg/mL

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End point title

Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL and ≥ 2.0 µg/mL ^[9]

End point description

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after vaccination [PI(M1)]

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 results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	168	51
Units: Subjects
Anti-PSA (PRE) ≥ 0.3 µg/mL [N=147;43]	10	4
Anti-PSA (PRE) ≥ 2.0 µg/mL [N=147;43]	2	1
Anti-PSA [PI(M1)] ≥ 0.3 µg/mL [N=162;36]	162	2
Anti-PSA [PI(M1)] ≥ 2.0 µg/mL [N=162;36]	162	1
Anti-PSC (PRE) ≥ 0.3 µg/mL [N=141;42]	3	1
Anti-PSC (PRE) ≥ 2.0 µg/mL [N=141;42]	1	1
Anti-PSC [PI(M1)] ≥ 0.3 µg/mL [N=168;51]	168	51
Anti-PSC [PI(M1)] ≥ 2.0 µg/mL [N=168;51]	166	50
Anti-PSW-135 (PRE) ≥ 0.3 µg/mL [N=141;39]	2	0
Anti-PSW-135 (PRE) ≥ 2.0 µg/mL [N=141;39]	1	0
Anti-PSW-135 [PI(M1)] ≥ 0.3 µg/mL [N=143;36]	143	0
Anti-PSW-135 [PI(M1)] ≥ 2.0 µg/mL [N=143;36]	131	0
Anti-PSY (PRE) ≥ 0.3 µg/mL [N=107;30]	1	1
Anti-PSY (PRE) ≥ 2.0 µg/mL [N=107;30]	0	0
Anti-PSY [PI(M1)] ≥ 0.3 µg/mL [N=152;32]	152	0
Anti-PSY [PI(M1)] ≥ 2.0 µg/mL [N=152;32]	147	0

No statistical analyses for this end point

Secondary: Anti-PS antibodies concentrations

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End point title

Anti-PS antibodies concentrations ^[10]

End point description

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after vaccination [PI(M1)]

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 results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	168	51
Units: µg/mL
geometric mean (confidence interval 95%)
Anti-PSA (PRE) [N=147;43]	0.17 (0.15 to 0.18)	0.18 (0.14 to 0.23)
Anti-PSA [PI(M1)] [N=162;36]	33.36 (29.07 to 38.27)	0.17 (0.14 to 0.2)
Anti-PSC (PRE) [N=141;42]	0.16 (0.15 to 0.17)	0.16 (0.14 to 0.18)
Anti-PSC [PI(M1)] [N=168;51]	13.47 (12 to 15.12)	8.29 (6.8 to 10.1)
Anti-PSW-135 (PRE) [N=141;39]	0.15 (0.15 to 0.16)	0.15 (0.15 to 0.15)
Anti-PSW-135 [PI(M1)] [N=143;36]	6.86 (5.87 to 8.02)	0.15 (0.15 to 0.15)
Anti-PSY (PRE) [N=107;30]	0.15 (0.15 to 0.15)	0.16 (0.14 to 0.17)
Anti-PSY [PI(M1)] [N=152;32]	10.35 (9.12 to 11.74)	0.15 (0.15 to 0.15)

No statistical analyses for this end point

Secondary: Number of subjects with anti-TT antibody concentrations ≥ 0.1 IU/mL

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End point title

Number of subjects with anti-TT antibody concentrations ≥ 0.1 IU/mL ^[11]

End point description

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after vaccination [PI(M1)]

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 results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	30	6
Units: Subjects
Anti-TT (PRE) [N=19;6]	18	5
Anti-TT [PI(M1)] [N=30;4]	30	4

No statistical analyses for this end point

Secondary: Anti-TT antibody concentrations

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End point title

Anti-TT antibody concentrations ^[12]

End point description

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after vaccination [PI(M1)]

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 results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	30	6
Units: IU/mL
geometric mean (confidence interval 95%)
Anti-TT (PRE) [N=19;6]	1.226 (0.609 to 2.47)	0.57 (0.102 to 3.188)
Anti-TT [PI(M1)] [N=30;4]	14.199 (9.628 to 20.94)	1.341 (0.316 to 5.686)

No statistical analyses for this end point

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

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End point title

Number of subjects with rSBA antibodies titers ≥ 1:8

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	216	66
Units: Subjects
rSBA-MenA (PRE) [N=185;64]	80	26
rSBA-MenA (PI[M1]) [N=216;61]	216	21
rSBA-MenA (PI[M12]) [N=212;49]	210	16
rSBA-MenC (PRE) [N=197;61]	78	20
rSBA-MenC (PI[M1]) [N=214;66]	214	66
rSBA-MenC (PI[M12]) [N=207;63]	203	50
rSBA-MenW-135 (PRE) [N=202;62]	57	23
rSBA-MenW-135 (PI[M1]) [N=216;61]	216	26
rSBA-MenW-135 (PI[M12]) [N=216;64]	216	38
rSBA-MenY (PRE) [N=202;66]	113	40
rSBA-MenY (PI[M1]) [N=216;65]	216	48
rSBA-MenY (PI[M12]) [N=216;66]	214	42

No statistical analyses for this end point

Secondary: rSBA antibodies titers

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End point title

rSBA antibodies titers

End point description

Antibody titers are presented as GMTs. This analysis was performed by the GSK Biologicals' laboratory.

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	216	66
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA (PRE) [N=185;64]	22.6 (16.7 to 30.6)	20.7 (12.3 to 34.9)
rSBA-MenA (PI[M1]) [N=216;61]	3684.2 (3302.8 to 4109.5)	16.9 (9.9 to 29)
rSBA-MenA (PI[M12]) [N=212;49]	967 (843 to 1109.3)	18.3 (9.5 to 35.1)
rSBA-MenC (PRE) [N=197;61]	14 (11 to 17.6)	10.2 (7.1 to 14.7)
rSBA-MenC (PI[M1]) [N=214;66]	864.2 (763.6 to 978.2)	448.2 (327.5 to 613.6)
rSBA-MenC (PI[M12]) [N=207;63]	195.3 (166.3 to 229.3)	77.1 (49.1 to 121.1)
rSBA-MenW-135 (PRE) [N=202;62]	11.3 (8.9 to 14.4)	15.5 (9.6 to 24.9)
rSBA-MenW-135 (PI[M1]) [N=216;61]	5386.9 (4859.3 to 5971.7)	20.2 (12.3 to 33.2)
rSBA-MenW-135 (PI[M12]) [N=216;64]	855.1 (757.1 to 965.9)	36.7 (22.6 to 59.7)
rSBA-MenY (PRE) [N=202;66]	34.6 (26.1 to 45.9)	44.1 (26.2 to 74.3)
rSBA-MenY (PI[M1]) [N=216;65]	2836.5 (2536.4 to 3172)	78.1 (46.6 to 130.9)
rSBA-MenY (PI[M12]) [N=216;66]	766.4 (661 to 888.5)	65.1 (36.9 to 114.7)

No statistical analyses for this end point

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

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End point title

Number of subjects with rSBA antibodies titers ≥ 1:8

End point description

This analysis was performed by the GSK Biologicals’ laboratory.

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

End point values	Nimenrix 2-11 years of age Group	Mencevax 2-11 years of age Group
Number of subjects analysed	216	75
Units: Subjects
rSBA-MenA (PRE) [N=175;62]	118	40
rSBA-MenA (PI[M1]) [N=214;75]	214	75
rSBA-MenA (PI[M12]) [N=216;71]	215	64
rSBA-MenC (PRE) [N=202;70]	128	36
rSBA-MenC (PI[M1]) [N=214;74]	214	74
rSBA-MenC (PI[M12]) [N=215;65]	214	52
rSBA-MenW-135 (PRE) [N=190;68]	113	39
rSBA-MenW-135 (PI[M1]) [N=214;75]	214	75
rSBA-MenW-135 (PI[M12]) [N=216;75]	216	75
rSBA-MenY (PRE) [N=210;70]	141	42
rSBA-MenY (PI[M1]) [N=214;75]	214	75
rSBA-MenY (PI[M12]) [N=216;71]	216	64

No statistical analyses for this end point

Secondary: rSBA antibodies titers

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End point title

rSBA antibodies titers

End point description

Antibody titers are presented as geometric mean titers (GMTs). The analysis was performed by the GSK Biologicals' laboratory.

End point type

Secondary

End point timeframe

Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

End point values	Nimenrix 2-11 years of age Group	Mencevax 2-11 years of age Group
Number of subjects analysed	216	75
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA (PRE) [N=175;62]	59.6 (44.1 to 80.3)	58.2 (33.8 to 100.1)
rSBA-MenA (PI[M1]) [N=214;75]	7395.3 (6652.7 to 8220.7)	2033.4 (1667.1 to 2480.2)
rSBA-MenA (PI[M12]) [N=216;71]	2448.1 (2149.6 to 2788.1)	358.5 (230.2 to 558.4)
rSBA-MenC (PRE) [N=202;70]	34.4 (26.6 to 44.5)	24.1 (15.2 to 38.2)
rSBA-MenC (PI[M1]) [N=214;74]	2488.5 (2145 to 2887)	750.2 (555.2 to 1013.7)
rSBA-MenC (PI[M12]) [N=215;65]	489.5 (419.5 to 571.1)	113.5 (67.3 to 191.5)
rSBA-MenW-135 (PRE) [N=190;68]	41.6 (31.1 to 55.8)	40.1 (23.9 to 67.3)
rSBA-MenW-135 (PI[M1]) [N=214;75]	11943.7 (10782.7 to 13229.7)	2186.3 (1723.1 to 2773.9)
rSBA-MenW-135 (PI[M12]) [N=216;75]	2983.3 (2628.2 to 3386.3)	463 (367.4 to 583.5)
rSBA-MenY (PRE) [N=210;70]	57.4 (43.5 to 75.9)	45.5 (26.8 to 77)
rSBA-MenY (PI[M1]) [N=214;75]	6666.3 (6057.7 to 7336.1)	1409.9 (1085.9 to 1830.5)
rSBA-MenY (PI[M12]) [N=216;71]	2172.1 (1939.6 to 2432.5)	332.4 (213.5 to 517.7)

No statistical analyses for this end point

Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL

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End point title

Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL

End point description

The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 μg/mL.

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	161	49
Units: Subjects
Anti-PSA (PRE) [N=142;44]	9	4
Anti-PSA (PI[M1]) [N=155;35]	155	2
Anti-PSA (PI[M12]) [N=131;38]	118	3
Anti-PSC (PRE) [N=137;41]	3	1
Anti-PSC (PI[M1]) [N=161;49]	161	49
Anti-PSC (PI[M12]) [N=128;35]	73	17
Anti-PSW-135 (PRE) [N=137;38]	2	0
Anti-PSW-135 (PI[M1]) [N=138;35]	138	0
Anti-PSW-135 (PI[M12]) [N=132;32]	124	0
Anti-PSY (PRE) [N=104;30]	1	1
Anti-PSY (PI[M1]) [N=145;31]	145	0
Anti-PSY (PI[M12]) [N=157;45]	153	2

No statistical analyses for this end point

Secondary: Anti-PS antibodies concentrations

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End point title

Anti-PS antibodies concentrations

End point description

Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (μg/mL)

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	161	49
Units: µg/mL
geometric mean (confidence interval 95%)
Anti-PSA (PRE) [N=142;44]	0.17 (0.15 to 0.18)	0.18 (0.14 to 0.23)
Anti-PSA (PI[M1]) [N=155;35]	33.31 (28.94 to 38.35)	0.17 (0.14 to 0.2)
Anti-PSA (PI[M12]) [N=131;38]	1.07 (0.89 to 1.3)	0.17 (0.15 to 0.18)
Anti-PSC (PRE) [N=137;41]	0.16 (0.15 to 0.17)	0.16 (0.14 to 0.19)
Anti-PSC (PI[M1]) [N=161;49]	13.44 (11.93 to 15.14)	8.53 (6.97 to 10.43)
Anti-PSC (PI[M12]) [N=128;35]	0.39 (0.33 to 0.46)	0.34 (0.24 to 0.47)
Anti-PSW-135 (PRE) [N=137;38]	0.15 (0.15 to 0.16)	0.15 (0.15 to 0.15)
Anti-PSW-135 (PI[M1]) [N=138;35]	6.87 (5.85 to 8.07)	0.15 (0.15 to 0.15)
Anti-PSW-135 (PI[M12]) [N=132;32]	1.33 (1.13 to 1.56)	0.15 (0.15 to 0.15)
Anti-PSY (PRE) [N=104;30]	0.15 (0.15 to 0.15)	0.16 (0.14 to 0.17)
Anti-PSY (PI[M1]) [N=145;31]	10.21 (8.96 to 11.62)	0.15 (0.15 to 0.15)
Anti-PSY (PI[M12]) [N=157;45]	1.97 (1.7 to 2.28)	0.16 (0.15 to 0.17)

No statistical analyses for this end point

Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL

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End point title

Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

End point values	Nimenrix 2-11 years of age Group	Mencevax 2-11 years of age Group
Number of subjects analysed	216	75
Units: Subjects
Anti-PSA (PRE) [N=209;75]	26	12
Anti-PSA (PI[M1]) [N=213;74]	213	73
Anti-PSA (PI[M12]) [N=213;73]	209	70
Anti-PSC (PRE) [N=216;74]	29	6
Anti-PSC (PI[M1]) [N=213;74]	213	74
Anti-PSC (PI[M12]) [N=216;75]	169	74
Anti-PSW-135 (PRE) [N=216;75]	2	1
Anti-PSW-135 (PI[M1]) [N=213;74]	213	72
Anti-PSW-135 (PI[M12]) [N=210;72]	206	65
Anti-PSY (PRE) [N=215;74]	4	0
Anti-PSY (PI[M1]) [N=214;74]	214	72
Anti-PSY (PI[M12]) [N=215;74]	213	71

No statistical analyses for this end point

Secondary: Anti-PS antibodies concentrations

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End point title

Anti-PS antibodies concentrations

End point description

Antibody concentrations are presented as GMCs and expressed in μg/mL.

End point type

Secondary

End point timeframe

Prior to (PRE), one month post vaccination [PI(M1)] and at Persistence Year 1 [PI(M12)]

End point values	Nimenrix 2-11 years of age Group	Mencevax 2-11 years of age Group
Number of subjects analysed	216	75
Units: µg/mL
geometric mean (confidence interval 95%)
Anti-PSA (PRE) [N=209;75]	0.19 (0.17 to 0.21)	0.2 (0.16 to 0.23)
Anti-PSA (PI[M1]) [N=213;74]	35.95 (31.79 to 40.65)	10.34 (7.79 to 13.72)
Anti-PSA (PI[M12]) [N=213;73]	2.33 (1.94 to 2.79)	4.05 (2.88 to 5.68)
Anti-PSC (PRE) [N=216;74]	0.2 (0.18 to 0.23)	0.19 (0.15 to 0.22)
Anti-PSC (PI[M1]) [N=213;74]	13.34 (11.7 to 15.2)	14.53 (11.13 to 18.95)
Anti-PSC (PI[M12]) [N=216;75]	0.76 (0.64 to 0.91)	4.4 (3.2 to 6.04)
Anti-PSW-135 (PRE) [N=216;75]	0.15 (0.15 to 0.15)	0.15 (0.15 to 0.16)
Anti-PSW-135 (PI[M1]) [N=213;74]	6.26 (5.43 to 7.22)	4.62 (3.37 to 6.35)
Anti-PSW-135 (PI[M12]) [N=210;72]	1.94 (1.7 to 2.22)	2.21 (1.54 to 3.15)
Anti-PSY (PRE) [N=215;74]	0.15 (0.15 to 0.16)	0.15 (0.15 to 0.15)
Anti-PSY (PI[M1]) [N=214;74]	11.2 (9.86 to 12.71)	15.45 (11.42 to 20.91)
Anti-PSY (PI[M12]) [N=215;74]	2.76 (2.43 to 3.15)	5.77 (4.2 to 7.93)

No statistical analyses for this end point

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

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End point title

Number of subjects with rSBA antibodies titers ≥ 1:8

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	199	52
Units: Subjects
rSBA-MenA (PRE) [N=171;48]	73	21
rSBA-MenA (PI[M1]) [N=199;47]	199	18
rSBA-MenA (PI[M12]) [N=195;36]	193	13
rSBA-MenA (PI[M24]) [N=190;45]	188	30
rSBA-MenC (PRE) [N=181;47]	72	16
rSBA-MenC (PI[M1]) [N=197;50]	197	50
rSBA-MenC (PI[M12]) [N=189;47]	188	47
rSBA-MenC (PI[M24]) [N=197;52]	185	38
rSBA-MenW-135 (PRE) [N=188;47]	54	16
rSBA-MenW-135 (PI[M1]) [N=199;48]	199	19
rSBA-MenW-135 (PI[M12]) [N=198;49]	198	29
rSBA-MenW-135 (PI[M24]) [N=199;44]	198	24
rSBA-MenY (PRE) [N=185;50]	104	31
rSBA-MenY (PI[M1]) [N=199;50]	199	38
rSBA-MenY (PI[M12]) [N=198;50]	196	35
rSBA-MenY (PI[M24]) [N=197;50]	193	37

No statistical analyses for this end point

Secondary: rSBA antibodies titers

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End point title

rSBA antibodies titers

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	199	52
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA (PRE) [N=171;48]	22.7 (16.5 to 31.2)	24 (12.9 to 44.6)
rSBA-MenA (PI[M1]) [N=199;47]	3743 (3341.1 to 4193.2)	20 (10.6 to 37.8)
rSBA-MenA (PI[M12]) [N=195;36]	961.4 (830 to 1113.5)	21.5 (9.8 to 47)
rSBA-MenA (PI[M24]) [N=190;45]	567.7 (489.8 to 658)	51.3 (29 to 90.8)
rSBA-MenC (PRE) [N=181;47]	13.7 (10.8 to 17.5)	11.2 (7.2 to 17.4)
rSBA-MenC (PI[M1]) [N=197;50]	870.9 (766 to 990.1)	626.4 (442.7 to 886.3)
rSBA-MenC (PI[M12]) [N=189;47]	203.9 (174.2 to 238.6)	163.7 (118.6 to 226)
rSBA-MenC (PI[M24]) [N=197;52]	117.4 (97.1 to 141.9)	57.7 (33.5 to 99.3)
rSBA-MenW-135 (PRE) [N=188;47]	11.5 (8.9 to 14.7)	13 (7.8 to 21.8)
rSBA-MenW-135 (PI[M1]) [N=199;48]	5424.4 (4867.9 to 6044.4)	17.6 (10.2 to 30.5)
rSBA-MenW-135 (PI[M12]) [N=198;49]	856.6 (755.4 to 971.3)	35.4 (20.4 to 61.5)
rSBA-MenW-135 (PI[M24]) [N=199;44]	415.9 (362.4 to 477.3)	27.5 (15.7 to 48.1)
rSBA-MenY (PRE) [N=185;50]	34 (25.4 to 45.5)	44.6 (24.8 to 80.2)
rSBA-MenY (PI[M1]) [N=199;50]	2797.6 (2494.9 to 3137.1)	86 (49.3 to 150)
rSBA-MenY (PI[M12]) [N=198;50]	749.4 (642.9 to 873.6)	82.7 (44.7 to 152.9)
rSBA-MenY (PI[M24]) [N=197;50]	504.1 (421 to 603.6)	93.5 (51.8 to 168.7)

No statistical analyses for this end point

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

Top of page

End point title

Number of subjects with rSBA antibodies titers ≥ 1:8

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

End point values	Nimenrix 2-11 years of age Group	Mencevax 2-11 years of age Group
Number of subjects analysed	210	59
Units: Subjects
rSBA-MenA (PRE) [N=170;48]	113	32
rSBA-MenA (PI[M1]) [N=209;59]	209	59
rSBA-MenA (PI[M12]) [N=208;57]	207	53
rSBA-MenA (PI[M24]) [N=208;56]	208	51
rSBA-MenC (PRE) [N=196;56]	125	34
rSBA-MenC (PI[M1]) [N=209;59]	209	59
rSBA-MenC (PI[M12]) [N=207;49]	207	49
rSBA-MenC (PI[M24]) [N=210;59]	207	39
rSBA-MenW-135 (PRE) [N=189;53]	115	32
rSBA-MenW-135 (PI[M1]) [N=209;59]	209	59
rSBA-MenW-135 (PI[M12]) [N=208;59]	208	59
rSBA-MenW-135 (PI[M24]) [N=210;54]	209	46
rSBA-MenY (PRE) [N=204;54]	138	31
rSBA-MenY (PI[M1]) [N=209;59]	209	59
rSBA-MenY (PI[M12]) [N=208;55]	208	52
rSBA-MenY (PI[M24]) [N=210;55]	210	41

No statistical analyses for this end point

Secondary: rSBA antibodies titers

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End point title

rSBA antibodies titers

End point description

This analysis was performed by the GSK Biologicals’ laboratory.

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

End point values	Nimenrix 2-11 years of age Group	Mencevax 2-11 years of age Group
Number of subjects analysed	210	59
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA (PRE) [N=170;48]	57.1 (42.1 to 77.4)	64.5 (34.9 to 119)
rSBA-MenA (PI[M1]) [N=209;59]	7392.2 (6645 to 8223.3)	2230.8 (1797.6 to 2768.3)
rSBA-MenA (PI[M12]) [N=208;57]	2475.3 (2170.5 to 2822.9)	450.6 (289 to 702.7)
rSBA-MenA (PI[M24]) [N=208;56]	1333.4 (1181.9 to 1504.2)	202.5 (135.3 to 303)
rSBA-MenC (PRE) [N=196;56]	35.4 (27.2 to 46)	33.7 (20 to 56.8)
rSBA-MenC (PI[M1]) [N=209;59]	2475.6 (2128.8 to 2878.9)	966.7 (695.7 to 1343.2)
rSBA-MenC (PI[M12]) [N=207;49]	490.3 (421.7 to 570.2)	277 (187.4 to 409.6)
rSBA-MenC (PI[M24]) [N=210;59]	256 (213.9 to 306.2)	59.9 (33 to 108.7)
rSBA-MenW-135 (PRE) [N=189;53]	43.9 (32.8 to 58.8)	46.2 (25.7 to 83)
rSBA-MenW-135 (PI[M1]) [N=209;59]	11892.6 (10744.2 to 13163.7)	2215 (1679.2 to 2921.7)
rSBA-MenW-135 (PI[M12]) [N=208;59]	2969.7 (2612.5 to 3375.9)	496.2 (383.5 to 641.9)
rSBA-MenW-135 (PI[M24]) [N=210;54]	1298 (1135.5 to 1483.7)	144 (90.1 to 230.2)
rSBA-MenY (PRE) [N=204;54]	58.3 (44 to 77.3)	40.9 (22.3 to 75)
rSBA-MenY (PI[M1]) [N=209;59]	6594.5 (5971.2 to 7282.9)	1574.2 (1177.1 to 2105.3)
rSBA-MenY (PI[M12]) [N=208;55]	2115.5 (1886.4 to 2372.5)	418 (269.2 to 649.2)
rSBA-MenY (PI[M24]) [N=210;55]	1530.2 (1339.2 to 1748.4)	96.9 (54.1 to 173.6)

No statistical analyses for this end point

Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL

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End point title

Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	161	39
Units: Subjects
Anti-PSA (PRE) [N=132;35]	7	4
Anti-PSA (PI[M1]) [N=143;27]	143	2
Anti-PSA (PI[M12]) [N=121;31]	109	2
Anti-PSA (PI[M24]) [N=140;39]	107	7
Anti-PSC (PRE) [N=126;31]	3	1
Anti-PSC (PI[M1]) [N=148;35]	148	35
Anti-PSC (PI[M12]) [N=117;30]	68	15
Anti-PSC (PI[M24]) [N=107;22]	38	6
Anti-PSW-135 (PRE) [N=127;29]	1	0
Anti-PSW-135 (PI[M1]) [N=129;24]	129	0
Anti-PSW-135 (PI[M12]) [N=122;26]	114	0
Anti-PSW-135 (PI[M24]) [N=135;32]	98	0
Anti-PSY (PRE) [N=96;22]	1	1
Anti-PSY (PI[M1]) [N=135;24]	135	0
Anti-PSY (PI[M12]) [N=144;35]	140	1
Anti-PSY (PI[M24]) [N=161;33]	144	1

No statistical analyses for this end point

Secondary: Anti-PS antibodies concentrations

Top of page

End point title

Anti-PS antibodies concentrations

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	161	39
Units: µg/mL
geometric mean (confidence interval 95%)
Anti-PSA (PRE) [N=132;35]	0.16 (0.15 to 0.18)	0.19 (0.14 to 0.25)
Anti-PSA (PI[M1]) [N=143;27]	32.63 (28.2 to 37.75)	0.18 (0.14 to 0.22)
Anti-PSA (PI[M12]) [N=121;31]	1.08 (0.89 to 1.32)	0.16 (0.14 to 0.18)
Anti-PSA (PI[M24]) [N=140;39]	0.59 (0.5 to 0.69)	0.19 (0.16 to 0.23)
Anti-PSC (PRE) [N=126;31]	0.16 (0.15 to 0.17)	0.16 (0.14 to 0.2)
Anti-PSC (PI[M1]) [N=148;35]	13.58 (12.01 to 15.36)	9.16 (7.31 to 11.47)
Anti-PSC (PI[M12]) [N=117;30]	0.39 (0.33 to 0.47)	0.36 (0.24 to 0.53)
Anti-PSC (PI[M24]) [N=107;22]	0.26 (0.22 to 0.3)	0.24 (0.17 to 0.36)
Anti-PSW-135 (PRE) [N=127;29]	0.15 (0.15 to 0.15)	0.15 (0.15 to 0.15)
Anti-PSW-135 (PI[M1]) [N=129;24]	6.58 (5.6 to 7.74)	0.15 (0.15 to 0.15)
Anti-PSW-135 (PI[M12]) [N=122;26]	1.33 (1.12 to 1.58)	0.15 (0.15 to 0.15)
Anti-PSW-135 (PI[M24]) [N=135;32]	0.65 (0.54 to 0.79)	0.15 (0.15 to 0.15)
Anti-PSY (PRE) [N=96;22]	0.15 (0.15 to 0.15)	0.16 (0.14 to 0.18)
Anti-PSY (PI[M1]) [N=135;24]	10.22 (8.96 to 11.67)	0.15 (0.15 to 0.15)
Anti-PSY (PI[M12]) [N=144;35]	1.95 (1.67 to 2.27)	0.15 (0.15 to 0.17)
Anti-PSY (PI[M24]) [N=161;33]	1.12 (0.96 to 1.3)	0.16 (0.14 to 0.19)

No statistical analyses for this end point

Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL

Top of page

End point title

Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

End point values	Nimenrix 2-11 years of age Group	Mencevax 2-11 years of age Group
Number of subjects analysed	210	59
Units: Subjects
Anti-PSA (PRE) [N=203;59]	24	11
Anti-PSA (PI[M1]) [N=208;59]	208	58
Anti-PSA (PI[M12]) [N=205;57]	201	54
Anti-PSA (PI[M24]) [N=199;56]	187	54
Anti-PSC (PRE) [N=210;58]	29	6
Anti-PSC (PI[M1]) [N=208;59]	208	59
Anti-PSC (PI[M12]) [N=208;59]	163	58
Anti-PSC (PI[M24]) [N=208;59]	131	57
Anti-PSW-135 (PRE) [N=210;59]	3	1
Anti-PSW-135 (PI[M1]) [N=208;59]	208	57
Anti-PSW-135 (PI[M12]) [N=202;57]	198	52
Anti-PSW-135 (PI[M24]) [N=204;58]	181	52
Anti-PSY (PRE) [N=209;58]	5	0
Anti-PSY (PI[M1]) [N=209;58]	209	56
Anti-PSY (PI[M12]) [N=207;59]	205	56
Anti-PSY (PI[M24]) [N=205;54]	198	50

No statistical analyses for this end point

Secondary: Anti-PS antibodies concentrations

Top of page

End point title

Anti-PS antibodies concentrations

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

End point values	Nimenrix 2-11 years of age Group	Mencevax 2-11 years of age Group
Number of subjects analysed	210	59
Units: µg/mL
geometric mean (confidence interval 95%)
Anti-PSA (PRE) [N=203;59]	0.18 (0.17 to 0.2)	0.21 (0.17 to 0.26)
Anti-PSA (PI[M1]) [N=208;59]	34.76 (30.83 to 39.19)	11.2 (8.1 to 15.47)
Anti-PSA (PI[M12]) [N=205;57]	2.27 (1.9 to 2.71)	4.62 (3.13 to 6.82)
Anti-PSA (PI[M24]) [N=199;56]	1.52 (1.28 to 1.81)	2.93 (2.07 to 4.14)
Anti-PSC (PRE) [N=210;58]	0.2 (0.18 to 0.23)	0.2 (0.16 to 0.25)
Anti-PSC (PI[M1]) [N=208;59]	12.94 (11.37 to 14.72)	15.28 (11.24 to 20.77)
Anti-PSC (PI[M12]) [N=208;59]	0.75 (0.63 to 0.9)	4.98 (3.51 to 7.06)
Anti-PSC (PI[M24]) [N=208;59]	0.54 (0.45 to 0.64)	2.81 (2.02 to 3.91)
Anti-PSW-135 (PRE) [N=210;59]	0.15 (0.15 to 0.16)	0.15 (0.15 to 0.16)
Anti-PSW-135 (PI[M1]) [N=208;59]	6.16 (5.34 to 7.11)	4.5 (3.13 to 6.47)
Anti-PSW-135 (PI[M12]) [N=202;57]	1.9 (1.66 to 2.17)	2.28 (1.53 to 3.4)
Anti-PSW-135 (PI[M24]) [N=204;58]	1.15 (0.99 to 1.34)	1.32 (0.92 to 1.9)
Anti-PSY (PRE) [N=209;58]	0.16 (0.15 to 0.16)	0.15 (0.15 to 0.15)
Anti-PSY (PI[M1]) [N=209;58]	11.1 (9.76 to 12.63)	14.91 (10.45 to 21.28)
Anti-PSY (PI[M12]) [N=207;59]	2.73 (2.39 to 3.11)	5.8 (4.01 to 8.39)
Anti-PSY (PI[M24]) [N=205;54]	1.72 (1.49 to 1.98)	2.9 (1.98 to 4.26)

No statistical analyses for this end point

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

Top of page

End point title

Number of subjects with rSBA antibodies titers ≥ 1:8

End point description

This analysis was performed by the GSK Biologicals’ laboratory.

End point type

Secondary

End point timeframe

Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]

End point values	Nimenrix™ 1-2 years of age Group	Meningitec™ 1-2 years of age Group
Number of subjects analysed	177	37
Units: Subjects
rSBA-MenA (PRE) [N=151;35]	65	15
rSBA-MenA (PI[M1]) [N=177;32]	177	10
rSBA-MenA (PI[M12]) [N=174;22]	172	7
rSBA-MenA (PI[M24]) [N=165;30]	164	21
rSBA-MenA (PI[M36]) [N=170;32]	168	27
rSBA-MenC (PRE) [N=163;34]	71	12
rSBA-MenC (PI[M1]) [N=175;36]	175	36
rSBA-MenC (PI[M12]) [N=169;35]	169	35
rSBA-MenC (PI[M24]) [N=171;36]	171	36
rSBA-MenC (PI[M36]) [N=174;37]	158	36
rSBA-MenW-135 (PRE) [N=167;33]	50	11
rSBA-MenW-135 (PI[M1]) [N=177;36]	177	14
rSBA-MenW-135 (PI[M12]) [N=176;35]	176	22
rSBA-MenW-135 (PI[M24]) [N=173;30]	172	15
rSBA-MenW-135 (PI[M36]) [N=174;33]	172	24
rSBA-MenY (PRE) [N=166;36]	96	24
rSBA-MenY (PI[M1]) [N=177;36]	177	29
rSBA-MenY (PI[M12]) [N=176;35]	175	24
rSBA-MenY (PI[M24]) [N=171;35]	168	27
rSBA-MenY (PI[M36]) [N=177;36]	174	33

No statistical analyses for this end point

Secondary: rSBA antibodies titers

Top of page

End point title

rSBA antibodies titers

End point description

This analysis was performed by the GSK Biologicals’ laboratory.

End point type

Secondary

End point timeframe

Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]

End point values	Nimenrix™ 1-2 years of age Group	Meningitec™ 1-2 years of age Group
Number of subjects analysed	177	37
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA (PRE) [N=151;35]	23 (16.4 to 32.2)	21.8 (10.8 to 44.1)
rSBA-MenA (PI[M1]) [N=177;32]	3787.4 (3353.2 to 4277.8)	14.4 (7 to 29.4)
rSBA-MenA (PI[M12]) [N=174;22]	974.4 (831 to 1142.4)	17.6 (6.5 to 47.6)
rSBA-MenA (PI[M24]) [N=165;30]	575.2 (494 to 669.9)	56.5 (28.5 to 112.2)
rSBA-MenA (PI[M36]) [N=170;32]	518.6 (447.6 to 600.8)	117.1 (65 to 211.2)
rSBA-MenC (PRE) [N=163;34]	15.5 (11.9 to 20)	12 (6.9 to 20.9)
rSBA-MenC (PI[M1]) [N=175;36]	887 (770.4 to 1021.2)	727.6 (478.7 to 1105.8)
rSBA-MenC (PI[M12]) [N=169;35]	223.5 (192.2 to 259.8)	218.3 (157.9 to 301.8)
rSBA-MenC (PI[M24]) [N=171;36]	141.2 (120.3 to 165.6)	158.6 (103.8 to 242.2)
rSBA-MenC (PI[M36]) [N=174;37]	125.1 (96.7 to 162)	185.7 (118.3 to 291.5)
rSBA-MenW-135 (PRE) [N=167;33]	11.7 (9 to 15.1)	12.6 (6.8 to 23.5)
rSBA-MenW-135 (PI[M1]) [N=177;36]	5563.5 (4976.9 to 6219.4)	17.5 (9.2 to 33.6)
rSBA-MenW-135 (PI[M12]) [N=176;35]	904.9 (792.5 to 1033.2)	37.9 (20.1 to 71.3)
rSBA-MenW-135 (PI[M24]) [N=173;30]	439.3 (379 to 509.4)	22.9 (11.6 to 45.1)
rSBA-MenW-135 (PI[M36]) [N=174;33]	439.8 (370.5 to 522)	64.5 (33.5 to 124.3)
rSBA-MenY (PRE) [N=166;36]	37.4 (27.4 to 51)	52.5 (26.7 to 103.3)
rSBA-MenY (PI[M1]) [N=177;36]	2875.6 (2540 to 3255.6)	101.5 (54.3 to 189.7)
rSBA-MenY (PI[M12]) [N=176;35]	799.2 (683.3 to 934.7)	75.7 (36.2 to 158.3)
rSBA-MenY (PI[M24]) [N=171;35]	532.8 (439.7 to 645.6)	100.6 (50.6 to 200)
rSBA-MenY (PI[M36]) [N=177;36]	583.2 (479 to 709.9)	176 (97.6 to 317.3)

No statistical analyses for this end point

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

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End point title

Number of subjects with rSBA antibodies titers ≥ 1:8

End point description

This analysis was performed by the GSK Biologicals’ laboratory.

End point type

Secondary

End point timeframe

Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]

End point values	Nimenrix™ 2-11 years of age Group	Mencevax™ 2-11 years of age Group
Number of subjects analysed	196	37
Units: Subjects
rSBA-MenA (PRE) [N=162;31]	109	20
rSBA-MenA (PI[M1]) [N=196;37]	196	37
rSBA-MenA (PI[M12]) [N=196;36]	195	34
rSBA-MenA (PI[M24]) [N=193;35]	193	33
rSBA-MenA (PI[M36]) [N=192;34]	192	31
rSBA-MenC (PRE) [N=184;35]	118	26
rSBA-MenC (PI[M1]) [N=196;37]	196	37
rSBA-MenC (PI[M12]) [N=195;34]	195	34
rSBA-MenC (PI[M24]) [N=195;37]	195	37
rSBA-MenC (PI[M36]) [N=192;37]	189	31
rSBA-MenW-135 (PRE) [N=173;33]	107	22
rSBA-MenW-135 (PI[M1]) [N=196;37]	196	37
rSBA-MenW-135 (PI[M12]) [N=196;37]	196	37
rSBA-MenW-135 (PI[M24]) [N=195;34]	194	30
rSBA-MenW-135 (PI[M36]) [N=196;35]	196	29
rSBA-MenY (PRE) [N=192;34]	127	19
rSBA-MenY (PI[M1]) [N=196;37]	196	37
rSBA-MenY (PI[M12]) [N=196;34]	196	32
rSBA-MenY (PI[M24]) [N=195;37]	195	30
rSBA-MenY (PI[M36]) [N=195;37]	195	30

No statistical analyses for this end point

Secondary: rSBA antibodies titers

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End point title

rSBA antibodies titers

End point description

This analysis was performed by the GSK Biologicals’ laboratory.

End point type

Secondary

End point timeframe

Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]

End point values	Nimenrix™ 2-11 years of age Group	Mencevax™ 2-11 years of age Group
Number of subjects analysed	196	37
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA (PRE) [N=162;31]	58.4 (42.8 to 79.6)	69.8 (30.6 to 158.8)
rSBA-MenA (PI[M1]) [N=196;37]	7513.7 (6740.4 to 8375.7)	2244.3 (1737.7 to 2898.6)
rSBA-MenA (PI[M12]) [N=196;36]	2533.4 (2211.6 to 2902.1)	576.2 (334.8 to 991.7)
rSBA-MenA (PI[M24]) [N=193;35]	1352.7 (1191.4 to 1535.7)	240.1 (149.5 to 385.7)
rSBA-MenA (PI[M36]) [N=192;34]	1184.2 (1054.2 to 1330.3)	218.8 (128.9 to 371.5)
rSBA-MenC (PRE) [N=184;35]	36.5 (27.8 to 48)	61.3 (31.4 to 119.7)
rSBA-MenC (PI[M1]) [N=196;37]	2524.9 (2162.1 to 2948.5)	1433.7 (939.4 to 2188)
rSBA-MenC (PI[M12]) [N=195;34]	509.4 (439.4 to 590.6)	437.6 (282.9 to 676.8)
rSBA-MenC (PI[M24]) [N=195;37]	273.1 (229.3 to 325.1)	237.9 (144 to 393)
rSBA-MenC (PI[M36]) [N=192;37]	244.3 (200.8 to 297.3)	163.5 (83.8 to 319.2)
rSBA-MenW-135 (PRE) [N=173;33]	45.4 (33.5 to 61.5)	57.4 (27.6 to 119.4)
rSBA-MenW-135 (PI[M1]) [N=196;37]	12158.8 (10949.9 to 13501.1)	2602.6 (1795.6 to 3772.4)
rSBA-MenW-135 (PI[M12]) [N=196;37]	3064.7 (2692.8 to 3488)	587 (411.3 to 837.9)
rSBA-MenW-135 (PI[M24]) [N=195;34]	1324.4 (1154.4 to 1519.4)	182.8 (104 to 321.2)
rSBA-MenW-135 (PI[M36]) [N=196;35]	1737.1 (1503.8 to 2006.7)	112.9 (59.9 to 212.6)
rSBA-MenY (PRE) [N=192;34]	55.4 (41.3 to 74.3)	37.2 (17.3 to 80.4)
rSBA-MenY (PI[M1]) [N=196;37]	6655.7 (6009.1 to 7372)	1813.8 (1235.6 to 2662.5)
rSBA-MenY (PI[M12]) [N=196;34]	2164 (1924.2 to 2433.6)	467.5 (261.3 to 836.5)
rSBA-MenY (PI[M24]) [N=195;37]	1556.4 (1355.9 to 1786.6)	116.2 (59.3 to 227.7)
rSBA-MenY (PI[M36]) [N=195;37]	1551.6 (1381.2 to 1743.1)	103.8 (54.3 to 198.3)

No statistical analyses for this end point

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

Top of page

End point title

Number of subjects with rSBA antibodies titers ≥ 1:8

End point description

This analysis was performed by the GSK Biologicals’ laboratory.

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	152	31
Units: Subjects
rSBA-MenA (PRE) [N=130;30]	62	11
rSBA-MenA (PI[M1]) [N=152;26]	152	7
rSBA-MenA (PI[M12]) [N=150;19]	148	6
rSBA-MenA (PI[M24]) [N=143;28]	142	19
rSBA-MenA (PI[M36]) [N=144;26]	143	22
rSBA-MenA (PI[M48]) [N=136;24]	133	21
rSBA-MenC (PRE) [N=138;30]	57	13
rSBA-MenC (PI[M1]) [N=150;29]	150	29
rSBA-MenC (PI[M12]) [N=146;29]	146	29
rSBA-MenC (PI[M24]) [N=148;31]	148	31
rSBA-MenC (PI[M36]) [N=148;30]	147	30
rSBA-MenC (PI[M48]) [N=137;30]	125	27
rSBA-MenW-135 (PRE) [N=143;28]	44	8
rSBA-MenW-135 (PI[M1]) [N=152;29]	152	12
rSBA-MenW-135 (PI[M12]) [N=152;29]	152	17
rSBA-MenW-135 (PI[M24]) [N=149;25]	148	12
rSBA-MenW-135 (PI[M36]) [N=147;28]	146	20
rSBA-MenW-135 (PI[M48]) [N=138;27]	133	18
rSBA-MenY (PRE) [N=143;31]	83	21
rSBA-MenY (PI[M1]) [N=152;29]	152	25
rSBA-MenY (PI[M12]) [N=152;30]	151	22
rSBA-MenY (PI[M24]) [N=147;30]	146	23
rSBA-MenY (PI[M36]) [N=150;29]	148	27
rSBA-MenY (PI[M48]) [N=138;29]	134	23

No statistical analyses for this end point

Secondary: rSBA antibodies titers

Top of page

End point title

rSBA antibodies titers

End point description

This analysis was performed by the GSK Biologicals’ laboratory.

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	152	31
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA (PRE) [N=130;30]	27.9 (19.2 to 40.4)	18.1 (8.3 to 39.3)
rSBA-MenA (PI[M1]) [N=152;26]	3911.7 (3443.2 to 4444)	12.4 (5.6 to 27.4)
rSBA-MenA (PI[M12]) [N=150;19]	938.4 (790.3 to 1114.3)	15.9 (5.6 to 45)
rSBA-MenA (PI[M24]) [N=143;28]	533 (451.6 to 629)	53.8 (25.9 to 112)
rSBA-MenA (PI[M36]) [N=144;26]	503 (432.3 to 585.3)	129.3 (65.9 to 254)
rSBA-MenA (PI[M48]) [N=136;24]	623.9 (507.1 to 767.6)	157.4 (79.1 to 313)
rSBA-MenC (PRE) [N=138;30]	14.9 (11.2 to 19.9)	15.4 (8.3 to 28.5)
rSBA-MenC (PI[M1]) [N=150;29]	922.5 (794.7 to 1070.8)	846.2 (537.3 to 1332.8)
rSBA-MenC (PI[M12]) [N=146;29]	236.8 (199.7 to 280.7)	233.9 (160.3 to 341.5)
rSBA-MenC (PI[M24]) [N=148;31]	162.5 (138.2 to 191.1)	185.3 (116.9 to 293.6)
rSBA-MenC (PI[M36]) [N=148;30]	176.1 (138.6 to 223.9)	210.3 (139.6 to 316.8)
rSBA-MenC (PI[M48]) [N=137;30]	141.9 (103.8 to 194)	150.5 (73.4 to 308.6)
rSBA-MenW-135 (PRE) [N=143;28]	11.9 (9 to 15.7)	10.9 (5.6 to 21.3)
rSBA-MenW-135 (PI[M1]) [N=152;29]	5495.6 (4864.5 to 6208.6)	19.8 (9.3 to 41.8)
rSBA-MenW-135 (PI[M12]) [N=152;29]	900.8 (782.6 to 1036.8)	36.5 (17.5 to 76.1)
rSBA-MenW-135 (PI[M24]) [N=149;25]	426.3 (364 to 499.3)	24.1 (10.8 to 54.1)
rSBA-MenW-135 (PI[M36]) [N=147;28]	454.9 (382.7 to 540.7)	62.8 (30.4 to 129.5)
rSBA-MenW-135 (PI[M48]) [N=138;27]	400.9 (316.6 to 507.7)	59.8 (26.5 to 135.1)
rSBA-MenY (PRE) [N=143;31]	37.9 (27.1 to 53.1)	52.7 (25.7 to 108.3)
rSBA-MenY (PI[M1]) [N=152;29]	2839.7 (2497.7 to 3228.4)	123.9 (66.4 to 231.4)
rSBA-MenY (PI[M12]) [N=152;30]	776.5 (655 to 920.5)	87.8 (40.7 to 189.5)
rSBA-MenY (PI[M24]) [N=147;30]	539.2 (444.7 to 653.7)	100 (47 to 212.5)
rSBA-MenY (PI[M36]) [N=150;29]	581.5 (472.5 to 715.6)	220.9 (117.8 to 414.2)
rSBA-MenY (PI[M48]) [N=138;29]	524.2 (417 to 658.9)	174.1 (74.6 to 406.6)

No statistical analyses for this end point

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

Top of page

End point title

Number of subjects with rSBA antibodies titers ≥ 1:8

End point description

This analysis was performed by the GSK Biologicals’ laboratory.

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]

End point values	Nimenrix 2-11 years of age Group	Mencevax 2-11 years of age Group
Number of subjects analysed	188	29
Units: Subjects
rSBA-MenA (PRE) [N=155;24]	105	14
rSBA-MenA (PI[M1]) [N=187;29]	187	29
rSBA-MenA (PI[M12]) [N=188;28]	188	26
rSBA-MenA (PI[M24]) [N=185;27]	185	25
rSBA-MenA (PI[M36]) [N=182;27]	182	24
rSBA-MenA (PI[M48]) [N=188;28]	188	24
rSBA-MenC (PRE) [N=176;28]	112	22
rSBA-MenC (PI[M1]) [N=187;29]	187	29
rSBA-MenC (PI[M12]) [N=187;28]	187	28
rSBA-MenC (PI[M24]) [N=186;29]	186	29
rSBA-MenC (PI[M36]) [N=181;29]	181	27
rSBA-MenC (PI[M48]) [N=188;29]	182	26
rSBA-MenW-135 (PRE) [N=165;27]	104	19
rSBA-MenW-135 (PI[M1]) [N=187;29]	187	29
rSBA-MenW-135 (PI[M12]) [N=188;29]	188	29
rSBA-MenW-135 (PI[M24]) [N=186;26]	185	22
rSBA-MenW-135 (PI[M36]) [N=185;28]	185	22
rSBA-MenW-135 (PI[M48]) [N=188;29]	188	22
rSBA-MenY (PRE) [N=183;26]	123	14
rSBA-MenY (PI[M1]) [N=187;29]	187	29
rSBA-MenY (PI[M12]) [N=188;27]	188	26
rSBA-MenY (PI[M24]) [N=186;29]	186	23
rSBA-MenY (PI[M36]) [N=185;29]	185	24
rSBA-MenY (PI[M48]) [N=188;29]	188	24

No statistical analyses for this end point

Secondary: rSBA antibodies titers

Top of page

End point title

rSBA antibodies titers

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]

End point values	Nimenrix 2-11 years of age Group	Mencevax 2-11 years of age Group
Number of subjects analysed	188	29
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA (PRE) [N=155;24]	59.5 (43.4 to 81.7)	58.3 (21.1 to 160.9)
rSBA-MenA (PI[M1]) [N=187;29]	7593.9 (6848.5 to 8420.4)	2075.1 (1544.1 to 2788.7)
rSBA-MenA (PI[M12]) [N=188;28]	2556.2 (2260.3 to 2890.9)	488.7 (246.6 to 968.3)
rSBA-MenA (PI[M24]) [N=185;27]	1317.2 (1155.9 to 1500.9)	203.2 (112.6 to 366.5)
rSBA-MenA (PI[M36]) [N=182;27]	1154.1 (1026.8 to 1297.2)	193.8 (102.1 to 367.9)
rSBA-MenA (PI[M48]) [N=188;28]	1932.3 (1684.9 to 2216.1)	182.8 (85.5 to 390.9)
rSBA-MenC (PRE) [N=176;28]	35.8 (27 to 47.4)	69.7 (34 to 142.9)
rSBA-MenC (PI[M1]) [N=187;29]	2578.5 (2221.9 to 2992.3)	1371.7 (837.1 to 2247.7)
rSBA-MenC (PI[M12]) [N=187;28]	510.1 (439.3 to 592.4)	444.8 (271.1 to 729.9)
rSBA-MenC (PI[M24]) [N=186;29]	278.5 (234.3 to 330.9)	307.4 (179.2 to 527.4)
rSBA-MenC (PI[M36]) [N=181;29]	255.7 (211.3 to 309.4)	260 (136.9 to 493.8)
rSBA-MenC (PI[M48]) [N=188;29]	203.6 (162.9 to 254.6)	211.9 (104.8 to 428.7)
rSBA-MenW-135 (PRE) [N=165;27]	47.4 (34.8 to 64.6)	63.7 (28.7 to 141.5)
rSBA-MenW-135 (PI[M1]) [N=187;29]	12275.6 (11099.2 to 13576.7)	2428 (1565 to 3767.1)
rSBA-MenW-135 (PI[M12]) [N=188;29]	3083.8 (2712.1 to 3506.3)	564.2 (366 to 869.7)
rSBA-MenW-135 (PI[M24]) [N=186;26]	1324.2 (1150.3 to 1524.3)	149.4 (72.4 to 308.1)
rSBA-MenW-135 (PI[M36]) [N=185;28]	1748.3 (1508.7 to 2025.9)	95.7 (44.5 to 205.8)
rSBA-MenW-135 (PI[M48]) [N=188;29]	1807.5 (1568.9 to 2082.5)	93.4 (44.2 to 197.5)
rSBA-MenY (PRE) [N=183;26]	56.8 (42.2 to 76.6)	34.7 (14 to 86)
rSBA-MenY (PI[M1]) [N=187;29]	6801.4 (6206.1 to 7453.9)	1696.6 (1103.1 to 2609.4)
rSBA-MenY (PI[M12]) [N=188;27]	2169.8 (1930.4 to 2438.9)	480.4 (260.9 to 884.9)
rSBA-MenY (PI[M24]) [N=186;29]	1550.8 (1352.6 to 1778)	106.6 (48.5 to 234.1)
rSBA-MenY (PI[M36]) [N=185;29]	1551.5 (1378.9 to 1745.7)	101.6 (50 to 206.5)
rSBA-MenY (PI[M48]) [N=188;29]	1545.5 (1356.6 to 1760.6)	113.1 (55.1 to 232.3)

No statistical analyses for this end point

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8 (HPA laboratory assay)

Top of page

End point title

Number of subjects with rSBA antibodies titers ≥ 1:8 (HPA laboratory assay)

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	152	31
Units: Subjects
rSBA-MenA (PI[M48]) [N=152;31]	93	0
rSBA-MenC (PI[M48]) [N=152;31]	46	8
rSBA-MenW-135 (PI[M48]) [N=152;31]	78	0
rSBA-MenY (PI[M48]) [N=152;31]	84	9

No statistical analyses for this end point

Secondary: rSBA antibodies titers (HPA laboratory assay)

Top of page

End point title

rSBA antibodies titers (HPA laboratory assay)

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	152	31
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA (PI[M48]) [N=152;31]	25.7 (19.1 to 34.7)	4 (4 to 4)
rSBA-MenC (PI[M48]) [N=152;31]	11.2 (8.3 to 15.1)	11.4 (5.2 to 25)
rSBA-MenW-135 (PI[M48]) [N=152;31]	31.3 (21.4 to 45.6)	4 (4 to 4)
rSBA-MenY (PI[M48]) [N=152;31]	29.9 (21.5 to 41.6)	12.5 (6 to 26.1)

No statistical analyses for this end point

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8 (HPA laboratory assay)

Top of page

End point title

Number of subjects with rSBA antibodies titers ≥ 1:8 (HPA laboratory assay)

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]

End point values	Nimenrix 2-11 years of age Group	Mencevax 2-11 years of age Group
Number of subjects analysed	188	29
Units: Subjects
rSBA-MenA (PI[M48]) [N=188;29]	157	5
rSBA-MenC (PI[M48]) [N=188;29]	94	12
rSBA-MenW-135 (PI[M48]) [N=187;29]	169	4
rSBA-MenY (PI[M48]) [N=187;29]	151	2

No statistical analyses for this end point

Secondary: rSBA antibodies titers (HPA laboratory assay)

Top of page

End point title

rSBA antibodies titers (HPA laboratory assay)

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]

End point values	Nimenrix 2-11 years of age Group	Mencevax 2-11 years of age Group
Number of subjects analysed	188	29
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA (PI[M48]) [N=188;29]	77.5 (59.3 to 101.3)	7.3 (4.3 to 12.4)
rSBA-MenC (PI[M48]) [N=188;29]	21.7 (16.2 to 29.1)	23.5 (9.8 to 56.3)
rSBA-MenW-135 (PI[M48]) [N=187;29]	671.1 (500.8 to 899.4)	7.6 (4 to 14.4)
rSBA-MenY (PI[M48]) [N=187;29]	134.8 (99.1 to 183.5)	4.7 (3.5 to 6.4)

No statistical analyses for this end point

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

Top of page

End point title

Number of subjects with rSBA antibodies titers ≥ 1:8

End point description

This analysis was performed by the GSK Biologicals’ laboratory.

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	49	11
Units: Subjects
rSBA-MenA (PRE) [N=41;8]	17	5
rSBA-MenA (PI[M1]) [N=49;9]	49	3
rSBA-MenA (PI[M12]) [N=48;6]	48	1
rSBA-MenA (PI[M24]) [N=48;8]	48	7
rSBA-MenA (PI[M36]) [N=45;9]	45	9
rSBA-MenA (PI[M48]) [N=40;7]	40	7
rSBA-MenC (PRE) [N=45;10]	15	3
rSBA-MenC (PI[M1]) [N=48;11]	48	11
rSBA-MenC (PI[M12]) [N=47;10]	47	10
rSBA-MenC (PI[M24]) [N=49;11]	49	11
rSBA-MenC (PI[M36]) [N=46;10]	46	10
rSBA-MenC (PI[M48]) [N=43;10]	43	9
rSBA-MenW-135 (PRE) [N=45;11]	14	3
rSBA-MenW-135 (PI[M1]) [N=49;11]	49	3
rSBA-MenW-135 (PI[M12]) [N=48;10]	48	7
rSBA-MenW-135 (PI[M24]) [N=49;8]	48	4
rSBA-MenW-135 (PI[M36]) [N=46;8]	45	5
rSBA-MenW-135 (PI[M48]) [N=40;9]	37	5
rSBA-MenY (PRE) [N=48;10]	30	8
rSBA-MenY (PI[M1]) [N=49;10]	49	8
rSBA-MenY (PI[M12]) [N=48;10]	48	8
rSBA-MenY (PI[M24]) [N=48;11]	48	10
rSBA-MenY (PI[M36]) [N=47;9]	47	8
rSBA-MenY (PI[M48]) [N=40;10]	39	8

No statistical analyses for this end point

Secondary: rSBA antibodies titers

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End point title

rSBA antibodies titers

End point description

This analysis was performed by the GSK Biologicals’ laboratory

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	49	11
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA (PRE) [N=41;8]	22.6 (11.4 to 44.4)	45.7 (7.3 to 287.7)
rSBA-MenA (PI[M1]) [N=49;9]	4931.9 (4071.9 to 5973.6)	16.7 (3.1 to 89.8)
rSBA-MenA (PI[M12]) [N=48;6]	1224.2 (958.4 to 1563.8)	7.8 (1.4 to 43.7)
rSBA-MenA (PI[M24]) [N=48;8]	668.3 (511.6 to 873)	119.5 (34.5 to 414.8)
rSBA-MenA (PI[M36]) [N=45;9]	578.5 (445.8 to 750.7)	210.8 (128.8 to 345.2)
rSBA-MenA (PI[M48]) [N=40;7]	782.4 (551.3 to 1110.2)	392 (192.7 to 797.6)
rSBA-MenC (PRE) [N=45;10]	10.7 (6.7 to 17.1)	9.4 (3.2 to 27.9)
rSBA-MenC (PI[M1]) [N=48;11]	1115.3 (878.3 to 1416.3)	536.8 (278.6 to 1034.1)
rSBA-MenC (PI[M12]) [N=47;10]	352.4 (251.3 to 494.2)	249.3 (128.8 to 482.4)
rSBA-MenC (PI[M24]) [N=49;11]	229.5 (169 to 311.6)	215.6 (77.6 to 599)
rSBA-MenC (PI[M36]) [N=46;10]	472.4 (285.2 to 782.3)	229.5 (82 to 642.1)
rSBA-MenC (PI[M48]) [N=43;10]	729.9 (468.4 to 1137.4)	332 (61.2 to 1802)
rSBA-MenW-135 (PRE) [N=45;11]	12.8 (7.4 to 22.2)	8.4 (3.1 to 22.7)
rSBA-MenW-135 (PI[M1]) [N=49;11]	6805 (5432.2 to 8524.7)	12.2 (3.4 to 43.8)
rSBA-MenW-135 (PI[M12]) [N=48;10]	956.5 (710.1 to 1288.3)	49.4 (13 to 188)
rSBA-MenW-135 (PI[M24]) [N=49;8]	408.5 (287.2 to 581.1)	25.9 (4.5 to 148.3)
rSBA-MenW-135 (PI[M36]) [N=46;8]	486 (316.5 to 746.5)	52.9 (8.2 to 342.5)
rSBA-MenW-135 (PI[M48]) [N=40;9]	419 (235.1 to 746.7)	31.3 (5.8 to 167.9)
rSBA-MenY (PRE) [N=48;10]	43.7 (24.5 to 78)	99.6 (23 to 431)
rSBA-MenY (PI[M1]) [N=49;10]	3555.6 (2928.3 to 4317.3)	138.7 (29.8 to 645.6)
rSBA-MenY (PI[M12]) [N=48;10]	976.8 (716.8 to 1331.2)	148 (30.5 to 717.9)
rSBA-MenY (PI[M24]) [N=48;11]	703 (500.8 to 986.9)	185.1 (59.5 to 576.3)
rSBA-MenY (PI[M36]) [N=47;9]	684 (468.3 to 998.9)	242.2 (45.3 to 1294.5)
rSBA-MenY (PI[M48]) [N=40;10]	601.5 (365.1 to 991)	189 (35.8 to 998.1)

No statistical analyses for this end point

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

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End point title

Number of subjects with rSBA antibodies titers ≥ 1:8

End point description

This analysis was performed by the GSK Biologicals’ laboratory

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]

End point values	Nimenrix 2-11 years of age Group	Mencevax 2-11 years of age Group
Number of subjects analysed	98	13
Units: Subjects
rSBA-MenA (PRE) [N=81;10]	57	4
rSBA-MenA (PI[M1]) [N=98;13]	98	13
rSBA-MenA (PI[M12]) [N=98;13]	98	12
rSBA-MenA (PI[M24]) [N=97;12]	97	11
rSBA-MenA (PI[M36]) [N=95;13]	95	12
rSBA-MenA (PI[M48]) [N=97;13]	97	11
rSBA-MenC (PRE) [N=94;13]	65	12
rSBA-MenC (PI[M1]) [N=98;13]	98	13
rSBA-MenC (PI[M12]) [N=97;12]	97	12
rSBA-MenC (PI[M24]) [N=98;13]	98	13
rSBA-MenC (PI[M36]) [N=96;13]	96	13
rSBA-MenC (PI[M48]) [N=97;13]	97	13
rSBA-MenW-135 (PRE) [N=86;12]	55	10
rSBA-MenW-135 (PI[M1]) [N=98;13]	98	13
rSBA-MenW-135 (PI[M12]) [N=98;13]	98	13
rSBA-MenW-135 (PI[M24]) [N=98;12]	98	10
rSBA-MenW-135 (PI[M36]) [N=98;12]	98	10
rSBA-MenW-135 (PI[M48]) [N=97;13]	97	11
rSBA-MenY (PRE) [N=94;13]	62	6
rSBA-MenY (PI[M1]) [N=98;13]	98	13
rSBA-MenY (PI[M12]) [N=98;13]	98	12
rSBA-MenY (PI[M24]) [N=98;13]	98	11
rSBA-MenY (PI[M36]) [N=97;13]	97	11
rSBA-MenY (PI[M48]) [N=97;13]	97	11

No statistical analyses for this end point

Secondary: rSBA antibodies titers

Top of page

End point title

rSBA antibodies titers

End point description

This analysis was performed by the GSK Biologicals’ laboratory.

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]

End point values	Nimenrix 2-11 years of age Group	Mencevax 2-11 years of age Group
Number of subjects analysed	98	13
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA (PRE) [N=81;10]	64.3 (41.9 to 98.7)	35.7 (4.6 to 277.8)
rSBA-MenA (PI[M1]) [N=98;13]	9195.5 (8097.2 to 10442.6)	2319 (1337.7 to 4019.9)
rSBA-MenA (PI[M12]) [N=98;13]	3031.2 (2569.8 to 3575.5)	491 (157.4 to 1531.1)
rSBA-MenA (PI[M24]) [N=97;12]	1641.7 (1375.5 to 1959.3)	187.9 (61.2 to 576.6)
rSBA-MenA (PI[M36]) [N=95;13]	1318.4 (1124.3 to 1545.9)	219.9 (87 to 555.5)
rSBA-MenA (PI[M48]) [N=97;13]	2365 (1957.2 to 2857.7)	135.4 (37.6 to 487.1)
rSBA-MenC (PRE) [N=94;13]	44.7 (30.2 to 66.2)	114 (41.5 to 313.6)
rSBA-MenC (PI[M1]) [N=98;13]	3604.6 (2921.3 to 4447.7)	2361.1 (1010.1 to 5518.9)
rSBA-MenC (PI[M12]) [N=97;12]	777.4 (633.7 to 953.7)	1002 (520 to 1931)
rSBA-MenC (PI[M24]) [N=98;13]	502.5 (402 to 628.1)	627.1 (248.2 to 1584.1)
rSBA-MenC (PI[M36]) [N=96;13]	514.4 (409.4 to 646.4)	865.2 (475.5 to 1574)
rSBA-MenC (PI[M48]) [N=97;13]	495.2 (386.7 to 634.1)	742.7 (356.7 to 1546.6)
rSBA-MenW-135 (PRE) [N=86;12]	50.5 (32.4 to 78.8)	86.8 (29.7 to 253.8)
rSBA-MenW-135 (PI[M1]) [N=98;13]	13562 (11976.3 to 15357.6)	2601 (1301.1 to 5199.6)
rSBA-MenW-135 (PI[M12]) [N=98;13]	3794.4 (3232 to 4454.6)	462.2 (235.5 to 907.5)
rSBA-MenW-135 (PI[M24]) [N=98;12]	1637.9 (1385.7 to 1936)	137.4 (42.5 to 443.9)
rSBA-MenW-135 (PI[M36]) [N=98;12]	2098.3 (1783.7 to 2468.3)	96.6 (28.5 to 327.6)
rSBA-MenW-135 (PI[M48]) [N=97;13]	2178.4 (1843.2 to 2574.4)	100.6 (37.9 to 267)
rSBA-MenY (PRE) [N=94;13]	54.3 (35.4 to 83.2)	15.7 (5.5 to 44.7)
rSBA-MenY (PI[M1]) [N=98;13]	7167.2 (6324.9 to 8121.8)	2085.3 (1028.6 to 4227.2)
rSBA-MenY (PI[M12]) [N=98;13]	2502.4 (2125.3 to 2946.3)	322.7 (113.1 to 920.9)
rSBA-MenY (PI[M24]) [N=98;13]	1907.1 (1574.2 to 2310.4)	112.3 (32 to 394)
rSBA-MenY (PI[M36]) [N=97;13]	1670.6 (1413.6 to 1974.3)	92.2 (31.9 to 266.4)
rSBA-MenY (PI[M48]) [N=97;13]	1736 (1430.4 to 2106.8)	83.3 (29.3 to 236.3)

No statistical analyses for this end point

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8 (HPA laboratory assay)

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End point title

Number of subjects with rSBA antibodies titers ≥ 1:8 (HPA laboratory assay)

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	49	11
Units: Subjects
rSBA-MenA (PI[M48]) [N=45;10]	29	0
rSBA-MenA (PI[M60]) [N=49;11]	36	0
rSBA-MenC (PI[M48]) [N=45;10]	44	8
rSBA-MenC (PI[M60]) [N=49;11]	38	7
rSBA-MenW-135 (PI[M48]) [N=45;10]	27	0
rSBA-MenW-135 (PI[M60]) [N=49;11]	17	2
rSBA-MenY (PI[M48]) [N=45;10]	28	3
rSBA-MenY (PI[M60]) [N=49;11]	21	2

No statistical analyses for this end point

Secondary: rSBA antibodies titers (HPA laboratory assay)

Top of page

End point title

rSBA antibodies titers (HPA laboratory assay)

End point description

End point type

Secondary

End point timeframe

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	49	11
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA (PI[M48]) [N=45;10]	35.1 (19.4 to 63.4)	4 (4 to 4)
rSBA-MenA (PI[M60]) [N=49;11]	37.4 (22.1 to 63.2)	4 (4 to 4)
rSBA-MenC (PI[M48]) [N=45;10]	109.7 (62.7 to 192)	137.2 (22.6 to 831.8)
rSBA-MenC (PI[M60]) [N=49;11]	48.9 (28.5 to 84)	26.5 (6.5 to 107.2)
rSBA-MenW-135 (PI[M48]) [N=45;10]	50.8 (24 to 107.6)	4 (4 to 4)
rSBA-MenW-135 (PI[M60]) [N=49;11]	18.2 (9.3 to 35.3)	7.1 (2.6 to 19.1)
rSBA-MenY (PI[M48]) [N=45;10]	44.9 (22.6 to 89.3)	12.1 (2.3 to 63.5)
rSBA-MenY (PI[M60]) [N=49;11]	20.6 (10.9 to 39.2)	11.7 (2.3 to 59.7)

No statistical analyses for this end point

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8 (HPA laboratory assay)

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End point title

Number of subjects with rSBA antibodies titers ≥ 1:8 (HPA laboratory assay)

End point description

End point type

Secondary

End point timeframe

End point values	Nimenrix 2-11 years of age Group	Mencevax 2-11 years of age Group
Number of subjects analysed	98	13
Units: Subjects
rSBA-MenA (PI[M48]) [N=97;13]	86	1
rSBA-MenA (PI[M60]) [N=98;13]	89	2
rSBA-MenC (PI[M48]) [N=97;13]	96	12
rSBA-MenC (PI[M60]) [N=98;13]	89	13
rSBA-MenW-135 (PI[M48]) [N=96;13]	92	2
rSBA-MenW-135 (PI[M60]) [N=98;13]	77	0
rSBA-MenY (PI[M48]) [N=96;13]	85	1
rSBA-MenY (PI[M60]) [N=98;13]	77	1

No statistical analyses for this end point

Secondary: rSBA antibodies titers (HPA laboratory assay)

Top of page

End point title

rSBA antibodies titers (HPA laboratory assay)

End point description

End point type

Secondary

End point timeframe

End point values	Nimenrix 2-11 years of age Group	Mencevax 2-11 years of age Group
Number of subjects analysed	98	13
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA (PI[M48]) [N=97;13]	123.5 (85.4 to 178.6)	5 (3.1 to 7.9)
rSBA-MenA (PI[M60]) [N=98;13]	141.3 (98.2 to 203.4)	4.7 (3.7 to 6)
rSBA-MenC (PI[M48]) [N=97;13]	118.3 (86 to 162.8)	206.8 (71.7 to 596.7)
rSBA-MenC (PI[M60]) [N=98;13]	79.7 (56 to 113.3)	128 (56.4 to 290.7)
rSBA-MenW-135 (PI[M48]) [N=96;13]	1031.4 (731 to 1455.4)	8.4 (2.8 to 25.7)
rSBA-MenW-135 (PI[M60]) [N=98;13]	208.5 (127.9 to 340)	4 (4 to 4)
rSBA-MenY (PI[M48]) [N=96;13]	216.8 (147.3 to 319.1)	4.2 (3.8 to 4.7)
rSBA-MenY (PI[M60]) [N=98;13]	143.3 (88 to 233.4)	5.5 (2.7 to 11.1)

No statistical analyses for this end point

Secondary: Number of subjects with hSBA antibodies titers ≥ 1:4

Top of page

End point title

Number of subjects with hSBA antibodies titers ≥ 1:4

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month post vaccination [PI(M1)] and at Persistence Year 1 [PI(M12)]

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	215	68
Units: Subjects
hSBA-MenA (PRE) [N=209;66]	3	3
hSBA-MenA (PI[M1]) [N=211;63]	196	3
hSBA-MenA (PI[M12]) [N=201;63]	47	3
hSBA-MenC (PRE) [N=208;65]	3	1
hSBA-MenC (PI[M1]) [N=215;66]	213	48
hSBA-MenC (PI[M12]) [N=200;64]	192	34
hSBA-MenW-135 (PRE) [N=199;62]	2	3
hSBA-MenW-135 (PI[M1]) [N=173;56]	141	1
hSBA-MenW-135 (PI[M12]) [N=175;62]	172	3
hSBA-MenY (PRE) [N=182;55]	7	2
hSBA-MenY (PI[M1]) [N=196;57]	131	3
hSBA-MenY (PI[M12]) [N=214;68]	200	8

No statistical analyses for this end point

Secondary: hSBA antibodies titers

Top of page

End point title

hSBA antibodies titers

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month post vaccination [PI(M1)] and at Persistence Year 1 [PI(M12)]

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	215	68
Units: Titers
geometric mean (confidence interval 95%)
hSBA-MenA (PRE) [N=209;66]	2 (2 to 2.1)	2.2 (2 to 2.4)
hSBA-MenA (PI[M1]) [N=211;63]	57.6 (47.9 to 69.3)	2.2 (1.9 to 2.5)
hSBA-MenA (PI[M12]) [N=201;63]	3.6 (3.1 to 4.2)	2.2 (2 to 2.4)
hSBA-MenC (PRE) [N=208;65]	2.1 (2 to 2.2)	2.1 (1.9 to 2.3)
hSBA-MenC (PI[M1]) [N=215;66]	187 (161.6 to 216.5)	22 (14.3 to 33.8)
hSBA-MenC (PI[M12]) [N=200;64]	88.7 (73.8 to 106.5)	12.2 (7.6 to 19.5)
hSBA-MenW-135 (PRE) [N=199;62]	2.1 (2 to 2.2)	2.2 (2 to 2.4)
hSBA-MenW-135 (PI[M1]) [N=173;56]	38.5 (29.3 to 50.5)	2.1 (2 to 2.2)
hSBA-MenW-135 (PI[M12]) [N=175;62]	225.1 (184.5 to 274.7)	2.4 (1.9 to 3)
hSBA-MenY (PRE) [N=182;55]	2.2 (2 to 2.3)	2.1 (2 to 2.2)
hSBA-MenY (PI[M1]) [N=196;57]	23.8 (18.1 to 31.4)	2.5 (1.9 to 3.2)
hSBA-MenY (PI[M12]) [N=214;68]	105.1 (85.2 to 129.7)	3.2 (2.3 to 4.4)

No statistical analyses for this end point

Secondary: Number of subjects with hSBA antibodies titers ≥ 1:4

Top of page

End point title

Number of subjects with hSBA antibodies titers ≥ 1:4

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	198	52
Units: Subjects
hSBA-MenA (PRE) [N=193;51]	3	3
hSBA-MenA (PI[M1]) [N=194;48]	180	2
hSBA-MenA (PI[M24]) [N=180;50]	73	6
hSBA-MenC (PRE) [N=192;49]	2	1
hSBA-MenC (PI[M1]) [N=198;50]	196	38
hSBA-MenC (PI[M24]) [N=191;51]	179	28
hSBA-MenW-135 (PRE) [N=183;47]	2	2
hSBA-MenW-135 (PI[M1]) [N=158;45]	130	1
hSBA-MenW-135 (PI[M24]) [N=178;51]	171	5
hSBA-MenY (PRE) [N=168;42]	6	2
hSBA-MenY (PI[M1]) [N=181;44]	121	3
hSBA-MenY (PI[M24]) [N=173;43]	157	13

No statistical analyses for this end point

Secondary: hSBA antibodies titers

Top of page

End point title

hSBA antibodies titers

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	198	51
Units: Titers
geometric mean (confidence interval 95%)
hSBA-MenA (PRE) [N=193;51]	2 (2 to 2.1)	2.2 (2 to 2.5)
hSBA-MenA (PI[M1]) [N=194;48]	58.8 (48.5 to 71.3)	2.2 (1.9 to 2.7)
hSBA-MenA (PI[M24]) [N=180;50]	5.1 (4.2 to 6.1)	2.3 (2 to 2.5)
hSBA-MenC (PRE) [N=192;49]	2.1 (2 to 2.1)	2.1 (1.9 to 2.4)
hSBA-MenC (PI[M1]) [N=198;50]	185.4 (159.3 to 215.9)	26.7 (16.1 to 44.3)
hSBA-MenC (PI[M24]) [N=191;51]	55.6 (45.1 to 68.5)	11.8 (6.8 to 20.6)
hSBA-MenW-135 (PRE) [N=183;47]	2.1 (2 to 2.2)	2.1 (2 to 2.3)
hSBA-MenW-135 (PI[M1]) [N=158;45]	38.7 (29.2 to 51.2)	2.1 (1.9 to 2.2)
hSBA-MenW-135 (PI[M24]) [N=178;51]	111.4 (90.9 to 136.5)	2.9 (2.1 to 4)
hSBA-MenY (PRE) [N=168;42]	2.1 (2 to 2.3)	2.1 (2 to 2.2)
hSBA-MenY (PI[M1]) [N=181;44]	23.1 (17.4 to 30.8)	2.6 (1.9 to 3.7)
hSBA-MenY (PI[M24]) [N=173;43]	72.5 (57 to 92.4)	5 (3.1 to 7.9)

No statistical analyses for this end point

Secondary: Number of subjects with hSBA antibodies titers ≥ 1:4

Top of page

End point title

Number of subjects with hSBA antibodies titers ≥ 1:4

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]

End point values	Nimenrix™ 1-2 years of age Group	Meningitec™ 1-2 years of age Group
Number of subjects analysed	176	37
Units: Subjects
hSBA-MenA (PRE) [N=172;37]	1	3
hSBA-MenA (PI[M1]) [N=172;36]	159	3
hSBA-MenA (PI[M36]) [N=170;36]	37	2
hSBA-MenC (PRE) [N=170;35]	2	0
hSBA-MenC (PI[M1]) [N=176;36]	174	31
hSBA-MenC (PI[M36]) [N=166;33]	147	25
hSBA-MenW-135 (PRE) [N=163;34]	2	2
hSBA-MenW-135 (PI[M1]) [N=138;33]	112	1
hSBA-MenW-135 (PI[M36]) [N=164;35]	131	3
hSBA-MenY (PRE) [N=149;31]	5	2
hSBA-MenY (PI[M1]) [N=161;34]	110	3
hSBA-MenY (PI[M36]) [N=159;33]	117	9

No statistical analyses for this end point

Secondary: hSBA antibodies titers

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End point title

hSBA antibodies titers

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]

End point values	Nimenrix™ 1-2 years of age Group	Meningitec™ 1-2 years of age Group
Number of subjects analysed	176	37
Units: Titers
geometric mean (confidence interval 95%)
hSBA-MenA (PRE) [N=172;37]	2 (2 to 2)	2.3 (2 to 2.7)
hSBA-MenA (PI[M1]) [N=172;36]	56.9 (46.4 to 69.9)	2.4 (1.9 to 3)
hSBA-MenA (PI[M36]) [N=170;36]	3.3 (2.8 to 3.8)	2.2 (1.9 to 2.6)
hSBA-MenC (PRE) [N=170;35]	2.1 (2 to 2.2)	2 (2 to 2)
hSBA-MenC (PI[M1]) [N=176;36]	182.7 (154.6 to 215.8)	44.1 (25.2 to 77.3)
hSBA-MenC (PI[M36]) [N=166;33]	65.1 (49.6 to 85.5)	32.5 (16 to 65.9)
hSBA-MenW-135 (PRE) [N=163;34]	2.1 (2 to 2.2)	2.2 (1.9 to 2.6)
hSBA-MenW-135 (PI[M1]) [N=138;33]	39.1 (28.8 to 53.1)	2.1 (1.9 to 2.3)
hSBA-MenW-135 (PI[M36]) [N=164;35]	40.8 (31.1 to 53.6)	3 (1.9 to 4.7)
hSBA-MenY (PRE) [N=149;31]	2.1 (2 to 2.2)	2.1 (1.9 to 2.3)
hSBA-MenY (PI[M1]) [N=161;34]	24.8 (18.3 to 33.5)	2.8 (1.8 to 4.4)
hSBA-MenY (PI[M36]) [N=159;33]	37.3 (27.2 to 51.2)	6 (3 to 11.9)

No statistical analyses for this end point

Secondary: Number of subjects with hSBA antibodies titers ≥ 1:4

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End point title

Number of subjects with hSBA antibodies titers ≥ 1:4

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	151	31
Units: Subjects
hSBA-MenA (PRE) [N=148;30]	0	2
hSBA-MenA (PI[M1]) [N=148;30]	137	1
hSBA-MenA (PI[M48]) [N=140;31]	57	8
hSBA-MenC (PRE) [N=146;28]	2	0
hSBA-MenC (PI[M1]) [N=151;29]	149	25
hSBA-MenC (PI[M48]) [N=147;31]	126	24
hSBA-MenW-135 (PRE) [N=141;27]	2	1
hSBA-MenW-135 (PI[M1]) [N=119;28]	100	1
hSBA-MenW-135 (PI[M48]) [N=143;31]	117	3
hSBA-MenY (PRE) [N=127;26]	5	1
hSBA-MenY (PI[M1]) [N=139;28]	93	2
hSBA-MenY (PI[M48]) [N=129;26]	100	12

No statistical analyses for this end point

Secondary: hSBA antibodies titers

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End point title

hSBA antibodies titers

End point description

End point type

Secondary

End point timeframe

Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	151	31
Units: Titers
geometric mean (confidence interval 95%)
hSBA-MenA (PRE) [N=148;30]	2 (2 to 2)	2.2 (1.9 to 2.5)
hSBA-MenA (PI[M1]) [N=148;30]	57.7 (46.1 to 72.1)	2.3 (1.8 to 2.9)
hSBA-MenA (PI[M48]) [N=140;31]	6 (4.7 to 7.7)	3.1 (2.3 to 4)
hSBA-MenC (PRE) [N=146;28]	2.1 (2 to 2.2)	2 (2 to 2)
hSBA-MenC (PI[M1]) [N=151;29]	192.5 (160.7 to 230.7)	45 (23.3 to 86.9)
hSBA-MenC (PI[M48]) [N=147;31]	51.4 (36.9 to 71.7)	32.4 (14.8 to 71.1)
hSBA-MenW-135 (PRE) [N=141;27]	2.1 (2 to 2.2)	2.1 (1.9 to 2.3)
hSBA-MenW-135 (PI[M1]) [N=119;28]	41.7 (30.4 to 57.3)	2.1 (1.9 to 2.3)
hSBA-MenW-135 (PI[M48]) [N=143;31]	48.3 (36.2 to 64.4)	2.8 (1.9 to 4.2)
hSBA-MenY (PRE) [N=127;26]	2.1 (2 to 2.2)	2.1 (1.9 to 2.3)
hSBA-MenY (PI[M1]) [N=139;28]	22.5 (16.3 to 31.1)	2.6 (1.7 to 4.1)
hSBA-MenY (PI[M48]) [N=129;26]	42.1 (30.6 to 58.1)	13.5 (5.6 to 32.3)

No statistical analyses for this end point

Secondary: Number of subjects with hSBA antibodies titers ≥ 1:4

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End point title

Number of subjects with hSBA antibodies titers ≥ 1:4

End point description

End point type

Secondary

End point timeframe

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	49	11
Units: Subjects
hSBA-MenA (PRE) [N=47;11]	0	0
hSBA-MenA (PI[M1]) [N=49;11]	48	0
hSBA-MenA (PI[M60]) [N=45;11]	16	3
hSBA-MenC (PRE) [N=45;10]	0	0
hSBA-MenC (PI[M1]) [N=48;11]	48	9
hSBA-MenC (PI[M60]) [N=48;11]	45	10
hSBA-MenW-135 (PRE) [N=44;9]	1	1
hSBA-MenW-135 (PI[M1]) [N=41;11]	37	0
hSBA-MenW-135 (PI[M60]) [N=46;9]	38	2
hSBA-MenY (PRE) [N=45;8]	2	2
hSBA-MenY (PI[M1]) [N=48;10]	40	0
hSBA-MenY (PI[M60]) [N=45;10]	36	4

No statistical analyses for this end point

Secondary: hSBA antibodies titers

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End point title

hSBA antibodies titers

End point description

End point type

Secondary

End point timeframe

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	49	11
Units: Titers
geometric mean (confidence interval 95%)
hSBA-MenA (PRE) [N=47;11]	2 (2 to 2)	2 (2 to 2)
hSBA-MenA (PI[M1]) [N=49;11]	78.5 (55.7 to 110.4)	2 (2 to 2)
hSBA-MenA (PI[M60]) [N=45;11]	5.2 (3.4 to 7.8)	3.6 (1.8 to 7.2)
hSBA-MenC (PRE) [N=45;10]	2 (2 to 2)	2 (2 to 2)
hSBA-MenC (PI[M1]) [N=48;11]	252 (193.2 to 328.6)	38.7 (10.5 to 142.9)
hSBA-MenC (PI[M60]) [N=48;11]	216.5 (123.6 to 379.1)	108.7 (21.2 to 557.2)
hSBA-MenW-135 (PRE) [N=44;9]	2.2 (1.8 to 2.5)	2.3 (1.6 to 3.3)
hSBA-MenW-135 (PI[M1]) [N=41;11]	81.3 (45.4 to 145.7)	2 (2 to 2)
hSBA-MenW-135 (PI[M60]) [N=46;9]	59.7 (35.1 to 101.4)	5.1 (1.2 to 20.9)
hSBA-MenY (PRE) [N=45;8]	2.1 (1.9 to 2.4)	2.6 (1.7 to 3.8)
hSBA-MenY (PI[M1]) [N=48;10]	46.1 (27.4 to 77.5)	2 (2 to 2)
hSBA-MenY (PI[M60]) [N=45;10]	70.6 (38.7 to 128.8)	11.6 (2.2 to 59.4)

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. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) (1 - < 2 years of age and 2 - < 6 years of age groups) and 50 mm (6 - < 11 years of age groups) of injection site, respectively. Relationship analysis was not performed.

End point type

Secondary

End point timeframe

During the 4-day (Day 0-3) follow-up period

End point values	Nimenrix 1-2 years of age Group	Nimenrix 2-6 years of age Group	Nimenrix 6-11 years of age Group	Meningitec 1-2 years of age Group	Mencevax 2-6 years of age Group	Mencevax 6-11 years of age Group
Number of subjects analysed	228	113	117	73	39	39
Units: Subjects
Any Pain	76	51	84	20	28	32
Grade 3 Pain	3	2	7	0	1	1
Any Redness	84	44	53	24	8	15
Grade 3 Redness	8	12	19	1	0	0
Any Swelling	36	29	42	11	3	6
Grade 3 Swelling	3	9	14	0	0	0

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 = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

End point type

Secondary

End point timeframe

During the 4-day (Day 0-3) follow-up period

End point values	Nimenrix 1-2 years of age Group	Nimenrix 2-6 years of age Group	Nimenrix 6-11 years of age Group	Meningitec 1-2 years of age Group	Mencevax 2-6 years of age Group	Mencevax 6-11 years of age Group
Number of subjects analysed	228	113	117	73	39	39
Units: Subjects
Any Drowsiness	63	30	45	25	5	8
Grade 3 Drowsiness	2	0	1	0	0	0
Related Drowsiness	61	29	45	25	5	8
Any Fever	36	7	11	9	2	1
Grade 3 Fever >40.0˚C	2	0	0	0	0	0
Related Fever	32	7	11	9	2	0
Any Irritability	88	18	23	29	11	5
Grade 3 Irritability	2	0	3	0	0	1
Related Irritability	85	18	21	29	10	4
Any Loss of appetite	54	16	31	17	6	6
Grade 3 Loss of appetite	2	0	1	0	0	0
Related Loss of appetite	52	16	29	17	5	5

No statistical analyses for this end point

Secondary: Number of subjects with rash

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End point title

Number of subjects with rash ^[13]

End point description

End point type

Secondary

End point timeframe

From administration of the vaccine dose until 6 months later

Notes
[13] - 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 results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group	Nimenrix 2-11 years of age Primary Phase Group	Mencevax 2-11 years of age Primary Phase Group
Number of subjects analysed	229	75	231	78
Units: Subjects
At least one symptom	10	6	9	1

No statistical analyses for this end point

Secondary: Number of subjects with New Onset of Chronic Illnesses (NOCIs)

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End point title

Number of subjects with New Onset of Chronic Illnesses (NOCIs) ^[14]

End point description

NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

End point type

Secondary

End point timeframe

From administration of the vaccine dose until 6 months later

Notes
[14] - 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 results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group	Nimenrix 2-11 years of age Primary Phase Group	Mencevax 2-11 years of age Primary Phase Group
Number of subjects analysed	229	75	231	78
Units: Subjects
At least one symptom	1	0	2	4

No statistical analyses for this end point

Secondary: Number of subjects with Adverse Events (AEs) resulting in an Emergency Room (ER) visit

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End point title

Number of subjects with Adverse Events (AEs) resulting in an Emergency Room (ER) visit ^[15]

End point description

End point type

Secondary

End point timeframe

From administration of the vaccine dose until 6 months later

Notes
[15] - 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 results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group	Nimenrix 2-11 years of age Primary Phase Group	Mencevax 2-11 years of age Primary Phase Group
Number of subjects analysed	229	75	231	78
Units: Subjects
At least one symptom	21	8	15	5

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 ^[16]

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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

End point type

Secondary

End point timeframe

During the 31-day (Days 0-30) post-vaccination period

Notes
[16] - 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 results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group	Nimenrix 2-11 years of age Primary Phase Group	Mencevax 2-11 years of age Primary Phase Group
Number of subjects analysed	229	75	231	78
Units: Subjects
Any AE(s)	121	38	83	24

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) ^[17]

End point description

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

Up to 6 Months after vaccination

Notes
[17] - 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 results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group	Nimenrix 2-11 years of age Primary Phase Group	Mencevax 2-11 years of age Primary Phase Group
Number of subjects analysed	229	75	231	78
Units: Subjects
Any SAE(s)	5	7	2	1

No statistical analyses for this end point

Secondary: Number of subjects with SAE(s)

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End point title

Number of subjects with SAE(s)

End point description

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

From 6 Months after vaccination up to Year 1

End point values	Nimenrix 1-2 years of age Group	Nimenrix 2-11 years of age Group	Meningitec 1-2 years of age Group	Mencevax 2-11 years of age Group
Number of subjects analysed	222	221	71	78
Units: Subjects
Any SAE(s)	0	0	0	0

No statistical analyses for this end point

Secondary: Number of subjects with SAE(s)

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End point title

Number of subjects with SAE(s)

End point description

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

From 6 Months after vaccination up to Year 2

End point values	Nimenrix 1-2 years of age Group	Nimenrix 2-11 years of age Group	Meningitec 1-2 years of age Group	Mencevax 2-11 years of age Group
Number of subjects analysed	208	215	53	61
Units: Subjects
Any SAE(s)	0	0	0	0

No statistical analyses for this end point

Secondary: Number of subjects with SAE(s)

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End point title

Number of subjects with SAE(s)

End point description

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

From 6 Months following vaccination up to Year 3

End point values	Nimenrix™ 1-2 years of age Group	Nimenrix™ 2-11 years of age Group	Meningitec™ 1-2 years of age Group	Mencevax™ 2-11 years of age Group
Number of subjects analysed	185	201	38	38
Units: Subjects
Any SAE(s)	0	0	0	0

No statistical analyses for this end point

Secondary: Number of subjects with SAE(s)

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End point title

Number of subjects with SAE(s)

End point description

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

From 6 Months following vaccination up to Year 4

End point values	Nimenrix 1-2 years of age Group	Nimenrix 2-11 years of age Group	Meningitec 1-2 years of age Group	Mencevax 2-11 years of age Group
Number of subjects analysed	165	192	34	32
Units: Subjects
Any SAE(s)	0	0	0	0

No statistical analyses for this end point

Secondary: Number of subjects with SAE(s)

Top of page

End point title

Number of subjects with SAE(s)

End point description

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

From 6 Months following vaccination up to Year 5

End point values	Nimenrix 1-2 years of age Group	Nimenrix 2-11 years of age Group	Meningitec 1-2 years of age Group	Mencevax 2-11 years of age Group
Number of subjects analysed	52	99	12	13
Units: Subjects
Any SAE(s)	0	0	0	0

No statistical analyses for this end point

Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL and ≥ 2.0 µg/mL

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End point title

Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL and ≥ 2.0 µg/mL

End point description

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after vaccination [PI(M1)]

End point values	Nimenrix 2-11 years of age Primary Phase Group	Mencevax 2-11 years of age Primary Phase Group
Number of subjects analysed	225	75
Units: Subjects
Anti-PSA ≥0.3µg/mL, PRE [N=218,75]	29	12
Anti-PSA ≥0.3µg/mL, PI(M1) [N=224,74]	224	73
Anti-PSA ≥2.0µg/mL, PRE [N=218,75]	9	2
Anti-PSA ≥2.0µg/mL, PI(M1) [N=224,74]	224	68
Anti-PSC ≥0.3µg/mL , PRE [N=225,74]	28	6
Anti-PSC ≥0.3µg/mL, PI(M1) [N=224,74]	224	74
Anti-PSC ≥2.0µg/mL, PRE [N=225,74]	9	2
Anti-PSC ≥2.0µg/mL, PI(M1) [N=224,74]	223	71
Anti-PSW-135 ≥0.3µg/mL , PRE [N=225,75]	3	1
Anti-PSW-135 ≥0.3µg/mL , PI(M1) [N=224,74]	224	72
Anti-PSW-135 ≥2.0µg/mL , PRE [N=225,75]	0	0
Anti-PSW-135 ≥2.0µg/mL , PI(M1) [N=224,74]	197	54
Anti-PSY ≥0.3µg/mL, PRE [N=224,74]	6	0
Anti-PSY ≥0.3µg/mL, PI(M1) [N=225,74]	225	72
Anti-PSY ≥2.0µg/mL, PRE [N=224,74]	1	0
Anti-PSY ≥2.0µg/mL, PI(M1) [N=225,74]	217	71

No statistical analyses for this end point

Secondary: Anti-PS antibodies concentrations

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End point title

Anti-PS antibodies concentrations

End point description

End point type

Secondary

End point timeframe

Prior to (PRE) and one month post vaccination [PI(M1)]

End point values	Nimenrix 2-11 years of age Primary Phase Group	Mencevax 2-11 years of age Primary Phase Group
Number of subjects analysed	225	75
Units: µg/mL
geometric mean (confidence interval 95%)
Anti-PSA, PRE [N=218,75]	0.19 (0.17 to 0.21)	0.2 (0.16 to 0.23)
Anti-PSA, PI(M1) [N=224,74]	36.35 (32.3 to 40.91)	10.34 (7.79 to 13.72)
Anti-PSC, PRE [N=225,74]	0.2 (0.18 to 0.22)	0.19 (0.15 to 0.22)
Anti-PSC, PI(M1) [N=224,74]	13.33 (11.75 to 15.12)	14.53 (11.13 to 18.95)
Anti-PSW-135, PRE [N=225,75]	0.15 (0.15 to 0.15)	0.15 (0.15 to 0.16)
Anti-PSW-135, PI(M1) [N=224,74]	6.35 (5.53 to 7.29)	4.62 (3.37 to 6.35)
Anti-PSY, PRE [N=224,74]	0.16 (0.15 to 0.16)	0.15 (0.15 to 0.15)
Anti-PSY, PI(M1) [N=225,74]	11.35 (10.01 to 12.87)	15.45 (11.42 to 20.91)

No statistical analyses for this end point

Secondary: Number of subjects with anti-TT antibody concentrations ≥ 0.1 IU/mL

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End point title

Number of subjects with anti-TT antibody concentrations ≥ 0.1 IU/mL

End point description

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after vaccination [PI(M1)]

End point values	Nimenrix 2-11 years of age Primary Phase Group	Mencevax 2-11 years of age Primary Phase Group
Number of subjects analysed	32	7
Units: Subjects
Anti-TT, PRE [N=19,4]	19	4
Anti-TT, PI(M1) [N=32,7]	32	7

No statistical analyses for this end point

Secondary: Anti-TT antibody concentrations

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End point title

Anti-TT antibody concentrations

End point description

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after vaccination [PI(M1)]

End point values	Nimenrix 2-11 years of age Primary Phase Group	Mencevax 2-11 years of age Primary Phase Group
Number of subjects analysed	32	7
Units: IU/mL
geometric mean (confidence interval 95%)
Anti-TT, PRE [N=19,4]	1.541 (0.856 to 2.775)	2.103 (0.129 to 34.398)
Anti-TT, PI(M1) [N=32,7]	20.951 (14.656 to 29.949)	1.74 (0.536 to 5.642)

No statistical analyses for this end point

Secondary: Number of subjects with hSBA antibodies titers ≥ 1:4

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End point title

Number of subjects with hSBA antibodies titers ≥ 1:4 ^[18]

End point description

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after vaccination [PI(M1)]

Notes
[18] - 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 results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	221	68
Units: Subjects
hSBA-MenA, PRE [N=215,68]	3	3
hBA-MenA, PI(M1) [N=217,65]	203	4
hSBA-MenC, PRE [N=214,67]	3	1
hSBA-MenC, PI(M1) [N=221,68]	219	49
hSBA-MenW-135, PRE [N=205,64]	2	3
hSBA-MenW-135, PI(M1) [N=177,58]	145	1
hSBA-MenY, PRE [N=189,57]	7	2
hSBA-MenY, PI(M1) [N=201,59]	135	3

No statistical analyses for this end point

Secondary: hSBA antibodies titers

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End point title

hSBA antibodies titers ^[19]

End point description

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after vaccination [PI(M1)]

Notes
[19] - 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 results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	221	68
Units: Titers
geometric mean (confidence interval 95%)
hSBA-MenA, PRE [N=215,68]	2 (2 to 2.1)	2.2 (2 to 2.3)
hBA-MenA, PI(M1) [N=217,65]	59 (49.3 to 70.6)	2.3 (2 to 2.6)
hSBA-MenC, PRE [N=214,67]	2.1 (2 to 2.2)	2.1 (1.9 to 2.3)
hSBA-MenC, PI(M1) [N=221,68]	190 (164.7 to 219.2)	21.2 (13.9 to 32.3)
hSBA-MenW-135, PRE [N=205,64]	2.1 (2 to 2.1)	2.2 (2 to 2.4)
hSBA-MenW-135, PI(M1) [N=177,58]	38.8 (29.7 to 50.6)	2 (2 to 2.1)
hSBA-MenY, PRE [N=189,57]	2.2 (2 to 2.3)	2.1 (2 to 2.2)
hSBA-MenY, PI(M1) [N=201,59]	24.4 (18.6 to 32.1)	2.4 (1.9 to 3.1)

No statistical analyses for this end point

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:128

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End point title

Number of subjects with rSBA antibodies titers ≥ 1:128 ^[20]

End point description

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after vaccination [PI(M1)]

Notes
[20] - 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 results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	222	68
Units: Subjects
rSBA-MenA, PRE [N=191,65]	59	20
rSBA-MenA, PI(M1) [N=222,63]	222	16
rSBA-MenC, PRE [N=203,61]	29	4
rSBA-MenC, PI(M1) [N=220,68]	218	56
rSBA-MenW-135, PRE [N=208,62]	38	16
rSBA-MenW-135, PI(M1) [N=222,63]	222	18
rSBA-MenY, PRE [N=208,67]	77	28
rSBA-MenY, PI(M1) [N=222,66]	221	31

No statistical analyses for this end point

Secondary: rSBA antibodies titers

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End point title

rSBA antibodies titers ^[21]

End point description

End point type

Secondary

End point timeframe

Prior to (PRE) and one month after vaccination [PI(M1)]

Notes
[21] - 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 results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.

End point values	Nimenrix 1-2 years of age Group	Meningitec 1-2 years of age Group
Number of subjects analysed	222	68
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA, PRE [N=191,65]	21.6 (16.1 to 29)	20.2 (12.1 to 33.8)
rSBA-MenA, PI(M1) [N=222,63]	3706.5 (3327.2 to 4128.9)	17.1 (10.1 to 29)
rSBA-MenC, PRE [N=203,61]	13.9 (11 to 17.5)	9.7 (6.8 to 13.9)
rSBA-MenC, PI(M1) [N=220,68]	878.7 (779.4 to 990.7)	415 (296.9 to 580)
rSBA-MenW-135, PRE [N=208,62]	11.3 (8.9 to 14.3)	16.5 (10.2 to 26.7)
rSBA-MenW-135, PI(M1) [N=222,63]	5394.6 (4869.9 to 5975.7)	20.3 (12.5 to 33.2)
rSBA-MenY, PRE [N=208,67]	33.8 (25.6 to 44.6)	45.3 (27 to 75.8)
rSBA-MenY, PI(M1) [N=222,66]	2823.8 (2529 to 3153.1)	77.1 (46.3 to 128.2)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Solicited symptoms during the 4-day (Day 0-3) follow-up vaccination period, Unsolicited AEs during the 31-day (Days 0-30) post-vaccination period, SAEs during the entire study periods.

Adverse event reporting additional description

The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

11.1

Reporting group title

Nimenrix™ 1-2 years of age Group

Reporting group description

Reporting group title

Meningitec™ 1-2 years of age Group

Reporting group description

Reporting group title

Mencevax™ 2-11 years of age Group

Reporting group description

Reporting group title

Nimenrix™ 2-11 years of age Group

Reporting group description

Serious adverse events	Nimenrix™ 1-2 years of age Group	Meningitec™ 1-2 years of age Group	Mencevax™ 2-11 years of age Group	Nimenrix™ 2-11 years of age Group
Total subjects affected by serious adverse events
subjects affected / exposed	5 / 229 (2.18%)	7 / 75 (9.33%)	1 / 78 (1.28%)	2 / 231 (0.87%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0
Injury, poisoning and procedural complications
Lower limb fracture
subjects affected / exposed	1 / 229 (0.44%)	0 / 75 (0.00%)	0 / 78 (0.00%)	0 / 231 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Stomatitis
subjects affected / exposed	1 / 229 (0.44%)	0 / 75 (0.00%)	0 / 78 (0.00%)	0 / 231 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Testicular torsion
subjects affected / exposed	0 / 229 (0.00%)	0 / 75 (0.00%)	1 / 78 (1.28%)	0 / 231 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
subjects affected / exposed	1 / 229 (0.44%)	2 / 75 (2.67%)	0 / 78 (0.00%)	0 / 231 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Pneumonia
subjects affected / exposed	1 / 229 (0.44%)	1 / 75 (1.33%)	0 / 78 (0.00%)	1 / 231 (0.43%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	1 / 229 (0.44%)	1 / 75 (1.33%)	0 / 78 (0.00%)	0 / 231 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	1 / 229 (0.44%)	1 / 75 (1.33%)	0 / 78 (0.00%)	0 / 231 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis rotavirus
subjects affected / exposed	0 / 229 (0.00%)	2 / 75 (2.67%)	0 / 78 (0.00%)	0 / 231 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Laryngitis
subjects affected / exposed	0 / 229 (0.00%)	0 / 75 (0.00%)	0 / 78 (0.00%)	1 / 231 (0.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Hyperglycemia
subjects affected / exposed	0 / 229 (0.00%)	0 / 75 (0.00%)	0 / 78 (0.00%)	1 / 231 (0.43%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Nimenrix™ 1-2 years of age Group	Meningitec™ 1-2 years of age Group	Mencevax™ 2-11 years of age Group	Nimenrix™ 2-11 years of age Group
Total subjects affected by non serious adverse events
subjects affected / exposed	193 / 229 (84.28%)	64 / 75 (85.33%)	67 / 78 (85.90%)	192 / 231 (83.12%)
General disorders and administration site conditions
Pain
alternative assessment type: Systematic
subjects affected / exposed ^[1]	76 / 228 (33.33%)	20 / 73 (27.40%)	60 / 78 (76.92%)	135 / 230 (58.70%)
occurrences all number	76	20	60	135
Redness
alternative assessment type: Systematic
subjects affected / exposed ^[2]	84 / 228 (36.84%)	24 / 73 (32.88%)	23 / 78 (29.49%)	97 / 230 (42.17%)
occurrences all number	84	24	23	97
Swelling
alternative assessment type: Systematic
subjects affected / exposed ^[3]	36 / 228 (15.79%)	11 / 73 (15.07%)	9 / 78 (11.54%)	71 / 230 (30.87%)
occurrences all number	36	11	9	71
Drowsiness
alternative assessment type: Systematic
subjects affected / exposed ^[4]	63 / 228 (27.63%)	25 / 73 (34.25%)	5 / 78 (6.41%)	30 / 230 (13.04%)
occurrences all number	63	25	5	30
Fever (Rectally)
alternative assessment type: Systematic
subjects affected / exposed ^[5]	36 / 228 (15.79%)	9 / 73 (12.33%)	3 / 78 (3.85%)	18 / 230 (7.83%)
occurrences all number	36	9	3	18
Irritability
alternative assessment type: Systematic
subjects affected / exposed ^[6]	88 / 228 (38.60%)	29 / 73 (39.73%)	11 / 78 (14.10%)	18 / 230 (7.83%)
occurrences all number	88	29	11	18
Loss of appetite
alternative assessment type: Systematic
subjects affected / exposed ^[7]	54 / 228 (23.68%)	17 / 73 (23.29%)	6 / 78 (7.69%)	16 / 230 (6.96%)
occurrences all number	54	17	6	16
Fatigue
alternative assessment type: Systematic
subjects affected / exposed ^[8]	0 / 228 (0.00%)	0 / 73 (0.00%)	8 / 39 (20.51%)	45 / 117 (38.46%)
occurrences all number	0	0	8	45
Gastrointestinal
alternative assessment type: Systematic
subjects affected / exposed ^[9]	0 / 228 (0.00%)	0 / 73 (0.00%)	5 / 39 (12.82%)	23 / 117 (19.66%)
occurrences all number	0	0	5	23
Headache
alternative assessment type: Systematic
subjects affected / exposed ^[10]	0 / 228 (0.00%)	0 / 75 (0.00%)	6 / 39 (15.38%)	31 / 117 (26.50%)
occurrences all number	0	0	6	31
Pyrexia
subjects affected / exposed	15 / 229 (6.55%)	10 / 75 (13.33%)	2 / 78 (2.56%)	12 / 231 (5.19%)
occurrences all number	15	10	2	12
Gastrointestinal disorders
Diarrhea
subjects affected / exposed	11 / 229 (4.80%)	7 / 75 (9.33%)	1 / 78 (1.28%)	5 / 231 (2.16%)
occurrences all number	11	7	1	5
Teething
subjects affected / exposed	5 / 229 (2.18%)	4 / 75 (5.33%)	0 / 78 (0.00%)	0 / 231 (0.00%)
occurrences all number	5	4	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	18 / 229 (7.86%)	5 / 75 (6.67%)	3 / 78 (3.85%)	5 / 231 (2.16%)
occurrences all number	18	5	3	5
Infections and infestations
Otitis media
subjects affected / exposed	16 / 229 (6.99%)	9 / 75 (12.00%)	1 / 78 (1.28%)	12 / 231 (5.19%)
occurrences all number	16	9	1	12
Rhinitis
subjects affected / exposed	19 / 229 (8.30%)	4 / 75 (5.33%)	0 / 78 (0.00%)	9 / 231 (3.90%)
occurrences all number	19	4	0	9
Upper respiratory tract infection
subjects affected / exposed	14 / 229 (6.11%)	8 / 75 (10.67%)	4 / 78 (5.13%)	10 / 231 (4.33%)
occurrences all number	14	8	4	10
Gastroenteritis
subjects affected / exposed	12 / 229 (5.24%)	1 / 75 (1.33%)	0 / 78 (0.00%)	4 / 231 (1.73%)
occurrences all number	12	1	0	4

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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
[8] - 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
[9] - 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
[10] - 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.

More information

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Were there any global substantial amendments to the protocol? Yes

10 Jan 2012

To support the data obtained by serum bactericidal assay (SBA) testing, antibody concentrations against meningococcal polysaccharides (PSs) were planned to be assessed by enzyme-linked immunosorbent assay (ELISA). The ELISA testing was performed prior to and one month after vaccination, and one and two years after vaccine administration, but the sponsor decided not to perform the ELISA testing at three, four and five years after vaccine administration for the following reasons: •the World Health Organization (WHO) considers SBA the primary means of assessing immune response to meningococcal conjugate vaccines [WHO, 2006; WHO, 1999]. •circulating bactericidal antibodies are more critical for persistent protection against meningococcal disease than non-functional antibodies against meningococcal PSs [Centers for Disease Control (CDC), 2011; WHO, 2006]. Although antibody concentrations will not be determined by ELISA at three, four and five years after vaccine administration, all subjects will be informed of their SBA antibody titers at each immunogenicity time point when statistical analyses at that time point have been completed.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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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 rSBA antibodies vaccine response

Primary: Number of subjects with rSBA antibodies vaccine response

Primary: Number of subjects with rSBA antibodies titers ≥ 1:8

Primary: Number of subjects with rSBA antibodies titers ≥ 1:8

Primary: Percentage of subjects with rSBA antibodies titers ≥ 1:8

Primary: Percentage of subjects with rSBA antibodies titers ≥ 1:8

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8 and ≥ 1:128

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8 and ≥ 1:128

Secondary: rSBA antibodies titers

Secondary: rSBA antibodies titers

Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL and ≥ 2.0 µg/mL

Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL and ≥ 2.0 µg/mL

Secondary: Anti-PS antibodies concentrations

Secondary: Anti-PS antibodies concentrations

Secondary: Number of subjects with anti-TT antibody concentrations ≥ 0.1 IU/mL

Secondary: Number of subjects with anti-TT antibody concentrations ≥ 0.1 IU/mL

Secondary: Anti-TT antibody concentrations

Secondary: Anti-TT antibody concentrations

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

Secondary: rSBA antibodies titers

Secondary: rSBA antibodies titers

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

Secondary: rSBA antibodies titers

Secondary: rSBA antibodies titers

Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL

Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL

Secondary: Anti-PS antibodies concentrations

Secondary: Anti-PS antibodies concentrations

Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL

Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL

Secondary: Anti-PS antibodies concentrations

Secondary: Anti-PS antibodies concentrations

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

Secondary: rSBA antibodies titers

Secondary: rSBA antibodies titers

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

Secondary: rSBA antibodies titers

Secondary: rSBA antibodies titers

Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL

Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL

Secondary: Anti-PS antibodies concentrations

Secondary: Anti-PS antibodies concentrations

Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL

Secondary: Number of subjects with anti-PS antibodies concentrations ≥ 0.3 µg/mL

Secondary: Anti-PS antibodies concentrations

Secondary: Anti-PS antibodies concentrations

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

Secondary: rSBA antibodies titers

Secondary: rSBA antibodies titers

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

Secondary: rSBA antibodies titers

Secondary: rSBA antibodies titers

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

Secondary: rSBA antibodies titers

Secondary: rSBA antibodies titers

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8

Secondary: rSBA antibodies titers

Secondary: rSBA antibodies titers

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8 (HPA laboratory assay)

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8 (HPA laboratory assay)

Secondary: rSBA antibodies titers (HPA laboratory assay)

Secondary: rSBA antibodies titers (HPA laboratory assay)

Secondary: Number of subjects with rSBA antibodies titers ≥ 1:8 (HPA laboratory assay)