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Clinical Trial Results:
A phase IIIb, open, multi-country, controlled, randomized study to demonstrate the immunogenicity and safety of GSK Biologicals' meningococcal conjugate vaccine, MenACWY-TT (GSK 134612) in healthy infants, given on a 3+1 primary and booster (2, 4, 6 and 15-18 months of age), a 1+1 primary and booster (6 and 15-18 months of age) or as a single dose at 15-18 months of age.

Summary
EudraCT number	2013-002537-37
Trial protocol	Outside EU/EEA
Global end of trial date	19 Oct 2015

Results information
Results version number	v2(current)
This version publication date	26 May 2022
First version publication date	29 Apr 2016
Other versions	v1
Version creation reason

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

114858

ISRCTN number

US NCT number

NCT01340898

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, +44 2089904466, GSKClinicalSupportHD@gsk.com

Scientific contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, +44 2089904466, 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?

Analysis stage

Final

Date of interim/final analysis

18 Nov 2016

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

19 Oct 2015

Was the trial ended prematurely?

Main objective of the trial

To demonstrate the immunogenicity of the MenACWY-TT conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroups A, C, W-135 and Y one month post-dose 3 of MenACWY-TT at 7 months of age in healthy infants. Criteria for immunogenicity: For each serogroup, one month after dose 3 of MenACWY-TT vaccination, the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 is greater than or equal to the pre-defined clinical limit of 80%.

Protection of trial subjects

All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged.

Background therapy

Evidence for comparator

Actual start date of recruitment

27 Jan 2012

Long term follow-up planned

Yes

Long term follow-up rationale

Efficacy

Long term follow-up duration

6 Months

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Mexico: 351

Country: Number of subjects enrolled

Lebanon: 402

Worldwide total number of subjects

753

EEA total number of subjects

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)

753

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Out of 753 subjects enrolled, 3 subjects were not vaccinated and hence not considered to have started the study.

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.

Number of subjects started

753

Number of subjects completed

750

Reason: Number of subjects

No vaccination: 3

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 3+1 Group

Arm description

Subjects, male and female, received 4 doses of Nimenrix vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT vaccine, GSK134612

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

The 3 vaccine doses were administered in the anterolateral region of the thigh at 2, 4 and 6 months of age.

Investigational medicinal product name

Synflorix

Investigational medicinal product code

Other name

10Pn vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

As part of the study all subjects received routine administration of Synflorix at 2, 4 and 6 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

Investigational medicinal product name

Infanrix-IPV

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

As part of the study all subjects received routine administration of Infanrix-IPV vaccine at 2, 4 and 6 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

Investigational medicinal product name

Hiberix

Investigational medicinal product code

Other name

Hib vaccine

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

As part of the study all subjects received routine administration of Hib vaccine at 2, 4 and 6 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

Nimenrix 1+1 Group

Arm description

Subjects, male and female, received 2 doses of Nimenrix vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.

Arm type

Experimental

Investigational medicinal product name

Synflorix

Investigational medicinal product code

Other name

10Pn vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

As part of the study all subjects received routine administration of Synflorix at 2, 4 and 6 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

Investigational medicinal product name

Infanrix-IPV

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

As part of the study all subjects received routine administration of Infanrix-IPV vaccine at 2, 4 and 6 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

Investigational medicinal product name

Hiberix

Investigational medicinal product code

Other name

Hib vaccine

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

As part of the study all subjects received routine administration of Hib vaccine at 2, 4 and 6 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT vaccine, GSK134612

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

The vaccine was administered in the anterolateral region of the thigh at 6 months of age.

Nimenrix Control Group

Arm description

Subjects, male and female, received 1 dose of Nimenrix at 15-18 months of age and 4 doses of Synflorix and Infanrix-IPV/Hiberix vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh.

Arm type

Active comparator

Investigational medicinal product name

Synflorix

Investigational medicinal product code

Other name

10Pn vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

As part of the study all subjects received routine administration of Synflorix at 2, 4 and 6 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

Investigational medicinal product name

Infanrix-IPV

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

As part of the study all subjects received routine administration of Infanrix-IPV vaccine at 2, 4 and 6 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

Investigational medicinal product name

Hiberix

Investigational medicinal product code

Other name

Hib vaccine

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

As part of the study all subjects received routine administration of Hib vaccine at 2, 4 and 6 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

Number of subjects in period 1 ^[1]	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Started	376	187	187
Completed	360	178	181
Not completed	16	9	6
Consent withdrawn by subject	8	7	5
Migrated/moved from study area	4	1	-
Lost to follow-up	4	1	-
Serious Adverse Events	-	-	1

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: Not all subjects who completed a period entered in the next one. The number of subjects who started each period depends on the number of subjects available at the time.

Period 2 title

Booster Phase

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Nimenrix 3+1 Group

Arm description

Subjects who received booster 1 dose of Nimenrix vaccine at 15-18 months of age.

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT vaccine, GSK134612

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

The vaccine was administered in the anterolateral region of the thigh at 15-18 months of age.

Investigational medicinal product name

Synflorix

Investigational medicinal product code

Other name

10Pn vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

As part of the study all subjects received routine administration of Synflorix at 15-18 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

Investigational medicinal product name

Infanrix-IPV

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

As part of the study all subjects received routine administration of Infanrix-IPV vaccine at 15-18 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

Investigational medicinal product name

Hiberix

Investigational medicinal product code

Other name

Hib vaccine

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

As part of the study all subjects received routine administration of Hib vaccine at 15-18 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

Nimenrix 1+1 Group

Arm description

Subjects who received booster 1 dose of Nimenrix vaccine 15-18 months of age.

Arm type

Experimental

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT vaccine, GSK134612

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

The vaccine was administered in the anterolateral region of the thigh at 15-18 months of age.

Investigational medicinal product name

Synflorix

Investigational medicinal product code

Other name

10Pn vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

As part of the study all subjects received routine administration of Synflorix at 15-18 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

Investigational medicinal product name

Infanrix-IPV

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

As part of the study all subjects received routine administration of Infanrix-IPV vaccine at 15-18 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

Investigational medicinal product name

Hiberix

Investigational medicinal product code

Other name

Hib vaccine

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

As part of the study all subjects received routine administration of Hib vaccine at 15-18 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

Nimenrix 1 Group

Arm description

Subjects who received 1 dose of Nimenrix vaccine at 15-18 months of age.

Arm type

Active comparator

Investigational medicinal product name

Nimenrix

Investigational medicinal product code

Other name

MenACWY-TT vaccine, GSK134612

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

The vaccine was administered in the anterolateral region of the thigh at 15-18 months of age.

Investigational medicinal product name

Synflorix

Investigational medicinal product code

Other name

10Pn vaccine

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

As part of the study all subjects received routine administration of Synflorix at 15-18 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

Investigational medicinal product name

Hiberix

Investigational medicinal product code

Other name

Hib vaccine

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

As part of the study all subjects received routine administration of Hib vaccine at 15-18 months of age, administered intramuscularly (IM) in the anterolateral region of the thigh.

Number of subjects in period 2 ^[2]	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix 1 Group
Started	342	166	170
Completed	332	164	163
Not completed	10	2	7
Consent withdrawn by subject	3	-	4
Migrated/moved from study area	3	-	-
Lost to follow-up	4	2	3

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 subjects who completed a period entered in the next one. The number of subjects who started each period depends on the number of subjects available at the time.

Baseline characteristics

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Reporting group title

Nimenrix 3+1 Group

Reporting group description

Reporting group title

Nimenrix 1+1 Group

Reporting group description

Reporting group title

Nimenrix Control Group

Reporting group description

Reporting group values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group	Total
Number of subjects	376	187	187	750
Age categorical
Units: Subjects
Age continuous
Units: weeks
arithmetic mean (standard deviation)	8.1 ( 1.6 )	8.1 ( 1.7 )	8.2 ( 1.7 )	-
Gender categorical
Units: Subjects
Female	182	105	95	382
Male	194	82	92	368
Race/Ethnicity, Customized
Units: Subjects
White - Arabic / North African Heritage	199	100	99	398
White - Caucasian / European Heritage	1	0	1	2
Mixed Origin	176	87	87	350

End points

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Reporting group title

Nimenrix 3+1 Group

Reporting group description

Reporting group title

Nimenrix 1+1 Group

Reporting group description

Reporting group title

Nimenrix Control Group

Reporting group description

Reporting group title

Nimenrix 3+1 Group

Reporting group description

Subjects who received booster 1 dose of Nimenrix vaccine at 15-18 months of age.

Reporting group title

Nimenrix 1+1 Group

Reporting group description

Subjects who received booster 1 dose of Nimenrix vaccine 15-18 months of age.

Reporting group title

Nimenrix 1 Group

Reporting group description

Subjects who received 1 dose of Nimenrix vaccine at 15-18 months of age.

Primary: Number of subjects with serum bactericidal assay using rabbit complement against Neisseria meningitidis serogroups antibody titers greater than or equal to (≥) the cut-off value for the Nimenrix 3+1 Group

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End point title

Number of subjects with serum bactericidal assay using rabbit complement against Neisseria meningitidis serogroups antibody titers greater than or equal to (≥) the cut-off value for the Nimenrix 3+1 Group ^[1] ^[2]

End point description

The cut-off value for the rSBA titers was ≥ 1:8. Neisseria meningitidis serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) antibodies were assessed. Immunogenicity was considered demonstrated if the lower limit of the two-sidedexact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥1:8 was greater than or equal to the pre-defined clinical limit of 80%.

End point type

Primary

End point timeframe

At Month 5 (one month post dose 3)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Not all arms in the Baseline Period are applicable for this endpoint.

End point values	Nimenrix 3+1 Group
Number of subjects analysed	328
Units: Participants
rSBA-MenA [N=328]	328
rSBA-MenC [N=328]	327
rSBA-MenW-135 [N=327]	325
rSBA-MenY [N=328]	327

No statistical analyses for this end point

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers greater than or equal to (≥) the 1:8 for the Nimenrix 3+1 Group

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End point title

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers greater than or equal to (≥) the 1:8 for the Nimenrix 3+1 Group ^[3]

End point description

The cut-off value for the rSBA titers was ≥ 1:8

End point type

Secondary

End point timeframe

At Month 13 (prior to booster dose) and at Month 14 (one month after booster dose)

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

End point values	Nimenrix 3+1 Group
Number of subjects analysed	284
Units: Participants
rSBA-MenA,M13 [N=276]	225
rSBA-MenA,M14 [N=283]	283
rSBA-MenC,M13 [N=276]	190
rSBA-MenC,M14 [N=283]	282
rSBA-MenW-135,M13 [N=257]	225
rSBA-MenW-135,M14 [N=284]	284
rSBA-MenY,M13 [N=275]	240
rSBA-MenY,M14[N=284]	284

No statistical analyses for this end point

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers greater than or equal to (≥) the 1:128 for the Nimenrix 3+1 Group

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End point title

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers greater than or equal to (≥) the 1:128 for the Nimenrix 3+1 Group ^[4]

End point description

The cut-off value for the rSBA titers was ≥ 1:128

End point type

Secondary

End point timeframe

At Month 5 (one month post dose 3), 13 (prior booster dose) and 14 (one month after booster dose)

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

End point values	Nimenrix 3+1 Group
Number of subjects analysed	328
Units: Participants
rSBA-MenA, M5 [N=328]	321
rSBA-MenA, M13 [N=276]	146
rSBA-MenA, M14 [N=283]	282
rSBA-MenC, M5 [N=328]	318
rSBA-MenC, M13 [N=276]	93
rSBA-MenC, M14 [N=283]	282
rSBA-MenW-135, M5 [N=327]	313
rSBA-MenW-135, M13 [N=275]	122
rSBA-MenW-135, M14 [N=284]	284
rSBA-MenY, M5 [N=328]	312
rSBA-MenY, M13 [N=275]	121
rSBA-MenY, M14 [N=284]	283

No statistical analyses for this end point

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers for the Nimenrix 3+1 Group

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End point title

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers for the Nimenrix 3+1 Group ^[5]

End point description

Antibody titers are presented as geometric mean titers (GMTs).

End point type

Secondary

End point timeframe

At Month 5 (one month post dose 3), 13 (prior booster dose) and 14 (one month after booster dose)

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: Not all arms in the Baseline Period are applicable for this endpoint.

End point values	Nimenrix 3+1 Group
Number of subjects analysed	328
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA, M5 [N=328]	577.5 (520.7 to 640.6)
rSBA-MenA, M13 [N=276]	71.1 (56.6 to 89.3)
rSBA-MenA, M14 [N=283]	2366.4 (2134.8 to 2623.1)
rSBA-MenC, M5 [N=328]	803.1 (710.4 to 907.8)
rSBA-MenC, M13 [N=276]	33.9 (27.4 to 41.9)
rSBA-MenC, M14 [N=283]	2761.2 (2461.2 to 3097.9)
rSBA-MenW-135, M5 [N=327]	1190.3 (1019.3 to 1390.1)
rSBA-MenW-135, M13 [N=275]	52.0 (42.2 to 64.2)
rSBA-MenW-135, M14 [N=284]	3696.9 (3242.8 to 4214.7)
rSBA-MenY, M5 [N=328]	647.4 (566.6 to 739.6)
rSBA-MenY, M13 [N=275]	66.3 (54.3 to 81.0)
rSBA-MenY, M14 [N=284]	2778.6 (2472.5 to 3122.5)

No statistical analyses for this end point

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers greater than or equal to (≥) the cut-off values for the Nimenrix 1+1 and Nimenrix Control Groups

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End point title

Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers greater than or equal to (≥) the cut-off values for the Nimenrix 1+1 and Nimenrix Control Groups ^[6]

End point description

The cut-off values for the rSBA antibody titers were ≥ 1:8 and ≥ 1:128

End point type

Secondary

End point timeframe

At Months 5 (one month post-primary dose for Nimenrix 1+1 Group), 13 (prior booster dose for Nimenrix 1+1 and prior primary dose for Nimenrix Control Group) and 14 (post booster dose for Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)

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

End point values	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	163	163
Units: Participants
rSBA-MenA, M5, ≥ 1:8 [N=163;163]	161	6
rSBA-MenA, M13, ≥ 1:8 [N=131;132]	107	19
rSBA-MenA, M14, ≥ 1:8 [N=139;135]	138	133
rSBA-MenC, M5, ≥ 1:8 [N=163;162]	162	6
rSBA-MenC, M13, ≥ 1:8 [N=131;132]	86	3
rSBA-MenC, M14, ≥ 1:8 [N=139;135]	138	130
rSBA-MenW-135, M5, ≥ 1:8 [N=163;163]	153	4
rSBA-MenW-135, M13, ≥ 1:8 [N=131;132]	102	7
rSBA-MenW-135, M14, ≥ 1:8 [N=139;135]	139	131
rSBA-MenY, M5, ≥ 1:8 [N=163;162]	161	16
rSBA-MenY, M13, ≥ 1:8 [N=131;132]	116	24
rSBA-MenY, M14, ≥ 1:8 [N=139;135]	139	131
rSBA-MenA, M5, ≥ 1:128 [N=163;163]	155	6
rSBA-MenA, M13, ≥ 1:128 [N=131;132]	88	16
rSBA-MenA, M14, ≥ 1:128 [N=139;135]	138	132
rSBA-MenC, M5, ≥ 1:128 [N=163;162]	151	5
rSBA-MenC, M13, ≥ 1:128 [N=131;132]	39	1
rSBA-MenC, M14, ≥ 1:128 [N=139;135]	137	128
rSBA-MenW-135, M5, ≥ 1:128 [N=163;163]	151	4
rSBA-MenW-135, M13, ≥ 1:128 [N=131;132]	65	7
rSBA-MenW-135, M14, ≥ 1:128 [N=139;135]	138	131
rSBA-MenY, M5, ≥ 1:128 [N=163;162]	159	16
rSBA-MenY, M13, ≥ 1:128 [N=131;132]	70	23
rSBA-MenY, M14, ≥ 1:128 [N=139;135]	137	131

No statistical analyses for this end point

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers Nimenrix 1+1 and Nimenrix Control Groups

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End point title

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers Nimenrix 1+1 and Nimenrix Control Groups ^[7]

End point description

Antibody titers are presented as geometric mean titers (GMTs).

End point type

Secondary

End point timeframe

At Months 5 (one month post-primary dose for Nimenrix 1+1 Group), 13 (prior booster dose for Nimenrix 1+1 and prior primary dose for Nimenrix Control Group) and 14 (post booster dose Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)

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

End point values	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	163	163
Units: Titers
geometric mean (confidence interval 95%)
rSBA-MenA, M5, ≥ 1:8 [N=163;163]	1332.9 (1035.2 to 1716.2)	4.8 (4.1 to 5.5)
rSBA-MenA, M13, ≥ 1:8 [N=131;132]	125.3 (84.4 to 186.1)	7.2 (5.5 to 9.3)
rSBA-MenA, M14, ≥ 1:8 [N=139;135]	2762.3 (2310.3 to 3302.8)	2918.7 (2264.6 to 3761.7)
rSBA-MenC, M5, ≥ 1:8 [N=163;162]	591.6 (482.3 to 725.8)	4.7 (4.1 to 5.4)
rSBA-MenC, M13, ≥ 1:8 [N=131;132]	27.4 (20.6 to 36.6)	4.2 (3.9 to 4.4)
rSBA-MenC, M14, ≥ 1:8 [N=139;135]	2525.2 (2102.1 to 3033.3)	768.1 (593.0 to 995.0)
rSBA-MenW-135, M5, ≥ 1:8 [N=163;163]	1255.9 (917.0 to 1720.0)	4.6 (4.0 to 5.2)
rSBA-MenW-135, M13, ≥ 1:8 [N=131;132]	63.3 (45.6 to 87.9)	5.0 (4.2 to 5.8)
rSBA-MenW-135, M14, ≥ 1:8 [N=139;135	3144.7 (2636.9 to 3750.4)	5240.7 (3855.5 to 7123.7)
rSBA-MenY, M5, ≥ 1:8 [N=163;162]	1469.9 (1186.5 to 1821.0)	6.3 (5.0 to 7.8)
rSBA-MenY, M13, ≥ 1:8 [N=131;132]	106.4 (76.4 to 148.1)	9.4 (6.8 to 12.9)
rSBA-MenY, M14, ≥ 1:8 [N=139;135]	2748.6 (2301.4 to 3282.6)	4202.5 (3219.9 to 5485.1)

No statistical analyses for this end point

Secondary: Number of subjects with booster responses for rSBA-MenA, C rSBA-MenC, Y rSBA-MenY and W-135 rSBA-MenW-135 in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group

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End point title

Number of subjects with booster responses for rSBA-MenA, C rSBA-MenC, Y rSBA-MenY and W-135 rSBA-MenW-135 in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group

End point description

Booster response defined as: for seronegative subjects, antibody titre ≥ 1:32 at post-booster vaccination; for seropositive subjects, antibody titre at post-booster vaccination ≥ 4-fold the pre-booster vaccination antibody titre; for initially seropositive subjects: antibody titre at M14 ≥ 4 fold the pre-vaccination antibody titre.

End point type

Secondary

End point timeframe

At Month 14 (one month post-booster dose for Nimenrix 3+1 and Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix 1 Group
Number of subjects analysed	275	131	132
Units: Participants
rSBA-MenA	248	108	125
rSBA-MenC	210	129	126
rSBA-MenW-135	272	122	128
rSBA-MenY	267	121	125

No statistical analyses for this end point

Secondary: Number of subjects with serum bactericidal assay using human complement against Neisseria meningitidis serogroups A, C, W-135, Y antibody titers greater than or equal to (≥) the cut-off value

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End point title

Number of subjects with serum bactericidal assay using human complement against Neisseria meningitidis serogroups A, C, W-135, Y antibody titers greater than or equal to (≥) the cut-off value ^[8]

End point description

The cut-off value for the hSBA titers was ≥ 1:4 and ≥ 1:8.

End point type

Secondary

End point timeframe

At Month 5 (One Month Post-primary for Nimenrix 3+1 and 1+1 Groups)

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

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group
Number of subjects analysed	147	66
Units: Participants
hSBA-MenA, ≥ 1:4 [N=136;59]	136	58
hSBA-MenC, ≥ 1:4 [N=147;66]	147	66
hSBA-MenW-135, ≥ 1:4 [N=107;47]	107	41
hSBA-MenY, ≥ 1:4 [N=127;52]	127	48
hSBA-MenA, ≥ 1:8 [N=136;59]	136	58
hSBA-MenC, ≥ 1:8 [N=147;66]	147	66
hSBA-MenW-135, ≥ 1:8 [N=107;47]	107	41
hSBA-MenY, ≥ 1:8 [N=127;52]	127	48

No statistical analyses for this end point

Secondary: hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y antibody titers at month 5 (One Month Post-primary for Nimenrix3+1 and Nimenrix 1+1 Groups) -Randomized Subset of 50% of Subjects of All Three Groups

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End point title

hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y antibody titers at month 5 (One Month Post-primary for Nimenrix3+1 and Nimenrix 1+1 Groups) -Randomized Subset of 50% of Subjects of All Three Groups ^[9]

End point description

Antibody titers are presented as geometric mean titers (GMTs).

End point type

Secondary

End point timeframe

At Month 5 (one month post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)

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: Not all arms in the Baseline Period are applicable for this endpoint.

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group
Number of subjects analysed	147	66
Units: Titers
geometric mean (confidence interval 95%)
hSBA-MenA [N=136;59]	808.0 (683.8 to 954.6)	270.5 (205.9 to 355.4)
hSBA-MenC [N=147;66]	3970.8 (3144.0 to 5015.1)	523.1 (381.5 to 717.3)
hSBA-MenW-135 [N=107;47]	1514.5 (1277.2 to 1795.8)	136.5 (78.4 to 237.6)
hSBA-MenY [N=127;52]	1276.2 (1077.3 to 1511.8)	194.8 (117.6 to 322.9)

No statistical analyses for this end point

Secondary: Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y titers greater than or equal to (≥) the cut-off value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control)

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End point title

Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y titers greater than or equal to (≥) the cut-off value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control) ^[10]

End point description

The cut-off value for the hSBA titers was ≥ 1:4 and ≥ 1:8.

End point type

Secondary

End point timeframe

At Month 13 (pre-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and pre-vaccination for Nimenrix Control), and at Month 14 (post-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and post-vaccination for Nimenrix Control)

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: Not all arms in the Baseline Period are applicable for this endpoint.

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group
Number of subjects analysed	198	92
Units: Participants
hSBA-MenA, ≥ 1:4, M13 [N=152;71]	131	48
hSBA-MenA, ≥ 1:4, M14 [N=173;83]	173	83
hSBA-MenC, ≥ 1:4, M13 [N=173;78]	168	76
hSBA-MenC, ≥ 1:4, M14 [N=198;92]	198	92
hSBA-MenW-135, ≥ 1:4, M13 [N=123;53]	123	53
hSBA-MenW-135, ≥ 1:4, M14 [N=129;59]	129	59
hSBA-MenY, ≥ 1:4, M13 [N=138;61]	137	60
hSBA-MenY, ≥ 1:4, M14 [N=149;69]	149	69
hSBA-MenA, ≥ 1:8, M13 [N=152;71]	130	47
hSBA-MenA, ≥ 1:8, M14 [N=173;83]	173	83
hSBA-MenC, ≥ 1:8, M13 [N=173;78]	168	75
hSBA-MenC, ≥ 1:8, M14 [N=198;92]	198	92
hSBA-MenW-135, ≥ 1:8, M13 [N=123;53]	123	53
hSBA-MenW-135, ≥ 1:8, M14 [N=129;59]	129	59
hSBA-MenY, ≥ 1:8, M13 [N=138;61]	137	60
hSBA-MenY, ≥ 1:8, M14 [N=149;69]	149	69

No statistical analyses for this end point

Secondary: hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y antibody titers at month 13 and 14

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End point title

hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y antibody titers at month 13 and 14 ^[11]

End point description

Antibody titers are presented as geometric mean titers (GMTs).

End point type

Secondary

End point timeframe

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: Not all arms in the Baseline Period are applicable for this endpoint.

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group
Number of subjects analysed	198	92
Units: Titers
geometric mean (confidence interval 95%)
hSBA-MenA, M13 [N=152;71]	64.6 (48.8 to 85.5)	20.8 (13.5 to 32.2)
hSBA-MenA, M14 [N=173;83]	2318.6 (1991.7 to 2699.1)	1415.6 (1140.2 to 1757.5)
hSBA-MenC, M13 [N=173;78]	209.0 (165.7 to 263.7)	150.8 (108.5 to 209.5)
hSBA-MenC, M14 [N=198;92]	15919.1 (13965.3 to 18146.2)	13360.1 (10952.9 to 16296.4)
hSBA-MenW-135, M13 [N=123;53]	307.9 (262.9 to 360.6)	428.6 (328.4 to 559.2)
hSBA-MenW-135, M14 [N=129;59]	8761.8 (7431.3 to 10330.5)	9015.6 (7045.2 to 11537.1)
hSBA-MenY, M13 [N=138;61]	363.2 (309.9 to 425.7)	389.2 (292.3 to 518.1)
hSBA-MenY, M14 [N=149;69]	5989.3 (5281.0 to 6792.6)	5977.6 (4746.8 to 7527.6)

No statistical analyses for this end point

Secondary: Number of subjects with booster responses for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix 1 Group

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End point title

Number of subjects with booster responses for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix 1 Group

End point description

Booster response defined as: for seronegative subjects, antibody titre ≥ 1:8 at post-booster vaccination; for seropositive subjects, antibody titre at post-booster vaccination ≥ 4-fold the pre-booster vaccination antibody titre; for initially seropositive subjects: antibody titre at M14 ≥ 4 fold the pre-vaccination antibody titre.

End point type

Secondary

End point timeframe

At Month 14 (one month after the booster dose in Nimenrix 3+1 and Nimenrix 1+1 and post-vaccination in Nimenrix 1 Group)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix 1 Group
Number of subjects analysed	163	75	65
Units: Participants
hSBA-MenA, Total [N=137;64;58]	130	61	51
hSBA-MenC, Total [N=163;75;65]	163	73	65
hSBA-MenW-135, Total [N=107;42;38]	106	40	37
hSBA-MenY, Total [N=122;49;34]	115	45	30

No statistical analyses for this end point

Secondary: Number of subjects with anti-pneumococcal antibody concentrations greater than or equal to (≥) 0.15 micrograms per millilitre (µg/mL).

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End point title

Number of subjects with anti-pneumococcal antibody concentrations greater than or equal to (≥) 0.15 micrograms per millilitre (µg/mL).

End point description

The anti-pneumococcal serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

End point type

Secondary

End point timeframe

At Month 5 (one month post-dose 3), Month 13 (prior booster dose) and Month 14 (one month after the booster dose)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	82	42	37
Units: Participants
anti-1, M5 [N=82;42;37]	82	42	37
anti-1, M13 [N=57;32;27]	36	19	19
anti-1, M14 [N=61;30;29]	61	29	29
anti-4, M5 [N=82;42;37]	82	42	37
anti-4, M13 [N=57;33;27]	38	22	20
anti-4, M14 [N=61;30;29]	61	30	29
anti-5, M5 [N=82;42;37]	81	42	37
anti-5, M13 [N=57;33;27]	32	18	17
anti-5, M14 [N=61;30;29]	60	29	27
anti-6A, M5 [N=69;37;28]	51	31	22
anti-6A, M13 [N=56;32;26]	44	26	16
anti-6A, M14 [N=51;25;25]	51	25	24
anti-6B, M5 [N=81;42;37]	81	41	37
anti-6B, M13 [N=57;33;27]	55	31	22
anti-6B, M14 [N=61;30;29]	61	30	28
anti-7F, M5 [N=82;42;37]	82	42	37
anti-7F, M13 [N=57;33;27]	55	32	23
anti-7F, M14 [N=61;30;29]	61	29	29
anti-9V, M5 [N=82;42;37]	82	42	37
anti-9V, M13 [N=57;33;27]	47	24	17
anti-9V, M14 [N=61;30;29]	61	29	29
anti-14, M5 [N=82;42;36]	82	42	36
anti-14, M13 [N=57;33;27]	56	33	25
anti-14, M14 [N=61;30;29]	61	30	29
anti-18C, M5 [N=82;42;37]	81	42	37
anti-18C, M13 [N=57;33;27]	43	20	19
anti-18C, M14 [N=61;30;29]	61	29	29
anti-19A, M5 [N=82;42;37]	49	26	27
anti-19A, M13 [N=57;33;27]	41	23	20
anti-19A, M14 [N=61;29;29]	57	27	27
anti-19F, M5 [N=81;42;37]	81	42	36
anti-19F, M13 [N=57;33;27]	57	33	25
anti-19F, M14 [N=61;30;29]	61	30	29
anti-23F, M5 [N=71;42;36]	66	42	35
anti-23F, M13 [N=57;33;26]	42	25	18
anti-23F, M14 [N=45;24;21]	45	23	21

No statistical analyses for this end point

Secondary: Number of subjects with anti-pneumococcal antibody concentrations greater than or equal to (≥) 0.35 micrograms per millilitre (µg/mL)

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End point title

Number of subjects with anti-pneumococcal antibody concentrations greater than or equal to (≥) 0.35 micrograms per millilitre (µg/mL)

End point description

The anti-pneumococcal serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

End point type

Secondary

End point timeframe

At Month 5 (one month post-dose 3), Month 13 (prior booster dose) and Month 14 (one month after the booster dose)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	82	42	37
Units: Participants
anti-1, M5 [N=82;42;37]	76	41	34
anti-1, M13 [N=57;32;27]	12	5	8
anti-1, M14 [N=61;30;29]	61	29	28
anti-4, M5 [N=82;42;37]	81	41	37
anti-4, M13 [N=57;33;27]	17	5	10
anti-4, M14 [N=61;30;29]	58	29	29
anti-5, M5 [N=82;42;37]	72	32	28
anti-5, M13 [N=57;33;27]	10	5	5
anti-5, M14 [N=61;30;29]	49	23	26
anti-6A, M5 [N=69;37;28]	36	20	13
anti-6A, M13 [N=56;32;26]	26	10	11
anti-6A, M14 [N=51;25;25]	47	22	23
anti-6B, M5 [N=81;42;37]	73	40	35
anti-6B, M13 [N=57;33;27]	37	23	15
anti-6B, M14 [N=61;30;29]	61	28	28
anti-7F, M5 [N=82;42;37]	81	42	37
anti-7F, M13 [N=57;33;27]	38	17	14
anti-7F, M14 [N=61;30;29]	61	29	28
anti-9V, M5 [N=82;42;37]	79	40	36
anti-9V, M13 [N=57;33;27]	19	10	9
anti-9V, M14[N=61;30;29]	59	28	28
anti-14, M5 [N=82;42;36]	80	41	36
anti-14, M13 [N=57;33;27]	44	28	21
anti-14, M14 [N=61;30;29]	61	29	28
anti-18C, M5 [N=82;42;37]	79	41	36
anti-18C, M13 [N=57;33;27]	18	9	11
anti-18C, M14 [N=61;30;29]	61	27	29
anti-19A, M5 [N=82;42;37]	28	14	13
anti-19A, M13 [N=57;33;27]	25	15	5
anti-19A, M14 [N=61;29;29]	52	21	22
anti-19F, M5 [N=81;42;37]	80	42	36
anti-19F, M13 [N=57;33;27]	52	30	20
anti-19F, M14 [N=61;30;29]	61	30	29
anti-23F, M5 [N=71;42;36]	62	42	32
anti-23F, M13 [N=57;33;26]	28	14	12
anti-23F, M14 [N=45;24;21]	45	23	20

No statistical analyses for this end point

Secondary: Anti-pneumococcal antibody concentrations

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End point title

Anti-pneumococcal antibody concentrations

End point description

Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in micrograms/millilitre (µg/mL)

End point type

Secondary

End point timeframe

At Month 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	82	42	37
Units: μg/mL
geometric mean (confidence interval 95%)
anti-1, M5 [N=82;42;37]	1.3 (1.1 to 1.6)	1.4 (1.1 to 1.8)	1.5 (1.1 to 2.1)
anti-1, M13 [N=57;32;27]	0.2 (0.1 to 0.2)	0.2 (0.1 to 0.2)	0.2 (0.2 to 0.3)
anti-1, M14 [N=61;30;29]	2.1 (1.6 to 2.6)	1.7 (1.2 to 2.5)	2.2 (1.5 to 3.2)
anti-4, M5 [N=82;42;37]	1.7 (1.5 to 2.0)	1.8 (1.4 to 2.2)	1.8 (1.3 to 2.5)
anti-4, M13 [N=57;33;27]	0.2 (0.2 to 0.3)	0.2 (0.2 to 0.3)	0.3 (0.2 to 0.4)
anti-4, M14 [N=61;30;29]	2.4 (1.8 to 3.1)	2.4 (1.8 to 3.1)	3.1 (2.3 to 4.2)
anti-5, M5 [N=82;42;37]	0.6 (0.6 to 0.7)	0.6 (0.5 to 0.7)	0.7 (0.5 to 0.9)
anti-5, M13 [N=57;33;27]	0.2 (0.1 to 0.2)	0.2 (0.1 to 0.2)	0.2 (0.1 to 0.2)
anti-5, M14 [N=61;30;29]	0.7 (0.6 to 0.9)	0.5 (0.4 to 0.7)	0.7 (0.5 to 1.0)
anti-6A, M5 [N=69;37;28]	0.3 (0.3 to 0.4)	0.4 (0.3 to 0.6)	0.3 (0.2 to 0.4)
anti-6A, M13 [N=56;32;26]	0.3 (0.2 to 0.4)	0.3 (0.2 to 0.4)	0.2 (0.2 to 0.4)
anti-6A, M14 [N=51;25;25]	1.7 (1.3 to 2.3)	1.4 (0.9 to 2.1)	1.6 (1.0 to 2.5)
anti-6B, M5 [N=81;42;37]	1.8 (1.4 to 2.3)	1.7 (1.3 to 2.4)	1.8 (1.3 to 2.5)
anti-6B, M13 [N=57;33;27]	0.6 (0.4 to 0.7)	0.5 (0.4 to 0.7)	0.4 (0.3 to 0.7)
anti-6B, M14 [N=61;30;29]	3.8 (3.1 to 4.8)	2.4 (1.7 to 3.5)	3.4 (2.2 to 5.2)
anti-7F, M5 [N=82;42;37]	2.5 (2.2 to 3.0)	2.2 (1.8 to 2.7)	2.8 (2.1 to 3.7)
anti-7F, M13 [N=57;33;27]	0.4 (0.4 to 0.5)	0.4 (0.3 to 0.5)	0.4 (0.3 to 0.6)
anti-7F, M14 [N=61;30;29]	3.5 (2.9 to 4.2)	2.2 (1.6 to 3.1)	3.4 (2.4 to 4.9)
anti-9V, M5 [N=82;42;37]	1.2 (1.0 to 1.4)	1.2 (1.0 to 1.5)	1.3 (1.0 to 1.7)
anti-9V, M13 [N=57;33;27]	0.3 (0.2 to 0.4)	0.3 (0.2 to 0.4)	0.2 (0.1 to 0.3)
anti-9V, M14 [N=61;30;29]	1.6 (1.3 to 2.0)	1.0 (0.8 to 1.4)	1.6 (1.2 to 2.2)
anti-14, M5 [N=82;42;36]	5.2 (4.1 to 6.5)	6.0 (4.4 to 8.0)	7.0 (4.9 to 10.0)
anti-14, M13 [N=57;33;27]	1.0 (0.7 to 1.3)	0.8 (0.6 to 1.0)	0.9 (0.5 to 1.4)
anti-14, M14 [N=61;30;29]	8.4 (6.8 to 10.4)	6.8 (4.8 to 9.7)	9.0 (6.0 to 13.5)
anti-18C, M5 [N=82;42;37]	2.3 (1.9 to 2.8)	2.0 (1.5 to 2.5)	2.9 (2.2 to 3.8)
anti-18C, M13 [N=57;33;27]	0.2 (0.2 to 0.3)	0.2 (0.1 to 0.3)	0.3 (0.2 to 0.4)
anti-18C, M14 [N=61;30;29]	3.6 (3.0 to 4.4)	2.3 (1.5 to 3.6)	3.4 (2.6 to 4.6)
anti-19A, M5 [N=82;42;37]	0.2 (0.2 to 0.3)	0.2 (0.2 to 0.4)	0.2 (0.2 to 0.3)
anti-19A, M13 [N=57;33;27]	0.3 (0.2 to 0.4)	0.3 (0.2 to 0.4)	0.2 (0.1 to 0.3)
anti-19A, M14 [N=61;29;29]	1.2 (0.8 to 1.7)	1.1 (0.6 to 1.9)	0.8 (0.5 to 1.2)
anti-19F, M5 [N=81;42;37]	3.7 (3.0 to 4.6)	3.8 (2.7 to 5.3)	4.7 (3.3 to 6.6)
anti-19F, M13 [N=57;33;27]	0.9 (0.7 to 1.2)	0.9 (0.7 to 1.3)	0.9 (0.5 to 1.5)
anti-19F, M14 [N=61;30;29]	8.0 (6.2 to 10.2)	6.9 (4.5 to 10.6)	9.8 (6.8 to 14.2)
anti-23F, M5 [N=71;42;36]	1.4 (1.0 to 1.9)	1.8 (1.4 to 2.4)	1.5 (1.0 to 2.2)
anti-23F, M13 [N=57;33;26]	0.3 (0.2 to 0.4)	0.3 (0.2 to 0.4)	0.2 (0.2 to 0.4)
anti-23F, M14 [N=45;24;21]	3.4 (2.6 to 4.5)	2.1 (1.3 to 3.4)	2.9 (1.8 to 4.7)

No statistical analyses for this end point

Secondary: Number of subjects with anti-diphtheria (anti-D) antibodies, by ATP cohort

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End point title

Number of subjects with anti-diphtheria (anti-D) antibodies, by ATP cohort

End point description

Cut-off values assessed were greater than or equal to (≥) 0.1 international units per millilitre (IU/mL). The analysis was performed in a randomized subset of 25% of subjects of all three groups.

End point type

Secondary

End point timeframe

At Month 5 (one month post dose 3)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	72	34	38
Units: Participants
Participants	72	34	38

No statistical analyses for this end point

Secondary: Concentration of antibodies against diphtheria antigens (anti-D), by ATP cohort

Top of page

End point title

Concentration of antibodies against diphtheria antigens (anti-D), by ATP cohort

End point description

End point type

Secondary

End point timeframe

At Month 5 (one month post dose 3)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	72	34	38
Units: IU/mL
geometric mean (confidence interval 95%)
IU/mL	2.259 (1.820 to 2.804)	3.028 (2.177 to 4.213)	2.462 (1.700 to 3.565)

No statistical analyses for this end point

Secondary: Number of subjects with anti-diphtheria (anti-D) antibodies, by TVC

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End point title

Number of subjects with anti-diphtheria (anti-D) antibodies, by TVC

End point description

Cut-off values assessed were greater than or equal to (≥) 0.1 international units per millilitre (IU/mL). The analysis was performed in a randomized subset of 25% of subjects of all three groups. Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis.

End point type

Secondary

End point timeframe

At Month 5 (one month post dose 3)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	76	36	39
Units: Participants
Participants	76	36	39

No statistical analyses for this end point

Secondary: Concentration of antibodies against diphtheria antigens (anti-D), by TVC

Top of page

End point title

Concentration of antibodies against diphtheria antigens (anti-D), by TVC

End point description

Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per millilitre (IU/mL). The analysis was performed in a randomized subset of 25% of subjects of all three groups. Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis.

End point type

Secondary

End point timeframe

At Month 5 (one month post dose 3)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	76	36	39
Units: IU/mL
geometric mean (confidence interval 95%)
IU/mL	2.435 (1.958 to 3.028)	3.069 (2.225 to 4.233)	2.423 (1.688 to 3.479)

No statistical analyses for this end point

Secondary: Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA), anti-pertactin (anti-PRN) Immunoglobulin G (IgG) antibodies, by ATP cohort

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End point title

Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA), anti-pertactin (anti-PRN) Immunoglobulin G (IgG) antibodies, by ATP cohort

End point description

End point type

Secondary

End point timeframe

At Month 5 (one month post dose 3)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	73	34	39
Units: Participants
anti-PT, M5	73	34	39
anti-FHA, M5	73	34	39
anti-PRN, M5	73	34	38

No statistical analyses for this end point

Secondary: Concentration of antibodies against pertussis toxoid (anti-PT), filamentous haemagglutinin (anti-FHA), pertactin (anti-PRN) antigens, by ATP cohort

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End point title

Concentration of antibodies against pertussis toxoid (anti-PT), filamentous haemagglutinin (anti-FHA), pertactin (anti-PRN) antigens, by ATP cohort

End point description

Concentrations are presented as geometric mean concentrations (GMCs) expressed in enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/ml).

End point type

Secondary

End point timeframe

At Month 5 (one month post dose 3)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	73	34	39
Units: EL.U/mL
geometric mean (confidence interval 95%)
anti-PT, M5	49.9 (43.3 to 57.6)	51.9 (40.8 to 66.0)	47.8 (38.3 to 59.7)
anti-FHA, M5	126.2 (108.8 to 146.3)	134.2 (108.3 to 166.4)	132.6 (107.8 to 163.1)
anti-PRN, M5	108.6 (88.8 to 132.9)	167.5 (117.6 to 238.7)	158.2 (106.5 to 235.1)

No statistical analyses for this end point

Secondary: Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA), anti-pertactin (anti-PRN) Immunoglobulin G (IgG) antibodies, by TVC

Top of page

End point title

Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA), anti-pertactin (anti-PRN) Immunoglobulin G (IgG) antibodies, by TVC

End point description

Cut-off values assessed were greater than or equal to ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/ml). The analysis was performed in a randomized subset of 25% of subjects of all three groups. Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis.

End point type

Secondary

End point timeframe

At Month 5 (one month post dose 3)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	77	36	40
Units: Participants
anti-PT, M5	77	36	40
anti-FHA, M5	77	36	40
anti-PRN, M5	77	36	39

No statistical analyses for this end point

Secondary: Concentration of antibodies against pertussis toxoid (anti-PT), filamentous haemagglutinin (anti-FHA), pertactin (anti-PRN) antigens, by TVC

Top of page

End point title

Concentration of antibodies against pertussis toxoid (anti-PT), filamentous haemagglutinin (anti-FHA), pertactin (anti-PRN) antigens, by TVC

End point description

Concentrations are presented as geometric mean concentrations (GMCs) expressed in enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/ml) Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis.

End point type

Secondary

End point timeframe

At Month 5 (one month post dose 3)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	77	36	40
Units: EL.U/mL
geometric mean (confidence interval 95%)
anti-PT, M5	50.4 (43.9 to 57.8)	54.7 (42.9 to 69.9)	46.4 (37.0 to 58.1)
anti-FHA, M5	127.3 (110.6 to 146.6)	143.3 (114.4 to 179.4)	129.4 (105.1 to 159.2)
anti-PRN, M5	116.7 (95.2 to 143.1)	178.9 (125.5 to 255.1)	154.8 (105.0 to 228.3)

No statistical analyses for this end point

Secondary: Number of subjects with anti-poliovirus type 1, 2 and 3 antibodies, by ATP cohort

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End point title

Number of subjects with anti-poliovirus type 1, 2 and 3 antibodies, by ATP cohort

End point description

Cut-off values assessed were greater than or equal to (≥) 1:8 titers. The analysis was performed in a randomized subset of 25% of subjects of all three groups.

End point type

Secondary

End point timeframe

At Month 5 (one month post dose 3)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	69	29	33
Units: Participants
anti-Polio 1, M5 [N=69,28,29]	69	28	29
anti-Polio 2, M5 [N=69;29;33]	69	29	33
anti-Polio 3, M5 [N=68;26;30]	68	26	30

No statistical analyses for this end point

Secondary: Antibody titers for anti-polio type 1, 2 and 3 antibodies, by ATP cohort

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End point title

Antibody titers for anti-polio type 1, 2 and 3 antibodies, by ATP cohort

End point description

Antibody titers are presented as geometric mean titers (GMTs). The analysis was performed in a randomized subset of 25% of subjects of all three groups.

End point type

Secondary

End point timeframe

At Month 5 (one month post dose 3)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	69	29	33
Units: Titers
geometric mean (confidence interval 95%)
anti-Polio 1, M5 [N=69,28,29]	788.8 (584.1 to 1065.2)	1102.9 (725.2 to 1677.2)	908.6 (549.1 to 1503.4)
anti-Polio 2, M5 [N=69;29;33]	850.4 (647.3 to 1117.3)	953.3 (579.0 to 1569.5)	1079.2 (704.9 to 1652.1)
anti-Polio 3, M5 [N=68;26;30]	1678.8 (1211.2 to 2326.9)	1676.7 (1011.1 to 2780.5)	1261.3 (720.8 to 2207.1)

No statistical analyses for this end point

Secondary: Number of subjects with anti-poliovirus type 1, 2 and 3 antibodies, by TVC

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End point title

Number of subjects with anti-poliovirus type 1, 2 and 3 antibodies, by TVC

End point description

Cut-off values assessed were greater than or equal to (≥) 1:8 titers. The analysis was performed in a randomized subset of 25% of subjects of all three groups. Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis.

End point type

Secondary

End point timeframe

At Month 5 (one month post dose 3)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	73	31	34
Units: Participants
anti-Polio 1, M5 [N=73;30;30]	73	30	30
anti-Polio 2, M5 [N=73;31;34]	73	31	34
anti-Polio 3, M5 [N=71;28;31]	71	28	31

No statistical analyses for this end point

Secondary: Antibody titers for anti-polio type 1, 2 and 3 antibodies, by TVC

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End point title

Antibody titers for anti-polio type 1, 2 and 3 antibodies, by TVC

End point description

Antibody titers are presented as geometric mean titers (GMTs). The analysis was performed in a randomized subset of 25% of subjects of all three groups. Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis.

End point type

Secondary

End point timeframe

At Month 5 (one month post dose 3)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	73	31	34
Units: Titers
geometric mean (confidence interval 95%)
anti-Polio 1, M5 [N=73;30;30]	827.2 (618.7 to 1105.8)	1048.1 (681.1 to 1612.7)	861.0 (523.3 to 1416.8)
anti-Polio 2, M5 [N=73;31;34]	931.3 (707.7 to 1225.6)	990.4 (606.5 to 1617.3)	1024.0 (668.6 to 1568.2)
anti-Polio 3, M5 [N=71;28;31]	1709.5 (1245.4 to 2346.7)	1618.7 (963.7 to 2719.0)	1184.8 (679.9 to 2064.4)

No statistical analyses for this end point

Secondary: Number of subjects with anti-tetanus (anti-T) antibodies, by ATP

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End point title

Number of subjects with anti-tetanus (anti-T) antibodies, by ATP

End point description

Cut-off values assessed were greater than or equal to (≥) 0.1 international units per millilitre (IU/mL). The analysis was performed in a randomized subset of 25% of subjects of all three groups.

End point type

Secondary

End point timeframe

At Month 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	77	36	40
Units: Participants
anti-T, M5 [N=77;36;40]	77	36	40
anti-T, M13 [N=59;29;26]	58	28	24
anti-T, M14 [N=62;22;23]	62	22	23

No statistical analyses for this end point

Secondary: Concentration of antibodies against tetanus antigens (anti-T), by ATP

Top of page

End point title

Concentration of antibodies against tetanus antigens (anti-T), by ATP

End point description

End point type

Secondary

End point timeframe

At Month 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	73	34	39
Units: IU/mL
geometric mean (confidence interval 95%)
anti-T, M5 [N=73, 34, 39]	5.798 (4.998 to 6.726)	7.246 (5.305 to 9.897)	5.973 (4.818 to 7.406)
anti-T, M13 [N=49, 24,21]	0.479 (0.398 to 0.576)	0.659 (0.427 to 1.018)	0.461 (0.297 to 0.716)
anti-T, M14 [N=57,20,21]	18.977 (16.013 to 22.489)	16.813 (12.386 to 22.821)	35.835 (23.802 to 53.951)

No statistical analyses for this end point

Secondary: Concentration of antibodies against tetanus antigens (anti-T), by TVC

Top of page

End point title

Concentration of antibodies against tetanus antigens (anti-T), by TVC

End point description

End point type

Secondary

End point timeframe

At Month 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	77	36	40
Units: IU/mL
geometric mean (confidence interval 95%)
anti-T, M5 [N=77;36;40]	6.099 (5.236 to 7.104)	7.402 (5.510 to 9.943)	5.901 (4.780 to 7.286)
anti-T, M13 [N=58;29;24]	0.535 (0.450 to 0.636)	0.610 (0.414 to 0.899)	0.419 (0.287 to 0.610)
anti-T, M14 [N=40;26;23]	18.889 (16.158 to 22.082)	16.809 (12.710 to 22.230)	36.593 (25.224 to 53.085)

No statistical analyses for this end point

Secondary: Number of subjects with anti-tetanus (anti-T) antibodies, by TVC

Top of page

End point title

Number of subjects with anti-tetanus (anti-T) antibodies, by TVC

End point description

End point type

Secondary

End point timeframe

At Month 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	77	36	40
Units: Participants
anti-T, M5 [N=77;36;40]	77	36	40
anti-T, M13 [N=58;29;24]	58	28	24
anti-T, 14 [N=40;26;23]	62	22	23

No statistical analyses for this end point

Secondary: Anti-PRP antibody concentrations (Geometric Mean Concentrations) in a randomized subset of 25% of the subjects

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End point title

Anti-PRP antibody concentrations (Geometric Mean Concentrations) in a randomized subset of 25% of the subjects

End point description

The endpoints evaluating immunogenicity of the Hib component (anti-polyribosyl ribitol phosphate [anti-PRP] antibody concentrations) has been cancelled owing to the extended delay in the re-development and re-validation of the PRP assay.

End point type

Secondary

End point timeframe

At Month 5 (one month post-dose 3)

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	0 ^[12]	0 ^[13]	0 ^[14]
Units: μg/mL
geometric mean (confidence interval 95%)	( to )	( to )	( to )

Notes
[12] - No subjects were analyzed because the Hib component immunogenicity assessment was cancelled.
[13] - No subjects were analyzed because the Hib component immunogenicity assessment was cancelled.
[14] - No subjects were analyzed because the Hib component immunogenicity assessment was cancelled.

No statistical analyses for this end point

Secondary: Number of subjects with solicited local symptoms (Primary Phase)

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End point title

Number of subjects with solicited local symptoms (Primary Phase)

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) of injection site.

End point type

Secondary

End point timeframe

Within 8 days (Day 0-7) post primary vaccination

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	369	182	184
Units: Participants
Any Pain Dose 1 [N=369;182;184]	220	115	108
Grade 3 Pain Dose 1 [N=369;182;184]	38	25	14
Any Redness Dose 1 [N=369;182;184]	94	39	43
Grade 3 Redness Dose 1 [N=369;182;184]	1	0	0
Any Swelling Dose 1 [N=369;182;184]	84	31	34
Grade 3 Swelling Dose 1 [N=369;182;184]	0	3	0
Any Pain Dose 2 [N=363;181;181]	177	92	101
Grade 3 Pain Dose 2 [N=363;181;181]	33	11	16
Any Redness Dose 2 [N=363;181;181]	93	51	48
Grade 3 Redness Dose 2 [N=363;181;181]	2	0	1
Any Swelling Dose 2 [N=363;181;181]	76	47	42
Grade 3 Swelling Dose 2 [N=363;181;181]	2	2	0
Any Pain Dose 3 [N=359;177;180]	148	73	93
Grade 3 Pain Dose 3 [N=359;177;180]	16	18	9
Any Redness Dose 3 [N=359;177;180]	74	46	42
Grade 3 Redness Dose 3 [N=359;177;180]	1	1	1
Any Swelling Dose 3 [N=359;177;180]	66	46	37
Grade 3 Swelling Dose 3 [N=359;177;180]	1	0	0
Any Pain Across Doses [N=369;182;184]	262	135	142
Grade 3 Pain Across Doses [N=369;182;184]	65	36	33
Any Redness Across Doses [N=369;182;184]	160	79	78
Grade 3 Redness Across Doses [N=369;182;184]	4	1	2
Any Swelling Across Doses [N=369;182;184]	147	74	70
Grade 3 Swelling Across Doses [N=369;182;184]	3	4	0

No statistical analyses for this end point

Secondary: Number of subjects with solicited local symptoms (Booster Phase)

Top of page

End point title

Number of subjects with solicited local symptoms (Booster Phase)

End point description

End point type

Secondary

End point timeframe

Within 8 days (Day 0-7) post booster vaccination

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix 1 Group
Number of subjects analysed	338	165	167
Units: Participants
Any Pain	139	71	77
Grade 3 Pain	21	19	14
Any Redness	74	32	39
Grade 3 Redness	1	1	3
Any Swelling	55	29	33
Grade 3 Swelling	2	1	3

No statistical analyses for this end point

Secondary: Number of subjects with solicited general symptoms (Primary Phase)

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End point title

Number of subjects with solicited general symptoms (Primary Phase)

End point description

Assessed solicited general symptoms were temperature [defined as rectally temperature equal to or above 38 degrees Celsius (°C)], drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

End point type

Secondary

End point timeframe

Within 8 days (Day 0-7) post primary vaccination

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	369	182	184
Units: Participants
Any Drowsiness Dose 1 [N=369;182;184]	177	93	84
Grade 3 Drowsiness Dose 1 [N=369;182;184]	18	10	2
Related Drowsiness Dose 1 [N=369;182;184]	160	84	79
Any Irritability Dose 1 [N=369;182;184]	200	107	99
Grade 3 Irritability Dose 1 [N=369;182;184]	19	9	10
Related Irritability Dose 1 [N=369;182;184]	188	96	89
Any Loss of appetite Dose 1 [N=369;182;184]	109	62	42
Grade 3 Loss of appetite Dose 1 [N=369;182;184]	7	5	3
Related Loss of appetite Dose 1 [N=369;182;184]	99	55	35
Any Temperature Dose 1 [N=369;182;184]	126	62	58
Grade 3 Temperature Dose 1 [N=369;182;184]	0	0	1
Related Temperature Dose 1 [N=369;182;184]	109	56	53
Any Drowsiness Dose 2 [N=363;181;181]	116	72	67
Grade 3 Drowsiness Dose 2 [N=363;181;181]	9	8	8
Related Drowsiness Dose 2 [N=363;181;181]	109	69	62
Any Irritability Dose 2 [N=363;181;181]	163	82	90
Grade 3 Irritability Dose 2 [N=363;181;181]	20	14	10
Related Irritability Dose 2 [N=363;181;181]	158	77	85
Any Loss of appetite Dose 2 [N=363;181;181]	89	50	44
Grade 3 Loss of appetite Dose 2 [N=363;181;181]	6	5	6
Related Loss of appetite Dose 2 [N=363;181;181]	80	48	39
Any Temperature Dose 2 [N=363;181;181]	119	64	63
Grade 3 Temperature Dose 2 [N=363;181;181]	0	0	0
Related Temperature Dose 2 [N=363;181;181]	116	59	54
Any Drowsiness Dose 3 [N=359;177;180]	102	54	64
Grade 3 Drowsiness Dose 3 [N=359;177;180]	11	8	4
Related Drowsiness Dose 3 [N=359;177;180]	95	54	60
Any Irritability Dose 3 [N=359;177;180]	140	73	73
Grade 3 Irritability Dose 3 [N=359;177;180]	14	14	3
Related Irritability Dose 3 [N=359;177;180]	132	72	69
Any Loss of appetite Dose 3 [N=359;177;180]	76	43	50
Grade 3 Loss of appetite Dose 3 [N=359;177;180]	7	6	3
Related Loss of appetite Dose 3 [N=359;177;180]	63	41	46
Any Temperature Dose 3 [N=359;177;180]	109	51	41
Grade 3 Temperature Dose 3 [N=359;177;180]	2	0	0
Related Temperature Dose 3 [N=359;177;180]	96	46	36
Any Drowsiness Across Doses [N=369;182;184]	217	121	118
Grade 3 Drowsiness Across Doses [N=369;182;184]	30	19	13
Related Drowsiness Across Doses [N=369;182;184]	205	116	114
Any Irritability Across Doses [N=369;182;184]	254	128	126
Grade 3 Irritability Across Doses [N=369;182;184]	42	27	18
Related Irritability Across Doses [N=369;182;184]	246	125	121
Any Loss of appetite Across [N=369;182;184]	165	89	82
Grade 3 Loss of appetite Across [N=369;182;184]	17	13	10
Related Loss of appetite Across [N=369;182;184]	151	84	77
Any Temperature Across Doses [N=369;182;184]	203	102	101
Grade 3 Temperature Across Doses [N=369;182;184]	2	0	1
Related Temperature Across Doses [N=369;182;184]	193	97	93

No statistical analyses for this end point

Secondary: Number of subjects with solicited general symptoms (Booster Phase)

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End point title

Number of subjects with solicited general symptoms (Booster Phase)

End point description

End point type

Secondary

End point timeframe

Within 8 days (Day 0-7) post booster vaccination

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix 1 Group
Number of subjects analysed	338	165	167
Units: Participants
Any Drowsiness	79	46	43
Grade 3 Drowsiness	4	7	5
Related Drowsiness	75	42	43
Any Irritability	112	54	61
Grade 3 Irritability	9	12	10
Related Irritability	106	52	60
Any Loss of appetite	69	37	39
Grade 3 Loss of appetite	5	5	1
Related Loss of appetite	60	34	37
Any Temperature	68	35	27
Grade 3 Temperature	2	1	0
Related Temperature	62	32	24

No statistical analyses for this end point

Secondary: Number of subjects with unsolicited adverse events (AEs) (Primary Phase)

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End point title

Number of subjects with unsolicited adverse events (AEs) (Primary Phase)

End point description

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

End point type

Secondary

End point timeframe

Within 31 days (Day 0-30) post each primary vaccine dose

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	376	187	187
Units: Participants
Any AE(s) Dose 1 [N=376;187;187]	67	36	34
Any AE(s) Dose 2 [N=368;182;182]	70	34	28
Any AE(s) Dose 3 [N=362;179;181]	97	49	45

No statistical analyses for this end point

Secondary: Number of subjects with unsolicited adverse events (AEs) (Booster phase)

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End point title

Number of subjects with unsolicited adverse events (AEs) (Booster phase)

End point description

End point type

Secondary

End point timeframe

Within 31 days (Day 0-30) post booster vaccination

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix 1 Group
Number of subjects analysed	342	166	170
Units: Participants
Participants	58	32	36

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)

End point description

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

End point type

Secondary

End point timeframe

From Day 0 to Month 18

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	376	187	187
Units: Participants
Participants	16	8	4

No statistical analyses for this end point

Secondary: Number of subjects with serious adverse events (SAEs)

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End point title

Number of subjects with serious adverse events (SAEs)

End point description

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

End point type

Secondary

End point timeframe

From Day 0 to Month 19

End point values	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Number of subjects analysed	376	187	187
Units: Participants
Participants	35	14	14

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Solicited local/general symptoms during the 8-day post-vaccination period (Days 0-7), Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Month 19).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

18.1

Reporting group title

Nimenrix 3+1 Group

Reporting group description

Reporting group title

Nimenrix 1+1 Group

Reporting group description

Reporting group title

Nimenrix Control Group

Reporting group description

Serious adverse events	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Total subjects affected by serious adverse events
subjects affected / exposed	35 / 376 (9.31%)	14 / 187 (7.49%)	14 / 187 (7.49%)
number of deaths (all causes)	0	0	1
number of deaths resulting from adverse events	0	0	0
Injury, poisoning and procedural complications
Burns first degree
subjects affected / exposed	1 / 376 (0.27%)	0 / 187 (0.00%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Burns second degree
subjects affected / exposed	1 / 376 (0.27%)	0 / 187 (0.00%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Foreign body
subjects affected / exposed	0 / 376 (0.00%)	0 / 187 (0.00%)	1 / 187 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Head injury
subjects affected / exposed	0 / 376 (0.00%)	2 / 187 (1.07%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skull fracture
subjects affected / exposed	0 / 376 (0.00%)	1 / 187 (0.53%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	0 / 376 (0.00%)	1 / 187 (0.53%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Toxicity to various agents
subjects affected / exposed	0 / 376 (0.00%)	0 / 187 (0.00%)	1 / 187 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
Epilepsy
subjects affected / exposed	1 / 376 (0.27%)	0 / 187 (0.00%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Febrile convulsion
subjects affected / exposed	1 / 376 (0.27%)	1 / 187 (0.53%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyponatraemic seizure
subjects affected / exposed	0 / 376 (0.00%)	0 / 187 (0.00%)	1 / 187 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Seizure
subjects affected / exposed	0 / 376 (0.00%)	1 / 187 (0.53%)	1 / 187 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	2 / 376 (0.53%)	0 / 187 (0.00%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Sudden infant death syndrome
subjects affected / exposed	0 / 376 (0.00%)	0 / 187 (0.00%)	1 / 187 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Immune system disorders
Anaphylactic shock
subjects affected / exposed	0 / 376 (0.00%)	1 / 187 (0.53%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Drug hypersensitivity
subjects affected / exposed	1 / 376 (0.27%)	1 / 187 (0.53%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Milk allergy
subjects affected / exposed	1 / 376 (0.27%)	0 / 187 (0.00%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	2 / 376 (0.53%)	0 / 187 (0.00%)	1 / 187 (0.53%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ileus paralytic
subjects affected / exposed	1 / 376 (0.27%)	0 / 187 (0.00%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Lung disorder
subjects affected / exposed	1 / 376 (0.27%)	0 / 187 (0.00%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Amoebic dysentery
subjects affected / exposed	0 / 376 (0.00%)	1 / 187 (0.53%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchiolitis
subjects affected / exposed	5 / 376 (1.33%)	1 / 187 (0.53%)	3 / 187 (1.60%)
occurrences causally related to treatment / all	0 / 7	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	3 / 376 (0.80%)	0 / 187 (0.00%)	1 / 187 (0.53%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Conjunctivitis
subjects affected / exposed	0 / 376 (0.00%)	0 / 187 (0.00%)	1 / 187 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ear infection
subjects affected / exposed	0 / 376 (0.00%)	0 / 187 (0.00%)	1 / 187 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	1 / 376 (0.27%)	2 / 187 (1.07%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	4 / 376 (1.06%)	1 / 187 (0.53%)	3 / 187 (1.60%)
occurrences causally related to treatment / all	0 / 4	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis rotavirus
subjects affected / exposed	1 / 376 (0.27%)	0 / 187 (0.00%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	2 / 376 (0.53%)	0 / 187 (0.00%)	1 / 187 (0.53%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Measles
subjects affected / exposed	1 / 376 (0.27%)	0 / 187 (0.00%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nasopharyngitis
subjects affected / exposed	0 / 376 (0.00%)	0 / 187 (0.00%)	2 / 187 (1.07%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Neurological infection
subjects affected / exposed	1 / 376 (0.27%)	0 / 187 (0.00%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Otitis media
subjects affected / exposed	0 / 376 (0.00%)	1 / 187 (0.53%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pharyngitis
subjects affected / exposed	1 / 376 (0.27%)	1 / 187 (0.53%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pharyngotonsillitis
subjects affected / exposed	1 / 376 (0.27%)	1 / 187 (0.53%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	13 / 376 (3.46%)	2 / 187 (1.07%)	3 / 187 (1.60%)
occurrences causally related to treatment / all	0 / 16	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia viral
subjects affected / exposed	1 / 376 (0.27%)	0 / 187 (0.00%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Roseola
subjects affected / exposed	1 / 376 (0.27%)	0 / 187 (0.00%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	0 / 376 (0.00%)	1 / 187 (0.53%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	2 / 376 (0.53%)	2 / 187 (1.07%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Viral infection
subjects affected / exposed	1 / 376 (0.27%)	0 / 187 (0.00%)	0 / 187 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	2 / 376 (0.53%)	1 / 187 (0.53%)	1 / 187 (0.53%)
occurrences causally related to treatment / all	0 / 2	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Nimenrix 3+1 Group	Nimenrix 1+1 Group	Nimenrix Control Group
Total subjects affected by non serious adverse events
subjects affected / exposed	334 / 376 (88.83%)	169 / 187 (90.37%)	169 / 187 (90.37%)
Nervous system disorders
Somnolence
subjects affected / exposed	224 / 376 (59.57%)	124 / 187 (66.31%)	120 / 187 (64.17%)
occurrences all number	475	265	258
General disorders and administration site conditions
Pain
subjects affected / exposed	273 / 376 (72.61%)	142 / 187 (75.94%)	145 / 187 (77.54%)
occurrences all number	684	351	379
Pyrexia
subjects affected / exposed	215 / 376 (57.18%)	112 / 187 (59.89%)	111 / 187 (59.36%)
occurrences all number	426	214	192
Swelling
subjects affected / exposed	157 / 376 (41.76%)	83 / 187 (44.39%)	78 / 187 (41.71%)
occurrences all number	281	153	146
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	36 / 376 (9.57%)	15 / 187 (8.02%)	10 / 187 (5.35%)
occurrences all number	38	16	10
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	23 / 376 (6.12%)	8 / 187 (4.28%)	5 / 187 (2.67%)
occurrences all number	25	8	5
Skin and subcutaneous tissue disorders
Erythema
subjects affected / exposed	177 / 376 (47.07%)	87 / 187 (46.52%)	87 / 187 (46.52%)
occurrences all number	335	168	172
Psychiatric disorders
Irritability
subjects affected / exposed	262 / 376 (69.68%)	130 / 187 (69.52%)	130 / 187 (69.52%)
occurrences all number	616	316	323
Infections and infestations
Nasopharyngitis
subjects affected / exposed	65 / 376 (17.29%)	27 / 187 (14.44%)	26 / 187 (13.90%)
occurrences all number	83	42	35
Pharyngitis
subjects affected / exposed	39 / 376 (10.37%)	17 / 187 (9.09%)	27 / 187 (14.44%)
occurrences all number	42	25	32
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	185 / 376 (49.20%)	95 / 187 (50.80%)	95 / 187 (50.80%)
occurrences all number	343	192	175

More information

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Were there any global substantial amendments to the protocol? Yes

26 Jul 2011

Amendment 1 One of the participating countries has requested that the subjects enrolled in that country be vaccinated with acellualr pertussis vaccine instead of whole cell pertussis vaccine in order to align with the national recommendation. On account of this request the following changes have been made in the protocol as part of this amendment. • All subjects will be co-administrated with Infanrix-IPV/Hiberix instead of Tritanrix-HepB/Hiberix that was foreseen in the original protocol. Consequently, changes have been made in the exclusion and elimination criteria, assays, secondary endpoints and the statistical analysis section. - HepB, and whole cell pertussis assays have been removed and assays for the evaluation of acellular pertussis and polio type 1, 2 and 3 have been included. - Secondary endpoints and the statistical analysis sections have been modified to remove whole cell pertussis and HepB analysis and to include acellular pertussis and polio type 1, 2 and 3 analysis. - Exclusion and elimination criteria have been revised based on the change in the co-administered vaccines • Subjects will receive both primary and booster doses of Infanrix- IPV/Hiberix • Interval during which concomitant vaccinations are allowed has been clarified in the exclusion and elimination criteria to ensure that no concomitant vaccination is given during the period between a study vaccine administration and the subsequent blood sampling visit, if applicable.

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 serum bactericidal assay using rabbit complement against Neisseria meningitidis serogroups antibody titers greater than or equal to (≥) the cut-off value for the Nimenrix 3+1 Group

Primary: Number of subjects with serum bactericidal assay using rabbit complement against Neisseria meningitidis serogroups antibody titers greater than or equal to (≥) the cut-off value for the Nimenrix 3+1 Group

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers greater than or equal to (≥) the 1:8 for the Nimenrix 3+1 Group

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers greater than or equal to (≥) the 1:8 for the Nimenrix 3+1 Group

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers greater than or equal to (≥) the 1:128 for the Nimenrix 3+1 Group

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers greater than or equal to (≥) the 1:128 for the Nimenrix 3+1 Group

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers for the Nimenrix 3+1 Group

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers for the Nimenrix 3+1 Group

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers greater than or equal to (≥) the cut-off values for the Nimenrix 1+1 and Nimenrix Control Groups

Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers greater than or equal to (≥) the cut-off values for the Nimenrix 1+1 and Nimenrix Control Groups

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers Nimenrix 1+1 and Nimenrix Control Groups

Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers Nimenrix 1+1 and Nimenrix Control Groups

Secondary: Number of subjects with booster responses for rSBA-MenA, C rSBA-MenC, Y rSBA-MenY and W-135 rSBA-MenW-135 in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group

Secondary: Number of subjects with booster responses for rSBA-MenA, C rSBA-MenC, Y rSBA-MenY and W-135 rSBA-MenW-135 in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group

Secondary: Number of subjects with serum bactericidal assay using human complement against Neisseria meningitidis serogroups A, C, W-135, Y antibody titers greater than or equal to (≥) the cut-off value

Secondary: Number of subjects with serum bactericidal assay using human complement against Neisseria meningitidis serogroups A, C, W-135, Y antibody titers greater than or equal to (≥) the cut-off value

Secondary: hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y antibody titers at month 5 (One Month Post-primary for Nimenrix3+1 and Nimenrix 1+1 Groups) -Randomized Subset of 50% of Subjects of All Three Groups

Secondary: hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y antibody titers at month 5 (One Month Post-primary for Nimenrix3+1 and Nimenrix 1+1 Groups) -Randomized Subset of 50% of Subjects of All Three Groups

Secondary: Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y titers greater than or equal to (≥) the cut-off value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control)

Secondary: Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y titers greater than or equal to (≥) the cut-off value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control)

Secondary: hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y antibody titers at month 13 and 14

Secondary: hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y antibody titers at month 13 and 14

Secondary: Number of subjects with booster responses for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix 1 Group

Secondary: Number of subjects with booster responses for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix 1 Group

Secondary: Number of subjects with anti-pneumococcal antibody concentrations greater than or equal to (≥) 0.15 micrograms per millilitre (µg/mL).

Secondary: Number of subjects with anti-pneumococcal antibody concentrations greater than or equal to (≥) 0.15 micrograms per millilitre (µg/mL).

Secondary: Number of subjects with anti-pneumococcal antibody concentrations greater than or equal to (≥) 0.35 micrograms per millilitre (µg/mL)

Secondary: Number of subjects with anti-pneumococcal antibody concentrations greater than or equal to (≥) 0.35 micrograms per millilitre (µg/mL)

Secondary: Anti-pneumococcal antibody concentrations

Secondary: Anti-pneumococcal antibody concentrations

Secondary: Number of subjects with anti-diphtheria (anti-D) antibodies, by ATP cohort

Secondary: Number of subjects with anti-diphtheria (anti-D) antibodies, by ATP cohort

Secondary: Concentration of antibodies against diphtheria antigens (anti-D), by ATP cohort

Secondary: Concentration of antibodies against diphtheria antigens (anti-D), by ATP cohort

Secondary: Number of subjects with anti-diphtheria (anti-D) antibodies, by TVC

Secondary: Number of subjects with anti-diphtheria (anti-D) antibodies, by TVC

Secondary: Concentration of antibodies against diphtheria antigens (anti-D), by TVC

Secondary: Concentration of antibodies against diphtheria antigens (anti-D), by TVC

Secondary: Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA), anti-pertactin (anti-PRN) Immunoglobulin G (IgG) antibodies, by ATP cohort

Secondary: Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA), anti-pertactin (anti-PRN) Immunoglobulin G (IgG) antibodies, by ATP cohort

Secondary: Concentration of antibodies against pertussis toxoid (anti-PT), filamentous haemagglutinin (anti-FHA), pertactin (anti-PRN) antigens, by ATP cohort

Secondary: Concentration of antibodies against pertussis toxoid (anti-PT), filamentous haemagglutinin (anti-FHA), pertactin (anti-PRN) antigens, by ATP cohort

Secondary: Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA), anti-pertactin (anti-PRN) Immunoglobulin G (IgG) antibodies, by TVC

Secondary: Number of subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA), anti-pertactin (anti-PRN) Immunoglobulin G (IgG) antibodies, by TVC

Secondary: Concentration of antibodies against pertussis toxoid (anti-PT), filamentous haemagglutinin (anti-FHA), pertactin (anti-PRN) antigens, by TVC

Secondary: Concentration of antibodies against pertussis toxoid (anti-PT), filamentous haemagglutinin (anti-FHA), pertactin (anti-PRN) antigens, by TVC

Secondary: Number of subjects with anti-poliovirus type 1, 2 and 3 antibodies, by ATP cohort

Secondary: Number of subjects with anti-poliovirus type 1, 2 and 3 antibodies, by ATP cohort

Secondary: Antibody titers for anti-polio type 1, 2 and 3 antibodies, by ATP cohort

Secondary: Antibody titers for anti-polio type 1, 2 and 3 antibodies, by ATP cohort

Secondary: Number of subjects with anti-poliovirus type 1, 2 and 3 antibodies, by TVC

Secondary: Number of subjects with anti-poliovirus type 1, 2 and 3 antibodies, by TVC

Secondary: Antibody titers for anti-polio type 1, 2 and 3 antibodies, by TVC

Secondary: Antibody titers for anti-polio type 1, 2 and 3 antibodies, by TVC

Secondary: Number of subjects with anti-tetanus (anti-T) antibodies, by ATP

Secondary: Number of subjects with anti-tetanus (anti-T) antibodies, by ATP

Secondary: Concentration of antibodies against tetanus antigens (anti-T), by ATP

Secondary: Concentration of antibodies against tetanus antigens (anti-T), by ATP

Secondary: Concentration of antibodies against tetanus antigens (anti-T), by TVC

Secondary: Concentration of antibodies against tetanus antigens (anti-T), by TVC

Secondary: Number of subjects with anti-tetanus (anti-T) antibodies, by TVC

Secondary: Number of subjects with anti-tetanus (anti-T) antibodies, by TVC

Secondary: Anti-PRP antibody concentrations (Geometric Mean Concentrations) in a randomized subset of 25% of the subjects

Secondary: Anti-PRP antibody concentrations (Geometric Mean Concentrations) in a randomized subset of 25% of the subjects

Secondary: Number of subjects with solicited local symptoms (Primary Phase)

Secondary: Number of subjects with solicited local symptoms (Primary Phase)

Secondary: Number of subjects with solicited local symptoms (Booster Phase)

Secondary: Number of subjects with solicited local symptoms (Booster Phase)

Secondary: Number of subjects with solicited general symptoms (Primary Phase)

Secondary: Number of subjects with solicited general symptoms (Primary Phase)

Secondary: Number of subjects with solicited general symptoms (Booster Phase)