Hib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00134719

First received: August 10, 2005

Last updated: June 15, 2012

Last verified: October 2011

History of Changes

Results First Received: June 15, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Conditions:	Meningococcal Infection Haemophilus Infection
Interventions:	Biological: MenHibrix (Hib-MenCY-TT) Biological: Infanrix® Penta Biological: Prevenar® Biological: ActHIB® Biological: Meningitec® Biological: M-M-R®II Biological: Varivax® Biological: PedvaxHIB®

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were randomised at the beginning of the primary vaccination phase and kept their group assignment during the fourth dose vaccination phase. Not all subjects who completed the primary vaccination phase returned for participation in the fourth dose vaccination phase.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One subject who had a subject number allocated, was not vaccinated.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Participant Flow for 2 periods

Period 1: Primary Vaccination Phase

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
STARTED	661	221	221
COMPLETED	647	215	216
NOT COMPLETED	14	6	5
Adverse Event	4	0	0
Protocol Violation	1	0	0
Withdrawal by Subject	2	3	2
Lost to Follow-up	7	3	3

Period 2: Fourth Dose Vaccination Phase

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
STARTED	625	206	204
COMPLETED	623	203	203
NOT COMPLETED	2	3	1
Lost to Follow-up	1	3	1
Mother just delivered a new baby	1	0	0

Baseline Characteristics

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Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
Total	Total of all reporting groups

Baseline Measures

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group	Total
Number of Participants [units: participants]	661	221	221	1103
Age [units: Days] Mean ± Standard Deviation
Days	61.0 ± 7.38	61.5 ± 7.22	61.5 ± 7.95	61.2 ± 7.46
Gender [units: Subjects]
Female	328	118	103	549
Male	333	103	118	554

Outcome Measures

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1. Primary:

Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL) [ Time Frame: One month after the 3-dose primary vaccination course ]

Measure Type	Primary
Measure Title	Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL)
Measure Description	The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.
Time Frame	One month after the 3-dose primary vaccination course
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only, on the Primary According-to-Protocol (ATP) Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	265	0	90
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL) [units: Subjects]	255		76

No statistical analysis provided for Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL)

2. Primary:

Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128 [ Time Frame: One month after the 3-dose primary vaccination course ]

Measure Type	Primary
Measure Title	Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128
Measure Description	The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB + Meningitec groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.
Time Frame	One month after the 3-dose primary vaccination course
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on subjects in the MenHibrix and ActHIB + Meningitec groups only, on the Primary According-to-Protocol Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	287	99	0
Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128 [units: Subjects]	271	95

No statistical analysis provided for Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128

3. Primary:

Number of Subjects Seroconverted for Anti-measles Antibodies [ Time Frame: 42 days after the fourth dose vaccination ]

Measure Type	Primary
Measure Title	Number of Subjects Seroconverted for Anti-measles Antibodies
Measure Description	The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-measles seroconversion is defined as the appearance of antibodies (i.e. concentration greater than or equal to the cut-off value of 150 milli-international units per milliliter (mIU/mL)) in the serum of subjects seronegative (below 150 mIU/mL) before vaccination.
Time Frame	42 days after the fourth dose vaccination
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	852	0	286
Number of Subjects Seroconverted for Anti-measles Antibodies [units: Subjects]	815		274

No statistical analysis provided for Number of Subjects Seroconverted for Anti-measles Antibodies

4. Primary:

Number of Subjects Seroconverted for Anti-mumps Antibodies [ Time Frame: 42 days after the fourth dose vaccination ]

Measure Type	Primary
Measure Title	Number of Subjects Seroconverted for Anti-mumps Antibodies
Measure Description	The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-mumps seroconversion is defined as titer greater than or equal to 28 ED50 in subjects seronegative (<28 ED50) before vaccination. ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.
Time Frame	42 days after the fourth dose vaccination
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	601	0	191
Number of Subjects Seroconverted for Anti-mumps Antibodies [units: Subjects]	595		191

No statistical analysis provided for Number of Subjects Seroconverted for Anti-mumps Antibodies

5. Primary:

Number of Subjects With an Anti-rubella Seroresponse [ Time Frame: 42 days after the fourth dose vaccination ]

Measure Type	Primary
Measure Title	Number of Subjects With an Anti-rubella Seroresponse
Measure Description	The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-rubella seroresponse is defined as post-vaccination concentration greater than or equal to 10 IU/mL (ELISA, Enzygnost) in subjects seronegative (concentration below 4 IU/mL) before vaccination.
Time Frame	42 days after the fourth dose vaccination
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	850	0	285
Number of Subjects With an Anti-rubella Seroresponse [units: Subjects]	848		284

No statistical analysis provided for Number of Subjects With an Anti-rubella Seroresponse

6. Primary:

Number of Subjects Seroconverted for Anti-varicella Antibodies [ Time Frame: 42 days after the fourth dose vaccination ]

Measure Type	Primary
Measure Title	Number of Subjects Seroconverted for Anti-varicella Antibodies
Measure Description	The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-varicella seroconversion is defined as post-vaccination titers greater than or equal to 1:5, in subjects seronegative (titers below 1:5) before vaccination.
Time Frame	42 days after the fourth dose vaccination
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	723	0	223
Number of Subjects Seroconverted for Anti-varicella Antibodies [units: Subjects]	722		223

No statistical analysis provided for Number of Subjects Seroconverted for Anti-varicella Antibodies

7. Secondary:

Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

Measure Type	Secondary
Measure Title	Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values
Measure Description	The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128.
Time Frame	After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	496	169	164
Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values [units: Subjects]
Post-dose 2 titer ≥ 1:8 (N=295; 100; 92)	282	97	2
Post-dose 3 titer ≥ 1:8 (N=287; 99; 99)	284	99	5
Pre-dose 4 titer ≥ 1:8 (N=495; 169; 164)	449	143	16
Post-dose 4 titer ≥ 1:8 (N=496; 162; 157)	494	155	16
Post-dose 2 titer ≥ 1:128 (N=295; 100; 92)	239	91	0
Post-dose 3 titer ≥ 1:128 (N=287; 99; 99)	271	95	0
Pre-dose 4 titer ≥ 1:128 (N=495; 169; 164)	241	50	1
Post-dose 4 titer ≥ 1:128 (N=496; 162; 157)	482	115	5

No statistical analysis provided for Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values

8. Secondary:

rSBA-MenC Titers [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

Measure Type	Secondary
Measure Title	rSBA-MenC Titers
Measure Description	The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers.
Time Frame	After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	496	169	164
rSBA-MenC Titers [units: titer] Geometric Mean ( 95% Confidence Interval )
Post-dose 2 (N=295; 100; 92)	356.9 ( 302.6 to 420.9 )	714.5 ( 541.6 to 942.7 )	4.2 ( 3.9 to 4.5 )
Post-dose 3 (N=287; 99; 99)	804.6 ( 699.9 to 924.9 )	790.1 ( 649.4 to 961.2 )	4.5 ( 4.0 to 5.0 )
Pre-dose 4 (N=495; 169; 164)	102.8 ( 90.1 to 117.3 )	53.7 ( 43.0 to 67.1 )	5.2 ( 4.6 to 5.9 )
Post-dose 4 (N=496; 162; 157)	1696.7 ( 1515.8 to 1899.2 )	261.9 ( 204.4 to 335.7 )	5.4 ( 4.7 to 6.2 )

No statistical analysis provided for rSBA-MenC Titers

9. Secondary:

Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

Measure Type	Secondary
Measure Title	Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values
Measure Description	The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128.
Time Frame	After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	514	167	159
Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values [units: Subjects]
Post-dose 2 titer ≥ 1:8 (N=293; 99; 92)	289	10	13
Post-dose 3 titer ≥ 1:8 (N=288; 98; 97)	287	16	22
Pre-dose 4 titer ≥ 1:8 (N= 514; 167; 159)	506	65	42
Post-dose 4 titer ≥ 1:8 (N=496; 164; 157)	496	162	90
Post-dose 2 titer ≥ 1:128 (N= 293; 99; 92)	224	2	3
Post-dose 3 titer ≥ 1:128 (N= 288; 98; 97)	264	9	5
Pre-dose 4 titer ≥ 1:128 (N= 514; 167; 159)	414	35	19
Post-dose 4 titer ≥ 1:128 (N=496; 164; 157)	493	152	59

No statistical analysis provided for Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values

10. Secondary:

rSBA-MenY Titers [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

Measure Type	Secondary
Measure Title	rSBA-MenY Titers
Measure Description	The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers.
Time Frame	After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	514	167	159
rSBA-MenY Titers [units: Titer] Geometric Mean ( 95% Confidence Interval )
Post-dose 2 (N=293; 99; 92)	315.6 ( 271.6 to 366.9 )	5.4 ( 4.5 to 6.5 )	5.9 ( 4.7 to 7.3 )
Post-dose 3 (N=288; 98; 97)	728.3 ( 635.5 to 834.7 )	7.1 ( 5.4 to 9.3 )	7.7 ( 5.9 to 10.2 )
Pre-dose 4 (N= 514; 167; 159)	264.4 ( 240.7 to 290.4 )	16.0 ( 12.0 to 21.2 )	10.5 ( 8.0 to 13.6 )
Post-dose 4 (N=496; 164; 157)	1986.5 ( 1825.9 to 2161.3 )	797.7 ( 658.5 to 966.2 )	34.4 ( 25.2 to 47.0 )

No statistical analysis provided for rSBA-MenY Titers

11. Secondary:

Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

Measure Type	Secondary
Measure Title	Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values
Measure Description	The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8.
Time Frame	After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	134	54	50
Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values [units: Subjects]
Post-dose 2 titer ≥ 1:4 (N= 89; 31; 25)	85	29	0
Post-dose 3 titer ≥ 1:4 (N= 83; 28; 28)	83	28	0
Pre-dose 4 titer ≥ 1:4 (N= 134; 54; 50)	125	46	5
Post-dose 4 titer ≥ 1:4 (N= 132; 43; 46)	131	41	1
Post-dose 2 titer ≥ 1:8 (N= 89; 31; 25)	84	29	0
Post-dose 3 titer ≥ 1:8 (N= 83; 28; 28)	83	28	0
Pre-dose 4 titer ≥ 1:8 (N= 134; 54; 50)	125	46	5
Post-dose 4 titer ≥ 1:8 (N= 132; 43; 46)	131	41	1

No statistical analysis provided for Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values

12. Secondary:

hSBA-MenC Titers [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

Measure Type	Secondary
Measure Title	hSBA-MenC Titers
Measure Description	The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers.
Time Frame	After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	134	54	50
hSBA-MenC Titers [units: Titer] Geometric Mean ( 95% Confidence Interval )
Post-dose 2 (N= 89; 31; 25)	179.4 ( 130.3 to 247.1 )	319.0 ( 173.6 to 586.2 )	2.0 ( 2.0 to 2.0 )
Post-dose 3 (N= 83; 28; 28)	379.4 ( 294.6 to 488.6 )	254.2 ( 192.7 to 335.4 )	2.0 ( 2.0 to 2.0 )
Pre-dose 4 (N= 134; 54; 50)	97.7 ( 74.0 to 128.9 )	34.6 ( 22.8 to 52.6 )	2.6 ( 2.0 to 3.3 )
Post-dose 4 (N= 132; 43; 46)	1807.6 ( 1398.2 to 2336.8 )	171.5 ( 94.7 to 310.8 )	2.2 ( 1.8 to 2.6 )

No statistical analysis provided for hSBA-MenC Titers

13. Secondary:

Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

Measure Type	Secondary
Measure Title	Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values
Measure Description	The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8.
Time Frame	After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	122	44	41
Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values [units: Subjects]
Post-dose 2 titer ≥ 1:4 (N= 88; 31; 25)	79	0	0
Post-dose 3 titer ≥ 1:4 (N= 85; 28; 29)	85	0	0
Pre-dose 4 titer ≥ 1:4 (N= 114; 44; 41)	104	1	0
Post-dose 4 titer ≥ 1:4 (N= 122; 34; 35)	119	15	16
Post-dose 2 titer ≥ 1:8 (N= 88; 31; 25)	73	0	0
Post-dose 3 titer ≥ 1:8 (N= 85; 28; 29)	85	0	0
Pre-dose 4 titer ≥ 1:8 (N= 114; 44; 41)	103	1	0
Post-dose 4 titer ≥ 1:8 (N= 122; 34; 35)	119	13	16

No statistical analysis provided for Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values

14. Secondary:

hSBA-MenY Titers [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

Measure Type	Secondary
Measure Title	hSBA-MenY Titers
Measure Description	The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers.
Time Frame	After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	122	44	41
hSBA-MenY Titers [units: Titer] Geometric Mean ( 95% Confidence Interval )
Post-dose 2 (N= 88; 31; 25)	25.6 ( 19.3 to 34.1 )	2.0 ( 2.0 to 2.0 )	2.0 ( 2.0 to 2.0 )
Post-dose 3 (N= 85; 28; 29)	86.4 ( 68.9 to 108.3 )	2.0 ( 2.0 to 2.0 )	2.0 ( 2.0 to 2.0 )
Pre-dose 4 (N= 114; 44; 41)	81.2 ( 58.6 to 112.6 )	2.2 ( 1.8 to 2.7 )	2.0 ( 2.0 to 2.0 )
Post-dose 4 (N= 122; 34; 35)	1002.2 ( 740.9 to 1355.7 )	8.8 ( 4.4 to 17.3 )	18.3 ( 7.7 to 43.6 )

No statistical analysis provided for hSBA-MenY Titers

15. Secondary:

Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

Measure Type	Secondary
Measure Title	Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
Measure Description	The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL.
Time Frame	After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	475	160	138
Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values [units: Subjects]
Post-dose 2 concentration ≥0.3 µg/mL (N=296;95;85)	296	95	7
Post-dose 3 concentration ≥0.3 µg/mL (N=276;95;91)	276	95	3
Pre-dose 4 concentration≥0.3 µg/mL (N=475;160;138)	417	138	2
Post-dose 4 concentration≥0.3µg/mL (N=490;160;122)	489	158	1
Post-dose 2 concentration ≥2.0 µg/mL (N=296;95;85)	248	81	1
Post-dose 3 concentration ≥2.0 µg/mL (N=276;95;91)	241	79	0
Pre-dose 4 concentration≥2.0 µg/mL (N=475;160;138)	53	31	0
Post-dose 4 concentration≥2.0µg/mL (N=490;160;122)	408	95	0

No statistical analysis provided for Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values

16. Secondary:

Anti-PSC Concentrations [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

Measure Type	Secondary
Measure Title	Anti-PSC Concentrations
Measure Description	The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.
Time Frame	After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	475	160	138
Anti-PSC Concentrations [units: Microgram per milliliter (µg/mL)] Geometric Mean ( 95% Confidence Interval )
Post-dose 2 (N= 296; 95; 85)	4.32 ( 3.98 to 4.69 )	3.54 ( 3.08 to 4.06 )	0.17 ( 0.15 to 0.19 )
Post-dose 3 (N= 276; 95; 91)	4.15 ( 3.87 to 4.46 )	3.94 ( 3.40 to 4.55 )	0.16 ( 0.15 to 0.17 )
Pre-dose 4 (N= 475; 160; 138)	0.77 ( 0.71 to 0.83 )	0.86 ( 0.73 to 1.01 )	0.15 ( 0.15 to 0.16 )
Post-dose 4 (N= 490; 160; 122)	4.78 ( 4.42 to 5.16 )	2.65 ( 2.24 to 3.14 )	0.15 ( 0.15 to 0.16 )

No statistical analysis provided for Anti-PSC Concentrations

17. Secondary:

Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

Measure Type	Secondary
Measure Title	Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
Measure Description	The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL.
Time Frame	After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	502	162	122
Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values [units: Subjects]
Post-dose 2 concentration ≥0.3 µg/mL (N=291;92;83)	291	3	6
Post-dose 3 concentration ≥0.3 µg/mL (N=269;91;88)	269	3	4
Pre-dose 4 concentration≥0.3 µg/mL (N=474;136;112)	469	2	4
Post-dose 4 concentration≥0.3µg/mL (N=502;162;122)	502	160	3
Post-dose 2 concentration ≥2.0 µg/mL (N=291;92;83)	268	0	0
Post-dose 3 concentration ≥2.0 µg/mL (N=269;91;88)	266	0	0
Pre-dose 4 concentration≥2.0 µg/mL (N=474;136;112)	278	1	2
Post-dose 4 concentration≥2.0µg/mL (N=502;162;122)	96	46	1

No statistical analysis provided for Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values

18. Secondary:

Anti-PSY Concentrations [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

Measure Type	Secondary
Measure Title	Anti-PSY Concentrations
Measure Description	The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.
Time Frame	After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	502	162	122
Anti-PSY Concentrations [units: Microgram per milliliter (µg/mL)] Geometric Mean ( 95% Confidence Interval )
Post-dose 2 (N= 291; 92; 83)	7.81 ( 7.04 to 8.67 )	0.16 ( 0.15 to 0.16 )	0.17 ( 0.15 to 0.19 )
Post-dose 3 (N= 269; 91; 88)	12.92 ( 11.80 to 14.14 )	0.15 ( 0.15 to 0.16 )	0.16 ( 0.15 to 0.17 )
Pre-dose 4 (N= 474; 136; 112)	2.44 ( 2.26 to 2.64 )	0.16 ( 0.15 to 0.16 )	0.16 ( 0.15 to 0.18 )
Post-dose 4 (N= 502; 162; 122)	16.92 ( 15.60 to 18.35 )	7.09 ( 6.05 to 8.31 )	0.16 ( 0.15 to 0.17 )

No statistical analysis provided for Anti-PSY Concentrations

19. Secondary:

Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

Measure Type	Secondary
Measure Title	Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
Measure Description	The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.15 µg/mL and 1.0 µg/mL.
Time Frame	After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	562	189	182
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values [units: Subjects]
Post-dose 2 ≥ 0.15 µg/mL (N= 280; 94; 85)	255	77	70
Post-dose 3 ≥ 0.15 µg/mL (N= 265; 88; 90)	265	85	88
Pre-dose 4 ≥ 0.15 µg/mL (N= 562; 189; 181)	541	160	159
Post-dose 4 ≥ 0.15 µg/mL (N= 549; 185; 182)	549	183	182
Post-dose 2 ≥ 1.0 µg/mL (N= 280; 94; 85)	151	41	40
Post-dose 3 ≥ 1.0 µg/mL (N= 265; 88; 90)	255	74	76
Pre-dose 4 ≥ 1.0 µg/mL (N= 562; 189; 181)	314	71	74
Post-dose 4 ≥ 1.0 µg/mL (N= 549; 185; 182)	547	176	179

No statistical analysis provided for Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values

20. Secondary:

Anti-PRP Concentrations [ Time Frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) ]

Measure Type	Secondary
Measure Title	Anti-PRP Concentrations
Measure Description	The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.
Time Frame	After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	562	189	182
Anti-PRP Concentrations [units: Microgram per milliliter (µg/mL)] Geometric Mean ( 95% Confidence Interval )
Post-dose 2 (N= 280; 94; 85)	1.320 ( 1.097 to 1.588 )	0.788 ( 0.571 to 1.089 )	0.861 ( 0.607 to 1.222 )
Post-dose 3 (N= 265; 88; 90)	8.551 ( 7.502 to 9.746 )	3.692 ( 2.747 to 4.961 )	5.014 ( 3.675 to 6.841 )
Pre-dose 4 (N= 562; 189; 181)	1.175 ( 1.061 to 1.300 )	0.668 ( 0.544 to 0.820 )	0.748 ( 0.611 to 0.916 )
Post-dose 4 (N= 549; 185; 182)	34.890 ( 31.687 to 38.417 )	13.442 ( 11.057 to 16.343 )	20.975 ( 17.668 to 24.899 )

No statistical analysis provided for Anti-PRP Concentrations

21. Secondary:

Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL [ Time Frame: Just prior to the fourth dose and 42 days after the fourth dose ]

Measure Type	Secondary
Measure Title	Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL
Measure Description	The cut-off value assessed was 150 mIU/mL.
Time Frame	Just prior to the fourth dose and 42 days after the fourth dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	542	185	178
Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL [units: Subjects]
Just prior to the fourth dose (N= 513; 174; 175)	0	1	0
42 days after the fourth dose (N= 542; 185; 178)	510	173	170

No statistical analysis provided for Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL

22. Secondary:

Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50 [ Time Frame: Just prior to the fourth dose and 42 days after the fourth dose ]

Measure Type	Secondary
Measure Title	Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50
Measure Description	ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.
Time Frame	Just prior to the fourth dose and 42 days after the fourth dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	509	170	165
Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50 [units: Subjects]
Just prior to the fourth dose (N= 494; 165; 159)	179	59	52
42 days after the fourth dose (N= 509; 170; 165)	505	169	163

No statistical analysis provided for Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50

23. Secondary:

Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL [ Time Frame: Just prior to the fourth dose and 42 days after the fourth dose ]

Measure Type	Secondary
Measure Title	Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL
Measure Description	The cut-off value assessed was 4 IU/mL.
Time Frame	Just prior to the fourth dose and 42 days after the fourth dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	540	185	177
Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL [units: Subjects]
Just prior to the fourth dose (N= 516; 175; 176)	2	1	0
42 days after the fourth dose (N= 540; 185; 177)	540	184	177

No statistical analysis provided for Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL

24. Secondary:

Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5 [ Time Frame: Just prior to the fourth dose and 42 days after the fourth dose ]

Measure Type	Secondary
Measure Title	Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5
Measure Description	The cut-off value assessed was a titer of 1:5.
Time Frame	Just prior to the fourth dose and 42 days after the fourth dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	548	184	179
Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5 [units: Subjects]
Just prior to the fourth dose (N= 533; 181; 177)	126	44	56
42 days after the fourth dose (N= 548; 184; 179)	547	183	179

No statistical analysis provided for Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5

25. Secondary:

Number of Subjects With a Fourth Dose Response for hSBA-MenC [ Time Frame: 42 days after the fourth dose ]

Measure Type	Secondary
Measure Title	Number of Subjects With a Fourth Dose Response for hSBA-MenC
Measure Description	Fourth dose response for hSBA-MenC is defined as: •For initially seronegative subjects (i.e., subjects with pre fourth dose hSBA antibody titer below 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:16; •For initially seropositive subjects (i.e., subjects with pre fourth dose antibody titer greater than or equal to 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:128.
Time Frame	42 days after the fourth dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	103	36	40
Number of Subjects With a Fourth Dose Response for hSBA-MenC [units: Subjects]	100	23	1

No statistical analysis provided for Number of Subjects With a Fourth Dose Response for hSBA-MenC

26. Secondary:

Number of Subjects With a Fourth Dose Response for hSBA-MenY [ Time Frame: 42 days after the fourth dose ]

Measure Type	Secondary
Measure Title	Number of Subjects With a Fourth Dose Response for hSBA-MenY
Measure Description	Fourth dose response for hSBA-MenY defined as: •For initially seronegative subjects (i.e., pre fourth dose hSBA antibody titer < 1:4), post fourth dose hSBA antibody titer greater than or equal to (≥) 1:16; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:4 and < 1:64, post fourth dose hSBA antibody titer at least 4-fold higher than the pre fourth dose hSBA antibody titer; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:64, post fourth dose hSBA antibody titer at least 2-fold higher than the pre fourth dose hSBA antibody titer.
Time Frame	42 days after the fourth dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	81	23	29
Number of Subjects With a Fourth Dose Response for hSBA-MenY [units: Subjects]	75	6	16

No statistical analysis provided for Number of Subjects With a Fourth Dose Response for hSBA-MenY

27. Secondary:

Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects [ Time Frame: 42 days after the fourth dose ]

Measure Type	Secondary
Measure Title	Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects
Measure Description	The pre-defined cut-off values were 150 mIU/mL and 200 mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL.
Time Frame	42 days after the fourth dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	501	173	171
Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects [units: Subjects]
Greater than or equal to 150 mIU/mL	469	164	163
Greater than or equal to 200 mIU/mL	466	163	162

No statistical analysis provided for Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects

28. Secondary:

Anti-measles Concentrations in Initially Seronegative Subjects [ Time Frame: 42 days after the fourth dose ]

Measure Type	Secondary
Measure Title	Anti-measles Concentrations in Initially Seronegative Subjects
Measure Description	Concentrations are presented as Geometric Mean Concentrations expressed as mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL.
Time Frame	42 days after the fourth dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	501	173	171
Anti-measles Concentrations in Initially Seronegative Subjects [units: Milli-International Units per Milliliter] Geometric Mean ( 95% Confidence Interval )	1627.494 ( 1469.996 to 1801.866 )	1773.293 ( 1500.779 to 2095.292 )	1786.404 ( 1523.083 to 2095.250 )

No statistical analysis provided for Anti-measles Concentrations in Initially Seronegative Subjects

29. Secondary:

Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects [ Time Frame: 42 days after the fourth dose ]

Measure Type	Secondary
Measure Title	Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects
Measure Description	The pre-defined cut-off values were 4 IU/mL and 10 IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 4 IU/mL.
Time Frame	42 days after the fourth dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	500	174	171
Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects [units: Subjects]
≥ 4 International Units per Milliliter	500	174	171
≥ 10 International Units per Milliliter	498	173	171

No statistical analysis provided for Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects

30. Secondary:

Anti-rubella Concentrations in Initially Seronegative Subjects [ Time Frame: 42 days after the fourth dose ]

Measure Type	Secondary
Measure Title	Anti-rubella Concentrations in Initially Seronegative Subjects
Measure Description	Concentrations are presented as Geometric Mean Concentrations expressed as IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-rubella concentration below 4 IU/mL.
Time Frame	42 days after the fourth dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	500	174	171
Anti-rubella Concentrations in Initially Seronegative Subjects [units: International Units per Milliliter] Geometric Mean ( 95% Confidence Interval )	78.779 ( 73.941 to 83.932 )	83.168 ( 74.535 to 92.801 )	76.691 ( 69.019 to 85.217 )

No statistical analysis provided for Anti-rubella Concentrations in Initially Seronegative Subjects

31. Secondary:

Number of Subjects With Anti-mumps Titer Greater Than or Equal to 28 ED50 in Subjects With Anti-mumps Titer Below 28 ED50 Before Vaccination [ Time Frame: 42 days after the fourth dose ]

Measure Type	Secondary
Measure Title	Number of Subjects With Anti-mumps Titer Greater Than or Equal to 28 ED50 in Subjects With Anti-mumps Titer Below 28 ED50 Before Vaccination
Measure Description	ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.
Time Frame	42 days after the fourth dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on subjects with a pre-vaccination anti-mumps titer below 28 ED50 in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	332	115	110
Number of Subjects With Anti-mumps Titer Greater Than or Equal to 28 ED50 in Subjects With Anti-mumps Titer Below 28 ED50 Before Vaccination [units: Subjects]	330	115	110

No statistical analysis provided for Number of Subjects With Anti-mumps Titer Greater Than or Equal to 28 ED50 in Subjects With Anti-mumps Titer Below 28 ED50 Before Vaccination

32. Secondary:

Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects [ Time Frame: 42 days after the fourth dose ]

Measure Type	Secondary
Measure Title	Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects
Measure Description	The pre-defined cut-off values were 28 ED50 and 51 ED50. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50.
Time Frame	42 days after the fourth dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	293	98	102
Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects [units: Subjects]
Greater than or equal to 28 ED50	293	98	102
Greater than or equal to 51 ED50	265	92	93

No statistical analysis provided for Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects

33. Secondary:

Anti-mumps Titers in Initially Seronegative Subjects [ Time Frame: 42 days after the fourth dose ]

Measure Type	Secondary
Measure Title	Anti-mumps Titers in Initially Seronegative Subjects
Measure Description	Titers are presented as Geometric Mean Titers expressed as ED50, the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50.
Time Frame	42 days after the fourth dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	293	98	102
Anti-mumps Titers in Initially Seronegative Subjects [units: Titer] Geometric Mean ( 95% Confidence Interval )	120.777 ( 111.967 to 130.281 )	145.405 ( 128.318 to 164.766 )	115.279 ( 101.835 to 130.498 )

No statistical analysis provided for Anti-mumps Titers in Initially Seronegative Subjects

34. Secondary:

Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects [ Time Frame: 42 days after the fourth dose ]

Measure Type	Secondary
Measure Title	Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects
Measure Description	The pre-defined cut-off values were 1:5 and 1:40. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5.
Time Frame	42 days after the fourth dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	404	136	119
Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects [units: Subjects]
Titer greater than or equal to 1:5	403	136	119
Titer greater than or equal to 1:40	403	136	119

No statistical analysis provided for Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects

35. Secondary:

Anti-varicella Titers in Initially Seronegative Subjects [ Time Frame: 42 days after the fourth dose ]

Measure Type	Secondary
Measure Title	Anti-varicella Titers in Initially Seronegative Subjects
Measure Description	Titers are presented as Geometric Mean Titers. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5.
Time Frame	42 days after the fourth dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	404	136	119
Anti-varicella Titers in Initially Seronegative Subjects [units: Titer] Geometric Mean ( 95% Confidence Interval )	414.633 ( 391.361 to 439.288 )	468.985 ( 421.845 to 521.393 )	438.280 ( 394.261 to 487.214 )

No statistical analysis provided for Anti-varicella Titers in Initially Seronegative Subjects

36. Secondary:

Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase [ Time Frame: During a 4-day period (Day 0-3) after any vaccine dose in the primary vaccination phase ]

Measure Type	Secondary
Measure Title	Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase
Measure Description	Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite.
Time Frame	During a 4-day period (Day 0-3) after any vaccine dose in the primary vaccination phase
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on all subjects with an available symptom sheet in the Primary Total Vaccinated Cohort, including all subjects vaccinated during the primary vaccination phase.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	659	220	220
Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase [units: Subjects]
Pain	432	171	152
Redness	556	189	189
Swelling	492	163	167
Drowsiness	530	193	176
Fever	196	83	80
Irritability	616	211	212
Loss of appetite	410	153	135

No statistical analysis provided for Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase

37. Secondary:

Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase [ Time Frame: During a 4-day period (Day 0-3) after the fourth dose vaccination phase ]

Measure Type	Secondary
Measure Title	Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase
Measure Description	Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite.
Time Frame	During a 4-day period (Day 0-3) after the fourth dose vaccination phase
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on all subjects with an available symptom sheet in the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the fourth dose vaccination phase.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	622	202	201
Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase [units: Subjects]
Pain	217	60	100
Redness	379	102	157
Swelling	225	63	123
Drowsiness	196	63	71
Fever	60	14	31
Irritability	361	120	117
Loss of appetite	224	76	62

No statistical analysis provided for Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase

38. Secondary:

Number of Subjects Reporting Unsolicited Adverse Events [ Time Frame: During the 31-day (Day 0-30) post-primary and post-fourth dose vaccination period ]

Measure Type	Secondary
Measure Title	Number of Subjects Reporting Unsolicited Adverse Events
Measure Description	Unsolicited adverse event covers any adverse event 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.
Time Frame	During the 31-day (Day 0-30) post-primary and post-fourth dose vaccination period
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Primary Total Vaccinated Cohort and the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the primary and fourth dose vaccination phases, respectively.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	661	221	221
Number of Subjects Reporting Unsolicited Adverse Events [units: Subjects]
Post-primary vaccination period	490	166	158
Post-fourth dose vaccination period	429	139	147

No statistical analysis provided for Number of Subjects Reporting Unsolicited Adverse Events

39. Secondary:

Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine [ Time Frame: During a 43-day (Day 0-42) after the fourth dose ]

Measure Type	Secondary
Measure Title	Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine
Measure Description	Specific solicited general symptoms assessed include fever (temperature greater than or equal to 38 degrees Celcius), meningismus/ febrile convulsion, parotid / salivary gland swelling and rash.
Time Frame	During a 43-day (Day 0-42) after the fourth dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Primary Total Vaccinated Cohort and the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the primary and fourth dose vaccination phases, respectively.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	622	202	201
Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine [units: Subjects]
Fever	324	107	112
Meningismus/ febrile convulsion	0	0	0
Parotid / salivary gland swelling	4	1	0
Rash	232	86	66

No statistical analysis provided for Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine

40. Secondary:

Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase [ Time Frame: From enrolment through the day preceding the fourth dose ]

Measure Type	Secondary
Measure Title	Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase
Measure Description	SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis.
Time Frame	From enrolment through the day preceding the fourth dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Primary Total Vaccinated Cohort, including all subjects vaccinated during the primary vaccination phase.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	661	221	221
Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase [units: Subjects]
Rash	176	67	51
New onset of chronic illnesses	124	39	36
Emergency room visits	81	22	14
Physician office visits	291	90	88
Serious adverse events	55	21	15

No statistical analysis provided for Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase

41. Secondary:

Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase [ Time Frame: From the day of administration of the fourth dose until the end of the extended safety follow-up period (last study contact at 18-21 months of age ]

Measure Type	Secondary
Measure Title	Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase
Measure Description	SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis.
Time Frame	From the day of administration of the fourth dose until the end of the extended safety follow-up period (last study contact at 18-21 months of age
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the ourth dose vaccination phase.

Reporting Groups

	Description
MenHibrix Group	Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB + Meningitec Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
ActHIB/PedvaxHIB Group	Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.

Measured Values

	MenHibrix Group	ActHIB + Meningitec Group	ActHIB/PedvaxHIB Group
Number of Participants Analyzed [units: participants]	625	206	204
Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase [units: Subjects]
Rash	52	15	13
New onset of chronic illnesses	20	8	5
Emergency room visits	42	13	10
Physician office visits	220	64	63
Serious adverse events	40	12	8

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Bryant K, McVernon J, Marchant C, Nolan T, Marshall G, Richmond P, Marshall H, Nissen M, Lambert S, Aris E, Mesaros N, Miller J. Immunogenicity and safety of measles-mumps-rubella and varicella vaccines coadministered with a fourth dose of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in toddlers: a pooled analysis of randomized trials. Hum Vaccin Immunother. 2012 Aug;8(8):1036-41. doi: 10.4161/hv.20357. Epub 2012 Aug 1.

Nolan T, Richmond P, Marshall H, McVernon J, Alexander K, Mesaros N, Aris E, Miller J, Poolman J, Boutriau D. Immunogenicity and safety of an investigational combined haemophilus influenzae type B-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine. Pediatr Infect Dis J. 2011 Mar;30(3):190-6.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00134719 History of Changes
Obsolete Identifiers:	NCT00787046
Other Study ID Numbers:	102370 (primary study), 102371
Study First Received:	August 10, 2005
Results First Received:	June 15, 2012
Last Updated:	June 15, 2012
Health Authority:	United States: Food and Drug Administration

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