Trial Outcomes & Findings for Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age (NCT NCT01978093)

NCT ID: NCT01978093

Last Updated: 2018-09-14

Results Overview

Percentage of subjects with Anti-PRP antibody concentrations≥1.0 µg/mL were assessed. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts. Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

600 participants

Primary outcome timeframe

1 month after the fourth dose for HibCY Group and 1 month after third dose for PedHIB Group [Month (M) 11-14]

Results posted on

2018-09-14

Participant Flow

600 subjects were recruited from 27 centers in the United States. The study consists of 2 epochs: Epoch 001: starting at Day 0 and ending at the day preceding the 4th vaccination (Month 10-13) and Epoch 002: starting at Month 10-13 and ending at Month 17-20, 31 days after the 2nd Havrix vaccination

All enrolled subjects were included in the study.

Participant milestones

Participant milestones
Measure	HibCY Group Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
Overall Study STARTED	297	303
Overall Study COMPLETED	232	230
Overall Study NOT COMPLETED	65	73

Reasons for withdrawal

Reasons for withdrawal
Measure	HibCY Group Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
Overall Study Death	1	0
Overall Study Adverse Event	0	5
Overall Study Protocol Violation	8	2
Overall Study Withdrawal by Subject	29	25
Overall Study Lost to Follow-up	11	15
Overall Study Migrated/moved from study area	11	13
Overall Study Loss of kaiser coverage	4	10
Overall Study Lost kaiser health plan unable to contac	1	0
Overall Study Mother lost custody of child	0	1
Overall Study Child was in care of grandmother	0	1
Overall Study N/A for vaccine administration	0	1

Baseline Characteristics

Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HibCY Group n=297 Participants Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group n=303 Participants Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	Total n=600 Participants Total of all reporting groups
Age, Categorical <=18 years	297 Participants n=93 Participants	303 Participants n=4 Participants	600 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	8.6 Weeks STANDARD_DEVIATION 1.1 • n=93 Participants	8.6 Weeks STANDARD_DEVIATION 1.1 • n=4 Participants	8.6 Weeks STANDARD_DEVIATION 1.1 • n=27 Participants
Sex: Female, Male Female	148 Participants n=93 Participants	140 Participants n=4 Participants	288 Participants n=27 Participants
Sex: Female, Male Male	149 Participants n=93 Participants	163 Participants n=4 Participants	312 Participants n=27 Participants
Race/Ethnicity, Customized African Heritage / African American	29 Participants n=93 Participants	19 Participants n=4 Participants	48 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	11 Participants n=93 Participants	12 Participants n=4 Participants	23 Participants n=27 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	5 Participants n=93 Participants	4 Participants n=4 Participants	9 Participants n=27 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	9 Participants n=93 Participants	8 Participants n=4 Participants	17 Participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=93 Participants	6 Participants n=4 Participants	8 Participants n=27 Participants
Race/Ethnicity, Customized White - Arabic / North African Heritage	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized White - Caucasian / European Heritage	201 Participants n=93 Participants	218 Participants n=4 Participants	419 Participants n=27 Participants
Race/Ethnicity, Customized Unspecified	36 Participants n=93 Participants	32 Participants n=4 Participants	68 Participants n=27 Participants

PRIMARY outcome

Timeframe: 1 month after the fourth dose for HibCY Group and 1 month after third dose for PedHIB Group [Month (M) 11-14]

Population: The analysis was performed on the Fourth dose According to Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who have received 3 vaccine doses in the first 3-doses vaccination course and who have received the fourth vaccine dose and the first Havrix dose.

Outcome measures

Outcome measures
Measure	HibCY Group n=223 Participants Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group n=218 Participants Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
Percentage of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 1.0 µg/mL	98.2 Percentage of subjects Interval 95.5 to 99.5	97.2 Percentage of subjects Interval 94.1 to 99.0

PRIMARY outcome

Timeframe: 2 months post-dose 2 of Rotarix (Month 4)

Population: The analysis was performed on the Rota ATP cohort for analysis of immunogenicity, which included all evaluable subjects who received the two doses of Rotarix vaccine and for whom immunogenicity results were available.

Anti-rotavirus serum IgA was assessed by ELISA, tabulated as GMCs and expressed in Units per mililiter (U/mL).Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts. Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per a hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch

Outcome measures

Outcome measures
Measure	HibCY Group n=155 Participants Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group n=161 Participants Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
Anti-rotavirus Serum Immunoglobulin A (IgA) Geometric Mean Concentrations (GMCs).	138.9 U/mL Interval 104.0 to 185.5	115.0 U/mL Interval 87.5 to 151.0

PRIMARY outcome

Timeframe: 1 month post-dose 3 of Prevnar 13 (Month 5)

Population: The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity, which included all evaluable subjects who have received three doses of Prevnar 13 vaccine and for whom immunogenicity results were available.

Antibody concentrations against S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F were assessed by ELISA, tabulated as GMCs and expressed in µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch.

Outcome measures

Outcome measures
Measure	HibCY Group n=156 Participants Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group n=158 Participants Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
Anti-Streptococcus (S) Pneumoniae GMCs Anti-1 antibody	1.49 µg/mL Interval 1.3 to 1.7	1.26 µg/mL Interval 1.1 to 1.44
Anti-Streptococcus (S) Pneumoniae GMCs Anti-6B antibody	1.00 µg/mL Interval 0.85 to 1.18	0.87 µg/mL Interval 0.73 to 1.05
Anti-Streptococcus (S) Pneumoniae GMCs Anti-9V antibody	0.78 µg/mL Interval 0.69 to 0.89	0.63 µg/mL Interval 0.55 to 0.73
Anti-Streptococcus (S) Pneumoniae GMCs Anti-19F antibody	2.25 µg/mL Interval 2.02 to 2.5	2.10 µg/mL Interval 1.87 to 2.37
Anti-Streptococcus (S) Pneumoniae GMCs Anti-23F antibody	0.94 µg/mL Interval 0.8 to 1.1	0.80 µg/mL Interval 0.67 to 0.94
Anti-Streptococcus (S) Pneumoniae GMCs Anti-3 antibody	0.55 µg/mL Interval 0.48 to 0.63	0.48 µg/mL Interval 0.42 to 0.55
Anti-Streptococcus (S) Pneumoniae GMCs Anti-4 antibody	0.81 µg/mL Interval 0.72 to 0.9	0.74 µg/mL Interval 0.66 to 0.84
Anti-Streptococcus (S) Pneumoniae GMCs Anti-5 antibody	0.80 µg/mL Interval 0.71 to 0.91	0.68 µg/mL Interval 0.59 to 0.78
Anti-Streptococcus (S) Pneumoniae GMCs Anti-6A antibody	1.76 µg/mL Interval 1.55 to 2.0	1.37 µg/mL Interval 1.18 to 1.6
Anti-Streptococcus (S) Pneumoniae GMCs Anti-7F antibody	2.59 µg/mL Interval 2.29 to 2.93	2.36 µg/mL Interval 2.1 to 2.65
Anti-Streptococcus (S) Pneumoniae GMCs Anti-14 antibody	4.77 µg/mL Interval 4.13 to 5.52	4.16 µg/mL Interval 3.5 to 4.94
Anti-Streptococcus (S) Pneumoniae GMCs Anti-18C antibody	0.91 µg/mL Interval 0.81 to 1.03	0.74 µg/mL Interval 0.65 to 0.84
Anti-Streptococcus (S) Pneumoniae GMCs Anti-19A antibody	1.31 µg/mL Interval 1.17 to 1.48	1.13 µg/mL Interval 0.98 to 1.31

PRIMARY outcome

Timeframe: 1 month post-dose 2 of Havrix (Month 17-20)

Population: The analysis was performed on the Havrix ATP cohort for analysis of immunogenicity which include all evaluable subjects who received two doses of Havrix vaccine and for whom immunogenicity results were available.

Percentage of subjects with Anti-Havrix (Anti-HAV) antibody concentrations was assessed. The cut-off value is ≥15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch

Outcome measures

Outcome measures
Measure	HibCY Group n=129 Participants Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group n=124 Participants Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
Percentage of Subjects With Anti-Hepatitis A (Anti-Havrix) Antibody Concentrations ≥ 15mIU/mL	100 Percentage of subjects Interval 97.2 to 100.0	100 Percentage of subjects Interval 97.1 to 100.0

PRIMARY outcome

Timeframe: 1 month post-dose 4 of Prevnar 13 (Month 11-14)

Population: The analysis was performed on the Forth dose ATP cohort for analysis of immunogenicity, which included all evaluable subjects who have received four doses of Prevnar 13 vaccine and for whom immunogenicity results were available.

Outcome measures

Outcome measures
Measure	HibCY Group n=216 Participants Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group n=205 Participants Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
Anti-S. Pneumoniae GMCs Anti-1 antibody	2.00 µg/mL Interval 1.78 to 2.25	1.60 µg/mL Interval 1.43 to 1.79
Anti-S. Pneumoniae GMCs Anti-4 antibody	1.36 µg/mL Interval 1.23 to 1.5	1.24 µg/mL Interval 1.1 to 1.39
Anti-S. Pneumoniae GMCs Anti-5 antibody	2.36 µg/mL Interval 2.1 to 2.64	2.23 µg/mL Interval 1.97 to 2.52
Anti-S. Pneumoniae GMCs Anti-14 antibody	7.14 µg/mL Interval 6.32 to 8.07	6.13 µg/mL Interval 5.48 to 6.86
Anti-S. Pneumoniae GMCs Anti-19A antibody	5.47 µg/mL Interval 4.87 to 6.14	5.03 µg/mL Interval 4.47 to 5.64
Anti-S. Pneumoniae GMCs Anti-3 antibody	0.52 µg/mL Interval 0.46 to 0.58	0.51 µg/mL Interval 0.44 to 0.59
Anti-S. Pneumoniae GMCs Anti-6A antibody	6.80 µg/mL Interval 6.1 to 7.57	5.63 µg/mL Interval 5.05 to 6.26
Anti-S. Pneumoniae GMCs Anti-6B antibody	5.57 µg/mL Interval 4.97 to 6.24	4.94 µg/mL Interval 4.4 to 5.55
Anti-S. Pneumoniae GMCs Anti-7F antibody	4.16 µg/mL Interval 3.76 to 4.61	3.81 µg/mL Interval 3.45 to 4.21
Anti-S. Pneumoniae GMCs Anti-9V antibody	1.38 µg/mL Interval 1.25 to 1.53	1.24 µg/mL Interval 1.11 to 1.39
Anti-S. Pneumoniae GMCs Anti-18C antibody	1.62 µg/mL Interval 1.46 to 1.8	1.42 µg/mL Interval 1.28 to 1.57
Anti-S. Pneumoniae GMCs Anti-19F antibody	6.23 µg/mL Interval 5.61 to 6.92	5.54 µg/mL Interval 4.97 to 6.18
Anti-S. Pneumoniae GMCs Anti-23F antibody	3.28 µg/mL Interval 2.9 to 3.71	2.68 µg/mL Interval 2.37 to 3.05

SECONDARY outcome

Timeframe: 2 months post-dose 2 [PedHib Group only (Month 4)], 1 month post-dose 3 (Month 5 for HibCY group and Months 11-14 for PedHib Group) and 1 month post-dose 4 [HibCY Group only (Month 11-14)]

Population: The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 4 and Month 5) and the Fourth doses ATP cohort for analysis of immunogenicity (for Months 11-14) which included all evaluable subjects for whom immunogenicity results were available.

The cut-off value for this assay was 0.15 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.

Outcome measures

Outcome measures
Measure	HibCY Group n=223 Participants Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group n=218 Participants Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
Percentage of Subjects With Anti-PRP Antibody Concentrations ≥0.15 µg/mL. Month 4	—	98.8 Percentage of subjects Interval 95.7 to 99.9
Percentage of Subjects With Anti-PRP Antibody Concentrations ≥0.15 µg/mL. Month 5	99.4 Percentage of subjects Interval 96.7 to 100.0	—
Percentage of Subjects With Anti-PRP Antibody Concentrations ≥0.15 µg/mL. Month 11-14	99.6 Percentage of subjects Interval 97.5 to 100.0	100 Percentage of subjects Interval 98.3 to 100.0

SECONDARY outcome

Timeframe: 2 months post-dose 2 [PedHib Group only (Month 4)], 1 month post-dose 3 (Month 5 for HibCY group and Month 11-14 for PedHib Group) and 1 month post-dose 4 [HibCY Group only (Month 11-14)]

Anti-PRP antibody concentrations were assessed by Enzyme-Linked-Immunosorbent-Assay (ELISA), tabulated as Geometric Mean Concentrations (GMCs) and expressed in micrograms per mililiter (µg/mL).The cut-off value for this assay was 0.15 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.

Outcome measures

Outcome measures
Measure	HibCY Group n=223 Participants Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group n=218 Participants Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
Anti-PRP GMCs≥ 0.15 µg/mL. Month 4	—	11.053 µg/mL Interval 8.74 to 13.979
Anti-PRP GMCs≥ 0.15 µg/mL. Month 5	8.414 µg/mL Interval 7.07 to 10.014	—
Anti-PRP GMCs≥ 0.15 µg/mL. Month 11-14	28.090 µg/mL Interval 24.012 to 32.862	20.869 µg/mL Interval 17.799 to 24.468

SECONDARY outcome

Timeframe: 2 months post-dose 2 [PedHib group only (Month 4)] and 1 month postdose 3 [HibCY group only (Month 5)].

Population: The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 4 and Month 5) which included all evaluable subjects for whom immunogenicity results were available.

The cut-off value for this assay was 1.0 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.

Outcome measures

Outcome measures
Measure	HibCY Group n=167 Participants Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group n=165 Participants Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
Percentage of Subjects With Anti-PRP Antibody Concentrations ≥1.0 µg/mL Month 5	94.0 Percentage of subjects Interval 89.3 to 97.1	—
Percentage of Subjects With Anti-PRP Antibody Concentrations ≥1.0 µg/mL Month 4	—	91.5 Percentage of subjects Interval 86.2 to 95.3

SECONDARY outcome

Timeframe: 1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14).

Population: The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 5) and the Fourth doses ATP cohort for analysis of immunogenicity (for Months11-14) which included all evaluable subjects for whom immunogenicity results were available.

The cut off values are dilutions of 1:8, 1:16 and 1:32. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.

Outcome measures

Outcome measures
Measure	HibCY Group n=215 Participants Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group n=187 Participants Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. hSBA-MenC, Month 5, ≥ 8	100 Percentage of subjects Interval 97.5 to 100.0	1.4 Percentage of subjects Interval 0.2 to 5.0
Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. hSBA-MenC, Month 5, ≥ 16	100 Percentage of subjects Interval 97.5 to 100.0	1.4 Percentage of subjects Interval 0.2 to 5.0
Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. hSBA-MenC, Month 5, ≥ 32	99.3 Percentage of subjects Interval 96.2 to 100.0	0.7 Percentage of subjects Interval 0.0 to 3.9
Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. hSBA-MenY, Month 5, ≥ 8	97.7 Percentage of subjects Interval 93.4 to 99.5	100 Percentage of subjects Interval 97.6 to 100.0
Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. hSBA-MenY, Month 5, ≥ 16	97.7 Percentage of subjects Interval 93.4 to 99.5	100 Percentage of subjects Interval 97.6 to 100.0
Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. hSBA-MenY, Month 5, ≥ 32	97.7 Percentage of subjects Interval 93.4 to 99.5	100 Percentage of subjects Interval 97.6 to 100.0
Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. hSBA-MenC, Month 11-14, ≥ 32	98.1 Percentage of subjects Interval 95.3 to 99.5	0.0 Percentage of subjects Interval 0.0 to 2.2
Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. hSBA-MenY, Month 11-14, ≥ 32	98.5 Percentage of subjects Interval 95.6 to 99.7	100 Percentage of subjects Interval 98.0 to 100.0
Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. hSBA-MenC, Month 11-14, ≥ 8	99.1 Percentage of subjects Interval 96.7 to 99.9	0.6 Percentage of subjects Interval 0.0 to 3.3
Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. hSBA-MenC, Month 11-14, ≥ 16	98.6 Percentage of subjects Interval 96.0 to 99.7	0.6 Percentage of subjects Interval 0.0 to 3.3
Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. hSBA-MenY, Month 11-14, ≥ 8	98.5 Percentage of subjects Interval 95.6 to 99.7	100 Percentage of subjects Interval 98.0 to 100.0
Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. hSBA-MenY, Month 11-14, ≥ 16	98.5 Percentage of subjects Interval 95.6 to 99.7	100 Percentage of subjects Interval 98.0 to 100.0

SECONDARY outcome

Timeframe: 1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14).

The cut-off values are dilutions of 1:8, 1:16 and 1:32. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.

Outcome measures

Outcome measures
Measure	HibCY Group n=215 Participants Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group n=187 Participants Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
Geometric Mean Titres (GMTs) of Human Complement Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and to hSBA-MenY hSBA-MenC, Month 5	807.3 Titres Interval 659.2 to 988.6	2.1 Titres Interval 2.0 to 2.3
Geometric Mean Titres (GMTs) of Human Complement Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and to hSBA-MenY hSBA-MenY, Month 5	510.9 Titres Interval 405.7 to 643.3	550.2 Titres Interval 474.4 to 638.1
Geometric Mean Titres (GMTs) of Human Complement Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and to hSBA-MenY hSBA-MenC, Month 11-14	2566.2 Titres Interval 2046.3 to 3218.1	2.0 Titres Interval 2.0 to 2.1
Geometric Mean Titres (GMTs) of Human Complement Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and to hSBA-MenY hSBA-MenY, Month 11-14	2761.4 Titres Interval 2274.2 to 3353.1	2728.2 Titres Interval 2412.7 to 3085.0

SECONDARY outcome

Timeframe: 2 month post-dose 2 of Rotarix (Month 4)

Population: The analysis was performed on the Rota ATP cohort for analysis of immunogenicity which included all vaccinated subjects for whom data were available.

The cut-off value is 20 Units (U)/mL Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.

Outcome measures

Outcome measures
Measure	HibCY Group n=155 Participants Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group n=161 Participants Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
Percentage of Subjects With Anti-rotavirus IgA Antibody Concentrations ≥ 20 Units (U)/mL	81.3 Percentage of subjects Interval 74.2 to 87.1	80.1 Percentage of subjects Interval 73.1 to 86.0

SECONDARY outcome

Timeframe: 1 month post-dose 1 of Havrix (Month 11-14)

Population: The analysis was performed on the Fourth dose ATP cohort for analysis of immunogenicity, which included all vaccinated subjects for whom data are available.

The cut-off value is 15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.

Outcome measures

Outcome measures
Measure	HibCY Group n=182 Participants Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group n=168 Participants Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
Percentage of Subjects With Anti-HAV Antibodies ≥ 15 mIU/mL	85.2 percentage of subjects Interval 79.2 to 90.0	89.3 percentage of subjects Interval 83.6 to 93.5

SECONDARY outcome

Timeframe: 1 month post-dose 1 of HAV (M11-14).

Population: The analysis was performed on the Fourth dose ATP cohort for analysis of immunogenicity, which included all vaccinated subjects for whom data are available.

Outcome measures

Outcome measures
Measure	HibCY Group n=182 Participants Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group n=168 Participants Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
Anti-HAV GMCs ≥ 15 mIU/mL	44.8 mIU/mL Interval 38.3 to 52.5	47.3 mIU/mL Interval 40.9 to 54.8

SECONDARY outcome

Timeframe: 1 month post-dose 2 of HAV (Month 17-20).

Population: This analysis was performed on Havrix ATP cohort for analysis of immunogenicity which included all evaluable subjects who have received the first and second dose of Havrix and for whom assay results were available.

Outcome measures

Outcome measures
Measure	HibCY Group n=129 Participants Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group n=124 Participants Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
GMCs for Anti-HAV Antibodies ≥15mIU/mL.	1590.7 mIU/mL Interval 1312.7 to 1927.5	1390.6 mIU/mL Interval 1147.8 to 1684.6

SECONDARY outcome

Timeframe: 1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14)

Population: This analysis was perfomed on First three doses ATP for analysis of immunogenicity and on the Fourth dose ATP cohort for analysis of immunogenicity which included all evaluable subjects for whom data were available.

The cut-off values are 0.15, 0.26, 0.35 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups

Outcome measures

Outcome measures
Measure	HibCY Group n=216 Participants Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group n=205 Participants Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-14 antibody, Month 5, ≥ 0.26	100 Percentage of subjects Interval 97.7 to 100.0	98.1 Percentage of subjects Interval 94.5 to 99.6
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-14 antibody, Month 5, ≥ 0.35	99.4 Percentage of subjects Interval 96.5 to 100.0	97.4 Percentage of subjects Interval 93.6 to 99.3
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-9V antibody, Month 5, ≥ 0.35	83.3 Percentage of subjects Interval 76.5 to 88.8	76.4 Percentage of subjects Interval 69.0 to 82.8
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-14 antibody, Month 5, ≥ 0.15	100 Percentage of subjects Interval 97.7 to 100.0	99.4 Percentage of subjects Interval 96.5 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-18C antibody, Month 5, ≥ 0.15	100 Percentage of subjects Interval 97.7 to 100.0	98.1 Percentage of subjects Interval 94.6 to 99.6
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-1 antibody, Month 5, ≥ 0.15	100 Percentage of subjects Interval 97.7 to 100.0	100 Percentage of subjects Interval 97.7 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-1 antibody, Month 5, ≥ 0.26	98.1 Percentage of subjects Interval 94.5 to 99.6	98.7 Percentage of subjects Interval 95.5 to 99.8
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-1 antibody, Month 5, ≥ 0.35	96.8 Percentage of subjects Interval 92.7 to 99.0	93.7 Percentage of subjects Interval 88.7 to 96.9
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-3 antibody, Month 5, ≥ 0.15	96.6 Percentage of subjects Interval 92.3 to 98.9	94.0 Percentage of subjects Interval 88.9 to 97.2
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-3 antibody, Month 5, ≥ 0.26	84.6 Percentage of subjects Interval 77.7 to 90.0	78.7 Percentage of subjects Interval 71.2 to 84.9
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-3 antibody, Month 5, ≥ 0.35	69.8 Percentage of subjects Interval 61.7 to 77.0	69.3 Percentage of subjects Interval 61.3 to 76.6
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-4 antibody, Month 5, ≥ 0.15	98.7 Percentage of subjects Interval 95.4 to 99.8	98.1 Percentage of subjects Interval 94.6 to 99.6
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-4 antibody, Month 5, ≥ 0.26	96.8 Percentage of subjects Interval 92.7 to 99.0	91.8 Percentage of subjects Interval 86.3 to 95.5
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-4 antibody, Month 5, ≥ 0.35	91.0 Percentage of subjects Interval 85.4 to 95.0	84.8 Percentage of subjects Interval 78.2 to 90.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-5 antibody, Month 5, ≥ 0.15	97.4 Percentage of subjects Interval 93.6 to 99.3	96.8 Percentage of subjects Interval 92.8 to 99.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-5 antibody, Month 5, ≥ 0.26	93.6 Percentage of subjects Interval 88.5 to 96.9	86.7 Percentage of subjects Interval 80.4 to 91.6
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-5 antibody, Month 5, ≥ 0.35	91.0 Percentage of subjects Interval 85.4 to 95.0	80.4 Percentage of subjects Interval 73.3 to 86.3
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-6A antibody, Month 5, ≥ 0.15	100 Percentage of subjects Interval 97.7 to 100.0	98.7 Percentage of subjects Interval 95.5 to 99.8
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-6A antibody, Month 5, ≥ 0.26	98.7 Percentage of subjects Interval 95.4 to 99.8	94.3 Percentage of subjects Interval 89.5 to 97.4
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-6A antibody, Month 5, ≥ 0.35	98.1 Percentage of subjects Interval 94.5 to 99.6	91.8 Percentage of subjects Interval 86.3 to 95.5
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-6B antibody, Month 5, ≥ 0.15	95.5 Percentage of subjects Interval 90.9 to 98.2	93.7 Percentage of subjects Interval 88.7 to 96.9
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-6B antibody, Month 5, ≥ 0.26	90.9 Percentage of subjects Interval 85.2 to 94.9	86.1 Percentage of subjects Interval 79.7 to 91.1
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-6B antibody, Month 5, ≥ 0.35	83.8 Percentage of subjects Interval 77.0 to 89.2	80.4 Percentage of subjects Interval 73.3 to 86.3
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-7F antibody, Month 5, ≥ 0.15	100 Percentage of subjects Interval 97.7 to 100.0	100 Percentage of subjects Interval 97.7 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-7F antibody, Month 5, ≥ 0.26	100 Percentage of subjects Interval 97.7 to 100.0	100 Percentage of subjects Interval 97.7 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-7F antibody, Month 5, ≥ 0.35	100 Percentage of subjects Interval 97.7 to 100.0	100 Percentage of subjects Interval 97.7 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-9V antibody, Month 5, ≥ 0.15	99.4 Percentage of subjects Interval 96.5 to 100.0	94.9 Percentage of subjects Interval 90.2 to 97.8
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-9V antibody, Month 5, ≥ 0.26	92.9 Percentage of subjects Interval 87.7 to 96.4	86.6 Percentage of subjects Interval 80.3 to 91.5
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-18C antibody, Month 5, ≥ 0.26	96.8 Percentage of subjects Interval 92.7 to 99.0	91.1 Percentage of subjects Interval 85.6 to 95.1
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-18C antibody, Month 5, ≥ 0.35	87.2 Percentage of subjects Interval 80.9 to 92.0	82.3 Percentage of subjects Interval 75.4 to 87.9
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-19A antibody, Month 5, ≥ 0.15	100 Percentage of subjects Interval 97.7 to 100.0	98.1 Percentage of subjects Interval 94.6 to 99.6
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-19A antibody, Month 5, ≥ 0.26	99.4 Percentage of subjects Interval 96.5 to 100.0	93.0 Percentage of subjects Interval 87.9 to 96.5
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-19A antibody, Month 5, ≥ 0.35	97.4 Percentage of subjects Interval 93.6 to 99.3	90.5 Percentage of subjects Interval 84.8 to 94.6
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-19F antibody, Month 5, ≥ 0.15	100 Percentage of subjects Interval 97.6 to 100.0	100 Percentage of subjects Interval 97.7 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-19F antibody, Month 5, ≥ 0.26	100 Percentage of subjects Interval 97.6 to 100.0	100 Percentage of subjects Interval 97.7 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-19F antibody, Month 5, ≥ 0.35	98.7 Percentage of subjects Interval 95.4 to 99.8	100 Percentage of subjects Interval 97.7 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-23F antibody, Month 5, ≥ 0.15	96.8 Percentage of subjects Interval 92.7 to 99.0	96.2 Percentage of subjects Interval 91.9 to 98.6
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-23F antibody, Month 5, ≥ 0.26	91.7 Percentage of subjects Interval 86.2 to 95.5	84.1 Percentage of subjects Interval 77.4 to 89.4
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-23F antibody, Month 5, ≥ 0.35	83.3 Percentage of subjects Interval 76.5 to 88.8	77.1 Percentage of subjects Interval 69.7 to 83.4
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-1 antibody, Month 11-14, ≥ 0.15	100 Percentage of subjects Interval 98.3 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-1 antibody, Month 11-14, ≥ 0.26	99.5 Percentage of subjects Interval 97.4 to 100.0	99.5 Percentage of subjects Interval 97.3 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-1 antibody, Month 11-14, ≥0.35	97.7 Percentage of subjects Interval 94.7 to 99.2	97.1 Percentage of subjects Interval 93.7 to 98.9
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-3 antibody, Month 11-14, ≥ 0.15	97.0 Percentage of subjects Interval 93.2 to 99.0	94.0 Percentage of subjects Interval 89.3 to 97.1
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-3 antibody, Month 11-14, ≥ 0.26	85.2 Percentage of subjects Interval 78.9 to 90.2	81.4 Percentage of subjects Interval 74.7 to 87.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-3 antibody, Month 11-14, ≥0.35	71.6 Percentage of subjects Interval 64.2 to 78.3	69.5 Percentage of subjects Interval 61.9 to 76.3
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-4 antibody, Month 11-14, ≥ 0.15	100 Percentage of subjects Interval 98.3 to 100.0	98.5 Percentage of subjects Interval 95.8 to 99.7
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-4 antibody, Month 11-14, ≥ 0.26	98.6 Percentage of subjects Interval 96.0 to 99.7	97.1 Percentage of subjects Interval 93.7 to 98.9
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-4 antibody, Month 11-14, ≥0.35	97.7 Percentage of subjects Interval 94.7 to 99.2	94.1 Percentage of subjects Interval 90.0 to 96.9
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-5 antibody, Month 11-14, ≥ 0.15	100 Percentage of subjects Interval 98.3 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-5 antibody, Month 11-14, ≥ 0.26	99.5 Percentage of subjects Interval 97.4 to 100.0	99.5 Percentage of subjects Interval 97.3 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-5 antibody, Month 11-14, ≥0.35	99.1 Percentage of subjects Interval 96.7 to 99.9	98.0 Percentage of subjects Interval 95.1 to 99.5
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-6A antibody, Month 11-14, ≥ 0.15	100 Percentage of subjects Interval 98.3 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-6A antibody, Month 11-14, ≥ 0.26	100 Percentage of subjects Interval 98.3 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-6A antibody, Month 11-14, ≥0.35	100 Percentage of subjects Interval 98.3 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-6B antibody, Month 11-14, ≥ 0.15	100 Percentage of subjects Interval 98.3 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-6B antibody, Month 11-14, ≥ 0.26	100 Percentage of subjects Interval 98.3 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-6B antibody, Month 11-14, ≥0.35	100 Percentage of subjects Interval 98.3 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-7F antibody, Month 11-14, ≥ 0.15	100 Percentage of subjects Interval 98.3 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-7F antibody, Month 11-14, ≥ 0.26	100 Percentage of subjects Interval 98.3 to 100.0	99.5 Percentage of subjects Interval 97.3 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-7F antibody, Month 11-14, ≥0.35	100 Percentage of subjects Interval 98.3 to 100.0	99.5 Percentage of subjects Interval 97.3 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-9V antibody, Month 11-14, ≥ 0.15	100 Percentage of subjects Interval 98.3 to 100.0	99.0 Percentage of subjects Interval 96.5 to 99.9
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-9V antibody, Month 11-14, ≥ 0.26	99.1 Percentage of subjects Interval 96.7 to 99.9	98.5 Percentage of subjects Interval 95.8 to 99.7
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-14 antibody, Month 11-14, ≥ 0.15	99.5 Percentage of subjects Interval 97.4 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-18C antibody, Month 11-14, ≥0.35	98.6 Percentage of subjects Interval 96.0 to 99.7	97.5 Percentage of subjects Interval 94.4 to 99.2
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-19A antibody, Month 11-14, ≥ 0.26	100 Percentage of subjects Interval 98.3 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-19A antibody, Month 11-14, ≥0.35	100 Percentage of subjects Interval 98.3 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-9V antibody, Month 11-14, ≥0.35	97.7 Percentage of subjects Interval 94.7 to 99.2	96.6 Percentage of subjects Interval 93.1 to 98.6
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-14 antibody, Month 11-14, ≥ 0.26	99.5 Percentage of subjects Interval 97.4 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-14 antibody, Month 11-14, ≥0.35	99.5 Percentage of subjects Interval 97.4 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-18C antibody, Month 11-14, ≥ 0.15	100 Percentage of subjects Interval 98.3 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-18C antibody, Month 11-14, ≥ 0.26	99.5 Percentage of subjects Interval 97.4 to 100.0	99.0 Percentage of subjects Interval 96.5 to 99.9
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-19A antibody, Month 11-14, ≥ 0.15	100 Percentage of subjects Interval 98.3 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-19F antibody, Month 11-14, ≥ 0.15	100 Percentage of subjects Interval 98.3 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-19F antibody, Month 11-14, ≥ 0.26	100 Percentage of subjects Interval 98.3 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-19F antibody, Month 11-14, ≥0.35	100 Percentage of subjects Interval 98.3 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-23F antibody, Month 11-14, ≥ 0.15	99.5 Percentage of subjects Interval 97.4 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-23F antibody, Month 11-14, ≥ 0.26	99.5 Percentage of subjects Interval 97.4 to 100.0	100 Percentage of subjects Interval 98.2 to 100.0
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Anti-23F antibody, Month 11-14, ≥0.35	98.1 Percentage of subjects Interval 95.3 to 99.5	100 Percentage of subjects Interval 98.2 to 100.0

SECONDARY outcome

Timeframe: 4 days (Day 0 to Day 3) after all vaccines post-primary and post-fourth dose

Population: This analysis was performed on First three doses Total Vaccinated cohort and on the Fourth dose total vaccinated cohort which included all evaluable subjects who received atleast one dose of any of the study vaccines:Hib-MenCY-TT, Pediarix, Prevnar 13, Rotarix, PedvaxHIB or Havrix, and with the vaccine administration documented.

Solicited local adverse events include pain, redness and swelling at injection site.

Outcome measures

Outcome measures
Measure	HibCY Group n=285 Participants Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group n=291 Participants Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Pain, Hib-MenCY-TT/PedvaxHIB, Dose 4	42.3 Percentage of subjects Interval 36.0 to 48.8	56.2 Percentage of subjects Interval 49.7 to 62.5
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Redness, Pediarix, Dose 1	27.1 Percentage of subjects Interval 22.0 to 32.7	25.1 Percentage of subjects Interval 20.2 to 30.5
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Redness, Prevnar 13, Dose 1	23.6 Percentage of subjects Interval 18.8 to 29.0	24.4 Percentage of subjects Interval 19.6 to 29.8
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Pain, Hib-MenCY-TT/PedvaxHIB, Dose 1	44.2 Percentage of subjects Interval 38.4 to 50.2	61.2 Percentage of subjects Interval 55.3 to 66.8
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Pain, Pediarix, Dose 1	50.5 Percentage of subjects Interval 44.6 to 56.5	57.4 Percentage of subjects Interval 51.5 to 63.1
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Pain, Prevnar 13, Dose 1	46.3 Percentage of subjects Interval 40.4 to 52.3	58.8 Percentage of subjects Interval 52.9 to 64.5
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Pain, Hib-MenCY-TT/PedvaxHIB, Dose 2	45.6 Percentage of subjects Interval 39.6 to 51.7	56.8 Percentage of subjects Interval 50.8 to 62.7
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Pain, Pediarix, Dose 2	45.2 Percentage of subjects Interval 39.2 to 51.3	55.8 Percentage of subjects Interval 49.7 to 61.7
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Pain, Prevnar 13, Dose 2	44.5 Percentage of subjects Interval 38.5 to 50.6	56.0 Percentage of subjects Interval 49.9 to 61.9
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Pain, Hib-MenCY-TT/PedvaxHIB, Dose 3	38.8 Percentage of subjects Interval 32.9 to 45.1	—
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Pain, Pediarix, Dose 3	42.7 Percentage of subjects Interval 36.7 to 49.0	50.8 Percentage of subjects Interval 44.6 to 56.9
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Pain, Prevnar 13, Dose 3	39.7 Percentage of subjects Interval 33.7 to 45.9	47.7 Percentage of subjects Interval 41.6 to 53.9
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Pain,Havrix , Dose 4	44.8 Percentage of subjects Interval 38.4 to 51.3	50.0 Percentage of subjects Interval 43.5 to 56.5
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Pain, Prevnar 13, Dose 4	41.5 Percentage of subjects Interval 35.2 to 48.0	46.7 Percentage of subjects Interval 40.3 to 53.2
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Redness, Hib-MenCY-TT/PedvaxHIB, Dose 1	21.1 Percentage of subjects Interval 16.5 to 26.3	35.4 Percentage of subjects Interval 29.9 to 41.2
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Redness, Hib-MenCY-TT/PedvaxHIB, Dose 2	30.3 Percentage of subjects Interval 24.8 to 36.1	41.4 Percentage of subjects Interval 35.5 to 47.4
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Redness, Pediarix, Dose 2	33.9 Percentage of subjects Interval 28.3 to 39.9	43.2 Percentage of subjects Interval 37.3 to 49.2
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Redness, Prevnar 13, Dose 2	30.6 Percentage of subjects Interval 25.2 to 36.5	41.2 Percentage of subjects Interval 35.3 to 47.2
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Redness, Hib-MenCY-TT/PedvaxHIB, Dose 3	31.5 Percentage of subjects Interval 25.9 to 37.6	—
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Redness, Pediarix, Dose 3	38.2 Percentage of subjects Interval 32.3 to 44.3	50.4 Percentage of subjects Interval 44.2 to 56.6
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Redness, Prevnar 13, Dose 3	36.3 Percentage of subjects Interval 30.4 to 42.4	45.8 Percentage of subjects Interval 39.7 to 52.1
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Redness,Havrix , Dose 4	38.6 Percentage of subjects Interval 32.4 to 45.1	43.8 Percentage of subjects Interval 37.5 to 50.3
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Redness, Hib-MenCY-TT/PedvaxHIB, Dose 4	38.6 Percentage of subjects Interval 32.4 to 45.1	50.8 Percentage of subjects Interval 44.3 to 57.3
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Redness, Prevnar 13, Dose 4	41.1 Percentage of subjects Interval 34.8 to 47.6	44.6 Percentage of subjects Interval 38.3 to 51.1
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Swelling, Hib-MenCY-TT/PedvaxHIB, Dose 1	11.3 Percentage of subjects Interval 7.8 to 15.5	22.0 Percentage of subjects Interval 17.4 to 27.2
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Swelling, Pediarix, Dose 1	18.7 Percentage of subjects Interval 14.3 to 23.7	16.2 Percentage of subjects Interval 12.1 to 20.9
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Swelling, Prevnar 13, Dose 1	14.8 Percentage of subjects Interval 10.9 to 19.5	16.2 Percentage of subjects Interval 12.1 to 20.9
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Swelling, Hib-MenCY-TT/PedvaxHIB, Dose 2	18.5 Percentage of subjects Interval 14.0 to 23.6	30.6 Percentage of subjects Interval 25.2 to 36.4
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Swelling, Pediarix, Dose 2	22.1 Percentage of subjects Interval 17.3 to 27.6	36.3 Percentage of subjects Interval 30.7 to 42.3
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Swelling, Prevnar 13, Dose 2	22.5 Percentage of subjects Interval 17.7 to 28.0	28.9 Percentage of subjects Interval 23.6 to 34.6
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Swelling, Hib-MenCY-TT/PedvaxHIB, Dose 3	19.2 Percentage of subjects Interval 14.6 to 24.6	—
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Swelling, Pediarix, Dose 3	29.4 Percentage of subjects Interval 23.9 to 35.3	37.9 Percentage of subjects Interval 32.0 to 44.0
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Swelling, Prevnar 13, Dose 3	24.4 Percentage of subjects Interval 19.3 to 30.1	31.4 Percentage of subjects Interval 25.9 to 37.4
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Swelling,Havrix , Dose 4	25.3 Percentage of subjects Interval 19.9 to 31.3	26.0 Percentage of subjects Interval 20.6 to 32.0
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Swelling, Hib-MenCY-TT/PedvaxHIB, Dose 4	22.8 Percentage of subjects Interval 17.7 to 28.6	34.3 Percentage of subjects Interval 28.3 to 40.6
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). Swelling, Prevnar 13, Dose 4	26.1 Percentage of subjects Interval 20.7 to 32.2	27.7 Percentage of subjects Interval 22.1 to 33.8

SECONDARY outcome

Timeframe: 4 days (Day 0 to Day 3) after all vaccines post-primary and post-fourth dose.

Population: The analysis was performed on First three doses Total Vaccinated cohort and on the Fourth dose Total Vaccinated cohort which included all evaluable subjects who received atleast one dose of any of the study vaccines:Hib-MenCY-TT, Pediarix, Prevnar 13, Rotarix, PedvaxHIB or Havrix, and with the vaccine administration documented.

Solicited general AEs include fever \[defined as temperature ≥38.0 degrees Celsius (°C) by any method\], drowsiness, irritability/fussiness and loss of appetite.

Outcome measures

Outcome measures
Measure	HibCY Group n=285 Participants Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group n=291 Participants Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
Percentage of Subjects Reporting Any Solicited General AEs. Drowsiness, Dose 2	54.2 Percentage of subjects Interval 48.1 to 60.2	65.1 Percentage of subjects Interval 59.2 to 70.7
Percentage of Subjects Reporting Any Solicited General AEs. Any Temperature (°C), Dose 1	11.2 Percentage of subjects Interval 7.8 to 15.5	20.6 Percentage of subjects Interval 16.1 to 25.7
Percentage of Subjects Reporting Any Solicited General AEs. Any Temperature (°C), Dose 2	19.4 Percentage of subjects Interval 14.9 to 24.6	29.0 Percentage of subjects Interval 23.8 to 34.7
Percentage of Subjects Reporting Any Solicited General AEs. Any Temperature (°C), Dose 3	16.4 Percentage of subjects Interval 12.1 to 21.5	17.0 Percentage of subjects Interval 12.7 to 22.1
Percentage of Subjects Reporting Any Solicited General AEs. Any Temperature (°C), Dose 4	8.7 Percentage of subjects Interval 5.5 to 13.0	10.4 Percentage of subjects Interval 6.8 to 14.9
Percentage of Subjects Reporting Any Solicited General AEs. Irritability / Fussiness, Dose 1	71.2 Percentage of subjects Interval 65.6 to 76.4	81.8 Percentage of subjects Interval 76.9 to 86.0
Percentage of Subjects Reporting Any Solicited General AEs. Irritability / Fussiness, Dose 2	70.0 Percentage of subjects Interval 64.1 to 75.3	83.5 Percentage of subjects Interval 78.6 to 87.6
Percentage of Subjects Reporting Any Solicited General AEs. Irritability / Fussiness, Dose 3	66.0 Percentage of subjects Interval 59.9 to 71.7	69.4 Percentage of subjects Interval 63.5 to 74.9
Percentage of Subjects Reporting Any Solicited General AEs. Irritability / Fussiness, Dose 4	66.0 Percentage of subjects Interval 59.6 to 71.9	74.3 Percentage of subjects Interval 68.3 to 79.7
Percentage of Subjects Reporting Any Solicited General AEs. Loss Of Appetite, Dose 1	31.6 Percentage of subjects Interval 26.2 to 37.3	42.3 Percentage of subjects Interval 36.5 to 48.2
Percentage of Subjects Reporting Any Solicited General AEs. Loss Of Appetite, Dose 2	29.7 Percentage of subjects Interval 24.3 to 35.5	31.7 Percentage of subjects Interval 26.2 to 37.5
Percentage of Subjects Reporting Any Solicited General AEs. Loss Of Appetite, Dose 3	29.8 Percentage of subjects Interval 24.3 to 35.7	28.7 Percentage of subjects Interval 23.3 to 34.5
Percentage of Subjects Reporting Any Solicited General AEs. Loss Of Appetite, Dose 4	33.2 Percentage of subjects Interval 27.3 to 39.5	39.8 Percentage of subjects Interval 33.6 to 46.3
Percentage of Subjects Reporting Any Solicited General AEs. Drowsiness, Dose 1	64.9 Percentage of subjects Interval 59.1 to 70.4	70.1 Percentage of subjects Interval 64.5 to 75.3
Percentage of Subjects Reporting Any Solicited General AEs. Drowsiness, Dose 3	48.9 Percentage of subjects Interval 42.7 to 55.1	52.5 Percentage of subjects Interval 46.3 to 58.6
Percentage of Subjects Reporting Any Solicited General AEs. Drowsiness, Dose 4	44.0 Percentage of subjects Interval 37.6 to 50.5	48.5 Percentage of subjects Interval 42.1 to 55.0

SECONDARY outcome

Timeframe: During 31 days (Day 0 to Day 30) after all vaccines post-primary (Dose 1-3) and post-fourth dose (Dose 4)

Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited adverse event.

Outcome measures

Outcome measures
Measure	HibCY Group n=297 Participants Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group n=303 Participants Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
Percentage of Subjects Reporting Any Unsolicited AEs. Dose 1-3	60.6 Percentage of subjects Interval 54.8 to 66.2	56.4 Percentage of subjects Interval 50.6 to 62.1
Percentage of Subjects Reporting Any Unsolicited AEs. Dose 4	39.9 Percentage of subjects Interval 33.8 to 46.3	42.0 Percentage of subjects Interval 35.8 to 48.4

SECONDARY outcome

Timeframe: During the entire study period (from Day 0 to Month 17-20)

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

Outcome measures

Outcome measures
Measure	HibCY Group n=297 Participants Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group n=303 Participants Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
Percentage of Subjects Reporting Any Serious Adverse Events (SAEs).	2.7 Percentage of subjects Interval 1.2 to 5.2	3.6 Percentage of subjects Interval 1.8 to 6.4

Adverse Events

HibCY Group

Serious events: 8 serious events

Other events: 282 other events

Deaths: 1 deaths

PedHIB Group

Serious events: 11 serious events

Other events: 291 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	HibCY Group n=297 participants at risk Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.	PedHIB Group n=303 participants at risk Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19.
Blood and lymphatic system disorders Anaemia	0.00% 0/297 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)	0.33% 1/303 • Number of events 1 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)
Blood and lymphatic system disorders Histiocytosis haematophagic	0.00% 0/297 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)	0.33% 1/303 • Number of events 1 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)
Blood and lymphatic system disorders Neutropenia	0.00% 0/297 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)	0.33% 1/303 • Number of events 1 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.34% 1/297 • Number of events 1 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)	0.00% 0/303 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)
General disorders Hypothermia	0.00% 0/297 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)	0.33% 1/303 • Number of events 1 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)
General disorders Sudden infant death syndrome	0.34% 1/297 • Number of events 1 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)	0.00% 0/303 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)
Infections and infestations Croup infectious	0.34% 1/297 • Number of events 1 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)	0.00% 0/303 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)
Infections and infestations Gastroenteritis	0.34% 1/297 • Number of events 1 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)	0.00% 0/303 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)
Infections and infestations Pneumonia	0.67% 2/297 • Number of events 3 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)	0.00% 0/303 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/297 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)	0.66% 2/303 • Number of events 2 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)
Infections and infestations Subcutaneous abscess	0.00% 0/297 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)	0.33% 1/303 • Number of events 1 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)
Infections and infestations Urinary tract infection	0.00% 0/297 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)	0.33% 1/303 • Number of events 1 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)
Infections and infestations Viral infection	0.00% 0/297 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)	0.33% 1/303 • Number of events 1 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)
Injury, poisoning and procedural complications Accidental overdose	0.34% 1/297 • Number of events 1 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)	0.00% 0/303 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/297 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)	0.33% 1/303 • Number of events 1 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)
Metabolism and nutrition disorders Failure to thrive	0.34% 1/297 • Number of events 1 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)	0.00% 0/303 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/297 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)	0.33% 1/303 • Number of events 1 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)
Metabolism and nutrition disorders Ketoacidosis	0.00% 0/297 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)	0.33% 1/303 • Number of events 1 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/297 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)	0.33% 1/303 • Number of events 1 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)
Respiratory, thoracic and mediastinal disorders Apparent life threatening event	0.34% 1/297 • Number of events 1 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)	0.33% 1/303 • Number of events 1 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)
Vascular disorders Kawasaki's disease	0.00% 0/297 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)	0.33% 1/303 • Number of events 1 • Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)