Trial Outcomes & Findings for Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age (NCT NCT00814710)

NCT ID: NCT00814710

Last Updated: 2020-01-03

Results Overview

Concentrations were expressed as Geometric Mean Concentrations (GMCs) in microgram per milliliter (µg/mL). Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 360 participants
• Primary outcome timeframe: One month after primary immunization (month 3)
• Results posted on: 2020-01-03

Participant Flow

Participant milestones

Measure	Synflorix and Tritanrix-HepB/Hib Group Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Overall Study STARTED	240	120
Overall Study COMPLETED	232	117
Overall Study NOT COMPLETED	8	3

Reasons for withdrawal

Measure	Synflorix and Tritanrix-HepB/Hib Group Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	7	3

Baseline Characteristics

Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age

Baseline characteristics by cohort

Measure	Synflorix and Tritanrix-HepB/Hib Group n=240 Participants Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group n=120 Participants Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Total n=360 Participants Total of all reporting groups
Age, Continuous	6.7 Weeks STANDARD_DEVIATION 1.08 • n=93 Participants	6.7 Weeks STANDARD_DEVIATION 1.05 • n=4 Participants	6.7 Weeks STANDARD_DEVIATION 1.07 • n=27 Participants
Sex: Female, Male Female	109 Participants n=93 Participants	66 Participants n=4 Participants	175 Participants n=27 Participants
Sex: Female, Male Male	131 Participants n=93 Participants	54 Participants n=4 Participants	185 Participants n=27 Participants

PRIMARY outcome

Timeframe: One month after primary immunization (month 3)

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Concentrations were expressed as Geometric Mean Concentrations (GMCs) in microgram per milliliter (µg/mL).

Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

Outcome measures

Measure	Synflorix and Tritanrix-HepB/Hib Group n=229 Participants Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group n=116 Participants Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-1	3.27 µg/mL Interval 2.91 to 3.67	0.03 µg/mL Interval 0.03 to 0.04
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-4	3.80 µg/mL Interval 3.33 to 4.33	0.04 µg/mL Interval 0.03 to 0.05
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-5	4.17 µg/mL Interval 3.72 to 4.67	0.05 µg/mL Interval 0.04 to 0.05
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-6B	0.71 µg/mL Interval 0.59 to 0.86	0.05 µg/mL Interval 0.04 to 0.06
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-7F	3.87 µg/mL Interval 3.47 to 4.31	0.06 µg/mL Interval 0.05 to 0.07
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-18C	15.23 µg/mL Interval 12.96 to 17.9	0.07 µg/mL Interval 0.05 to 0.08
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-9V	4.21 µg/mL Interval 3.71 to 4.78	0.06 µg/mL Interval 0.05 to 0.08
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-14	5.21 µg/mL Interval 4.51 to 6.01	0.26 µg/mL Interval 0.2 to 0.34
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-19F	11.78 µg/mL Interval 10.26 to 13.53	0.12 µg/mL Interval 0.1 to 0.16
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes Anti-23F	1.18 µg/mL Interval 0.98 to 1.42	0.05 µg/mL Interval 0.04 to 0.05

PRIMARY outcome

Timeframe: One month after primary immunization (month 3)

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Concentrations were expressed as GMCs GSK's 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Outcome measures

Measure	Synflorix and Tritanrix-HepB/Hib Group n=227 Participants Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group n=116 Participants Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Concentration of Antibody Against Protein D (PD)	2981.7 EL.U/mL Interval 2703.0 to 3289.2	63.9 EL.U/mL Interval 55.8 to 73.1

SECONDARY outcome

Timeframe: One month after primary immunization (month 3)

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

Cross-reactive pneumococcal serotypes included 6A and 19A.

Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8.

Outcome measures

Measure	Synflorix and Tritanrix-HepB/Hib Group n=116 Participants Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group n=57 Participants Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Opsono-1 (N=116; 57)	105 subjects	3 subjects
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Opsono-4 (N=116; 55)	114 subjects	24 subjects
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Opsono-5 (N= 116; 56)	111 subjects	2 subjects
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Opsono-6B (N=116; 54)	98 subjects	5 subjects
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Opsono-7F (N=116; 53)	116 subjects	35 subjects
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Opsono-9V (N=115; 56)	113 subjects	9 subjects
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Opsono-14 (N=115; 56)	110 subjects	14 subjects
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Opsono-18C (N=115; 55)	113 subjects	2 subjects
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Opsono-19F (N=116; 56)	114 subjects	7 subjects
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Opsono-23F (N=116; 54)	113 subjects	9 subjects
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Opsono-6A (N=110;57)	54 subjects	7 subjects
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes Opsono-19A (N=109;57)	35 subjects	0 subjects

SECONDARY outcome

Timeframe: One month after primary immunization

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.

The cut-off was defined as 0.20 microgram per milliliter (µg/mL).

Outcome measures

Measure	Synflorix and Tritanrix-HepB/Hib Group n=229 Participants Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group n=116 Participants Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value Anti-1	228 subjects	2 subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value Anti-4	225 subjects	10 subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value Anti-5	226 subjects	10 subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value Anti-6B	178 subjects	9 subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value Anti-7F	228 subjects	16 subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value Anti-9V	227 subjects	21 subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value Anti-14	229 subjects	66 subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value Anti-18C	227 subjects	20 subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value Anti-19F	227 subjects	40 subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value Anti-23F	205 subjects	12 subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value Anti-6A (N=229;115)	95 subjects	12 subjects
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value Anti-19A	146 subjects	21 subjects

SECONDARY outcome

Timeframe: One month after primary immunization (month 3)

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Concentrations were expressed as GMCs in µg/mL. Pneumococcal cross-reactive serotypes included 6A and 19A.

Outcome measures

Measure	Synflorix and Tritanrix-HepB/Hib Group n=229 Participants Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group n=116 Participants Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes Anti-6A (N=229;115)	0.15 µg/mL Interval 0.13 to 0.18	0.06 µg/mL Interval 0.05 to 0.08
Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes Anti-19A	0.33 µg/mL Interval 0.27 to 0.39	0.08 µg/mL Interval 0.06 to 0.09

SECONDARY outcome

Timeframe: One month after primary immunization (month 3)

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.

Seropositivity was defined as a titer equal to or greater than 0.05 µg/mL

Outcome measures

Measure	Synflorix and Tritanrix-HepB/Hib Group n=229 Participants Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group n=116 Participants Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Number of Subjects Seropositive for Pneumococcal Serotypes Anti-6A (N=229;115)	188 subjects	62 subjects
Number of Subjects Seropositive for Pneumococcal Serotypes Anti-19A	207 subjects	71 subjects
Number of Subjects Seropositive for Pneumococcal Serotypes Anti-1	228 subjects	19 subjects
Number of Subjects Seropositive for Pneumococcal Serotypes Anti-4	228 subjects	24 subjects
Number of Subjects Seropositive for Pneumococcal Serotypes Anti-5	229 subjects	46 subjects
Number of Subjects Seropositive for Pneumococcal Serotypes Anti-6B	215 subjects	40 subjects
Number of Subjects Seropositive for Pneumococcal Serotypes Anti-7F	229 subjects	52 subjects
Number of Subjects Seropositive for Pneumococcal Serotypes Anti-9V	228 subjects	49 subjects
Number of Subjects Seropositive for Pneumococcal Serotypes Anti-14	229 subjects	101 subjects
Number of Subjects Seropositive for Pneumococcal Serotypes Anti-18C	227 subjects	56 subjects
Number of Subjects Seropositive for Pneumococcal Serotypes Anti-19F	229 subjects	90 subjects
Number of Subjects Seropositive for Pneumococcal Serotypes Anti-23F	220 subjects	37 subjects

SECONDARY outcome

Timeframe: One month after primary immunization (month 3)

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Seropositivity for PD was defined greater than or equal to 100 EL.U/mL.

Outcome measures

Measure	Synflorix and Tritanrix-HepB/Hib Group n=227 Participants Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group n=116 Participants Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Number of Subjects Seropositive for Protein D (PD)	226 subjects	16 subjects

SECONDARY outcome

Timeframe: One month after primary immunization (month 3)

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Concentration is expressed as GMC in µg/mL.

Outcome measures

Measure	Synflorix and Tritanrix-HepB/Hib Group n=113 Participants Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group n=116 Participants Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)	31.367 µg/mL Interval 26.417 to 37.246	34.415 µg/mL Interval 26.847 to 44.116

SECONDARY outcome

Timeframe: One month after primary immunization (month 3)

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Concentrations were expressed as GMCs in international units per milliliter (IU/mL).

Outcome measures

Measure	Synflorix and Tritanrix-HepB/Hib Group n=113 Participants Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group n=116 Participants Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT) Anti-DT	2.580 IU/mL Interval 2.146 to 3.102	2.065 IU/mL Interval 1.736 to 2.457
Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT) Anti-TT	3.726 IU/mL Interval 3.182 to 4.363	1.542 IU/mL Interval 1.316 to 1.807

SECONDARY outcome

Timeframe: One month after primary immunization (month 3)

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Concentration was expressed as GMC in EL.U/mL.

Outcome measures

Measure	Synflorix and Tritanrix-HepB/Hib Group n=113 Participants Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group n=116 Participants Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Concentration of Antibody Against Bordetella Pertussis (B. Pertussis)	90.3 EL.U/mL Interval 80.3 to 101.6	114.5 EL.U/mL Interval 101.2 to 129.5

SECONDARY outcome

Timeframe: One month after primary immunization (month 3)

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Concentration was expressed as GMC in milli international units per milliliter (mIU/mL). As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table shows results following partial or complete retesting/reanalysis.

Outcome measures

Measure	Synflorix and Tritanrix-HepB/Hib Group n=92 Participants Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group n=89 Participants Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Concentration of Antibody Against Hepatitis B (Anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA).	1970.5 mIU/mL Interval 1614.9 to 2404.5	1378.2 mIU/mL Interval 1115.6 to 1702.6

SECONDARY outcome

Timeframe: One month after primary immunization (month 3)

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Seropositivity was defined as and antibody concentration equal to or greater than 15 EL.U/mL.

Outcome measures

Measure	Synflorix and Tritanrix-HepB/Hib Group n=113 Participants Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group n=116 Participants Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Number of Subjects Seropostive for B. Pertussis	113 subjects	116 subjects

SECONDARY outcome

Timeframe: One month after primary immunization (month 3)

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Seroprotection was defined as:

Anti-DT antibody concentration equal to or greater than 0.1 IU/mL. Anti-TT antibody concentration equal to or greater than 0.1 IU/mL. Anti-PRP antibody concentration equal to or greater than 0.15 µg/mL Anti-HBs antibody concentration greater than or equal to 10 mIU/mL.

Outcome measures

Measure	Synflorix and Tritanrix-HepB/Hib Group n=113 Participants Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group n=116 Participants Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs) Anti-DT	113 subjects	116 subjects
Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs) Anti-TT	113 subjects	116 subjects
Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs) Anti-PRP 0.15	113 subjects	115 subjects
Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs) Anti-HBs (N=92,89)	92 subjects	89 subjects

SECONDARY outcome

Timeframe: One month after primary immunization (month 3)

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects with available immunogenicity data.

Anti-PRP antibody concentration equal to or greater than 1.0 µg/mL.

Outcome measures

Measure	Synflorix and Tritanrix-HepB/Hib Group n=113 Participants Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group n=116 Participants Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL)	113 subjects	114 subjects

SECONDARY outcome

Timeframe: Within 4 days (day 0-3) after vaccination

Population: Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. However, the total number of subjects analyzed in this Total Vaccinated cohort included all subjects having returned their symptom sheets.

Solicited local symptoms included pain, redness and swelling. Solicited general symptoms included drowsiness, fever (equal to or above 38 degrees Celsius and above 39 degrees Celsius), irritability and loss of appetite.

Outcome measures

Measure	Synflorix and Tritanrix-HepB/Hib Group n=238 Participants Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group n=119 Participants Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Number of Subjects With Solicited Local and General Symptoms Loss of appetite	96 subjects	49 subjects
Number of Subjects With Solicited Local and General Symptoms Pain	209 subjects	105 subjects
Number of Subjects With Solicited Local and General Symptoms Redness	128 subjects	76 subjects
Number of Subjects With Solicited Local and General Symptoms Swelling	166 subjects	83 subjects
Number of Subjects With Solicited Local and General Symptoms Drowsiness	73 subjects	34 subjects
Number of Subjects With Solicited Local and General Symptoms Fever ≥38.0˚C	182 subjects	85 subjects
Number of Subjects With Solicited Local and General Symptoms Fever >39.0˚C	24 subjects	5 subjects
Number of Subjects With Solicited Local and General Symptoms Irritability	178 subjects	88 subjects

SECONDARY outcome

Timeframe: Within 31 days (day 0-30) after vaccination

Population: Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Unsolicited AE covers any AE 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

Outcome measures

Measure	Synflorix and Tritanrix-HepB/Hib Group n=240 Participants Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group n=120 Participants Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Number of Subjects With Unsolicited Adverse Events (AEs)	38 subjects	17 subjects

SECONDARY outcome

Timeframe: Following first vaccination (Month 0) throughout the entire study period (month 3)

Population: Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

SAEs assessed include 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.

Outcome measures

Measure	Synflorix and Tritanrix-HepB/Hib Group n=240 Participants Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group n=120 Participants Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Number of Subjects With Serious Adverse Events (SAEs)	5 subjects	1 subjects

Adverse Events

Synflorix and Tritanrix-HepB/Hib Group

Serious events: 5 serious events

Other events: 231 other events

Deaths: 0 deaths

Hiberix Group and Tritanrix-HepB Group

Serious events: 1 serious events

Other events: 114 other events

Deaths: 0 deaths

Serious adverse events

Measure	Synflorix and Tritanrix-HepB/Hib Group n=240 participants at risk Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group n=120 participants at risk Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Blood and lymphatic system disorders Anaemia	1.2% 3/240 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.	0.00% 0/120 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.
Infections and infestations Bronchopneumonia	0.83% 2/240 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.	0.83% 1/120 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.
Infections and infestations Chikungunya virus infection	0.42% 1/240 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.	0.00% 0/120 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.
Infections and infestations Gastroenteritis	0.42% 1/240 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.	0.00% 0/120 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.
Blood and lymphatic system disorders Hypochromic anaemia	0.42% 1/240 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.	0.00% 0/120 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.
General disorders Pyrexia	0.42% 1/240 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.	0.00% 0/120 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.
Infections and infestations Sepsis	0.42% 1/240 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.	0.00% 0/120 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.42% 1/240 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.	0.00% 0/120 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.

Other adverse events

Measure	Synflorix and Tritanrix-HepB/Hib Group n=240 participants at risk Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)	Hiberix Group and Tritanrix-HepB Group n=120 participants at risk Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
General disorders Pain	87.8% 209/238 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.	88.2% 105/119 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.
General disorders Redness	53.8% 128/238 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.	63.9% 76/119 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.
General disorders Swelling	69.7% 166/238 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.	69.7% 83/119 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.
General disorders Drowsiness	30.7% 73/238 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.	28.6% 34/119 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.
General disorders Fever	76.5% 182/238 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.	71.4% 85/119 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.
General disorders Irritability	74.8% 178/238 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.	73.9% 88/119 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.
General disorders Loss of appetite	40.3% 96/238 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.	41.2% 49/119 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.
Infections and infestations Rhinitis	5.4% 13/240 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.	5.0% 6/120 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.
Respiratory, thoracic and mediastinal disorders Cough	5.4% 13/240 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.	3.3% 4/120 • For other AEs day 0-3 (solicited) and day 0-30 unsolcited. For SAEs month 0 to Month 3.

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