Trial Outcomes & Findings for Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants (NCT NCT00158756)

Last Updated: 2018-06-06

Results Overview

Seroprotection status (SP) defined vaccinated subjects with antibody concentrations greater than or equal to (≥) 0.1 international units per millitre (IU/mL) as assessed by the Enzyme-linked Immunosorbent Assay (ELISA) or ≥ 0.016 IU/mL by neautralization assay on Vero cells in subjects seronegative for ELISA.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

308 participants

Primary outcome timeframe

At one month post dose 3 [PIII(M4)]

Results posted on

2018-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	Tritanrix-HepB+Rotarix Group Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Tritanrix-HepB+Placebo Group Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Rotarix Group Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Placebo Group Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Triple Antigen+Engerix-B Group Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Overall Study STARTED	80	25	81	23	99
Overall Study COMPLETED	75	25	73	22	96
Overall Study NOT COMPLETED	5	0	8	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Tritanrix-HepB+Rotarix Group Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Rotarix Group Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Placebo Group Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Triple Antigen+Engerix-B Group Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Overall Study Withdrawal by Subject	5	6	1	3
Overall Study Adverse Event	0	1	0	0
Overall Study Serious adverse event	0	1	0	0

Baseline Characteristics

Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tritanrix-HepB+Rotarix Group n=80 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Tritanrix-HepB+Placebo Group n=25 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Rotarix Group n=81 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Placebo Group n=23 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Triple Antigen+Engerix-B Group n=99 Participants Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.	Total n=308 Participants Total of all reporting groups
Age, Continuous	13.0 Weeks STANDARD_DEVIATION 1.70 • n=5 Participants	13.4 Weeks STANDARD_DEVIATION 1.87 • n=7 Participants	12.8 Weeks STANDARD_DEVIATION 1.39 • n=5 Participants	12.8 Weeks STANDARD_DEVIATION 1.56 • n=4 Participants	12.9 Weeks STANDARD_DEVIATION 1.33 • n=21 Participants	12.93 Weeks STANDARD_DEVIATION 1.51 • n=10 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	6 Participants n=7 Participants	45 Participants n=5 Participants	11 Participants n=4 Participants	48 Participants n=21 Participants	152 Participants n=10 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants	12 Participants n=4 Participants	51 Participants n=21 Participants	156 Participants n=10 Participants

PRIMARY outcome

Timeframe: At one month post dose 3 [PIII(M4)]

Population: The analysis were performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.

Outcome measures

Outcome measures
Measure	Tritanrix-HepB+Rotarix Group n=68 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Tritanrix-HepB+Placebo Group n=20 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Rotarix Group n=62 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Placebo Group n=17 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Triple Antigen+Engerix-B Group n=87 Participants Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies	100 IU/mL Interval 94.7 to 100.0	100 IU/mL Interval 83.2 to 100.0	100 IU/mL Interval 94.2 to 100.0	100 IU/mL Interval 80.5 to 100.0	98.9 IU/mL Interval 93.8 to 100.0

SECONDARY outcome

Timeframe: At one month post dose 3 [PIII(M4)]

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met all eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.

A seroprotected subject is a vaccinated subject with concentrations ≥ 0.1 IU/mL.

Outcome measures

Outcome measures
Measure	Tritanrix-HepB+Rotarix Group n=68 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Tritanrix-HepB+Placebo Group n=20 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Rotarix Group n=62 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Placebo Group n=17 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Triple Antigen+Engerix-B Group n=87 Participants Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA	65 Subjects	17 Subjects	60 Subjects	17 Subjects	85 Subjects

SECONDARY outcome

Timeframe: At one most post dose 3 [PIII(M4)]

A seroprotected subject was defined as a vaccinated subject with antibody concentrations ≥ 10 milli-international units per millilitre (mIU/mL).

Outcome measures

Outcome measures
Measure	Tritanrix-HepB+Rotarix Group n=64 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Tritanrix-HepB+Placebo Group n=19 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Rotarix Group n=58 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Placebo Group n=16 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Triple Antigen+Engerix-B Group n=86 Participants Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies	64 Subjects	19 Subjects	58 Subjects	16 Subjects	84 Subjects

SECONDARY outcome

Timeframe: At one month post dose 3 [PIII(M4)]

A seropositive subject was defined as a subject with Anti-BPT antibody concentrations ≥ 15 ELISA units per millilitre (EL.U/mL), as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA).

Outcome measures

Outcome measures
Measure	Tritanrix-HepB+Rotarix Group n=67 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Tritanrix-HepB+Placebo Group n=20 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Rotarix Group n=62 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Placebo Group n=17 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Triple Antigen+Engerix-B Group n=86 Participants Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values	67 Subjects	19 Subjects	60 Subjects	16 Subjects	79 Subjects

SECONDARY outcome

Timeframe: At one month post dose 3 [PIII(M4)]

Vaccine response (VR) was defined as the appearance of antibodies in subjects seronegative at pre-vaccination and antibody concentrations ≥ the cut-off values post-vaccination in subjects who were seropositive at pre-vaccination.

Outcome measures

Outcome measures
Measure	Tritanrix-HepB+Rotarix Group n=67 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Tritanrix-HepB+Placebo Group n=20 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Rotarix Group n=62 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Placebo Group n=17 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Triple Antigen+Engerix-B Group n=86 Participants Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Number of Subjects With Vaccine Response to BPT Antigen	67 Subjects	19 Subjects	60 Subjects	16 Subjects	79 Subjects

SECONDARY outcome

Timeframe: At 2.5 months after dose 2 of Rotarix [PIII(M4)]

A seropositive subject was defined as a subject with anti-RV antibody concentrations ≥ 20 units per millilitre (U/mL).

Outcome measures

Outcome measures
Measure	Tritanrix-HepB+Rotarix Group n=60 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Tritanrix-HepB+Placebo Group n=17 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Rotarix Group n=55 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Placebo Group n=17 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Triple Antigen+Engerix-B Group Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values	42 Subjects	0 Subjects	41 Subjects	0 Subjects	—

SECONDARY outcome

Timeframe: At one month post dose 3 [PIII(M4)]

A seroprotected subject was defined as a vaccinated subject with anti-T antibody concentrations ≥ the cut-off value of 0.1 international units per millilitre (IU/mL).

Outcome measures

Outcome measures
Measure	Tritanrix-HepB+Rotarix Group n=68 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Tritanrix-HepB+Placebo Group n=20 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Rotarix Group n=62 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Placebo Group n=17 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Triple Antigen+Engerix-B Group n=87 Participants Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen	68 Subjects	20 Subjects	62 Subjects	17 Subjects	87 Subjects

SECONDARY outcome

Timeframe: At one month post dose 3 [PIII(M4)]

A seroprotected subject was defined as a vaccinated subject with anti-Polio type 1,2 ,3 antibody titers ≥ 8

Outcome measures

Outcome measures
Measure	Tritanrix-HepB+Rotarix Group n=58 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Tritanrix-HepB+Placebo Group n=18 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Rotarix Group n=57 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Placebo Group n=15 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Triple Antigen+Engerix-B Group n=79 Participants Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) Anti-Polio 1, [N=54,17,47,14,72]	54 Subjects	17 Subjects	47 Subjects	14 Subjects	72 Subjects
Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) Anti-Polio 2, [N=58,18,57,14,79]	58 Subjects	18 Subjects	57 Subjects	14 Subjects	79 Subjects
Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) Anti-Polio 3, [N=57,18,55,15,79]	56 Subjects	17 Subjects	55 Subjects	15 Subjects	79 Subjects

SECONDARY outcome

Timeframe: At one month post dose 3 [PIII(M4)]

Concentrations of anti-HB, antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in mIU/mL.

Outcome measures

Outcome measures
Measure	Tritanrix-HepB+Rotarix Group n=64 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Tritanrix-HepB+Placebo Group n=19 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Rotarix Group n=58 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Placebo Group n=16 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Triple Antigen+Engerix-B Group n=84 Participants Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Concentrations of Anti-HBs Antibodies	600.5 mIU/mL Interval 473.1 to 762.3	732.7 mIU/mL Interval 472.0 to 1137.3	789.8 mIU/mL Interval 626.8 to 995.1	850.6 mIU/mL Interval 527.7 to 1371.2	578.6 mIU/mL Interval 442.3 to 757.0

SECONDARY outcome

Timeframe: At one month post dose 3 [PIII(M4)]

Concentrations of anti-DT antibodies, expressed as Geometric Mean Concentrations (GMCs), were measured in IU/mL.

Outcome measures

Outcome measures
Measure	Tritanrix-HepB+Rotarix Group n=68 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Tritanrix-HepB+Placebo Group n=20 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Rotarix Group n=62 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Placebo Group n=17 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Triple Antigen+Engerix-B Group n=87 Participants Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Concentrations of Anti-DT Antibodies	0.667 IU/mL Interval 0.517 to 0.862	0.545 IU/mL Interval 0.276 to 1.078	0.957 IU/mL Interval 0.725 to 1.262	0.906 IU/mL Interval 0.569 to 1.444	1.096 IU/mL Interval 0.869 to 1.381

SECONDARY outcome

Timeframe: At one month post dose 3 [PIII(M4)]

Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in international units per millillitre (IU/mL).

Outcome measures

Outcome measures
Measure	Tritanrix-HepB+Rotarix Group n=68 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Tritanrix-HepB+Placebo Group n=20 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Rotarix Group n=62 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Placebo Group n=17 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Triple Antigen+Engerix-B Group n=87 Participants Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Concentrations of Anti-T Antibodies	3.138 IU/mL Interval 2.58 to 3.817	3.350 IU/mL Interval 2.173 to 5.164	3.737 IU/mL Interval 3.079 to 4.535	5.323 IU/mL Interval 3.411 to 8.306	3.319 IU/mL Interval 2.838 to 3.881

SECONDARY outcome

Timeframe: At one month post dose 3 [PIII(M4)]

Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in EL.U/mL.

Outcome measures

Outcome measures
Measure	Tritanrix-HepB+Rotarix Group n=67 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Tritanrix-HepB+Placebo Group n=20 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Rotarix Group n=62 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Placebo Group n=17 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Triple Antigen+Engerix-B Group n=86 Participants Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Concentrations of Anti-BPT Antibodies	65.7 EL.U/mL Interval 57.9 to 74.5	50.8 EL.U/mL Interval 36.5 to 70.6	40.1 EL.U/mL Interval 33.8 to 47.5	37.2 EL.U/mL Interval 25.6 to 54.3	38.0 EL.U/mL Interval 32.5 to 44.4

SECONDARY outcome

Timeframe: At 2.5 months post dose 2 of Rotarix [PIII(M4)]

Concentrations, expressed as Geometric Mean Concentrations (GMCs), were measured in U/mL.

Outcome measures

Outcome measures
Measure	Tritanrix-HepB+Rotarix Group n=60 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Tritanrix-HepB+Placebo Group n=17 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Rotarix Group n=55 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Placebo Group n=17 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Triple Antigen+Engerix-B Group Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Concentrations of Anti-RV Antibodies	96.4 U/mL Interval 57.5 to 161.8	10.0 U/mL Interval 10.0 to 10.0	93.1 U/mL Interval 56.1 to 154.3	10.0 U/mL Interval 10.0 to 10.0	—

SECONDARY outcome

Timeframe: At one month post dose 3 [PIII(M4)]

Anti-Polio type 1, 2 and 3 antibody titers were expressed as Geometric Mean Titers (GMTs).

Outcome measures

Outcome measures
Measure	Tritanrix-HepB+Rotarix Group n=58 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Tritanrix-HepB+Placebo Group n=18 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Rotarix Group n=57 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Placebo Group n=15 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Triple Antigen+Engerix-B Group n=79 Participants Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Anti-Polio Type 1, 2, 3 Antibody Titers Anti-Polio 2, [N=58,18,57,14,79]	811.2 Titers Interval 655.3 to 1004.1	1024.0 Titers Interval 679.8 to 1542.2	774.2 Titers Interval 602.4 to 994.9	882.6 Titers Interval 538.2 to 1447.4	825.9 Titers Interval 661.7 to 1031.0
Anti-Polio Type 1, 2, 3 Antibody Titers Anti-Polio 1, [N=54,17,47,14,72]	900.7 Titers Interval 643.1 to 1261.5	1181.0 Titers Interval 604.4 to 2307.7	877.7 Titers Interval 612.3 to 1257.9	779.9 Titers Interval 391.3 to 1554.1	1155.0 Titers Interval 877.8 to 1519.7
Anti-Polio Type 1, 2, 3 Antibody Titers Anti-Polio 3, [N=57,18,55,15,79]	326.6 Titers Interval 234.7 to 454.3	369.1 Titers Interval 163.6 to 832.8	313.3 Titers Interval 240.8 to 407.7	330.3 Titers Interval 185.4 to 588.4	351.3 Titers Interval 267.5 to 461.3

SECONDARY outcome

Timeframe: During the 8-Day (Days 0-7) follow-up period

Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.

Solicited local symptoms were pain, redness and swelling. Any = occurence of symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 30 millimeters (mm).

Outcome measures

Outcome measures
Measure	Tritanrix-HepB+Rotarix Group n=78 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Tritanrix-HepB+Placebo Group n=25 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Rotarix Group n=76 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Placebo Group n=23 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Triple Antigen+Engerix-B Group n=98 Participants Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling, Across [N=78;25;76;23;98]	9 Subjects	2 Subjects	8 Subjects	4 Subjects	16 Subjects
Number of Subjects With Solicited Local Symptoms Any Pain, Dose 1 [N=78;25;76;23;98]	40 Subjects	13 Subjects	46 Subjects	14 Subjects	51 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Pain, Dose 1 [N=78;25;76;23;98]	6 Subjects	0 Subjects	8 Subjects	4 Subjects	13 Subjects
Number of Subjects With Solicited Local Symptoms Any Redness, Dose 1 [N=78;25;76;23;98]	49 Subjects	15 Subjects	54 Subjects	17 Subjects	61 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Redness, Dose 1 [N=78;25;76;23;98]	8 Subjects	1 Subjects	6 Subjects	1 Subjects	8 Subjects
Number of Subjects With Solicited Local Symptoms Any Swelling, Dose 1 [N=78;25;76;23;98]	27 Subjects	9 Subjects	33 Subjects	7 Subjects	31 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling, Dose 1 [N=78;25;76;23;98]	7 Subjects	1 Subjects	4 Subjects	3 Subjects	8 Subjects
Number of Subjects With Solicited Local Symptoms Any Pain, Dose 2 [N=76;25;75;22;96]	31 Subjects	11 Subjects	36 Subjects	11 Subjects	43 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Pain, Dose 2 [N=76;25;75;22;96]	3 Subjects	0 Subjects	3 Subjects	1 Subjects	8 Subjects
Number of Subjects With Solicited Local Symptoms Any Redness, Dose 2 [N=76;25;75;22;96]	48 Subjects	16 Subjects	58 Subjects	15 Subjects	61 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Redness, Dose 2 [N=76;25;75;22;96]	3 Subjects	0 Subjects	3 Subjects	0 Subjects	4 Subjects
Number of Subjects With Solicited Local Symptoms Any Swelling, Dose 2 [N=76;25;75;22;96]	32 Subjects	8 Subjects	36 Subjects	7 Subjects	37 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling, Dose 2 [N=76;25;75;22;96]	1 Subjects	1 Subjects	3 Subjects	0 Subjects	6 Subjects
Number of Subjects With Solicited Local Symptoms Any Pain, Dose 3 [N=76;25;75;22;96]	35 Subjects	8 Subjects	34 Subjects	10 Subjects	41 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Pain, Dose 3 [N=76;25;75;22;96]	3 Subjects	1 Subjects	5 Subjects	1 Subjects	5 Subjects
Number of Subjects With Solicited Local Symptoms Any Redness, Dose 3 [N=76;25;75;22;96]	48 Subjects	16 Subjects	53 Subjects	15 Subjects	57 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Redness, Dose 3 [N=76;25;75;22;96]	2 Subjects	1 Subjects	3 Subjects	0 Subjects	11 Subjects
Number of Subjects With Solicited Local Symptoms Any Swelling, Dose 3 [N=76;25;75;22;96]	33 Subjects	10 Subjects	38 Subjects	9 Subjects	47 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling, Dose 3 [N=76;25;75;22;96]	2 Subjects	1 Subjects	4 Subjects	2 Subjects	4 Subjects
Number of Subjects With Solicited Local Symptoms Any Pain, Across [N=78;25;76;23;98]	51 Subjects	17 Subjects	58 Subjects	18 Subjects	62 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Pain, Across [N=78;25;76;23;98]	9 Subjects	1 Subjects	11 Subjects	6 Subjects	22 Subjects
Number of Subjects With Solicited Local Symptoms Any Redness, Across [N=78;25;76;23;98]	60 Subjects	20 Subjects	65 Subjects	20 Subjects	77 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Redness, Across [N=78;25;76;23;98]	10 Subjects	2 Subjects	11 Subjects	1 Subjects	18 Subjects
Number of Subjects With Solicited Local Symptoms Any Swelling, Across [N=78;25;76;23;98]	44 Subjects	16 Subjects	52 Subjects	12 Subjects	57 Subjects

SECONDARY outcome

Timeframe: During the 8-day period (Days 0-7) post-vaccination

Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.

Assessed solicited general symptoms were diarrhea, drowsiness, fever \[defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)\], irritability, loss of appetite \[loss of appet.\] and vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Grade 3 loss of appetite = symptoms that prevents eating. Grade 3 diarrhea = ≥ 6 looser than normal stools per (/) day. Grade 3 vomiting = ≥ 3 episodes of vomiting/day.

Outcome measures

Outcome measures
Measure	Tritanrix-HepB+Rotarix Group n=78 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Tritanrix-HepB+Placebo Group n=25 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Rotarix Group n=77 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Placebo Group n=23 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Triple Antigen+Engerix-B Group n=98 Participants Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Number of Subjects With Any Solicited General Symptoms Any Fever, Dose 1[N=78;25;77;23;98]	43 Subjects	13 Subjects	49 Subjects	12 Subjects	68 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Fever, Dose 1[N=78;25;77;23;98]	1 Subjects	0 Subjects	1 Subjects	1 Subjects	2 Subjects
Number of Subjects With Any Solicited General Symptoms Related Fever, Dose 1[N=78;25;77;23;98]	42 Subjects	12 Subjects	49 Subjects	11 Subjects	67 Subjects
Number of Subjects With Any Solicited General Symptoms Any Irritability, Dose 1[N=78;25;77;23;98]	54 Subjects	23 Subjects	56 Subjects	17 Subjects	70 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Irritability, Dose 1[N=78;25;77;23;98]	6 Subjects	1 Subjects	4 Subjects	2 Subjects	10 Subjects
Number of Subjects With Any Solicited General Symptoms Related Irritability, Dose 1[N=78;25;77;23;98]	49 Subjects	17 Subjects	52 Subjects	13 Subjects	65 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Loss of appet., Dose 1[N=78;25;77;23;98]	1 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Any Solicited General Symptoms Related Loss of appet., Dose 1[N=78;25;77;23;98]	28 Subjects	5 Subjects	27 Subjects	10 Subjects	27 Subjects
Number of Subjects With Any Solicited General Symptoms Any Vomiting, Dose 1[N=78;25;77;23;98]	9 Subjects	1 Subjects	7 Subjects	1 Subjects	11 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Vomiting, Dose 1[N=78;25;77;23;98]	1 Subjects	0 Subjects	0 Subjects	0 Subjects	1 Subjects
Number of Subjects With Any Solicited General Symptoms Related Vomiting, Dose 1[N=78;25;77;23;98]	4 Subjects	0 Subjects	5 Subjects	0 Subjects	8 Subjects
Number of Subjects With Any Solicited General Symptoms Related Drowsiness, Dose 2[N=76;25;75;22;96]	26 Subjects	7 Subjects	31 Subjects	9 Subjects	35 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Diarrhea, Dose 2[N=76;25;75;22;96]	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Any Solicited General Symptoms Related Diarrhea, Dose 2[N=76;25;75;22;96]	0 Subjects	0 Subjects	2 Subjects	2 Subjects	2 Subjects
Number of Subjects With Any Solicited General Symptoms Any Drowsiness, Dose 2[N=76;25;75;22;96]	29 Subjects	9 Subjects	32 Subjects	11 Subjects	41 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Drowsiness, Dose 2[N=76;25;75;22;96]	1 Subjects	0 Subjects	0 Subjects	0 Subjects	2 Subjects
Number of Subjects With Any Solicited General Symptoms Related Loss of appet., Dose 2[N=76;25;75;22;96]	28 Subjects	9 Subjects	12 Subjects	4 Subjects	22 Subjects
Number of Subjects With Any Solicited General Symptoms Any Fever, Dose 2[N=76;25;75;22;96]	22 Subjects	10 Subjects	31 Subjects	11 Subjects	45 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Fever, Dose 2[N=76;25;75;22;96]	0 Subjects	0 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Any Solicited General Symptoms Related Fever, Dose 2[N=76;25;75;22;96]	20 Subjects	9 Subjects	30 Subjects	10 Subjects	44 Subjects
Number of Subjects With Any Solicited General Symptoms Any Irritability, Dose 2[N=76;25;75;22;96]	41 Subjects	10 Subjects	49 Subjects	11 Subjects	61 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Irritability, Dose 2[N=76;25;75;22;96]	2 Subjects	0 Subjects	2 Subjects	1 Subjects	3 Subjects
Number of Subjects With Any Solicited General Symptoms Related Irritability, Dose 2[N=76;25;75;22;96]	37 Subjects	9 Subjects	44 Subjects	9 Subjects	55 Subjects
Number of Subjects With Any Solicited General Symptoms Any Loss of appet., Dose 2[N=76;25;75;22;96]	22 Subjects	9 Subjects	12 Subjects	5 Subjects	23 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Loss of appet., Dose 2[N=76;25;75;22;96]	0 Subjects	0 Subjects	1 Subjects	0 Subjects	2 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Vomiting, Dose 2[N=76;25;75;22;96]	0 Subjects	0 Subjects	0 Subjects	0 Subjects	2 Subjects
Number of Subjects With Any Solicited General Symptoms Related Vomiting, Dose 2[N=76;25;75;22;96]	2 Subjects	0 Subjects	3 Subjects	0 Subjects	6 Subjects
Number of Subjects With Any Solicited General Symptoms Any Diarrhea, Dose 3[N=76;25;73;22;96]	1 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Diarrhea, Dose 3[N=76;25;73;22;96]	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Any Solicited General Symptoms Related Diarrhea, Dose 3[N=76;25;73;22;96]	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Any Solicited General Symptoms Any Drowsiness, Dose 3[N=76;25;73;22;96]	25 Subjects	13 Subjects	26 Subjects	13 Subjects	36 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Drowsiness, Dose 3[N=76;25;73;22;96]	1 Subjects	0 Subjects	1 Subjects	0 Subjects	0 Subjects
Number of Subjects With Any Solicited General Symptoms Any Fever, Dose 3[N=76;25;73;22;96]	24 Subjects	8 Subjects	27 Subjects	11 Subjects	41 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Fever, Dose 3[N=76;25;73;22;96]	0 Subjects	2 Subjects	1 Subjects	0 Subjects	1 Subjects
Number of Subjects With Any Solicited General Symptoms Related Fever, Dose 3[N=76;25;73;22;96]	22 Subjects	7 Subjects	27 Subjects	10 Subjects	41 Subjects
Number of Subjects With Any Solicited General Symptoms Any Irritability, Dose 3[N=76;25;73;22;96]	38 Subjects	15 Subjects	40 Subjects	13 Subjects	53 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Loss of appet., Dose 3[N=76;25;73;22;96]	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Any Solicited General Symptoms Related Loss of appet., Dose 3[N=76;25;73;22;96]	18 Subjects	5 Subjects	13 Subjects	6 Subjects	16 Subjects
Number of Subjects With Any Solicited General Symptoms Any Vomiting, Dose 3[N=76;25;73;22;96]	3 Subjects	1 Subjects	2 Subjects	0 Subjects	7 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Vomiting, Dose 3[N=76;25;73;22;96]	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Any Solicited General Symptoms Any Drowsiness, Across[N=78;25;77;23;98]	58 Subjects	19 Subjects	54 Subjects	19 Subjects	68 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Fever, Across[N=78;25;77;23;98]	1 Subjects	0 Subjects	3 Subjects	1 Subjects	4 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Irritability, Across[N=78;25;77;23;98]	8 Subjects	1 Subjects	7 Subjects	3 Subjects	12 Subjects
Number of Subjects With Any Solicited General Symptoms Any Vomiting, Dose 2[N=76;25;75;22;96]	3 Subjects	0 Subjects	4 Subjects	0 Subjects	8 Subjects
Number of Subjects With Any Solicited General Symptoms Related Drowsiness, Dose 3[N=76;25;73;22;96]	22 Subjects	7 Subjects	24 Subjects	11 Subjects	33 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Irritability, Dose 3[N=76;25;73;22;96]	1 Subjects	0 Subjects	2 Subjects	1 Subjects	2 Subjects
Number of Subjects With Any Solicited General Symptoms Related Irritability, Dose 3[N=76;25;73;22;96]	35 Subjects	13 Subjects	37 Subjects	12 Subjects	51 Subjects
Number of Subjects With Any Solicited General Symptoms Any Loss of appet., Dose 3[N=76;25;73;22;96]	20 Subjects	8 Subjects	15 Subjects	6 Subjects	17 Subjects
Number of Subjects With Any Solicited General Symptoms Any Diarrhea, Dose 1[N=78;25;77;23;98]	6 Subjects	0 Subjects	5 Subjects	1 Subjects	1 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Diarrhea, Dose 1[N=78;25;77;23;98]	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Any Solicited General Symptoms Related Diarrhea, Dose 1[N=78;25;77;23;98]	4 Subjects	0 Subjects	4 Subjects	0 Subjects	1 Subjects
Number of Subjects With Any Solicited General Symptoms Any Drowsiness, Dose 1[N=78;25;77;23;98]	50 Subjects	16 Subjects	52 Subjects	15 Subjects	56 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Drowsiness, Dose 1[N=78;25;77;23;98]	1 Subjects	1 Subjects	1 Subjects	1 Subjects	6 Subjects
Number of Subjects With Any Solicited General Symptoms Related Drowsiness, Dose 1[N=78;25;77;23;98]	42 Subjects	9 Subjects	49 Subjects	13 Subjects	48 Subjects
Number of Subjects With Any Solicited General Symptoms Any Loss of appet., Dose 1[N=78;25;77;23;98]	35 Subjects	9 Subjects	34 Subjects	11 Subjects	32 Subjects
Number of Subjects With Any Solicited General Symptoms Any Diarrhea, Dose 2[N=76;25;75;22;96]	1 Subjects	0 Subjects	3 Subjects	2 Subjects	3 Subjects
Number of Subjects With Any Solicited General Symptoms Related Irritability, Across[N=78;25;77;23;98]	59 Subjects	20 Subjects	64 Subjects	19 Subjects	80 Subjects
Number of Subjects With Any Solicited General Symptoms Any Loss of appet., Across[N=78;25;77;23;98]	43 Subjects	14 Subjects	39 Subjects	14 Subjects	48 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Loss of appet., Across[N=78;25;77;23;98]	1 Subjects	0 Subjects	2 Subjects	0 Subjects	3 Subjects
Number of Subjects With Any Solicited General Symptoms Related Loss of appet., Across[N=78;25;77;23;98]	39 Subjects	13 Subjects	34 Subjects	12 Subjects	45 Subjects
Number of Subjects With Any Solicited General Symptoms Any Vomiting, Across[N=78;25;77;23;98]	12 Subjects	2 Subjects	12 Subjects	1 Subjects	20 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Vomiting, Across[N=78;25;77;23;98]	1 Subjects	0 Subjects	0 Subjects	0 Subjects	3 Subjects
Number of Subjects With Any Solicited General Symptoms Related Vomiting, Across[N=78;25;77;23;98]	7 Subjects	1 Subjects	10 Subjects	0 Subjects	14 Subjects
Number of Subjects With Any Solicited General Symptoms Related Vomiting, Dose 3[N=76;25;73;22;96]	3 Subjects	1 Subjects	2 Subjects	0 Subjects	5 Subjects
Number of Subjects With Any Solicited General Symptoms Any Diarrhea, Across[N=78;25;77;23;98]	8 Subjects	0 Subjects	6 Subjects	3 Subjects	4 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Diarrhea, Across[N=78;25;77;23;98]	0 Subjects	0 Subjects	0 Subjects	0 Subjects	0 Subjects
Number of Subjects With Any Solicited General Symptoms Related Diarrhea, Across[N=78;25;77;23;98]	4 Subjects	0 Subjects	5 Subjects	2 Subjects	3 Subjects
Number of Subjects With Any Solicited General Symptoms Grade 3 Drowsiness, Across[N=78;25;77;23;98]	3 Subjects	1 Subjects	2 Subjects	1 Subjects	6 Subjects
Number of Subjects With Any Solicited General Symptoms Related Drowsiness, Across[N=78;25;77;23;98]	50 Subjects	13 Subjects	52 Subjects	18 Subjects	62 Subjects
Number of Subjects With Any Solicited General Symptoms Any Fever, Across[N=78;25;77;23;98]	54 Subjects	20 Subjects	59 Subjects	17 Subjects	80 Subjects
Number of Subjects With Any Solicited General Symptoms Related Fever, Across[N=78;25;77;23;98]	53 Subjects	18 Subjects	59 Subjects	15 Subjects	78 Subjects
Number of Subjects With Any Solicited General Symptoms Any Irritability, Across[N=78;25;77;23;98]	61 Subjects	23 Subjects	66 Subjects	20 Subjects	84 Subjects

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) follow-up period

Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.

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

Outcome measures

Outcome measures
Measure	Tritanrix-HepB+Rotarix Group n=80 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Tritanrix-HepB+Placebo Group n=25 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Rotarix Group n=81 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Placebo Group n=23 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Triple Antigen+Engerix-B Group n=99 Participants Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Number of Subjects With Unsolicited Adverse Events (AEs)	8 Subjects	6 Subjects	19 Subjects	5 Subjects	12 Subjects

SECONDARY outcome

Timeframe: From Month 0 to Month 4

Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and the symptom sheet filled in.

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	Tritanrix-HepB+Rotarix Group n=80 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Tritanrix-HepB+Placebo Group n=25 Participants Subjects received 3 doses of Tritanrix-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Rotarix Group n=81 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix vaccine at 3 and 4.5 months of age.	Zilbrix+Placebo Group n=23 Participants Subjects received 3 doses of Zilbrix vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix vaccine at 3 and 4.5 months of age.	Triple Antigen+Engerix-B Group n=99 Participants Subjects received 3 separate doses of Triple Antigen and Engerix-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Number of Subjects With Serious Adverse Events (SAEs)	1 Subjects	0 Subjects	7 Subjects	0 Subjects	2 Subjects

Adverse Events

Tritanrix™-HepB+Rotarix™ Group

Serious events: 1 serious events

Other events: 74 other events

Deaths: 0 deaths

Tritanrix™-HepB+Placebo Group

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Zilbrix™+Rotarix™ Group

Serious events: 7 serious events

Other events: 74 other events

Deaths: 0 deaths

Zilbrix™+Placebo Group

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Triple Antigen™+Engerix™-B Group

Serious events: 2 serious events

Other events: 96 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tritanrix™-HepB+Rotarix™ Group n=80 participants at risk Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.	Tritanrix™-HepB+Placebo Group n=25 participants at risk Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.	Zilbrix™+Rotarix™ Group n=81 participants at risk Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.	Zilbrix™+Placebo Group n=23 participants at risk Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.	Triple Antigen™+Engerix™-B Group n=99 participants at risk Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	1.2% 1/80 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/25 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	3.7% 3/81 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/23 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	1.0% 1/99 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4
Infections and infestations Enterocolitis infectious	0.00% 0/80 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/25 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	3.7% 3/81 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/23 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/99 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4
Blood and lymphatic system disorders Anemia	0.00% 0/80 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/25 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	2.5% 2/81 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/23 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/99 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4
Infections and infestations Ear infection	0.00% 0/80 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/25 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	1.2% 1/81 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/23 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/99 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4
Infections and infestations Injection site abscess	0.00% 0/80 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/25 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	1.2% 1/81 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/23 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/99 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4
Gastrointestinal disorders Intussusception	0.00% 0/80 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/25 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	1.2% 1/81 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/23 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/99 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4
Infections and infestations Laryngotracheitis obstructive	0.00% 0/80 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/25 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/81 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/23 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	1.0% 1/99 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4
Infections and infestations Overgrowth bacterial	0.00% 0/80 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/25 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	1.2% 1/81 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/23 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/99 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4
Infections and infestations Pneumonia	0.00% 0/80 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/25 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	1.2% 1/81 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/23 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/99 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4

Other adverse events

Other adverse events
Measure	Tritanrix™-HepB+Rotarix™ Group n=80 participants at risk Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.	Tritanrix™-HepB+Placebo Group n=25 participants at risk Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.	Zilbrix™+Rotarix™ Group n=81 participants at risk Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.	Zilbrix™+Placebo Group n=23 participants at risk Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.	Triple Antigen™+Engerix™-B Group n=99 participants at risk Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
Infections and infestations Upper respiratory tract infection	1.2% 1/80 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	4.0% 1/25 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	3.7% 3/81 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	8.7% 2/23 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	5.1% 5/99 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4
Skin and subcutaneous tissue disorders Dermatitis allergic	1.2% 1/80 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	12.0% 3/25 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	1.2% 1/81 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/23 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/99 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4
General disorders Pain	65.4% 51/78 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	68.0% 17/25 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	76.3% 58/76 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	78.3% 18/23 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	63.3% 62/98 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4
General disorders Redness	76.9% 60/78 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	80.0% 20/25 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	85.5% 65/76 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	87.0% 20/23 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	78.6% 77/98 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4
General disorders Swelling	56.4% 44/78 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	64.0% 16/25 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	68.4% 52/76 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	52.2% 12/23 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	58.2% 57/98 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4
General disorders Diarrhea	10.3% 8/78 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	0.00% 0/25 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	7.8% 6/77 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	13.0% 3/23 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	4.1% 4/98 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4
General disorders Drowsiness	74.4% 58/78 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	76.0% 19/25 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	70.1% 54/77 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	82.6% 19/23 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	69.4% 68/98 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4
General disorders Fever	69.2% 54/78 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	80.0% 20/25 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	76.6% 59/77 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	73.9% 17/23 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	81.6% 80/98 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4
General disorders Irritability	78.2% 61/78 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	92.0% 23/25 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	85.7% 66/77 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	87.0% 20/23 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	85.7% 84/98 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4
General disorders Loss of appetite	55.1% 43/78 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	56.0% 14/25 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	50.6% 39/77 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	60.9% 14/23 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	49.0% 48/98 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4
General disorders Vomiting	15.4% 12/78 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	8.0% 2/25 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	15.6% 12/77 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	4.3% 1/23 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4	20.4% 20/98 • Solicited local+general during the 8-day (Days 0-7) post vaccination; AEs within the 31-Day;SAEs up to study end at Month 4

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