Trial Outcomes & Findings for Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants (NCT NCT01171963)

NCT ID: NCT01171963

Last Updated: 2018-08-06

Results Overview

A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating wild-type (WT) RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode. Severe RVGE was defined as an episode of RV GE with score equal to or higher than (\>=) 11 on a 20-point Vesikari scoring system.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3340 participants

Primary outcome timeframe

From Month 1 ½ to Month 21

Results posted on

2018-08-06

Participant Flow

Duration of the study was of a maximum of 21 months, with the enrolment of subjects starting in August 2010, and subjects being followed up to May 2012 (study Month 21 and Study End), end of the rotavirus season in China.

Subjects were assigned to 2 sub-cohorts (1:1 ratio). Sub-cohort 1 and Sub-cohort 2 subjects received their OPV and Infanrix™ EPI vaccination respectively independently of, and concomitantly with their Rotarix™/placebo vaccination. 3340 subjects were allocated study subject number allocated and 3333 vaccinated .

Participant milestones

Participant milestones
Measure	Rotarix Group Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
Overall Study STARTED	1666	1667
Overall Study COMPLETED	1518	1499
Overall Study NOT COMPLETED	148	168

Reasons for withdrawal

Reasons for withdrawal
Measure	Rotarix Group Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
Overall Study Adverse Event	10	15
Overall Study Lost to Follow-up	23	24
Overall Study Other - diarrhoea	1	0
Overall Study Withdrawal by Subject	114	129

Baseline Characteristics

Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rotarix Group n=1666 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group n=1667 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.	Total n=3333 Participants Total of all reporting groups
Age, Continuous	9.5 Weeks STANDARD_DEVIATION 2.64 • n=99 Participants	9.7 Weeks STANDARD_DEVIATION 2.59 • n=107 Participants	9.6 Weeks STANDARD_DEVIATION 2.62 • n=206 Participants
Sex: Female, Male Female	795 Participants n=99 Participants	836 Participants n=107 Participants	1631 Participants n=206 Participants
Sex: Female, Male Male	871 Participants n=99 Participants	831 Participants n=107 Participants	1702 Participants n=206 Participants

PRIMARY outcome

Timeframe: From Month 1 ½ to Month 21

Population: The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½.

Outcome measures

Outcome measures
Measure	Rotarix Group n=1575 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group n=1573 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains	21 Participants	75 Participants

SECONDARY outcome

Timeframe: From Month 1 ½ to Month 21

Outcome measures

Outcome measures
Measure	Rotarix Group n=1575 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group n=1573 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild-type Strains	70 Participants	167 Participants

SECONDARY outcome

Timeframe: From Month 1 ½ to Month 21

A gastroenteritis episode was classified positive for rotavirus (RV) if RV was identified in a stool sample collected during the episode. RV types assessed were G1 Wild Type (G1WT), G2, G3, G9, GX (G type unknown, but not vaccine strain), P4, P8 Wild Type (P8WT), P9, PX (P type unknown, but not vaccine strain) and Pooled Non-G1WT.

Outcome measures

Outcome measures
Measure	Rotarix Group n=1575 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group n=1573 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. Subjects with G1WT RVGE	22 Participants	46 Participants
Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. Subjects with G2 RVGE	42 Participants	105 Participants
Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. Subjects with G3 RVGE	1 Participants	12 Participants
Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. Subjects with G9 RVGE	1 Participants	5 Participants
Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. Subjects with GX RVGE	6 Participants	8 Participants
Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. Subjects with P4 RVGE	43 Participants	107 Participants
Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. Subjects with P8WT RVGE	25 Participants	59 Participants
Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. Subjects with P9 RVGE	0 Participants	1 Participants
Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. Subjects with PX RVGE	4 Participants	1 Participants
Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. Subjects with Pooled Non-G1WT RVGE	49 Participants	129 Participants

SECONDARY outcome

Timeframe: From Month 1 ½ to Month 21

A gastroenteritis episode was classified positive for rotavirus (RV) if RV was identified in a stool sample collected during the episode. Severe RVGE was defined as an episode of RVGE with score equal to or higher than (\>=) 11 on a 20-point Vesikari scoring system. RV types assessed were G1 Wild Type (G1WT), G2, G3, G9, GX (G type unknown, but not vaccine strain), P4, P8 Wild Type (P8WT), P9, PX (P type unknown, but not vaccine strain) and Pooled Non-G1WT.

Outcome measures

Outcome measures
Measure	Rotarix Group n=1575 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group n=1573 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. Subjects with severe PX RVGE	1 Participants	1 Participants
Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. Subjects with severe G1WT RVGE	9 Participants	25 Participants
Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. Subjects with severe G2 RVGE	11 Participants	43 Participants
Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. Subjects with severe G3 RVGE	0 Participants	3 Participants
Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. Subjects with severe G9 RVGE	0 Participants	3 Participants
Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. Subjects with severe GX RVGE	1 Participants	6 Participants
Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. Subjects with severe P4 RVGE	12 Participants	43 Participants
Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. Subjects with severe P8WT RVGE	9 Participants	31 Participants
Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. Subjects with severe Pooled Non-G1WT RVGE	12 Participants	54 Participants

SECONDARY outcome

Timeframe: From Month 1 ½ to Month 21

A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating WT RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode.

Outcome measures

Outcome measures
Measure	Rotarix Group n=1575 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group n=1573 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
Number of Subjects With Episodes of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains Requiring Hospitalization	4 Participants	21 Participants

SECONDARY outcome

Timeframe: From Month 1 ½ to Month 21

Severe GE was defined as an episode of GE with score equal to or higher than (\>=) 11 on a 20-point Vesikari scoring system. This outcome measure concerns results for GE episodes due to any cause.

Outcome measures

Outcome measures
Measure	Rotarix Group n=1575 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group n=1573 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
Number of Subjects With Any and Severe Gastroenteritis (GE) Due to Any Cause Subjects with any GE	728 Participants	759 Participants
Number of Subjects With Any and Severe Gastroenteritis (GE) Due to Any Cause Subjects with any severe GE	187 Participants	206 Participants

SECONDARY outcome

Timeframe: Within the 8-day (Days 0-7) follow-up periods after any dose of Rotarix vaccine/placebo

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented, solely on subjects not part of Sub-cohort 2.

Assessed solicited general symptoms were fever,defined as axillary temperature (T) above or equal to \[\>=\] 37.5 degrees Celsius \[°C\] (if GSK scale) or \>= 37.1°C (if Chinese scale), fussiness/irritability, loss of appetite, cough/runny nose, diarrhea and vomiting. Any = any occurrence of the specified solicited general symptom regardless of the intensity grade or relationship to vaccination. This outcome measure was only assessed in subjects from Sub-cohort 1, who received the EPI vaccination independently of study vaccination with the Rotarix vaccine/placebo.

Outcome measures

Outcome measures
Measure	Rotarix Group n=1513 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group n=1514 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
Number of Subjects With Any Solicited General Symptoms Following Vaccination With the Rotarix Vaccine/Placebo Any cough/runny nose	313 Participants	366 Participants
Number of Subjects With Any Solicited General Symptoms Following Vaccination With the Rotarix Vaccine/Placebo Any diarrhoea	127 Participants	123 Participants
Number of Subjects With Any Solicited General Symptoms Following Vaccination With the Rotarix Vaccine/Placebo Any Irritability/Fussiness	415 Participants	448 Participants
Number of Subjects With Any Solicited General Symptoms Following Vaccination With the Rotarix Vaccine/Placebo Any Loss of appetite	253 Participants	250 Participants
Number of Subjects With Any Solicited General Symptoms Following Vaccination With the Rotarix Vaccine/Placebo Any Fever - Chinese scale: Axillary T >= 37.1°C	302 Participants	313 Participants
Number of Subjects With Any Solicited General Symptoms Following Vaccination With the Rotarix Vaccine/Placebo Any Fever - GSK scale: Axillary T >= 37.5°C	83 Participants	104 Participants
Number of Subjects With Any Solicited General Symptoms Following Vaccination With the Rotarix Vaccine/Placebo Any Vomiting	213 Participants	232 Participants

SECONDARY outcome

Timeframe: Within the 8-day (Days 0-7) follow-up periods following Doses 1 and 2 of the OPV vaccine and Dose 1 of the Infanrix vaccine

Solicited general symptoms assessed following administration of the co-administered EPI vaccines were drowsiness, gastrointestinal symptoms, fussiness/irritability, loss of appetite, and fever, defined as axillary temperature (T) above or equal to \[\>=\] 37.5 degrees Celsius \[°C\] (if GSK scale) or \>= 37.1°C (if Chinese scale ). Any = any occurrence of the specified solicited general symptom regardless of the intensity grade or relationship to vaccination. This outcome measure was only assessed in subjects from Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo.

Outcome measures

Outcome measures
Measure	Rotarix Group n=153 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group n=153 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
Number of Subjects With Any Solicited General Symptoms Following Administration of the Co-administered EPI Vaccines Any Drowsiness	44 Participants	38 Participants
Number of Subjects With Any Solicited General Symptoms Following Administration of the Co-administered EPI Vaccines Any Gastrointestinal symptoms	43 Participants	38 Participants
Number of Subjects With Any Solicited General Symptoms Following Administration of the Co-administered EPI Vaccines Any Irritability/Fussiness	56 Participants	52 Participants
Number of Subjects With Any Solicited General Symptoms Following Administration of the Co-administered EPI Vaccines Any Loss of appetite	43 Participants	32 Participants
Number of Subjects With Any Solicited General Symptoms Following Administration of the Co-administered EPI Vaccines Any Fever - Chinese scale: Axillary T >= 37.1°C	18 Participants	20 Participants
Number of Subjects With Any Solicited General Symptoms Following Administration of the Co-administered EPI Vaccines Any Fever - GSK scale: Axillary T >= 37.5°C	6 Participants	7 Participants

SECONDARY outcome

Timeframe: Within the 8-day (Days 0-7) follow-up periods following Dose 2 of the Rotarix vaccine/placebo

Solicited local symptoms assessed following administration of the co-administered EPI vaccines were pain, swelling, and redness. Any = any occurrence of the specified solicited local symptom regardless of the intensity grade. This outcome measure was only assessed in subjects from Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo.

Outcome measures

Outcome measures
Measure	Rotarix Group n=150 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group n=151 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
Number of Subjects With Any Solicited Local Symptoms Following Dose 2 of the Rotarix Vaccine/Placebo Any Pain	14 Participants	9 Participants
Number of Subjects With Any Solicited Local Symptoms Following Dose 2 of the Rotarix Vaccine/Placebo Any Redness	20 Participants	13 Participants
Number of Subjects With Any Solicited Local Symptoms Following Dose 2 of the Rotarix Vaccine/Placebo Any Swelling	13 Participants	6 Participants

SECONDARY outcome

Timeframe: Within the 31-day (Days 0-30) follow-up periods following any dose of the Rotarix vaccine or placebo

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented.

An unsolicited AE is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 = occurrence of an unsolicited AE regardless of the intensity grade or relationship to vaccination.

Outcome measures

Outcome measures
Measure	Rotarix Group n=1666 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group n=1667 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	310 Participants	368 Participants

SECONDARY outcome

Timeframe: Throughout the entire study period (from Day 0 to Study End at Month 21)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, or result in disability/incapacity. Any = occurrence of an SAE regardless of the intensity grade or relationship to vaccination.

Outcome measures

Outcome measures
Measure	Rotarix Group n=1666 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group n=1667 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
Number of Subjects With Any Serious Adverse Events (SAEs)	183 Participants	246 Participants

SECONDARY outcome

Timeframe: At Month 2 and at 12 months of age

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity Sub-cohort 1, which included subjects vaccinated with at least 1 dose of HRV vaccine/Placebo, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.

A seroconverted subject was defined as a subject seronegative at baseline (Day 0) with the appearance of anti-RV IgA antibody concentration greater than or equal to (≥) 20 units per milliliter (U/mL) at the time point assessed. A seronegative subject was defined as a subject with anti-RV IgA antibody concentration lower than (\<) 20 U/mL.

Outcome measures

Outcome measures
Measure	Rotarix Group n=257 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group n=254 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies Anti-RV IgA - 12 months of age	176 Participants	118 Participants
Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies Anti-RV IgA - Month 2	192 Participants	9 Participants

SECONDARY outcome

Timeframe: At Month 2 and at 12 months of age

Population: Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point.

Outcome measures

Outcome measures
Measure	Rotarix Group n=134 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group n=139 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies. Anti-RV IgA - Month 2	86 Participants	13 Participants
Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies. Anti-RV IgA - 12 months of age	62 Participants	29 Participants

SECONDARY outcome

Timeframe: At Month 2 and at 12 months of age

Population: Analysis was performed on the ATP cohort for immunogenicity, which included eligible subjects in the ATP cohorts for immunogenicity sub-cohorts 1 and 2 seronegative for serum anti-rotavirus immunoglobulin A (IgA) antibodies at Day 0 and with availability immunogenicity data at pre and post sampling time-points.

Outcome measures

Outcome measures
Measure	Rotarix Group n=391 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group n=393 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies. Anti-RV IgA - 12 months of age	238 Participants	147 Participants
Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies. Anti-RV IgA - Month 2	278 Participants	22 Participants

SECONDARY outcome

Timeframe: At Day 0, Month 2 and at 12 months of age

A subject seropositive for anti-rotavirus (anti-RV) immunoglobulin A (IgA) antibodies was defined as a subject anti-RV IgA antibody concentration greater than or equal to (≥) the seropositivity cut-off of 20 units per milliliter (U/mL).

Outcome measures

Outcome measures
Measure	Rotarix Group n=257 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group n=254 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies. Anti-RV IgA - Day 0	0 Participants	0 Participants
Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies. Anti-RV IgA - Month 2	192 Participants	9 Participants
Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies. Anti-RV IgA - 12 months of age	176 Participants	118 Participants

SECONDARY outcome

Timeframe: At Day 0, Month 2 and at 12 months of age

Outcome measures

Outcome measures
Measure	Rotarix Group n=134 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group n=139 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies. Anti-RV IgA - 12 months of age	62 Participants	29 Participants
Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies. Anti-RV IgA - Month 2	86 Participants	13 Participants
Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies. Anti-RV IgA - Day 0	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Day 0, Month 2 and at 12 months of age

Outcome measures

Outcome measures
Measure	Rotarix Group n=391 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group n=393 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies. Anti-RV IgA - Day 0	0 Participants	0 Participants
Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies. Anti-RV IgA - Month 2	278 Participants	22 Participants
Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies. Anti-RV IgA - 12 months of age	238 Participants	147 Participants

SECONDARY outcome

Timeframe: At Day 0, Month 2 and at 12 months of age

Concentrations were expressed as geometric mean concentrations (GMCs), in units per milliliter (U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 20 U/mL).

Outcome measures

Outcome measures
Measure	Rotarix Group n=257 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group n=254 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations Anti-RV IgA - Day 0	NA U/mL At this time-point, no subjects had an antibody concentration equal or above to the cut-off (20 U/mL).	NA U/mL At this time-point, no subjects had an antibody concentration equal or above to the cut-off (20 U/mL).
Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations Anti-RV IgA - Month 2	90.2 U/mL Interval 73.3 to 111.1	NA U/mL At this time-point, no subjects had an antibody concentration equal or above to the cut-off (20 U/mL).
Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations Anti-RV IgA - 12 months of age	66.5 U/mL Interval 54.6 to 81.0	35.3 U/mL Interval 29.3 to 42.5

SECONDARY outcome

Timeframe: At Day 0, Month 2 and at 12 months of age.

Concentrations were expressed as geometric mean concentrations (GMCs), in units per milliliter (U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 20 U/mL).

Outcome measures

Outcome measures
Measure	Rotarix Group n=134 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix and OPV vaccines were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.	Placebo Group n=139 Participants Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix vaccine was administered intramuscularly in the left anterolateral thigh.
Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations. Anti-RV IgA - 12 months of age	31.3 U/mL Interval 24.6 to 39.8	NA U/mL At this time-point, no subjects had an antibody concentration equal or above to the cut-off (20 U/mL).
Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations. Anti-RV IgA - Day 0	NA U/mL At this time-point, no subjects had an antibody concentration equal or above to the cut-off (20 U/mL).	NA U/mL At this time-point, no subjects had an antibody concentration equal or above to the cut-off (20 U/mL).
Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations. Anti-RV IgA - Month 2	84.0 U/mL Interval 58.9 to 119.8	NA U/mL At this time-point, no subjects had an antibody concentration equal or above to the cut-off (20 U/mL).

SECONDARY outcome

Timeframe: At Day 0, Month 2 and at 12 months of age

Concentrations were expressed as geometric mean concentrations (GMCs), in units per milliliter (U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 20 U/mL).