Study to Assess the Efficacy, Immunogenicity and Safety o... | NCT01171963

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rotarix Group	Experimental	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.	Biological: GSK Biologicals' liquid human rotavirus vaccine 444563 Biological: Infanrix™ Biological: Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)
Placebo Group	Placebo Comparator	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.

Name	Type	Description	Arm Group Labels	Other Names
GSK Biologicals' liquid human rotavirus vaccine 444563	Biological	Oral administration	Rotarix Group

Measure	Description	Time Frame
Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains	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.	From Month 1 ½ to Month 21

Measure	Description	Time Frame
Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild-type Strains	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.	From Month 1 ½ to Month 21

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who the investigator believes that their parents/Legally Acceptable Representatives can and will comply with the requirements of the protocol.
A male or female infant of Chinese origin between, and including, 6 and 16 weeks of age at the time of the first vaccination.
Written informed consent obtained from the parents/Legally Acceptable Representatives of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria:

Child in care.
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
Planned administration/administration of a vaccine not foreseen by the study protocol within 14 days before each dose of study vaccine(s) and ending 14 days after the first dose of the human rotavirus vaccine or placebo except for the routine childhood vaccinations.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
Any clinically significant history of gastrointestinal disease including any uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for intussusception .
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Family history of congenital or hereditary immunodeficiency.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Major congenital defects or serious chronic illness.
History of confirmed rotavirus gastroenteritis.
Acute disease and/or fever at the time of enrolment.
Gastroenteritis within 7 days preceding the study vaccine or placebo administration.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

In addition to the criteria mentioned above, the following criteria will be applicable to all subjects in the immunogenicity subgroup 2:

History of diphtheria, tetanus and pertussis disease.
History of seizures or progressive neurological disease.
Previous vaccination against diphtheria, tetanus, pertussis and poliomyelitis.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Hechi	Guangxi	547000	China
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
24013441	Derived	Li RC, Huang T, Li Y, Luo D, Tao J, Fu B, Si G, Nong Y, Mo Z, Liao X, Luan I, Tang H, Rathi N, Karkada N, Han HH. Human rotavirus vaccine (RIX4414) efficacy in the first two years of life: a randomized, placebo-controlled trial in China. Hum Vaccin Immunother. 2014;10(1):11-8. doi: 10.4161/hv.26319. Epub 2013 Sep 6.
23807360	Derived

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
113808	Statistical Analysis Plan	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains

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.

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.

Posted

Count of Participants

Participants

From Month 1 ½ to Month 21

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG0001575 OG0011573

Title

Denominators

Categories

Title	Measurements
	OG00021 OG00175

Secondary

Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild-type Strains

Posted

Count of Participants

Participants

From Month 1 ½ to Month 21

ID	Title	Description
OG000	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.

Secondary

Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type.

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.

Posted

Count of Participants

Participants

From Month 1 ½ to Month 21

ID	Title	Description
OG000	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.

Secondary

Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type.

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.

Posted

Count of Participants

Participants

From Month 1 ½ to Month 21

ID	Title	Description
OG000	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.Not Applicable

Secondary

Number of Subjects With Episodes of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains Requiring Hospitalization

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.

Posted

Count of Participants

Participants

From Month 1 ½ to Month 21

ID	Title	Description
OG000	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.

Secondary

Number of Subjects With Any and Severe Gastroenteritis (GE) Due to Any Cause

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.

Posted

Count of Participants

Participants

From Month 1 ½ to Month 21

ID	Title	Description
OG000	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.

Secondary

Number of Subjects With Any Solicited General Symptoms Following Vaccination With the Rotarix Vaccine/Placebo

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.

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.

Secondary

Number of Subjects With Any Solicited General Symptoms Following Administration of the Co-administered EPI Vaccines

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.

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 only on subjects in sub-cohort 2, for whom results were available.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.

Secondary

Number of Subjects With Any Solicited Local Symptoms 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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.

Secondary

Number of Subjects With Any Unsolicited Adverse Events (AEs)

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.

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.

Secondary

Number of Subjects With Any Serious Adverse Events (SAEs)

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.

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.

Secondary

Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies

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.

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.

Posted

Count of Participants

Participants

At Month 2 and at 12 months of age

ID	Title	Description
OG000	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.

Secondary

Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.

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.

Posted

Count of Participants

Participants

At Month 2 and at 12 months of age

ID	Title	Description
OG000	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.

Secondary

Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.

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.

Posted

Count of Participants

Participants

At Month 2 and at 12 months of age

ID	Title	Description
OG000	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.

Secondary

Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.

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).

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.

Secondary

Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.

Secondary

Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.

Secondary

Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations

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).

Posted

Geometric Mean

95% Confidence Interval

U/mL

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

ID	Title	Description
OG000	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.

Secondary

Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations.

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).

Posted

Geometric Mean

95% Confidence Interval

U/mL

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

ID	Title	Description
OG000	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.

Secondary

Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations.

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).

Posted

Geometric Mean

95% Confidence Interval

U/mL

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

ID	Title	Description
OG000	Overall Study Arm	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.

Secondary

Number of Subjects Seroprotected Against Diphtheria and Tetanus

A subject seroprotected against diphtheria/tetanus was defined as a subject with an anti-diphtheria (anti-D)/anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo

Posted

Count of Participants

Participants

At Day 0 and at Month 4

ID	Title	Description
OG000	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.

Secondary

Anti-Diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations

Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The cut-off of the assay was the seroprotection cut-off assay (≥ 0.1 IU/mL). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

At Day 0 and at Month 4

ID	Title	Description
OG000	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.

Secondary

Number of Subjects Seroprotected Against Poliovirus Types 1, 2 and 3.

A subject seroprotected against poliovirus types 1, 2 and 3 was defined as a subject with anti-poliovirus type 1 (anti-polio 1)/anti-polio 2/anti-polio 3 antibody titer greater than or equal to (≥) 8 estimated doses 50% (ED50). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo (cf. population definition below).

Posted

Count of Participants

Participants

At Day 0 and at Month 4

ID	Title	Description
OG000	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.

Secondary

Titers for Anti-poliovirus Type 1 (Anti-polio 1), Anti-polio 2 and Anti-polio 3 Antibodies

Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seroprotection cut-off (≥ 8 estimated doses 50% [ED50] for anti-poliovirus type 1 [anti-polio 1]/anti-polio 2/anti-polio 3 antibodies. This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo.

Posted

Geometric Mean

95% Confidence Interval

titers

At Day 0 and at Month 4

ID	Title	Description
OG000	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.

Secondary

Number of Subjects Seropositive for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies.

Antibody assessment was performed by enzyme-linked immunosorbent assay (ELISA). A subject seropositive for anti-PT/anti-FHA/anti-PRN antibodies was defined as a subject with an anti-PT/anti-FHA/anti-PRN antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U/mL). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo.

Posted

Count of Participants

Participants

At Day 0 and at Month 4

ID	Title	Description
OG000	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.

Secondary

Concentrations of Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies

Antibody assessment was performed by enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off (≥ 5 EL.U/mL) for all antibodies assessed (anti-PT, anti-FHA and anti-PRN). This outcome measure concerns solely subjects in Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo.

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

At Day 0 and at Month 4

ID	Title	Description
OG000	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.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bronchitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG00074 affected1,666 at risk EG00198 affected1,667 at risk
Bronchopneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG00058 affected1,666 at risk EG00161 affected1,667 at risk
Enteritis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG00044 affected1,666 at risk EG00173 affected1,667 at risk
Pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG00014 affected1,666 at risk EG00114 affected1,667 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0004 affected1,666 at risk EG00111 affected1,667 at risk
Pharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected1,666 at risk EG0018 affected1,667 at risk
Hand-foot-and-mouth disease	Infections and infestations	MedDRA	Non-systematic Assessment	EG0005 affected1,666 at risk EG0014 affected1,667 at risk
Tracheitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0004 affected1,666 at risk EG0014 affected1,667 at risk
Acute tonsillitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0005 affected1,666 at risk EG0012 affected1,667 at risk
Candidiasis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0003 affected1,666 at risk EG0011 affected1,667 at risk
Gastroenteritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected1,666 at risk EG0012 affected1,667 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0013 affected1,667 at risk
Glucose-6-phosphate dehydrogenase deficiency	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment	EG0003 affected1,666 at risk EG0011 affected1,667 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0013 affected1,667 at risk
Laryngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected1,666 at risk EG0012 affected1,667 at risk
Diarrhoea infectious	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0012 affected1,667 at risk
Multi-organ failure	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0012 affected1,667 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0012 affected1,667 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected1,666 at risk EG0010 affected1,667 at risk
Convulsion	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0011 affected1,667 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected1,666 at risk EG0010 affected1,667 at risk
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0011 affected1,667 at risk
Febrile convulsion	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0012 affected1,667 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0012 affected1,667 at risk
Heart disease congenital	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0012 affected1,667 at risk
Herpangina	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0011 affected1,667 at risk
Inguinal hernia, obstructive	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0011 affected1,667 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0012 affected1,667 at risk
Intussusception	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0011 affected1,667 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected1,666 at risk EG0010 affected1,667 at risk
Thalassaemia beta	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment	EG0002 affected1,666 at risk EG0010 affected1,667 at risk
Varicella	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected1,666 at risk EG0010 affected1,667 at risk
Ventricular septal defect	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0012 affected1,667 at risk
Acute lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Bacterial diarrhoea	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Brain herniation	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Central nervous system infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0010 affected1,667 at risk
Cerebral haematoma	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Cortical dysplasia	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0010 affected1,667 at risk
Death	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Deficiency anaemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Drowning	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0010 affected1,667 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Epilepsy	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0010 affected1,667 at risk
Extrapyramidal disorder	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Food poisoning	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0010 affected1,667 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0010 affected1,667 at risk
Hernia	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Histiocytosis haematophagic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0010 affected1,667 at risk
Hydrocephalus	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0010 affected1,667 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0010 affected1,667 at risk
Infectious mononucleosis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0010 affected1,667 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Liver function test abnormal	Investigations	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Lobar pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Meningitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0010 affected1,667 at risk
Myocarditis	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0010 affected1,667 at risk
Otitis media	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0010 affected1,667 at risk
Patent ductus arteriosus	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0010 affected1,667 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Shigella infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,666 at risk EG0011 affected1,667 at risk
Thalassaemia	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0010 affected1,667 at risk
Tracheobronchitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0010 affected1,667 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0010 affected1,667 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0010 affected1,667 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0002 affected1,666 at risk EG0013 affected1,667 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG00016 affected1,666 at risk EG00126 affected1,667 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0003 affected1,666 at risk EG0011 affected1,667 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0013 affected1,667 at risk
Bronchiolitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,666 at risk EG0011 affected1,667 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG000119 affected1,666 at risk EG001124 affected1,667 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG000103 affected1,666 at risk EG001123 affected1,667 at risk
Cough/runny nose	General disorders	MedDRA	Systematic Assessment	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.	EG000313 affected1,513 at risk EG001366 affected1,514 at risk
Diarrhoea	General disorders	MedDRA	Systematic Assessment	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.	EG000127 affected1,513 at risk EG001123 affected1,514 at risk
Irritability/Fussiness	General disorders	MedDRA	Systematic Assessment	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.	EG000415 affected1,513 at risk EG001448 affected1,514 at risk
Loss of appetite	General disorders	MedDRA	Systematic Assessment	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.	EG000253 affected1,513 at risk EG001250 affected1,514 at risk
Fever (GSK scale) (Axillary T >= 37.5°C)	General disorders	MedDRA	Systematic Assessment	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.	EG00083 affected1,513 at risk EG001104 affected1,514 at risk
Vomiting	General disorders	MedDRA	Systematic Assessment	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.	EG000213 affected1,513 at risk EG001232 affected1,514 at risk
Pain	General disorders	MedDRA	Systematic Assessment	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 only on subjects in sub-cohort 2, for whom results were available.	EG00014 affected150 at risk EG0019 affected151 at risk
Redness	General disorders	MedDRA	Systematic Assessment	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 only on subjects in sub-cohort 2, for whom results were available.	EG00020 affected150 at risk EG00113 affected151 at risk
Swelling	General disorders	MedDRA	Systematic Assessment	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 only on subjects in sub-cohort 2, for whom results were available.	EG00013 affected150 at risk EG0016 affected151 at risk
Drowsiness	General disorders	MedDRA	Systematic Assessment	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 only on subjects in sub-cohort 2, for whom results were available.	EG00044 affected153 at risk EG00138 affected153 at risk
Irritability/Fussiness	General disorders	MedDRA	Systematic Assessment	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 only on subjects in sub-cohort 2, for whom results were available.	EG00056 affected153 at risk EG00152 affected153 at risk
Loss of appetite	General disorders	MedDRA	Systematic Assessment	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 only on subjects in sub-cohort 2, for whom results were available.	EG00043 affected153 at risk EG00132 affected153 at risk
Fever - Chinese scale: Axillary T >= 37.1°C	General disorders	MedDRA	Systematic Assessment	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.	EG000302 affected1,513 at risk EG001313 affected1,514 at risk
Gastrointestinal symptoms	General disorders	MedDRA	Systematic Assessment	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 only on subjects in sub-cohort 2, for whom results were available.	EG00043 affected153 at risk EG00138 affected153 at risk
Fever - Chinese scale: Axillary T >= 37.1°C	General disorders	MedDRA	Systematic Assessment	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 only on subjects in sub-cohort 2, for whom results were available.	EG00018 affected153 at risk EG00120 affected153 at risk

ID	Term
D012088	Reoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections

ID	Term
D022681	Diphtheria-Tetanus-acellular Pertussis Vaccines
D004369	Pentetic Acid

ID	Term
D010567	Pertussis Vaccine
D001428	Bacterial Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D004168	Diphtheria Toxoid
D014121	Toxoids
D013745	Tetanus Toxoid
D017778	Vaccines, Combined
D022282	Vaccines, Acellular
D022223	Vaccines, Subunit
D011073	Polyamines
D000588	Amines
D009930	Organic Chemicals
D000085	Acetates
D000144	Acids, Acyclic
D002264	Carboxylic Acids

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.			183	1,666	838	1,666
EG001	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.			246	1,667	880	1,667