RV1 NCT00158756‐RUS.

Methods	RCT Length of follow‐up: 1 year Adverse event data collection methods: Not reported
Participants	Number: 308 enrolled; 209 evaluated (1 study arm was not included in analyses of this review) Age range: 11 to 17 weeks of age at the time of the first vaccination Inclusion criteria: infants who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol, administration of 1 dose of hepatitis B vaccine at birth, male or female between and including 11 and 17 weeks of age at the time of the first DTPw vaccination, free of obvious health problems as established by medical history and clinical examination before entering into the study Exclusion criteria: use of any investigational or non‐registered product (drug or vaccine) other than the study vaccine(s) 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, any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required), administration of immunoglobulins or any blood products, or both, since birth or planned administration during the study period
Interventions	1. RV1 at 3 and 4½ months + DTPw‐HBV at 3, 4½ and 6 months (80 participants) 2. Placebo at 3 and 4½ months + DTPw‐HBV at 3, 4½ and 6 months (25 participants) 3. RV1 at 3 and 4½ months + DTPw‐HBV Kft. at 3, 4½ and 6 months (81 participants) 4. Placebo at 3 and 4½ months + DTPw‐HBV Kft. at 3, 4½ and 6 months (23 participants) 5. DTPwcsl + HBV at 3, 4½ and 6 months (99 participants), this group was not included in analyses of this review
Outcomes	Clinical outcome measures (safety and efficacy) 1. Reactogenicity 2. Serious adverse events 3. All‐cause death 4. Intussusception 5. Dropouts Outcomes to measure immunogenicity 6. Seroconversion
Immunization status	GlaxoSmithKline (GSK) Biologicals' Tritanrix™HepB and GSK Biologicals Kft's DTPwHBV Vaccines as compared to concomitant administration of Commonwealth Serum Laboratory's (CSL's) DTPw (Triple Antigen™) and GSK Biologicals' HBV (Engerix™B), when co‐administered with GSK Biologicals' oral live attenuated Human Rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of Hepatitis B vaccine
Location	9 sites, Russian Federation WHO mortality strata: C
Notes	Date: September 2005 to November 2006 Source of funding: GlaxoSmithKline Study rationale: To compare the 2 formulations of GSK Biologicals' DTPw‐HBV vaccine to concomitant administration of CSL's DTPw vaccine and GSK Biologicals' HBV with respect to the antibody response to the diphtheria antigen after a 3‐dose primary vaccination course.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomized (4:1:4:1:5) using GSK Biologicals central randomization system (SBIR)
Allocation concealment (selection bias)	Low risk	Cental allocation.
Blinding (performance bias and detection bias) All outcomes	Low risk	The study was conducted in a double‐blind manner with respect to the Rotarix and placebo groups and in single‐blinded manner with respect to the Tritanrix‐HepB and Zilbrix groups. The study was open with respect to the Triple Antigen + Engerix‐B group
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants included in analysis
Selective reporting (reporting bias)	Low risk	All outcomes reported
Other bias	Low risk	No apparent other bias