RV1 GSK[041] 2007‐KOR

Methods	RCT Length of follow‐up: 2 months after dose 2 Adverse event data collection methods: not reported
Participants	Number: 155 enrolled; 151 evaluable Age range: 1 to 3 months (beginning); 3 to 6 months (end) Inclusion criteria: full‐term infants; healthy infants aged between 6 and 12 weeks (42 to 90 days) at the time of the first vaccination for whom the vaccination history was available Exclusion criteria: previous confirmed occurrence of rotavirus gastroenteritis
Interventions	RV1 1. RIX4414 (RV1): 106.5 PFU; 103 participants (randomized) 2. Placebo: 52 participants (randomized) Schedule: 2 oral doses starting at about 2 months of age; second dose at 4 months of age
Outcomes	Clinical outcome measures (safety and efficacy) 1. Reactogenicity: for each type of solicited symptom, occurrence of the symptom within the 15‐day (days 0 to 14) solicited follow‐up period after each dose; occurrence of unsolicited adverse events within 43 days (days 0 to 42) after each dose, according to MedDRA classification; up to 43 days after vaccine/placebo 2. Serious adverse events: no definition; occurrence throughout the entire study period (up to 2 months after dose 2) 3. Dropouts: measured up to 2 months after dose 2 4. Rotavirus diarrhoea: presence of rotavirus in gastroenteritis episode stools collected from dose 1 of vaccine/placebo up to 2 months after dose 2 5. All‐cause death 6. Adverse events resulting in discontinuation Outcomes to measure immunogenicity 7. Seroconversion: appearance of anti‐rotavirus immunoglobulin A antibody concentration 20 U/mL in participants who were seronegative before vaccination (review includes data from 2 months after dose 2)
Immunization status	H. influenzae type b vaccine administered concomitantly along with the 2 doses of vaccine/placebo and at 2 months after dose 2; other routine childhood vaccines were to be given at least 14 days before trial vaccine/placebo
Location	6 centres in Korea WHO mortality stratum B
Notes	Date: 15 July 2005 to 11 May 2006 Registration number: NCT00134732 Source of funding: GlaxoSmithKline Biologicals Study rationale: "to assess immunogenicity and safety of 2 doses of the HRV [human rotavirus] vaccine in Korean infants aged approximately 2 months at the time of the first dose"
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated, using a SAS programme
Allocation concealment (selection bias)	Low risk	Central allocation
Blinding (performance bias and detection bias) All outcomes	Low risk	Parent/guardian and study personnel were not aware of the treatment administered
Incomplete outcome data (attrition bias) All outcomes	Low risk	4/103 participants in the vaccine arm did not complete the study
Selective reporting (reporting bias)	Low risk	All planned outcomes were reported
Other bias	Unclear risk	No details