RV5 Mo 2017‐CHN

Methods	RCT Length of follow‐up: 2 years Adverse event data collection methods: Passive: All adverse events were collected for 30 days following each dose.
Participants	Number: 4040 enrolled; 4040 evaluable Age range: 6 – 12 weeks (at start of study) Inclusion criteria: Healthy infants at least 6 weeks and up to 12 weeks of age at the time of the first study vaccination Exclusion criteria: History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhoea, failure to thrive, or abdominal surgery; history of intussusception; impairment of immunological function; acute disease, severe chronic disease, or chronic disease during the acute period; participation in another interventional study; any condition which, in the opinion of the investigator, may interfere with the evaluation of the study objectives
Interventions	1. RV5, 2 mL (n=2020 randomized) 1.1 RV5 alongside staggered EPI (OPV administered as a 1 g oral solution at age ˜2½, 3½, and 4½ months, and DTaP administered as a 0.5 mL intramuscular injection at age ˜3½, 4½, and 5½ months) 1.2.RV5 with concomitant EPI (OPV administered as a 1 g oral solution at age ˜2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ˜3, 4, and 5 months) 2. Placebo (n=2020 randomized) 2.1 placebo alongside staggered EPI (OPV administered as a 1 g oral solution at age ˜2½, 3½, and 4½ months, and DTaP administered as a 0.5 mL intramuscular injection at age ˜3½, 4½, and 5½ months) 2.2 placebo with concomitant EPI (OPV administered as a 1 g oral solution at age ˜2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ˜3, 4, and 5 months) Schedule: RV5 or placebo at age 2, 3, and 4 months
Outcomes	Clinical outcome measures (safety and efficacy) 1. Severe Rotavirus diarrhoea 2. All‐cause deaths 3. Serious adverse events 4. Intussusception 5. Rotavirus diarrhoea (any severity) 6. Reactogenicity: fever, diarrhoea, vomiting 7. Adverse events due to discontinuation 8. Dropouts from the trial
Immunization status	Routine EPI vaccines (OPV, DTaP) either staggered or concomitantly with RV5 or placebo
Location	5 sites, China WHO mortality stratum B
Notes	Date: May 2014 ‐ June 2015 Source of funding: Merck Sharp & Dohme Corp. Study rationale: assess the efficacy, safety, and immunogenicity of a 3 dose regimen of RotaTeq™ (V260) in healthy Chinese infants
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Study reported to be randomized, but no details provided on the randomization process
Allocation concealment (selection bias)	Unclear risk	No details reported
Blinding (performance bias and detection bias) All outcomes	Low risk	Blinded for vaccine versus placebo, not for staggered versus concomitant
Incomplete outcome data (attrition bias) All outcomes	Low risk	Low attrition and reasons provided
Selective reporting (reporting bias)	Low risk	All relevant outcomes reported
Other bias	Low risk	No apparent other bias