RV1 Anh 2011‐VNM.
| Methods | RCT Length of follow‐up: 1 month after last dose Adverse event data collection methods: not reported |
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| Participants |
Number: 375 enrolled; ATP safety cohort: 352; ATP immunogenicity cohort: 330 Inclusion criteria: healthy infants aged 6 to 10 weeks at the time of the first study vaccination dose with a birth weight of > 2 kg Exclusion criteria: use of any investigational drug or vaccine other than the study vaccine or confirmed immunosuppression/immunodeficient conditions or allergy to RIX4414 vaccine/placebo components |
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| Interventions | 1. 2 doses of RIX4414* plus 1 dose of placebo according to a V‐V‐PL schedule 2. 2 doses of RIX4414* plus 1 dose of placebo according to a V‐PL‐V schedule 3. 3 placebo doses * Human rotavirus [RV1] liquid vaccine, oral suspension (GSK Biologicals, Belgium), containing at least 106 median Cell Culture Infective Dose 50 percent (CCID50) of live attenuated RIX4414 human rotavirus strain (G1P[8]) Schedule: 3 doses according to a 0‐, 1‐, and 2‐month schedule |
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| Outcomes |
Clinical outcome measures (Safety and Efficacy) 1. Reactogenicity, including fever, diarrhoea and vomiting, 8 days after each dose (collected from GSK report) 2. Adverse events leading to discontinuation 3. Serious adverse events 4. Fatal serious adverse events 5. Dropouts 6. * Rotavirus diarrhoea, rotavirus antigen isolated from any of the stool samples collected from children with diarrhoea episodes, up to 1 month after last dose (outcome not included in the prepublished protocol) 7. * All‐cause diarrhoea, up to 1 month after last dose (outcome not included in the prepublished protocol) Outcomes to measure immunogenicity 8. Anti‐rotavirus IgA antibody seroconversion, ≥ 20 U/ML * Outcome reported as proportion (P) with 95% CI. Events (n) and totals (N) were estimated by using the values when 2 formulae for the standard error (SE) converged |
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| Immunization status | Commercially‐available diphtheria, tetanus, whole‐cell pertussis (DTPw), hepatitis B (HBV) and oral poliovirus (OPV) vaccines were administered concomitantly with the study vaccine/placebo as part of the routine Expanded Programme of Immunization (EPI) in Vietnam | |
| Location | Vietnam (11 satellite centres) WHO mortality stratum B |
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| Notes | Study known as RIX GSK[051] 2008‐AS in previously published versions of this review Date: September 2006 to March 2007 Source of funding: GlaxoSmithKline Biologicals Study rationale: "To provide specific data on immunogenicity of GSK Biologicals' human rotavirus liquid vaccine, when co‐administered with the routine Expanded Program of Immunization (EPI) in Vietnam. The study will also assess reactogenicity and safety of the human rotavirus liquid vaccine relative to the placebo" |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated Quote: "Block randomization scheme (2:2:1 ratio) with standard SAS program was used" |
| Allocation concealment (selection bias) | Low risk | Central allocation Quote: "Based on the block size, the vaccine doses were distributed to each of the study centers" |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Participants and key personnel were blinded Quote: "The study was double‐blind with respect to the RIX4414 oral suspension (liquid formulation), placebo and scheduling of doses. The parents/guardians of infants, investigators and study personnel were unaware of the study vaccine/ placebo administered" Quote: "The placebo was identical to the vaccine in composition" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition balanced across groups with reasons for dropout/exclusion reported |
| Selective reporting (reporting bias) | Unclear risk | One outcome (rotavirus diarrhoea) not included in the prepublished protocol |
| Other bias | Low risk | No apparent other bias |