RV1 GSK[033] 2007‐LA.
| Methods | RCT Length of follow‐up: 1 month after dose 2 Adverse event data collection methods: not reported |
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| Participants |
Number: 854 enrolled; 795 evaluable Age range: 1 to 3 months (beginning); 3 to 6 months (end) Inclusion criteria: healthy infants, born after a normal gestation period of ≥ 36 weeks; 6 to 12 weeks of age at the time of the first dose of the study vaccination course, free of obvious health problems as established by medical history and clinical examination before entering into the study Exclusion criteria: any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator and previous confirmed occurrence of rotavirus gastroenteritis |
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| Interventions | RV1 1. RIX4414 (RV1): 106.5 PFU*; 730 participants (randomized) 1.1. Received RV1 vaccine Lot A 1.2. Received RV1 vaccine Lot B 1.3. Received RV1 vaccine Lot C *Dose unclear, some use 106.5 PFU and some 105 PFU 2. Placebo: 124 participants (randomized) Schedule: 2 oral doses given at 2 and 4 months; visits 1, 2, and 3 correspond to months 0, 2, and 4 in the schedule |
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| Outcomes |
Clinical outcome measures (safety and efficacy) 1. Reactogenicity: for each type of solicited symptom, occurrence of the symptom within the 8‐day (days 0 to 7) solicited follow‐up period after each dose; occurrence of unsolicited adverse events within 31 days (days 0 to 30) after each dose, according to MedDRA classification; measured up to 31 days after vaccine/placebo 2. Serious adverse events: occurrence throughout entire study period; measured up to 31 days after vaccine/placebo 3. Dropouts: measured up to 31 days after vaccine/placebo 4. All‐cause death 5. Adverse events resulting in discontinuation Outcomes to measure immunogenicity 6. Vaccine virus shedding: presence of rotavirus antigen in stool samples collected on day of vaccination and on planned days following each dose in a subset of participants [review includes data from combined time points] 7. Seroconversion: appearance of serum anti‐rotavirus IgA antibody concentrations ≥ 20 U/mL [review includes data from 2 months after dose 2] |
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| Immunization status | Use of other vaccines not mentioned | |
| Location | 7 study centres (2 in Colombia, 1 in Mexico, and 4 in Peru) WHO mortality strata B, D |
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| Notes |
Date: 8 August 2003 to 29 January 2004 Source of funding: GlaxoSmithKline Biologicals Study rationale: "to assess the clinical consistency of 3 production lots of human rotavirus vaccine in terms of immunogenicity and safety when given to healthy infants at 2 and 4 months of age" |
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| 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 | 795/854 completed the study. Reasons for dropping out were reported and were balanced between study groups |
| Selective reporting (reporting bias) | Low risk | All planned outcomes were reported |
| Other bias | Unclear risk | No details |