RV1 GSK[021] 2007‐PAN.
| Methods | RCT Length of follow‐up: 1 month after dose 3 Adverse event data collection methods: not reported |
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| Participants |
Number: 228 enrolled; 203 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 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*; 177 participants (randomized) 1.1 Received modified vaccine formulation 1.2 Received a licensed RV1 vaccine *Dose unclear; in the same study, some use 106.5 PFU and some 105 PFU 2. Placebo: 51 participants (randomized) 2.1 Received a placebo of the modified vaccine formulation 2.2 Received a placebo of the licensed RV1 vaccine Schedule: 3 doses at 2, 4, and 6 months of age |
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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. Viral shedding: number (%) of participants with rotavirus in at least 1 stool (review includes data from combined time points) 7. Seroconversion: appearance of anti‐rotavirus antibody concentration ≥ 20 U/mL in participants negative for rotavirus before vaccination (review includes data from 2 months after dose 1 and 2 months after dose 2, and 1 month after dose 3) |
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| Immunization status | Use of other vaccines not mentioned | |
| Location | 1 centre in Panama WHO mortality stratum B |
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| Notes |
Date: 23 August 2002 to 9 May 2003 Source of funding: GlaxoSmithKline Biologicals Study rationale: "to compare the immunogenicity and safety of a modified vaccine formulation to the licensed human rotavirus [Rotarix] vaccine" |
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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 | 203/228 participants completed the study. Reasons for withdrawal were reported and balanced between groups. |
| Selective reporting (reporting bias) | Low risk | All planned outcomes were reported |
| Other bias | Unclear risk | No details |