VAC Bhandari 2014‐IND.
| Methods | RCT Length of follow‐up: up to 2 years of age Adverse event data collection methods: All participants were contacted weekly at home by trained field workers to identify gastroenteritis, signs and symptoms of suspected intussusception, hospitalizations, and other illnesses. In addition, families reported any adverse events |
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| Participants |
Number: 6799 enrolled, randomized and received at least one dose Age range: 6 to 7 weeks at recruitment Inclusion criteria: parents consented to participation and had no plans to move out of the study area during the next 24 months Exclusion criteria: infants were excluded if they had received a rotavirus vaccine, had documented immunodeficiency or chronic gastroenteritis or any other condition judged by the investigator as an exclusion criterion. Presence of any illness requiring hospital referral and diarrhoea on the day of enrolment was a temporary exclusion |
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| Interventions | Rotavac 1. Rotavac (ORV 116E) vaccine (1 x 105 FFU), n = 4532 2. Placebo, n = 2267 Schedule: 3 doses given at 4‐week intervals (6 to 7 weeks, ≥ 10 weeks, and ≥ 14 weeks of age) |
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| Outcomes |
Clinical outcome measures (safety and efficacy) 1. Severe rotavirus gastroenteritis (≥ 11 on the 20‐point Vesikari scoring scale) 2. All‐cause death 3. Intussusception (Brighton criteria level 1) 4. Serious adverse events 5. Severe all‐cause diarrhoea 6. Rotavirus diarrhoea: any severity Outcomes to measure immunogenicity 7. Seroconversion (4‐fold rise in titre from paired serum samples) |
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| Immunization status | Other childhood vaccines (DTPw, Hib, Hep B, and OPV) given concurrently | |
| Location | 3 sites: Delhi, Pune, and Vellore in India WHO mortality stratum D |
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| Notes |
Date: March 2011 to November 2012 Registration number: NCT01305109; CTRI/2010/091/000102 Source of funding: The Department of Biotechnology, and Biotechnology Industry Research Assistance Council, Government of India; the Bill & Melinda Gates Foundation to PATH; Research Council of Norway; Department for International Development, UK; National Institutes of Health, USA; Bharat Biotech International Ltd. Moved from ongoing Other NCT01305109 and Other CTRI‐091‐000102. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomization was performed by Cenduit, LLC, Germany, with stratification by site, and a block size of 12 |
| Allocation concealment (selection bias) | Low risk | The letter code on the vaccine/placebo vial was masked with the participant identification number before sending the vial to the clinical co‐ordinator administering the test article to the enrolled infant |
| Blinding (performance bias and detection bias) All outcomes | Low risk | The placebo was identical in content, packaging, and appearance to the vaccine but did not contain the virus |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | < 1% loss to follow‐up |
| Selective reporting (reporting bias) | Low risk | No indication of selective reporting, all outcomes in the trial register reported |
| Other bias | Low risk | No apparent other bias |