VAC Chandola 2017‐IND.
| Methods | RCT Length of follow‐up: 1 year Adverse event data collection methods: Daily contacts through telephone calls or home visit for 14 days after each dose. Thereafter, weekly contacts were made until infants were 1 year of age |
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| Participants |
Number: 1356 enrolled and randomized, 1327 completed 1 year follow‐up Age range: 6 to 8 weeks Inclusion criteria: healthy infants whose parents were willing to participate and had no plans for moving away were eligible for enrolment Exclusion criteria: had already received the first dose of the childhood vaccines or any other rotavirus vaccine, had immunodeficiency disease or chronic gastroenteritis disease, and/or any condition warranting exclusion by the investigator |
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| Interventions | Rotavac 1. Rotavac vaccine, 1 x 104 FFU, in 3 production lots, n = 1017 2. Placebo, n= 339 Schedule: 3 doses given at a 4‐ to 8‐week intervals (6 – 7 weeks, 10 ‐ < 14, and 14 ‐ < 18 weeks of age) |
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| Outcomes |
Clinical outcome measures (safety and efficacy) 1. All‐cause death 2. Serious adverse events 3. Intussusception (level 1 Brighton criteria) 4. Reactogenicity Outcomes to measure immunogenicity 5. Immunogenicity: seroconversion (≥4 fold rise in IgA antibody titer to rotavirus) |
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| Immunization status | Co‐administered with EPI vaccines: OPV and combined DPT, HepB and Hib | |
| Location | 1 site in Delhi, India WHO mortality stratum D |
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| Notes |
Date: May 2014 to August 2015 Registration number: CTRI/2014/05/004592 Source of funding: PATH, USA |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomization was done by Diagnosearch Life Sciences Pvt. Ltd. and the randomization list was available with an independent biostatistician" |
| Allocation concealment (selection bias) | Low risk | Central allocation Quote: "Randomization was done by Diagnosearch Life Sciences Pvt. Ltd. and the randomization list was available with an independent biostatistician" |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "The placebo was identical in content, packaging, and appearance to the vaccine. The study team received ROTAVAC® or placebo vials labeled with the subject Identification (ID) number to maintain blinding. The study team, vaccine administrators and laboratory personnel were not aware of the treatment status." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat population was analyzed for safety outcomes. Less than 5% 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 |
ATP: according to protocol; BCG: bacillus Calmette‐Guerin; eCRF: electronic case report form; ELISA: Enzyme Linked Immunosorbent Assay; FF: focus‐forming unit; ITT: intention‐to‐treat; LAR: legally acceptable representative; MedDRA: Medical Dictionary for Regulatory Activities; OPV: oral poliovirus; PFU: plaque‐forming unit; RCT: randomized controlled trial; RT‐PCR: reverse transcriptase‐polymerase chain reaction; (S)AE: (serious) adverse event; VRC: vaccine report card
Immunogenicity: only data for review‐relevant outcomes listed in these tables.