Trial reportVaccine2014
Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian children in the second year of life.
Trial report in Vaccine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 55 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase III, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Protective Efficacy of Three Doses of Oral Rotavirus Vaccine (ORV) 116E, Against Severe Rotavirus Gastroenteritis in Infants
An Open-label, Randomized, Controlled, Single Centre, Phase IIb Study to Assess the Immunogenicity, Reactogenicity and Safety of Three Live Oral Rotavirus Vaccines, ROTAVAC® , ROTAVAC 5CM and Rotarix® in Healthy Zambian Infants
Who cites it
55 citing papers in PubMed, 3 syntheses or guidelines pooled it, 100 citations in OpenAlex.
- Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2021Pooled it
- Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2019Pooled it
- Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2019Pooled it
- Early-life gut microbiome associates with positive vaccine take and shedding in neonatal schedule of the human neonatal rotavirus vaccine RV3-BB.Nature communications · 2025Trial
- Immunogenicity of RV1 and RV5 vaccines administered in standard and interchangeable mixed schedules: a randomized, double-blind, non-inferiority clinical trial in Mexican infants.Frontiers in public health · 2024Trial
- Phase III randomized clinical studies to evaluate the immunogenicity, lot-to-lot consistency, and safety of ROTAVAC® liquid formulations (ROTAVAC 5C & 5D) and non-inferiority comparisons with licensed ROTAVAC® (frozen formulation) in healthy infants.Human vaccines & immunotherapeutics · 2023Trial
- Rotavirus vaccine efficacy up to 2 years of age and against diverse circulating rotavirus strains in Niger: Extended follow-up of a randomized controlled trial.PLoS medicine · 2021Trial
- Immunogenicity and safety of two monovalent rotavirus vaccines, ROTAVAC® and ROTAVAC 5D® in Zambian infants.Vaccine · 2021Trial
- Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial.The Lancet. Infectious diseases · 2021Trial
- Diarrheal Etiology and Impact of Coinfections on Rotavirus Vaccine Efficacy Estimates in a Clinical Trial of a Monovalent Human-Bovine (116E) Oral Rotavirus Vaccine, Rotavac, India.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Trial
- A Phase 4, multicentre, randomized, single-blind clinical trial to evaluate the immunogenicity of the live, attenuated, oral rotavirus vaccine (116E), ROTAVAC®, administered simultaneously with or without the buffering agent in healthy infants in India.Human vaccines & immunotherapeutics · 2018Trial
- Human Neonatal Rotavirus Vaccine (RV3-BB) to Target Rotavirus from Birth.The New England journal of medicine · 2018Trial
- Trial
- Novel non-aqueous rotavirus vaccine: Formulated for thermostability and easy administration.Human vaccines & immunotherapeutics · 2026Article
- Trends and burden of diarrhoeal diseases across India, 1990 - 2023: A systematic analysis from the global burden of disease study 2023.New microbes and new infections · 2026Article
- Rotavirus Infections: Pathophysiology, Symptoms, and Vaccination.Pathogens (Basel, Switzerland) · 2025Review
- Voices of Nanomedicine: Blueprint Guidelines for Collaboration in Addressing Global Unmet Medical Needs.ACS nano · 2025Review
- Progress in research and development of preventive vaccines for children in China.Frontiers in pediatrics · 2024Review
- Impact of vaccination with different types of rotavirus vaccines on the incidence of intussusception: a randomized controlled meta-analysis.Frontiers in pediatrics · 2023Review
- Established and new rotavirus vaccines: a comprehensive review for healthcare professionals.Human vaccines & immunotherapeutics · 2022Review
Corrections and comments
- Commented on by
Authors and funding
29 authors at 10 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
unlabelledRotavirus gastroenteritis is one of the leading causes of diarrhea in Indian children less than 2 years of age. The 116E rotavirus strain was developed as part of the Indo-US Vaccine Action Program and has undergone efficacy trials. This paper reports the efficacy and additional safety data in children up to 2 years of age. In a double-blind placebo controlled multicenter trial, 6799 infants aged 6-7 weeks were randomized to receive three doses of an oral human-bovine natural reassortant vaccine (116E) or placebo at ages 6, 10, and 14 weeks. The primary outcome was severe (≥11 on the Vesikari scale) rotavirus gastroenteritis. Efficacy outcomes and adverse events were ascertained through active surveillance. We randomly assigned 4532 and 2267 subjects to receive vaccine and placebo, respectively, with over 96% subjects receiving all three doses of the vaccine or placebo. The per protocol analyses included 4354 subjects in the vaccine and 2187 subjects in the placebo group. The overall incidence of severe RVGE per 100 person years was 1.3 in the vaccine group and 2.9 in the placebo recipients. Vaccine efficacy against severe rotavirus gastroenteritis in children up to 2 years of age was 55.1% (95% CI 39.9 to 66.4; p<0.0001); vaccine efficacy in the second year of life of 48.9% (95% CI 17.4 to 68.4; p=0.0056) was only marginally less than in the first year of life [56.3% (95% CI 36.7 to 69.9; p<0.0001)]. The number of infants needed to be immunized to prevent one episode of severe RVGE in the first 2 years of life was 40 (95% CI 28.0 to 63.0) and for RVGE of any severity, it was 21 (95% CI 16.0 to 32.0). Serious adverse events were observed at the same rates in the two groups. None of the eight intussusception events occurred within 30 days of a vaccine dose and all were reported only after the third dose. The sustained efficacy of the 116E in the second year of life is reassuring. CLINICAL TRIAL REGISTRY: The trial is registered with Clinical Trial Registry-India (# CTRI/2010/091/000102) and Clinicaltrials.gov (# NCT01305109).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.