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Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial

Open access
Bhandari, Nita, Rongsen-Chandola, Temsunaro, Bavdekar, Ashish, John, Jacob, Antony, Kalpana, Taneja, Sunita, Goyal, Nidhi, Kawade, Anand, Kang, Gagandeep, Rathore, Sudeep Singh, Juvekar, Sanjay, Muliyil, Jayaprakash, Arya, Alok, Shaikh, Hanif, Abraham, Vinod, Vrati, Sudhanshu, Proschan, Michael, Kohberger, Robert, Thiry, Georges, Glass, Roger, Greenberg, Harry B, Curlin, George, Mohan, Krishna, Harshavardhan, G V J A, Prasad, Sai, Rao, T S, Boslego, John, Bhan, Maharaj Kishan·2014·The Lancet
DOI 10.1016/s0140-6736(13)62630-6
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Abstract

Background Rotavirus is the most common cause of severe dehydrating gastroenteritis in developing countries. Safe, effective, and affordable rotavirus vaccines are needed for developing countries. Methods In a double-blind placebo controlled multicentre trial, 6799 infants aged 6 to 7 weeks were randomised to receive three doses of an oral human-bovine natural reassortant vaccine (116E) or placebo at ages 6, 10, and 14 weeks. Primary outcome was severe (≥11 on the Vesikari scale) rotavirus gastroenteritis. Efficacy outcomes and adverse events were ascertained through active surveillance. Findings At analyses, the median age was 17·2 months; over 96% subjects received all three doses of the vaccine/placebo and ~1% were lost to follow up. 4532 and 2267 subjects were randomly assigned to receive vaccine and placebo, respectively. The per protocol analyses included 4354 subjects in the vaccine and 2187 subjects in the placebo group. 71 events of severe rotavirus gastroenteritis were reported in 4752 person years among the vaccinees compared to 76 events in 2360 person years in the placebo recipients; vaccine efficacy against severe rotavirus gastroenteritis was 53·6% (95% CI 35·0–66·9; P<0·001) and 56·4% (95% CI 36·6–70·1; P <0·001) in the first year of life. The number of infants needed to be immunized to prevent one severe rotavirus gastroenteritis episode was 55 (95% CI 37–97). The incidence of severe rotavirus gastroenteritis/100 person years was 1·5 in vaccine and 3·2 in placebo group and an incidence rate ratio of 0·46 (95% CI 0·33–0·65). The absolute rate reduction for severe rotavirus gastroenteritis was 1·7 (95% CI 2·5–0·9). Efficacy against severe gastroenteritis of any aetiology was 18·6% (95% CI 1·9–32·3); it was 24·1% (95% CI 5·8–38·7) in the first year of life. The prevalence of immediate, solicited, and serious adverse events were similar in both groups. There were six cases of intussusception amongst 4532 vaccinees and two amongst 2267 placebo recipients (P=0·73). All intussusception cases occurred after the third dose. Among vaccine and placebo recipients, the minimum interval between dosing and intussusception was 112 and 36 days, respectively. Interpretation The monovalent human-bovine (116E) rotavirus vaccine is effective and well-tolerated in Indian infants.

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Metadata

Authors
Bhandari, N., Rongsen-Chandola, T., Bavdekar, A., John, J., Antony, K., Taneja, S., Goyal, N., Kawade, A., Kang, G., Rathore, S. S., Juvekar, S., Muliyil, J., Arya, A., Shaikh, H., Abraham, V., Vrati, S., Proschan, M., Kohberger, R., Thiry, G., Glass, R., Greenberg, H. B., Curlin, G., Mohan, K., Harshavardhan, G. V. J. A., Prasad, S., Rao, T. S., Boslego, J., & Bhan, M. K.
Venue
The Lancet
Publisher
Elsevier BV
Published
2014-06
Volume
383
Issue
9935
Pages
2136-2143
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
DOI
10.1016/s0140-6736(13)62630-6
OpenAlex
W2101380815
Cited by
326
References
23
FWCI
24.66
Type
journal article
Language
en
Open access
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CoChat. (2026). Citation check: Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial. https://app.cochat.ai/papers/10.1016/s0140-6736(13)62630-6
The paper
Bhandari, N., Rongsen-Chandola, T., Bavdekar, A., John, J., Antony, K., Taneja, S., Goyal, N., Kawade, A., Kang, G., Rathore, S. S., Juvekar, S., Muliyil, J., Arya, A., Shaikh, H., Abraham, V., Vrati, S., Proschan, M., Kohberger, R., Thiry, G., . . . Bhan, M. K. (2014). Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial. The Lancet. https://doi.org/10.1016/s0140-6736(13)62630-6

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.