Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian children in the second year of life

• DOI: 10.1016/j.vaccine.2014.04.079
• Publication Date: 2014-08-02T15:37:14Z
• Authors: Nita Bhandari; Temsunaro Rongsen...; Ashish Bavdekar; Jacob John; Kalpana Antony; Sunita Taneja; Nidhi Goyal; Anand Kawade; Gagandeep Kang; Sudeep Singh Rathore; Sanjay Juvekar; Jayaprakash Muliyil; Alok Arya; Hanif Shaikh; Vinod Abraham; Sudhanshu Vrati; Michael Proschan; Robert Kohberger; Georges Thiry; Roger Glass; Harry B. Greenberg; George Curlin; Krishna Mohan; G.V.J.A. Harshava...; Sai Prasad; T.S. Rao; John Boslego; Maharaj Kishan Bhan
• Keywords: Rotavirus vaccine; Vaccine efficacy

Rotavirus gastroenteritis is one of the leading causes diarrhea in Indian children less than 2 years age. The 116E rotavirus strain was developed as part Indo-US Vaccine Action Program and has undergone efficacy trials. This paper reports additional safety data up to In a double-blind placebo controlled multicenter trial, 6799 infants aged 6–7 weeks were randomized receive three doses an oral human-bovine natural reassortant vaccine (116E) or at ages 6, 10, 14 weeks. primary outcome severe (≥11 on Vesikari scale) gastroenteritis. Efficacy outcomes adverse events ascertained through active surveillance. We randomly assigned 4532 2267 subjects placebo, respectively, with over 96% receiving all placebo. per protocol analyses included 4354 2187 group. overall incidence RVGE 100 person 1.3 group 2.9 recipients. against age 55.1% (95% CI 39.9 66.4; p < 0.0001); second year life 48.9% 17.4 68.4; = 0.0056) only marginally first [56.3% 36.7 69.9; 0.0001)]. number needed be immunized prevent episode 40 28.0 63.0) for any severity, it 21 16.0 32.0). Serious observed same rates two groups. None eight intussusception occurred within 30 days dose reported after third dose. sustained reassuring. trial registered Clinical Trial Registry-India (# CTRI/2010/091/000102) Clinicaltrials.gov NCT01305109).