• DOI:10.1056/NEJMOA052664
• Corpus ID: 32718773

Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine.

@article{Vesikari2006SafetyAE,
  title={Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine.},
  author={Timo Vesikari and David O. Matson and Penelope H. Dennehy and Pierre van Damme and Mathuram Santosham and Zoe M Rodriguez and Michael J. Dallas and Joseph F. Heyse and Michelle G. Goveia and Steven B. Black and Henry R. Shinefield and Celia D. C. Christie and Samuli Ylitalo and Robbin F. Itzler and Michele L Coia and Matthew T. Onorato and Ben A Adeyi and Gary S. Marshall and Leif Gothefors and Dirk Campens and Aino Karvonen and James P. Watt and Katherine L. O'Brien and Mark J. Dinubile and Harold F. Clark and John W. Boslego and Paul A. Offit and Penny M Heaton},
  journal={The New England journal of medicine},
  year={2006},
  volume={354 1},
  pages={
          23-33
        }
}

• T. Vesikari, D. Matson, +25 authors Penny M Heaton
• Published 5 January 2006
• Medicine
• The New England journal of medicine

BACKGROUND
Rotavirus is a leading cause of childhood gastroenteritis and death worldwide.

METHODS
We studied healthy infants approximately 6 to 12 weeks old who were randomly assigned to receive three oral doses of live pentavalent human-bovine (WC3 strain) reassortant rotavirus vaccine containing human serotypes G1, G2, G3, G4, and P[8] or placebo at 4-to-10-week intervals in a blinded fashion. Active surveillance was used to identify subjects with serious adverse and other events.

RESULTS
The 34,035 infants in the vaccine group and 34,003 in the placebo group were monitored for serious adverse events. Intussusception occurred in 12 vaccine recipients and 15 placebo recipients within one year after the first dose including six vaccine recipients and five placebo recipients within 42 days after any dose (relative risk, 1.6; 95 percent confidence interval, 0.4 to 6.4). The vaccine reduced hospitalizations and emergency department visits related to G1-G4 rotavirus gastroenteritis occurring 14 or more days after the third dose by 94.5 percent (95 percent confidence interval, 91.2 to 96.6 percent). In a nested substudy, efficacy against any G1-G4 rotavirus gastroenteritis through the first full rotavirus season after vaccination was 74.0 percent (95 percent confidence interval, 66.8 to 79.9 percent); efficacy against severe gastroenteritis was 98.0 percent (95 percent confidence interval, 88.3 to 100 percent). The vaccine reduced clinic visits for G1-G4 rotavirus gastroenteritis by 86.0 percent (95 percent confidence interval, 73.9 to 92.5 percent).

CONCLUSIONS
This vaccine was efficacious in preventing rotavirus gastroenteritis, decreasing severe disease and health care contacts. The risk of intussusception was similar in vaccine and placebo recipients. (ClinicalTrials.gov number, NCT00090233.)