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Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine.
N Engl J Med 2006; 354(1):23-33NEJM

Abstract

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.)

Authors+Show Affiliations

University of Tampere Medical School, Tampere, Finland.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

16394299

Citation

Vesikari, Timo, et al. "Safety and Efficacy of a Pentavalent Human-bovine (WC3) Reassortant Rotavirus Vaccine." The New England Journal of Medicine, vol. 354, no. 1, 2006, pp. 23-33.
Vesikari T, Matson DO, Dennehy P, et al. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med. 2006;354(1):23-33.
Vesikari, T., Matson, D. O., Dennehy, P., Van Damme, P., Santosham, M., Rodriguez, Z., ... Heaton, P. M. (2006). Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. The New England Journal of Medicine, 354(1), pp. 23-33.
Vesikari T, et al. Safety and Efficacy of a Pentavalent Human-bovine (WC3) Reassortant Rotavirus Vaccine. N Engl J Med. 2006 Jan 5;354(1):23-33. PubMed PMID: 16394299.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. AU - Vesikari,Timo, AU - Matson,David O, AU - Dennehy,Penelope, AU - Van Damme,Pierre, AU - Santosham,Mathuram, AU - Rodriguez,Zoe, AU - Dallas,Michael J, AU - Heyse,Joseph F, AU - Goveia,Michelle G, AU - Black,Steven B, AU - Shinefield,Henry R, AU - Christie,Celia D C, AU - Ylitalo,Samuli, AU - Itzler,Robbin F, AU - Coia,Michele L, AU - Onorato,Matthew T, AU - Adeyi,Ben A, AU - Marshall,Gary S, AU - Gothefors,Leif, AU - Campens,Dirk, AU - Karvonen,Aino, AU - Watt,James P, AU - O'Brien,Katherine L, AU - DiNubile,Mark J, AU - Clark,H Fred, AU - Boslego,John W, AU - Offit,Paul A, AU - Heaton,Penny M, AU - ,, PY - 2006/1/6/pubmed PY - 2006/1/13/medline PY - 2006/1/6/entrez SP - 23 EP - 33 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 354 IS - 1 N2 - 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.) SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/16394299/Safety_and_efficacy_of_a_pentavalent_human_bovine__WC3__reassortant_rotavirus_vaccine_ L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa052664?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -