Safety and Efficacy of a Pentavalent Human–Bovine (WC3) Reassortant Rotavirus Vaccine
Timo VesikariFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JDavid O. MatsonFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JPenelope H. DennehyFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JPierre Van DammeFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JMathuram SantoshamFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JZoe RodriguezFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JMichael J. DallasFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JJoseph F. HeyseFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JMichelle G. GoveiaFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JSteven BlackFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JHenry R. ShinefieldFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JC D C ChristieFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JSamuli YlitaloFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JRobbin ItzlerFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JMichele L. CoiaMerck Research Laboratories, West Point, PaMatthew OnoratoFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JBen AdeyiFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JGary S. MarshallFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JLeif GotheforsFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JDirk CampensFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JAino KarvonenFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JJames WattFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JKatherine L. O’BrienFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JMark J. DiNubileFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JH. F. ClarkFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JJohn W. BoslegoFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JPaul A. OffitFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., JPenny M. HeatonFrom the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., J
2006en
ABI
Аннотация
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.)
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