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

被引:1422
作者
Vesikari, T
Matson, DO
Dennehy, P
Van Damme, P
Santosham, M
Rodriguez, Z
Dallas, MJ
Heyse, JF
Goveia, MG
Black, SB
Shinefield, HR
Christie, CDC
Ylitalo, S
Itzler, RF
Coia, ML
Onorato, MT
Adeyi, BA
Marshall, GS
Gothefors, L
Campens, D
Karvonen, A
Watt, JP
O'Brien, KL
DiNubile, MJ
Clark, HF
Boslego, JW
Offit, PA
Heaton, PM
机构
[1] Univ Tampere, Sch Med, FIN-33101 Tampere, Finland
[2] Eastern Virginia Med Sch, Ctr Pediat Res, Norfolk, VA 23501 USA
[3] Rhode Isl Hosp, Div Pediat Infect Dis, Providence, RI USA
[4] Univ Antwerp, Ctr Evaluat Vaccinat, B-2020 Antwerp, Belgium
[5] Johns Hopkins Univ, Bloomberg Sch Publ Hlth, Dept Int Hlth, Ctr Amer Indian Hlth, Baltimore, MD USA
[6] Univ Puerto Rico, Sch Med, San Juan, PR 00936 USA
[7] Merck Res Labs, West Point, PA 19486 USA
[8] Kaiser Permanente Vaccine Study Ctr, Oakland, CA USA
[9] Inst Vaccine & Pharmacol Res San Francisco, San Francisco, CA USA
[10] Univ W Indies, Dept Pediat, Kingston 7, Jamaica
[11] Univ Louisville, Sch Med, Dept Pediat, Louisville, KY 40292 USA
[12] Umea Univ, Dept Clin Sci Pediat, Umea, Sweden
[13] Sanofi Pasteur Merck, Sharp & Dohme, Lyon, France
[14] Childrens Hosp, Philadelphia, PA 19104 USA
[15] Univ Penn, Sch Med, Philadelphia, PA 19104 USA
关键词
D O I
10.1056/NEJMoa052664
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
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收藏
页码:23 / 33
页数:11
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