Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children

作者：STEVEN B. BLACK, Henry R. Shinefield, BRUCE H. FIREMAN, Edwin M. Lewis, Paula Ray, John R. Hansen, Laura Elvin, KATHY M. ENSOR, Jill G. Hackell, George R. Siber, Frank J. Malinoski, Dace Viceps Madore, Ih Chang, Robert C. Kohberger, Wendy K. Watson, ROBERT C. AUSTRIAN, KATHY EDWARDS · 发表于：The Pediatric Infectious Disease Journal · 年份：2000 · DOI：10.1097/00006454-200003000-00003 · 被引用次数：2301 · 研究领域：Pneumonia and Respiratory Infections、Ear Surgery and Otitis Media、Sinusitis and nasal conditions

OBJECTIVE: To determine the efficacy, safety and immunogenicity of the heptavalent CRM197 pneumococcal conjugate vaccine against invasive disease caused by vaccine serotypes and to determine the effectiveness of this vaccine against clinical episodes of otitis media. METHODS: The Wyeth Lederle Heptavalent CRM197 (PCV) was given to infants at 2, 4, 6 and 12 to 15 months of age in a double blind trial; 37,868 children were randomly assigned 1:1 to receive either the pneumococcal conjugate vaccine or meningococcus type C CRM197 conjugate. The primary study outcome was invasive disease caused by vaccine serotype. Other outcomes included overall impact on invasive disease regardless of serotype, effectiveness against clinical otitis media visits and episodes, impact against frequent and severe otitis media and ventilatory tube placement. In addition the serotype-specific efficacy against otitis media was estimated in an analysis of spontaneously draining ears. RESULTS: In the interim analysis in August, 1998, 17 of the 17 cases of invasive disease caused by vaccine serotype in fully vaccinated children and 5 of 5 of partially vaccinated cases occurred in the control group for a vaccine efficacy of 100%. Blinded case ascertainment was continued until April, 1999. As of that time 40 fully vaccinated cases of invasive disease caused by vaccine serotype had been identified, all but 1 in controls for an efficacy of 97.4% (95% confidence interval, 82.7 to 99.9%), and 52 cases, all but 3...