Black S, Shinefield H, Ray P, Lewis EM, Fireman B, Austrian R, Siber G, Hackell J, Kohberger R, Chang I; Interscience Conference on Antimicrobial Agents and Chemotherapy; the Kaiser Permanente Vaccine Study Group.
Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 1999 Sep 26-29; 39: 379 (abstract no. 1398).
Kaiser Permanente Vaccine Study Ctr., Oakland, CA
Beginning in October 1995, the Wyeth Lederle Heptavalent CRM[197] (PCV) was offered to infants at 2, 4, 6 & 12-15 mo. in a double blind trial. 37,000 children were randomly assigned 1:1 to receive either the PCV or meningococcus type C CRM[197] conjugate. Outcomes included invasive disease, clinical otitis media and pneumonia. As of July 1998, 17 of the 17 cases in fully vaccinated children and 5 of 5 of partially vaccinated cases occurred in the control group for a vaccine efficacy of 100%. Since that time additional cases have been identified due to vaccine serotype with 37 fully vaccinated cases-all in controls for efficacy of 100% (95% CI 89.8-100%) and 48 cases-all in controls in the ITT analysis for efficacy of 100% (95% CI 91.5-100%). There was no evidence of any increase of disease due to non-vaccine serotypes. For otitis, efficacy against visits, episodes, frequent otitis and PE tube placement was 8.9%, 6.4%, 9.3%, and 20.1% with p < 0.04 for all. For pneumonia, outcomes included a clinical diagnosis of pneumonia, x-ray confirmed pneumonia and consolidation /2.5 cm as agreed to by both a pediatric and radiologist review of the films. Efficacy (95% CI) was: [table: see text]. In conclusion, this heptavalent pneumococcal conjugate appears to be highly effective in preventing invasive disease and pneumonia in young children and to have a significant impact on otitis media as well.
Publication Types:
Keywords:
- California
- Child
- Clinical Trials as Topic
- Double-Blind Method
- Humans
- Infant
- Otitis Media
- Pneumococcal Vaccines
- Pneumonia
- Pneumonia, Pneumococcal
Other ID:
UI: 102245467
From Meeting Abstracts