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- Title
Protective Efficacy of a Second Pneumococcal Conjugate Vaccine against Pneumococcal Acute Otitis Media in Infants and Children: Randomized, Controlled Trial of a 7-Valent Pneumococcal Polysaccharide--Meningococcal Outer Membrane Protein Complex Conjugate
- Authors
Kilpi, Terhi; Åhman, Heidi; Jokinen, Jukka; Lankinen, Kari S.; Palmu, Arto; Savolainen, Heljä; Grönholm, Marko; Leinonen, Maija; Hovi, Tapani; Eskola, Juhani; Käyhty, Helena; Bohidar, Norman; Sadoff, Jerald C.; Mäkelä, P. Helena
- Abstract
To assess the efficacy of a 7-valent pneumococcal polysaccharidemeningococcal outer membrane protein complex cinjugate vaccine (PncOMPC) against acute otitis media (aOM), 1666 infants were randomly assigned to receive either PncOMPC or control vaccine (hepatitis B vaccine) at 2, 4, 6, and 12 months of age. Of the 835 children assigned to receive PncOMPC, 187 received a 23-valent pneumococcal polysaccharide vaccine (PncPS) at 12 months of age instead. Whenever AOM was diagnosed, middle ear fluid was aspirated for bacterial culture. In the PncOMPC and control groups, there were 110 and 250 AOM episodes, respectively, in children between 6.5 and 24 months of age that could be attributed to vaccine serotypes, which indicates a vaccine efficacy of 56% (95% confidence interval, 44%–66%). The serotype-specific efficacy ranged from 37% for 19F to 82% for 9V. The 2 boosters seemed to provide equal protection against AOM, but PncPS induced markedly higher antibody concentrations. The efficacy of PncOMPC was comparable to that of the recently licensed pneumococcal conjugated vaccine.
- Subjects
VACCINES; EAR diseases; PREVENTIVE medicine; ANTI-infective agents
- Publication
Clinical Infectious Diseases, 2003, Vol 37, Issue 9, p1155
- ISSN
1058-4838
- Publication type
Article