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 vaccine in 1666 children.
abstract: To assess the efficacy of a 7-valent pneumococcal polysaccharide-meningococcal outer membrane protein complex conjugate 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 conjugate vaccine.
authors.affiliation: National Public Health Institute (KTL), Helsinki, Finland. terhi.kilpi@ktl.fi
authors.forename: Terhi
authors.initials: T
authors.lastname: Kilpi
authors.forename: Heidi
authors.initials: H
authors.lastname: Ahman
authors.forename: Jukka
authors.initials: J
authors.lastname: Jokinen
authors.forename: Kari S
authors.initials: KS
authors.lastname: Lankinen
authors.forename: Arto
authors.initials: A
authors.lastname: Palmu
authors.forename: Heljä
authors.initials: H
authors.lastname: Savolainen
authors.forename: Marko
authors.initials: M
authors.lastname: Grönholm
authors.forename: Maija
authors.initials: M
authors.lastname: Leinonen
authors.forename: Tapani
authors.initials: T
authors.lastname: Hovi
authors.forename: Juhani
authors.initials: J
authors.lastname: Eskola
authors.forename: Helena
authors.initials: H
authors.lastname: Käyhty
authors.forename: Norman
authors.initials: N
authors.lastname: Bohidar
authors.forename: Jerald C
authors.initials: JC
authors.lastname: Sadoff
authors.forename: P Helena
authors.initials: PH
authors.lastname: Mäkelä
mesh_terms: D000208:Acute Disease; D001425:Bacterial Outer Membrane Proteins / Q000008:administration & dosage / Q000737:chemistry; D002648:Child; D015331:Cohort Studies; D004311:Double-Blind Method; D006801:Humans; D007117:Immunization, Secondary; D007223:Infant; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry; D010033:Otitis Media / Q000276:immunology / Q000517:prevention & control*; D011008:Pneumococcal Infections / Q000517:prevention & control; D022242:Pneumococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D013296:Streptococcus pneumoniae; D018074:Vaccines, Conjugate / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D001425:Bacterial Outer Membrane Proteins; D022401:Meningococcal Vaccines; D022242:Pneumococcal Vaccines; D018074:Vaccines, Conjugate