BACKGROUND: Acute otitis media is one of the most commonly-diagnosed childhood infections. This study assessed the efficacy of a novel vaccine that contained polysaccharides from 11 different Streptococcus pneumoniae serotypes each conjugated to Haemophilus influenzae-derived protein D in prevention of acute otitis media. METHODS: 4968 infants were randomly assigned to receive either pneumococcal protein D conjugate or hepatitis A vaccine at the ages of 3, 4, 5, and 12-15 months and were followed-up until the end of the second year of life. Middle-ear fluid was obtained for bacteriological culture and serotyping in children who presented with abnormal tympanic membrane or presence of middle-ear effusion, plus two predefined clinical symptoms. The primary endpoint was protective efficacy against the first episode of acute otitis media caused by vaccine pneumococcal serotypes. Analysis was per protocol. FINDINGS: From 2 weeks after the third dose to 24-27 months of age, 333 clinical episodes of acute otitis media were recorded in the protein D conjugate group (n=2455) and 499 in the control group (n=2452), giving a significant (33.6% [95% CI 20.8-44.3]) reduction in the overall incidence of acute otitis media. Vaccine efficacy was shown for episodes of acute otitis media caused by pneumococcal vaccine serotypes (52.6% [35.0-65.5] for the first episode and 57.6% [41.4-69.3] for any episode). Efficacy was also shown against episodes of acute otitis media caused by non-typable H influenzae (35.3% [1.8-57.4]). The vaccine reduced frequency of infection from vaccine-related cross-reactive pneumococcal serotypes by 65.5%, but did not significantly change the number of episodes caused by other non-vaccine serotypes. INTERPRETATION: These results confirm that using the H influenzae-derived protein D as a carrier protein for pneumococcal polysaccharides not only allowed protection against pneumococcal otitis, but also against acute otitis media due to non-typable H influenzae. Whether this approach would also allow improved protection against lower respiratory tract infections warrants further investigation.

• MeSH
• akutní nemoc MeSH
• bakteriální polysacharidy imunologie   MeSH
• bakteriální proteiny imunologie   MeSH
• dvojitá slepá metoda MeSH
• financování organizované MeSH
• Haemophilus influenzae izolace a purifikace   klasifikace   patogenita   MeSH
• imunoglobulin D MeSH
• kojenec MeSH
• lidé MeSH
• lipoproteiny imunologie   MeSH
• otitis media s výpotkem mikrobiologie   MeSH
• otitis media imunologie   mikrobiologie   prevence a kontrola   MeSH
• pneumokokové vakcíny imunologie   terapeutické užití   MeSH
• sérotypizace MeSH
• Streptococcus pneumoniae izolace a purifikace   klasifikace   patogenita   MeSH
• transportní proteiny imunologie   MeSH
• vakcína proti hepatitidě A MeSH
• Check Tag
• kojenec MeSH
• lidé MeSH
• Publikační typ
• randomizované kontrolované studie MeSH

• MeSH
• dítě MeSH
• lidé MeSH
• otitis media s výpotkem epidemiologie   mikrobiologie   MeSH
• rezistence na penicilin MeSH
• Check Tag
• dítě MeSH
• lidé MeSH
• Geografické názvy
• Francie MeSH

• MeSH
• amoxicilin aplikace a dávkování   terapeutické užití   MeSH
• antibakteriální látky aplikace a dávkování   terapeutické užití   MeSH
• dítě MeSH
• lidé MeSH
• otitis media s výpotkem farmakoterapie   chirurgie   mikrobiologie   MeSH
• otitis media farmakoterapie   chirurgie   mikrobiologie   MeSH
• střední ucho chirurgie   MeSH
• Check Tag
• dítě MeSH
• lidé MeSH