A Efficacy Against Otitis Media in Children With 11 Valent Pneumococcal Vaccine

Summary

The purpose of this study is to assess the efficacy in young children in preventing acute otitis media due to vaccine serotype pneumococcal or non typable Hemophilus influenza, following immunization with an 11-valent pneumococcal vaccine according to a 3 dose primary vaccination in the first year of life, with booster dose in the second year of life. Prophylactic immunization with pneumococcal conjugate vaccine is compared to placebo (hepatitis A vaccine).

Timeline

Start

2000-10

Primary completion

2004-06

Completion

2004-06

Publications

• Background Poolman J, Kriz P, Feron C, Di-Paolo E, Henckaerts I, Miseur A, Wauters D, Prymula R, Schuerman L. Pneumococcal serotype 3 otitis media, limited effect of polysaccharide conjugate immunisation and strain characteristics. Vaccine. 2009 May 21;27(24):3213-22. doi: 10.1016/j.vaccine.2009.03.017. Epub 2009 Mar 26.
• Background Poolman J, Frasch C, Nurkka A, Kayhty H, Biemans R, Schuerman L. Impact of the conjugation method on the immunogenicity of Streptococcus pneumoniae serotype 19F polysaccharide in conjugate vaccines. Clin Vaccine Immunol. 2011 Feb;18(2):327-36. doi: 10.1128/CVI.00402-10. Epub 2010 Dec 1.
• Background Prymula R, Peeters P, Chrobok V, Kriz P, Novakova E, Kaliskova E, Kohl I, Lommel P, Poolman J, Prieels JP, Schuerman L. Pneumococcal capsular polysaccharides conjugated to protein D for prevention of acute otitis media caused by both Streptococcus pneumoniae and non-typable Haemophilus influenzae: a randomised double-blind efficacy study. Lancet. 2006 Mar 4;367(9512):740-8. doi: 10.1016/S0140-6736(06)68304-9.
• Background Prymula R, Chlibek R, Splino M, Kaliskova E, Kohl I, Lommel P, Schuerman L. Safety of the 11-valent pneumococcal vaccine conjugated to non-typeable Haemophilus influenzae-derived protein D in the first 2 years of life and immunogenicity of the co-administered hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio virus, Haemophilus influenzae type b and control hepatitis A vaccines. Vaccine. 2008 Aug 18;26(35):4563-70. doi: 10.1016/j.vaccine.2008.05.080. Epub 2008 Jun 17.
• Background Schuerman L, Prymula R, Henckaerts I, Poolman J. ELISA IgG concentrations and opsonophagocytic activity following pneumococcal protein D conjugate vaccination and relationship to efficacy against acute otitis media. Vaccine. 2007 Mar 1;25(11):1962-8. doi: 10.1016/j.vaccine.2006.12.008. Epub 2006 Dec 26.
• Background Schuerman L, Prymula R, Chrobok V, Dieussaert I, Poolman J. Kinetics of the immune response following pneumococcal PD conjugate vaccination. Vaccine. 2007 Mar 1;25(11):1953-61. doi: 10.1016/j.vaccine.2006.12.007. Epub 2006 Dec 26.
• Background Schuerman L, Borys D, Hoet B, Forsgren A, Prymula R. Prevention of otitis media: now a reality? Vaccine. 2009 Sep 25;27(42):5748-54. doi: 10.1016/j.vaccine.2009.07.070. Epub 2009 Aug 8.

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