Clinical trial NCT00119743: A Efficacy Against Otitis Media in Children With 11 Valent Pneumococcal Vaccine
Official title: Assess, in Young Children, the Efficacy in Preventing Acute Otitis Media (AOM) of GSK Biologicals Undecavalent Pneumococcal-protein D Conjugate Vaccine, When Administered as a Three Dose Primary Vaccination Course During the First Year of Life With a Booster Dose in the Second Year of Life.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hepatitis A
Keywords: Prophylaxis pneumococcal vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-07-14
Enrollment: 5000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 27
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).


Eligibility criteria: Inclusion Criteria:

* Male or female between 6 weeks and 5 months (42-152 days) of age at the time of first vaccination.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

Primary outcomes:
measure: To demonstrate the efficacy of the 11 Pn-PD vaccine in preventing AOM caused by vaccine-type pneumococcus in fully vaccinated children less than 2 years of age.
Secondary outcomes:
measure: To assess the efficacy of the 11 Pn-PD vaccine in preventing AOM caused by NTHI in fully vaccinated children less than 2 years of age.
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: GSK Investigational Site
city: Ceske Budejovice
country: Czech Republic
facility: GSK Investigational Site
city: Decin
country: Czech Republic
facility: GSK Investigational Site
city: Frydek-Mistek
country: Czech Republic
facility: GSK Investigational Site
city: Havlickuv Brod
country: Czech Republic
facility: GSK Investigational Site
city: Hlinsko v Cechach
country: Czech Republic
facility: GSK Investigational Site
city: Jicin
country: Czech Republic
facility: GSK Investigational Site
city: Jindrichuv Hradec
country: Czech Republic
facility: GSK Investigational Site
city: Karvina
country: Czech Republic
facility: GSK Investigational Site
city: Litomerice
country: Czech Republic
facility: GSK Investigational Site
city: Nachod
country: Czech Republic
facility: GSK Investigational Site
city: Ostrava
country: Czech Republic
facility: GSK Investigational Site
city: Pardubice
country: Czech Republic
facility: GSK Investigational Site
city: Praha 2
country: Czech Republic
facility: GSK Investigational Site
city: Praha 4
country: Czech Republic
facility: GSK Investigational Site
city: Praha 5
country: Czech Republic
facility: GSK Investigational Site
city: Praha 6
country: Czech Republic
facility: GSK Investigational Site
city: Praha 8
country: Czech Republic
facility: GSK Investigational Site
city: Praha 9
country: Czech Republic
facility: GSK Investigational Site
city: Usti nad Labem
country: Czech Republic
facility: GSK Investigational Site
city: Usti nad Labem
country: Czech Republic
facility: GSK Investigational Site
city: Znojmo
country: Czech Republic
facility: GSK Investigational Site
city: Dolny Kubin
country: Slovakia
facility: GSK Investigational Site
city: Dubnica Nad Vahom
country: Slovakia
facility: GSK Investigational Site
city: Kostany Nad Turcom
country: Slovakia
facility: GSK Investigational Site
city: Liptovsky Hradok
country: Slovakia
facility: GSK Investigational Site
city: Liptovsky Mikulas
country: Slovakia
facility: GSK Investigational Site
city: Martin
country: Slovakia
facility: GSK Investigational Site
city: Namestovo
country: Slovakia
facility: GSK Investigational Site
city: Nitra
country: Slovakia
facility: GSK Investigational Site
city: Nova Dubnica
country: Slovakia
facility: GSK Investigational Site
city: Nove Mesto nad Vahom
country: Slovakia
facility: GSK Investigational Site
city: Nove Zamky
country: Slovakia
facility: GSK Investigational Site
city: Povazska Bystrica
country: Slovakia
facility: GSK Investigational Site
city: Puchov
country: Slovakia
facility: GSK Investigational Site
city: Ruzomberok
country: Slovakia
facility: GSK Investigational Site
city: Sturovo
country: Slovakia
facility: GSK Investigational Site
city: Sucany
country: Slovakia
facility: GSK Investigational Site
city: Surany
country: Slovakia
facility: GSK Investigational Site
city: Trencin
country: Slovakia
facility: GSK Investigational Site
city: Zlate Moravce
country: Slovakia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.