Hepatitis A Clinical Trial
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.
Verified date | March 2017 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 5000 |
Est. completion date | June 2004 |
Est. primary completion date | June 2004 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Weeks to 27 Months |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Czech Republic | GSK Investigational Site | Brno | |
Czech Republic | GSK Investigational Site | Ceske Budejovice | |
Czech Republic | GSK Investigational Site | Decin | |
Czech Republic | GSK Investigational Site | Frydek-Mistek | |
Czech Republic | GSK Investigational Site | Havlickuv Brod | |
Czech Republic | GSK Investigational Site | Hlinsko v Cechach | |
Czech Republic | GSK Investigational Site | Jicin | |
Czech Republic | GSK Investigational Site | Jindrichuv Hradec | |
Czech Republic | GSK Investigational Site | Karvina | |
Czech Republic | GSK Investigational Site | Litomerice | |
Czech Republic | GSK Investigational Site | Nachod | |
Czech Republic | GSK Investigational Site | Ostrava | |
Czech Republic | GSK Investigational Site | Pardubice | |
Czech Republic | GSK Investigational Site | Praha 2 | |
Czech Republic | GSK Investigational Site | Praha 4 | |
Czech Republic | GSK Investigational Site | Praha 5 | |
Czech Republic | GSK Investigational Site | Praha 6 | |
Czech Republic | GSK Investigational Site | Praha 8 | |
Czech Republic | GSK Investigational Site | Praha 9 | |
Czech Republic | GSK Investigational Site | Usti nad Labem | |
Czech Republic | GSK Investigational Site | Usti nad Labem | |
Czech Republic | GSK Investigational Site | Znojmo | |
Slovakia | GSK Investigational Site | Dolny Kubin | |
Slovakia | GSK Investigational Site | Dubnica Nad Vahom | |
Slovakia | GSK Investigational Site | Kostany Nad Turcom | |
Slovakia | GSK Investigational Site | Liptovsky Hradok | |
Slovakia | GSK Investigational Site | Liptovsky Mikulas | |
Slovakia | GSK Investigational Site | Martin | |
Slovakia | GSK Investigational Site | Namestovo | |
Slovakia | GSK Investigational Site | Nitra | |
Slovakia | GSK Investigational Site | Nova Dubnica | |
Slovakia | GSK Investigational Site | Nove Mesto nad Vahom | |
Slovakia | GSK Investigational Site | Nove Zamky | |
Slovakia | GSK Investigational Site | Povazska Bystrica | |
Slovakia | GSK Investigational Site | Puchov | |
Slovakia | GSK Investigational Site | Ruzomberok | |
Slovakia | GSK Investigational Site | Sturovo | |
Slovakia | GSK Investigational Site | Sucany | |
Slovakia | GSK Investigational Site | Surany | |
Slovakia | GSK Investigational Site | Trencin | |
Slovakia | GSK Investigational Site | Zlate Moravce |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Czech Republic, Slovakia,
Poolman J, Frasch C, Nurkka A, Käyhty 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. |
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