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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00129116 |
This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age. Antibody persistence and immune responses to booster vaccinations were additionally assessed at 12 to 18 months of age.
Condition | Intervention | Phase |
---|---|---|
Meningococcal Infection Haemophilus Infection |
Biological: Hib-MenCY-TT and Hib-MenC-TT vaccines |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | See Detailed Description |
Estimated Enrollment: | 400 |
Study Start Date: | March 2003 |
Primary & booster vaccination study to evaluate the immuno,reacto & safety of 3 diff. formulations of GSKBio'combined Haemophilus influenzae typeb-meningococcal serogroups C & Y-conjugate vaccine & one formulation of GSKBio' Haemophilus influenzae typeb-meningococcal serogroup C conjugate vaccine each given concomitantly With Infanrix penta (DTaP-IPV-HepB vaccine), vs Meningitec meningococcal SerogroupC conj.vaccine) given concomitantly With Infanrix hexa (DTaP-IPV-HepB-Hib vaccine) in infants according a 2-3-4 mth schedule
Ages Eligible for Study: | 6 Weeks to 12 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
GSK Investigational Site | |
Oudenaerde, Belgium, 9700 | |
GSK Investigational Site | |
Sint-Amandsberg, Belgium, 9040 | |
GSK Investigational Site | |
Gent, Belgium, 9000 | |
GSK Investigational Site | |
Drongen, Belgium, 9031 | |
GSK Investigational Site | |
Merelbeke, Belgium, 9820 | |
GSK Investigational Site | |
Asse, Belgium, 1730 | |
Germany | |
GSK Investigational Site | |
Berlin, Germany, 14197 | |
GSK Investigational Site | |
Berlin, Germany, 13355 | |
GSK Investigational Site | |
Berlin, Germany, 10315 | |
GSK Investigational Site | |
Berlin, Germany, 12627 | |
GSK Investigational Site | |
Hamburg, Germany, 22307 | |
Germany, Bayern | |
GSK Investigational Site | |
Muenchen, Bayern, Germany, 81675 | |
GSK Investigational Site | |
Noerdlingen, Bayern, Germany, 86720 | |
GSK Investigational Site | |
Cham, Bayern, Germany, 93413 | |
GSK Investigational Site | |
Olching, Bayern, Germany, 82140 | |
GSK Investigational Site | |
Kaufering, Bayern, Germany, 86916 | |
GSK Investigational Site | |
Muenchen, Bayern, Germany, 80939 | |
Germany, Nordrhein-Westfalen | |
GSK Investigational Site | |
Kirchlengern, Nordrhein-Westfalen, Germany, 32278 | |
GSK Investigational Site | |
Loehne, Nordrhein-Westfalen, Germany, 32584 | |
GSK Investigational Site | |
Detmold, Nordrhein-Westfalen, Germany, 32756 | |
Germany, Sachsen | |
GSK Investigational Site | |
Leipzig, Sachsen, Germany, 04178 | |
Germany, Schleswig-Holstein | |
GSK Investigational Site | |
Flensburg, Schleswig-Holstein, Germany, 24937 | |
GSK Investigational Site | |
Flensburg, Schleswig-Holstein, Germany, 24943 | |
GSK Investigational Site | |
Bredstedt, Schleswig-Holstein, Germany, 25821 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 792014/003, 100381 |
Study First Received: | August 10, 2005 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00129116 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Invasive bacterial disease caused by Hib Neisseria meningitidis serogroups C & Y |
Haemophilus Infections Bacterial Infections Meningococcal Infections Neisseria meningitidis |
Meningococcal infection Neisseriaceae Infections Gram-Negative Bacterial Infections |
Pasteurellaceae Infections Communicable Diseases Infection |