Trial intelligence / Profile preview

Phase III infant primary and booster vaccination study of Hib-MenC plus Infanrix-IPV versus licensed MenC vaccine plus Pediacel

2004-003769-33Phase 3Completed

Sponsor
GSK
Start
Jul 2005
Modality
Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
Countries
1
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Overview

Phase 3, double-blind trial of Hib-MenC-TT, tetanus toxoid + diphtheria toxoid + acellular pertussis + inactivated poliovirus vaccine, diphtheria toxoid + tetanus toxoid + acellular pertussis vaccine + inactivated poliovirus vaccine + haemophilus influenzae type b conjugate vaccine and Meningococcal group C polysaccharide conjugate vaccine in Haemophilus influenzae type b disease (Hib) and meningococcal group C disease (2 arms), sponsored by GSK. Primary endpoints: Primary vaccination immunogenicity and Booster phase immunogenicity. Started Jul 2005; status: completed.

02

Drugs

Hib-MenC-TTtetanus toxoid + diphtheria toxoid + acellular pertussis + inactivated poliovirus vaccinediphtheria toxoid + tetanus toxoid + acellular pertussis vaccine + inactivated poliovirus vaccine + haemophilus influenzae type b conjugate vaccineMeningococcal group C polysaccharide conjugate vaccine
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Conditions

Haemophilus influenzae type b disease (Hib)meningococcal group C disease

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