Trial intelligence / Profile preview

Safety and Immunogenicity of DTaP-Hep B-PRP-T vs Tritanrix-HepB/Hib in Filipino Infants

NCT00348881Phase 3Completed

Sponsor
Sanofi
Start
Jun 2006
Primary completion
Oct 2007
Modality
Vaccines & Immunotherapeutics
Countries
1
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Overview

Phase 3, randomised, double-blind trial of diphtheria + tetanus + acellular pertussis + hepatitis B + haemophilus influenzae type b conjugate vaccine in diphtheria, Tetanus, pertussis and 2 more (2 arms), sponsored by Sanofi. Primary endpoints: Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies and Number of Participants With Observed High Fever. Started Jun 2006; status: completed.

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Drugs

diphtheria + tetanus + acellular pertussis + hepatitis B + haemophilus influenzae type b conjugate vaccine
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Conditions

diphtheriaTetanuspertussishepatitis B (HBV)Haemophilus influenzae type b infection (Hib)

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