Trial intelligence / Profile preview

Immunogenicity of Hexavalent DTaP-IPV-Hep B-PRP~T Vaccine in Argentinean Infants

NCT00831311Phase 2Completed

Sponsor
Sanofi
Start
Oct 2004
Primary completion
Nov 2005
Modality
Recombinant Proteins and Enzymes, Split/Subunit Vaccines
Countries
1
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Overview

Phase 2, randomised, open-label trial of DTaP-IPV-Hep B-PRP-T vaccine in diphtheria, Tetanus, pertussis and 3 more (2 arms), sponsored by Sanofi. Primary endpoints: Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies, Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies at Day 150 and 2 more. Started Oct 2004; status: completed.

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Drugs

DTaP-IPV-Hep B-PRP-T vaccine
03

Conditions

diphtheriaTetanuspertussishepatitis B (HBV)poliomyelitis

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