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Safety and Immunogenicity of DAPTACEL as 5th Dose in Children Previously Immunized with PENTACEL
NCT00802867Phase 4
Key facts
- Status
- Completed
- Start
- Feb 2004
- Primary completion
- Jun 2005
- Countries
- 1
- Sponsor
- Sanofi
- Modality
- Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
- Conditions
- diphtheriaTetanuspertussis
01
Overview
Phase 4, open-label, single-arm trial of diphtheria and tetanus toxoids and acellular pertussis adsorbed in diphtheria, Tetanus and pertussis, sponsored by Sanofi. Primary endpoint: Percentage of Participants With Solicited Local or Systemic Reactions. Started Feb 2004; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Pentacel-primed subjects
Children 4-6 years old previously immunized with 4 doses of PENTACEL receiving DAPTACEL as a 5th dose.
03
Who it enrols
Children aged 4-6 years who have previously received 4 doses of PENTACEL vaccine in specific prior studies (494-01 or 494-03).
04
Endpoints
Primary
Percentage of Participants With Solicited Local or Systemic Reactions
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