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Safety and Immunogenicity of TdcP-IPV vs TdcP-IPV + Hepatitis B in Adolescents
NCT02040636Phase 2
Key facts
- Status
- Completed
- Start
- Jan 1999
- Primary completion
- May 2000
- Countries
- 1
- Sponsor
- Sanofi
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- Tetanusdiphtheriapertussispoliomyelitis
01
Overview
Phase 2, randomised, open-label trial of diphtheria + tetanus + acellular pertussis + inactivated poliovirus vaccine (adsorbed) in Tetanus, diphtheria, pertussis and 1 more (2 arms), sponsored by Sanofi. Primary endpoints: Seroprotection against diphtheria and tetanus antigens at 10 years, Geometric Mean Titers for Diphtheria and Tetanus at 10 years and 1 more. Started Jan 1999; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Study Group 1
TdcP-IPV at Day 0, Hep B at Months 1, 2, 7
Study Group 2
TdcP-IPV + Hep B at Day 28, Hep B at Months 2, 7
03
Who it enrols
Healthy adolescents 11-14 years of age without prior vaccination for relevant diseases within 5 years.
04
Endpoints
Primary
Seroprotection against diphtheria and tetanus antigens
Geometric Mean Titers for Diphtheria and Tetanus
Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events
Secondary
Geometric Mean Titers for Pertussis antibodies
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