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Immunogenicity and Safety of Pentaxim in Chinese Infants
NCT00453570Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2007
- Primary completion
- Dec 2008
- Countries
- 1
- Sponsor
- Sanofi
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- diphtheriaTetanuspertussispoliomyelitisHaemophilus influenzae type b infection (Hib)
01
Overview
Phase 3, randomised, open-label trial of diphtheria toxoid + tetanus toxoid + acellular pertussis vaccine + inactivated poliovirus vaccine + haemophilus influenzae type b conjugate vaccine in diphtheria, Tetanus, pertussis and 2 more (3 arms), sponsored by Sanofi. Primary endpoint: Immunogenicity of DTacP-IPV//PRP~T combined vaccine. Started Mar 2007; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
Pentaxim (2, 3, 4 mo)
Pentaxim administered at 2, 3, and 4 months of age.
Pentaxim (3, 4, 5 mo)
Pentaxim administered at 3, 4, and 5 months of age.
Control (3, 4, 5 mo)
Separate DTacP, Act-HIB, and IPV vaccines administered at 3, 4, and 5 months of age.
03
Who it enrols
Healthy infants aged 2 months (60 to 74 days) born at full term with birth weight >= 2.5 kg.
04
Endpoints
Primary
Immunogenicity of DTacP-IPV//PRP~T combined vaccine
Secondary
Safety of DTacP-IPV//PRP~T combined vaccine
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