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Immunogenicity of Pentacel Given Concurrently or Staggered with Prevnar
NCT00772928Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2003
- Primary completion
- May 2006
- Countries
- 1
- Sponsor
- Sanofi
- Modality
- Split/Subunit Vaccines
- Drugs
- pertactin
- Conditions
- diphtheriaTetanuspertussispoliomyelitisHaemophilus influenzae type b infection (Hib)
01
Overview
Phase 3, randomised, open-label trial of pertactin in diphtheria, Tetanus, pertussis and 2 more (2 arms), sponsored by Sanofi. Primary endpoints: Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 and Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus. Started Oct 2003; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Concurrent
Pentacel administered concurrently with Prevnar
Staggered
Pentacel administered at different times from Prevnar
03
Who it enrols
Healthy infants 2 months of age (42-89 days) with at least 36 weeks gestation, having received 1 dose of Hepatitis B vaccine. Excludes those with HIV, immune impairment, or prior receipt of study vaccine components.
04
Endpoints
Primary
Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3
Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus
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