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Safety and Immunogenicity of Hexavalent Vaccine HR5I Formulations in Infants
NCT00551915Phase 2Completed
- Sponsor
- Merck & Co.
- Start
- May 2001
- Primary completion
- Jan 2003
- Modality
- Split/Subunit Vaccines
01
Overview
Phase 2, randomised, open-label trial of DTaP-IPV-Hep B-PRP-T vaccine in diphtheria, Tetanus, pertussis and 3 more (4 arms), sponsored by Merck & Co. Primary endpoints: Percentage of participants with anti-PRP antibodies >1.0 μg/mL at 7 months, Percentage of participants with anti-HBsAg antibodies ≥10 mIU/L at 7 months and 4 more. Started May 2001; status: completed.
02
Drugs
DTaP-IPV-Hep B-PRP-T vaccine
03
Conditions
diphtheriaTetanuspertussispoliomyelitishepatitis B (HBV)
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