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Phase III infant study of Hiberix lot consistency and comparison with ActHIB and Pentacel
2013-004194-27Phase 3
- Sponsor
- GSK
- Start
- Jun 2015
- Modality
- Vaccines & Immunotherapeutics, Split/Subunit Vaccines → Inactivated Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics
- Countries
- 1
01
Overview
Phase 3, randomised, double-blind trial of haemophilus influenzae type b vaccine and Bordetella pertussis toxoid antigen (glutaraldehyde inactivated) in Haemophilus influenzae type b disease (Hib) (5 arms), sponsored by GSK. Primary endpoints: Consistency of immune response post-dose 3 to PRP across 3 Hiberix lots, Post-primary immunogenicity to PRP and 1 more.
02
Drugs
haemophilus influenzae type b vaccineBordetella pertussis toxoid antigen (glutaraldehyde inactivated)
03
Conditions
Haemophilus influenzae type b disease (Hib)
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