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Phase II study of investigational hexavalent infant vaccine versus Infanrix hexa in healthy infants
2006-000554-46Phase 2Completed
- Sponsor
- GSK
- Start
- Jun 2006
- Modality
- Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
- Countries
- 1
01
Overview
Phase 2, randomised, single-blind trial of pertussis filamentous haemagglutinin and diphtheria toxoid + tetanus toxoid + acellular pertussis vaccine + hepatitis B vaccine + inactivated poliovirus vaccine + Haemophilus influenzae type b conjugate vaccine in diphtheria, Tetanus, pertussis and 3 more (3 arms), sponsored by GSK. Primary endpoints: Immunogenicity one month after dose 3, Non-inferiority of preservative-free DSSITGDPa-HBV-IPV/Hib formulation and 1 more. Started Jun 2006; status: completed.
02
Drugs
pertussis filamentous haemagglutinindiphtheria toxoid + tetanus toxoid + acellular pertussis vaccine + hepatitis B vaccine + inactivated poliovirus vaccine + Haemophilus influenzae type b conjugate vaccine
03
Conditions
diphtheriaTetanuspertussishepatitis B (HBV)poliomyelitis
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