Trial intelligence / Profile preview

Infanrix hexa primary infant vaccination study with comparator vaccines

2013-004304-19Phase 3

Sponsor
GSK
Start
Jul 2015
Modality
Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes, Split/Subunit Vaccines → Inactivated Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics
Countries
1
01

Overview

Phase 3, randomised, open-label trial of pertussis filamentous haemagglutinin, Bordetella pertussis toxoid antigen (glutaraldehyde inactivated), haemophilus influenzae type b vaccine, Hepatitis B vaccine, pneumococcal 7-valent conjugate vaccine and 2 more in diphtheria, Tetanus, pertussis and 5 more (2 arms), sponsored by GSK. Primary endpoint: Primary immunogenicity endpoint.

02

Drugs

pertussis filamentous haemagglutininBordetella pertussis toxoid antigen (glutaraldehyde inactivated)haemophilus influenzae type b vaccineHepatitis B vaccinepneumococcal 7-valent conjugate vaccine
03

Conditions

diphtheriaTetanuspertussishepatitis B (HBV)poliomyelitis

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