A Registration Study of the Safety, Tolerability, and Immunogenicity of V441 in Healthy Infants in Taiwan

NCT00092469 Phase 3 COMPLETED

The purpose of this study is to evaluate the safety, tolerability, and immune response of an investigational vaccine being evaluated to reduce the incidence of diphtheria, pertussis, tetanus, hepatitis B, poliomyelitis, and Haemophilus influenza type b.

Details

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	COMPLETED
Enrolment	151
Start date	2002-03
Completion	2003-08

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Hepatitis B
• Poliomyelitis

Interventions

• V441, diptheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant), & Haemophilus influenza type b conjugate vaccine

Primary outcomes

• Tolerability and immune responses adequate to be protective against diphtheria, tetanus, pertussis, polio, Haemophilus Influenzae Type B, and Hepatitis B.