Study of an Investigational Vaccine in Healthy Infants in Taiwan (V441-001)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Poliomyelitis; Diphtheria; Tetanus; Hepatitis B; Pertussis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092469

V441-001

2004_079

Details and patient eligibility

About

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.

Full description

The duration of treatment is 65 weeks.

Sex: All

Ages: 6 to 8 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy infant who received Hepatitis B vaccine within 5 days of birth and whose mother is negative to Hepatitis B surface antigen

Exclusion criteria

• Problems with immune system
• Recent illness with fever

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)