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

Merck Sharp & Dohme LLC151 enrolled

Overview

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.

The duration of treatment is 65 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

151

Conditions

Diphtheria Tetanus Pertussis Hepatitis B Poliomyelitis

Interventions

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

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 8 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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