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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092469

Enrollment

151

Registered

2004-09-27

Start date

2002-03-31

Completion date

2003-08-31

Last updated

2015-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diphtheria, Hepatitis B, Pertussis, Poliomyelitis, Tetanus

Brief summary

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.

Detailed description

The duration of treatment is 65 weeks.

Interventions

BIOLOGICALV441, diptheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant), & Haemophilus influenza type b conjugate vaccine

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Weeks to 8 Weeks

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026