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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00092469
• Other study ID #: V441-001
• Secondary ID: 2004_079
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2004
• Last updated: October 6, 2015
• Start date: March 2002
• Est. completion date: August 2003

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

The duration of treatment is 65 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 8 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Hepatitis B
• Pertussis
• Poliomyelitis
• Tetanus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

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