Study in Healthy Young Adults to Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured by a Process Upgrade - Assessment of Hepatitis B Vaccine Manufactured by a Process Upgrade

• Conditions: Acute hepatitis B without delta-agent and without hepatic coma; MedDRA version: 7.1Level: LLTClassification code 10019731

• Registration Number: EUCTR2004-005023-18-FI
• Lead Sponsor: Merck & Co., Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 860

Inclusion Criteria

1. Twenty to 35 years of age.
2. In general good health based on a medical history taken on Day 1 prior to receiving the first injection of vaccine. Any underlying chronic illness must be documented to be in stable condition.
3. For women, a negative urine pregnancy test just prior to vaccination on Day 1.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of previous hepatitis B infection.
2. History of vaccination with any hepatitis B vaccine.
3. Recent (less than 72 hours) history of febrile illness (oral temperature =37.7ºC/100.0ºF).
4. Known or suspected hypersensitivity to any component of RECOMBIVAX HB vaccine (e.g., aluminum, yeast).
5. Recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product.
6. Receipt of licensed inactivated vaccines within 14 days prior to first injection with the study vaccine. Receipt of licensed live virus vaccines within the 30 days prior to injection with the study vaccine.
7. Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine.
8. Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids.
9. Pregnant women, nursing mothers, and women planning to become pregnant within the study period.
10. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified