A Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process - Older Adult Study

• Conditions: Hepatitis B; MedDRA version: 8.1Level: LLTClassification code 10019731Term: Hepatitis B

• Registration Number: EUCTR2006-003649-18-DK
• Lead Sponsor: Merck & Co. Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-16
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

• Generally healthy male and female adults =50 years of age.
• Prior to vaccination a full medical history.

Are the trial subjects under 18?
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Prior history of hepatitis B infection or vaccination with any hepatitis B vaccine
•Recent febrile illness
•Known or suspected hypersensitivity to any component of HBVAXPRO™ or ENGERIX-B™ (e.g., aluminium, yeast).
• 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.
• Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
• Known or suspected impairment of immunologic function or recent (within past 14 days) use of immunomodulatory medications (e.g., systemic corticosteroids
• Receipt of investigational drugs or other investigational vaccines within 14 days prior to first injection with the study vaccine.

Study & Design

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