Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00440531
First received: February 26, 2007
Last updated: March 31, 2009
Last verified: March 2009
  Purpose

The purpose of this trial is to determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis B vaccine and a currently licensed hepatitis B vaccine (RECOMBIVAX HB™).


Condition Intervention Phase
Hepatitis B
Biological: Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant)
Biological: Comparator: Modified Process Hepatitis B Vaccine (Experimental)
Biological: Comparator: ENGERIX-B™ (currently licensed product)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine) [ Time Frame: 7 months (1 month after third vaccination) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine) [ Time Frame: 7 months (1 month after third vaccination) ] [ Designated as safety issue: No ]
  • The Total Number of Participants With One or More Injection-Site Adverse Experiences [ Time Frame: Days 1-5 After Any Vaccination ] [ Designated as safety issue: Yes ]
  • The Total Number of Participants With a Maximum Temperature >=100.0F/37.8C [ Time Frame: Day 1-5 After Vaccination ] [ Designated as safety issue: Yes ]
  • The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences [ Time Frame: During Entire Study Period (from first vaccination until the participant completes or discontinues: up to 7 months) ] [ Designated as safety issue: Yes ]

Enrollment: 540
Study Start Date: November 2006
Study Completion Date: February 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
RECOMBIVAX HB™
Biological: Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant)
RECOMBIVAX HB™ (currently licensed product) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.
Experimental: 2
Modified Process Hepatitis B Vaccine
Biological: Comparator: Modified Process Hepatitis B Vaccine (Experimental)
Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.
Active Comparator: 3
ENGERIX-B™
Biological: Comparator: ENGERIX-B™ (currently licensed product)
ENGERIX-B™ given IM (Intramuscular) in 3 doses of 20 mcg (micrograms)/1.0 mL each over 6 months.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female older adults greater than or equal to 50 years of age

Exclusion Criteria:

  • Any adult with a history of previous hepatitis B infection
  • A history of vaccination with any hepatitis B vaccine
  • Recent (<72 hours) history of febrile illness (oral temperature =37.8ºC/=100.0ºF)
  • Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ or ENGERIX-B™ (e.g., aluminum, 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
  • 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
  • Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine
  • Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids
  • Pregnant women, nursing mothers, and women planning to become pregnant within the study period
  • Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440531

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00440531     History of Changes
Other Study ID Numbers: 2007_516, V232-059
Study First Received: February 26, 2007
Results First Received: November 11, 2008
Last Updated: March 31, 2009
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on April 20, 2014