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Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00440531
First received: February 26, 2007
Last updated: March 31, 2009
Last verified: March 2009
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided by Merck

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 May 23, 2013