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A Research Study to Test Safety and Tolerance of a Vaccine for Hepatitis B Manufactured With an Upgrade to the Production Process

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00489099
First received: June 20, 2007
Last updated: March 11, 2009
Last verified: March 2009
History of Changes
  Purpose

A study to evaluate the safety, tolerability and effectiveness of a hepatitis B vaccine that is being manufactured using an upgrade to the process


Condition Intervention Phase
Hepatitis B
 Biological: V232, Hepatitis B Vaccine (Recombinant) / Duration of Treatment: 7 Months
 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: Treatment
Official Title: A Study in Healthy Young Adults To Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With a Process Upgrade

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • That the hepatitis B vaccine manufactured using the process upgrade will show the same level of protection against hepatitis B as the prior manufacturing process as evidence by a blood test [ Time Frame: after 7 weeks of treatment ]

Secondary Outcome Measures:
  • The process upgrade vaccine will be generally well tolerated when compared with the current manufacturing process vaccine.

Enrollment: 860
Study Start Date: April 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 20 to 35 years of age in general good health
  • Female patients must test negative for pregnancy

Exclusion Criteria:

  • History of Hepatitis B Infection or vaccine
  • Participation on prior study using an investigational drug or vaccine in prior 3 months
  • Pregnant or nursing women or women planning to become pregnant within the study period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489099

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Publications:

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00489099     History of Changes
Other Study ID Numbers: 2007_565, V232-054
Study First Received: June 20, 2007
Last Updated: March 11, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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 June 17, 2013