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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00489099
First received: June 20, 2007
Last updated: March 11, 2009
Last verified: March 2009
  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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489099

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  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 July 24, 2014