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A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00489099
First Posted: June 21, 2007
Last Update Posted: March 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B vaccine manufactured using an upgrade to the production process. The primary hypotheses tested at 1 month after the third dose of vaccine are the following: 1) the 3 lots of the process upgrade vaccine induce similar seroprotection rates to hepatitis B surface antigen (HBsAg), 2) the combined lots of the process upgrade vaccine induce adequate seroprotection to HBsAg, and 3) the process upgrade vaccine will induce geometric mean antibody titers to HBsAg that are non-inferior or superior to those induced by the current process vaccine.

Condition Intervention Phase
Hepatitis B Infection Biological: V232 Modified Process Hepatitis B Vaccine: Lot A Biological: V232 Modified Process Hepatitis B Vaccine: Lot B Biological: V232 Modified Process Hepatitis B Vaccine: Lot C Biological: V232 Current Process Hepatitis B Vaccine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 by a Process Upgrade

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants with Seroprotection to Hepatitis B Surface Antigen [ Time Frame: 1 month after the third vaccination (Month 7) ]
  • Geometric Mean Titers to Hepatitis B Surface Antigen [ Time Frame: 1 month after the third vaccination (Month 7) ]

Secondary Outcome Measures:
  • Percentage of Participants with an Adverse Experience [ Time Frame: Up to 15 days after any vaccination ]
  • Percentage of Participants with an Injection-site Adverse Experience [ Time Frame: Up to 15 days after any vaccination ]
  • Percentage of Participants with a Systemic Adverse Experience [ Time Frame: Up to 15 days after any vaccination ]
  • Percentage of Participants with Fever (>=37.8°C, 100.0°F) [ Time Frame: Up to 5 days after any vaccination ]

Enrollment: 860
Study Start Date: June 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V232 Modified Process Hepatitis B Vaccine: Lot A
Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot A administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
Biological: V232 Modified Process Hepatitis B Vaccine: Lot A
Experimental: V232 Modified Process Hepatitis B Vaccine: Lot B
Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot B administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
Biological: V232 Modified Process Hepatitis B Vaccine: Lot B
Experimental: V232 Modified Process Hepatitis B Vaccine: Lot C
Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot C administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
Biological: V232 Modified Process Hepatitis B Vaccine: Lot C
Active Comparator: V232 Current Process Hepatitis B Vaccine
Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) current process administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
Biological: V232 Current Process Hepatitis B Vaccine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • In general good health
  • Female participants have a negative pregnancy test just prior to vaccination on Day 1

Exclusion Criteria:

  • History of Hepatitis B Infection or vaccination
  • Known or suspected hypersensitivity to any component of Recombivax HB™ vaccine (e.g., aluminum, yeast)
  • Administration of hepatitis B immune globulin, serum immune globulin, or any other blood-derived product within 3 months prior to vaccination on Day 1
  • Receipt of an inactivated virus vaccine within 14 days or a live virus vaccine within 30 days prior to vaccination on Day 1
  • Participation on prior study using an investigational drug or vaccine in prior 3 months
  • Known or suspected impairment of immunologic function or recent use of immunomodulatory medications, excluding topical or inhaled steroids
  • Pregnant or nursing women or women planning to become pregnant within the study period
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489099


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

Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00489099     History of Changes
Other Study ID Numbers: V232-054
2007_565
First Submitted: June 20, 2007
First Posted: June 21, 2007
Last Update Posted: March 16, 2017
Last Verified: March 2017

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs