Hepatitis B Challenge Dose in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT01251276
First received: November 23, 2010
Last updated: October 10, 2011
Last verified: October 2011
  Purpose

Primary objective:

=> To describe the Seroprotection rate (SPR) at least 2 years following completion of a primary series with an Hepatitis B vaccine and 1 month following a challenge dose of HBVaxPro.

Secondary Objective:

=> To describe the safety and tolerability of a challenge dose of HBVaxPro in adults ≥50 years of age.


Condition Intervention Phase
Hepatitis B
Biological: 1 dose at Day 1
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Study to Estimate the Immune Response Following a Challenge Dose in Adults (≥50 Years Old) Vaccinated With a Primary Series of an Hepatitis B Vaccine

Resource links provided by NLM:


Further study details as provided by Sanofi Pasteur MSD:

Primary Outcome Measures:
  • Pre-challenge anti HBs seroprotection rate (percentage of subjects with titre >=10 mIU/mL) [ Time Frame: Day 1 (Day of vaccination) ] [ Designated as safety issue: No ]
  • Post-challenge anti HBs seroprotection rate (percentage of subjects with titre >=10 mIU/mL) [ Time Frame: 1 month post challenge dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Injection-site reactions, systemic injection site reactions, adverse events and serious adverse events [ Time Frame: Day 1 to Day 30 post challenge dose ] [ Designated as safety issue: No ]

Enrollment: 204
Study Start Date: November 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HBVaxPro Biological: 1 dose at Day 1
1 dose 10μg/mL (1mL)

  Eligibility

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

Inclusion Criteria:

  • In general good health based on a medical history.
  • Received 3 doses of an Hepatitis B vaccine at least 2 years prior to enrollment in this study.

Exclusion Criteria:

  • Known history of previous Hepatitis B infection.
  • History of vaccination with any Hepatitis B vaccine within the last 2 years.
  • History of febrile illness.
  • Known or suspected hypersensitivity to any component of HBVaxPro.
  • Receipt of medication / vaccine that may interfere with study assessments.
  • Known or suspected immune impairment.
  • Pregnant women and nursing mothers.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251276

Locations
Canada
Sanofi Pasteur MSD Investigational Site
Coquitlam, Canada
Sanofi Pasteur MSD Investigational Site
Gatineau, Canada
Sanofi Pasteur MSD Investigational Site
Halifax, Canada
Sanofi Pasteur MSD Investigational Site
Pointe Claire, Canada
Sanofi Pasteur MSD Investigational Site
Sherbrooke, Canada
Sanofi Pasteur MSD Investigational Site
Surrey, Canada
Sanofi Pasteur MSD Investigational Site
Toronto, Canada
Sanofi Pasteur MSD Investigational Site
Truro, Canada
Denmark
Sanofi Pasteur MSD Investigational Site
Arhus, Denmark
Sanofi Pasteur MSD Investigational Site
Odense C, Denmark
Sweden
Sanofi Pasteur MSD Investigational Site
Jönköping, Sweden
Sanofi Pasteur MSD Investigational Site
Umeå, Sweden
Sanofi Pasteur MSD Investigational Site
Uppsala, Sweden
Sanofi Pasteur MSD Investigational Site
Örebro, Sweden
United Kingdom
Sanofi Pasteur MSD Investigational Site
Addlestone, Surrey, United Kingdom
Sanofi Pasteur MSD Investigational Site
Bexhill on Sea, East Sussex, United Kingdom
Sanofi Pasteur MSD Investigational Site
Blackpool, Lancashire, United Kingdom
Sanofi Pasteur MSD Investigational Site
Bradford Upon Avon, United Kingdom
Sanofi Pasteur MSD Investigational Site
Yaxley, Peterborough, United Kingdom
Sponsors and Collaborators
Sanofi Pasteur MSD
Investigators
Study Director: Marie Wehrlen-Grandjean, MD Sanofi Pasteur MSD
  More Information

No publications provided

Responsible Party: Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT01251276     History of Changes
Other Study ID Numbers: rHB01C
Study First Received: November 23, 2010
Last Updated: October 10, 2011
Health Authority: Denmark: Danish Medicines Agency
Canada: Health Canada
Sweden: Medical Products Agency
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 April 17, 2014