Hepatitis B Challenge Dose in Adults
This study has been completed.
Sponsor:
Sanofi Pasteur MSD
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
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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 May 16, 2013