- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02135666
Evaluation of the Long-term Hepatitis A and B Antibody Persistence in Healthy Adult Subjects, Primed 16 to 20 Years Earlier With GSK Biologicals' Combined Hepatitis A and B Vaccine, Twinrix® (SB208127) in Study HAB-084 (208127/084)
November 16, 2015 updated by: GlaxoSmithKline
Long-term Hepatitis A and B Antibody Persistence in Healthy Adult Subjects, Primed 16 to 20 Years Earlier With GSK Biologicals' Combined Hepatitis A and B Vaccine, Twinrix® (SB208127) in Study HAB-084 (208127/084)
The purpose of this study is to assess the long-term persistence of immunity to hepatitis A and B in adults who were vaccinated 16-20 years earlier with the combined hepatitis A and hepatitis B vaccine, Twinrix.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hradec Kralove, Czech Republic, 500 01
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- A male or female who received two/three doses of Twinrix according to his/her group allocation in study HAB-084 (208127/084), and received no further dose of any hepatitis A and/or B vaccine since then.
- Written informed consent obtained from the subject.
Exclusion Criteria:
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to study entry. Inhaled and topical steroids are allowed.
- Administration of long-acting immune-modifying drugs within six months prior to the study entry.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
- Administration of any hepatitis A and/or B vaccine at any time since completion of the primary vaccination series in HAB-084 (208127/084) study, including a challenge dose of the study vaccine, as a part of the study procedures, during the long-term persistence phase.
- Documented history of hepatitis A or B disease since completion of the primary vaccination series in HAB-084 (208127/084) study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Administration of immunoglobulins within six months prior to study entry.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 2-dose Primed Group
Adolescent subjects in this group received 2 doses of Twinrix Adult (720/20) (licensed as Ambirix in the EU) according to a 0, 6 months schedule in the primary study HAB-084 (208127/084).
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At Years 16 - 20 after first dose of the primary vaccination in HAB-084 (208127/084) study.
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Experimental: 3-dose Primed Group
Adolescent subjects in this group received 3 doses of Twinrix Junior (360/10) according to a 0, 1, 6 months schedule in the primary study HAB-084 (208127/084).
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At Years 16 - 20 after first dose of the primary vaccination in HAB-084 (208127/084) study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Immunogenicity with respect to components of the study vaccine in terms of antibody titres
Time Frame: At each long-term follow-up (LTFU) visit (16-20 years after the first dose of primary vaccination)
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At each long-term follow-up (LTFU) visit (16-20 years after the first dose of primary vaccination)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of Serious adverse events (SAEs)
Time Frame: During the entire study period (Year 16-20)
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During the entire study period (Year 16-20)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Anticipated)
October 1, 2019
Study Completion (Anticipated)
October 1, 2019
Study Registration Dates
First Submitted
May 8, 2014
First Submitted That Met QC Criteria
May 8, 2014
First Posted (Estimate)
May 12, 2014
Study Record Updates
Last Update Posted (Estimate)
November 18, 2015
Last Update Submitted That Met QC Criteria
November 16, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 117307
- 2013-004586-13 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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