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)
Phase 4
Withdrawn
- Conditions
- Hepatitis BHepatitis A
- Registration Number
- NCT02135666
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Immunogenicity with respect to components of the study vaccine in terms of antibody titres At each long-term follow-up (LTFU) visit (16-20 years after the first dose of primary vaccination)
- Secondary Outcome Measures
Name Time Method Occurrence of Serious adverse events (SAEs) During the entire study period (Year 16-20)
Trial Locations
- Locations (1)
GSK Investigational Site
🇨🇿Hradec Kralove, Czech Republic
GSK Investigational Site🇨🇿Hradec Kralove, Czech Republic