Last updated: 11/03/2018 20:16:28
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)
GSK study ID
117307
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: 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)
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Immunogenicity with respect to components of the study vaccine in terms of antibody titres
Timeframe: At each long-term follow-up (LTFU) visit (16-20 years after the first dose of primary vaccination)
Secondary outcomes:
Occurrence of Serious adverse events (SAEs)
Timeframe: During the entire study period (Year 16-20)
Interventions:
Enrollment:
0
Primary completion date:
2019-01-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Exclusion criteria:
- 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.
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.
Trial location(s)
Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01
Status
Will Be Recruiting
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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