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
Withdrawn
Withdrawn
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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:
Procedure/surgery: Blood sampling
Enrollment:
0
Observational study model:
Not applicable
Primary completion date:
2019-01-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
SB208127
Collaborators
Not applicable
Study date(s)
May 2015 to October 2019
Type
Interventional
Phase
4

Participation criteria

Sex
Female & Male
Age
18 - 64 years
Accepts healthy volunteers
Yes
  • 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.

Trial location(s)

Location
Status
Contact us
Contact us
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
Withdrawn
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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