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)

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT02135666

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B Hepatitis A	Procedure: Blood sampling	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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)

Study Start Date :

May 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2019

Anticipated Study Completion Date :

Oct 1, 2019

Arms and Interventions

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).	Procedure: Blood sampling At Years 16 - 20 after first dose of the primary vaccination in HAB-084 (208127/084) study.
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).	Procedure: Blood sampling At Years 16 - 20 after first dose of the primary vaccination in HAB-084 (208127/084) study.

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).

Procedure: Blood sampling

At Years 16 - 20 after first dose of the primary vaccination in HAB-084 (208127/084) study.

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).

Procedure: Blood sampling

At Years 16 - 20 after first dose of the primary vaccination in HAB-084 (208127/084) study.

Outcome Measures

Primary Outcome Measures

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

Occurrence of Serious adverse events (SAEs) [During the entire study period (Year 16-20)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.