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)

NCT ID: NCT02135666

Last Updated: 2015-11-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2019-10-31

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.

Conditions

Hepatitis B; Hepatitis A

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Blood sampling

Intervention Type: PROCEDURE

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

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).

Group Type: EXPERIMENTAL

Blood sampling

Intervention Type: PROCEDURE

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

Interventions

Blood sampling

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Hradec Králové, , Czechia

Countries

Czechia

Other Identifiers

2013-004586-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

117307

Identifier Type: -

Identifier Source: org_study_id