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Withdrawn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 B; Hepatitis A
• Interventions: Procedure: Blood sampling

• 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

Study Timeline

• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2014-05-08
• Study First Posted: 2014-05-12
• Study Start: 2015-05
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-18
• Primary Completion: 2019-10
• Study Completion: 2019-10

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• Status: WITHDRAWN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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3-dose Primed Group	Blood sampling	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).
2-dose Primed Group	Blood sampling	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).

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