Evaluation of the Long-term Persistence of Hepatitis A Antibodies in Healthy Adults Who Were Vaccinated 21-25 Years Earlier With GlaxoSmithKline (GSK) Biologicals' Hepatitis A Vaccine, Havrix®

Phase 4

Withdrawn

• Conditions: Hepatitis A
• Interventions: Procedure: Blood sampling

• Registration Number: NCT02124785
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to assess the long-term persistence of immunity to hepatitis A in adults who were vaccinated 21-25 years earlier with hepatitis A vaccine, Havrix®.

Detailed Description

This is a long-term persistence study in which subjects who participated in the primary studies HAV-112 (208109/108) or HAV-123 (208109/114) and did not receive an additional dose of hepatitis A vaccine since then, will be invited to provide a blood sample at Years 21 to 25 after their second vaccine dose. No vaccine will be administered during the study period.

Study Timeline

• Study First Submitted: 2014-04-24
• Study First Submitted QC: 2014-04-24
• Study First Posted: 2014-04-28
• Study Start: 2015-05
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-18
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• A male or female who received two doses of Havrix in study HAV-112 (208109/108) or HAV-123 (208109/114), and received no further booster dose since then.
• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. return for follow-up visits).
• Written informed consent obtained from the subject.

Read More

Exclusion Criteria

• History of hepatitis A disease since completion of the primary vaccination series in studies HAV-112 (208109/108) or HAV-123 (208109/114).
• Administration of a hepatitis A vaccine at any time since completion of the primary vaccination series in studies HAV-112 (208109/108) or HAV-123 (208109/114) including a challenge dose of the study vaccine, as a part of the study procedures, during the long-term persistence phase.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
• Administration of hepatitis A immunoglobulins and/or any blood products and/or long-acting immune-modifying drugs within six months prior to study entry.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study entry. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
• Administration of long-acting immune-modifying drugs within six months prior to study entry (e.g. infliximab).
• Concurrently participating in another clinical study during the period starting 30 days before and ending 30 days after each study visit, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HAV Group	Blood sampling	Subjects who were previously vaccinated with Havrix in primary studies.

Primary Outcome Measures

Name	Time	Method
Immunogenicity with respect to components of the study vaccine in terms of anti-HAV seropositivity status and GMCs.	21 to 25 years after the second vaccine dose.

Secondary Outcome Measures

Name	Time	Method
Occurrence of serious adverse events (SAEs).	During the entire study period (Year 21 to Year 25).

Trial Locations

Locations (1)

GSK Investigational Site; 🇧🇪 Wilrijk, Belgium