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®

November 16, 2015 updated by: GlaxoSmithKline

Long-term Persistence of Hepatitis A Antibodies in Healthy Adults, Primed 21 to 25 Years Earlier With GSK Biologicals' Hepatitis A Vaccine Havrix® (SB208109) in Studies HAV-112 (208109/108) or HAV-123 (208109/114)

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®.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Wilrijk, Belgium, 2610
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HAV Group
Subjects who were previously vaccinated with Havrix in primary studies.
Procedure: Blood sampling
At Years 21 to 25 after their second vaccine dose.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of serious adverse events (SAEs).
Time Frame: During the entire study period (Year 21 to Year 25).
During the entire study period (Year 21 to Year 25).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

April 24, 2014

First Submitted That Met QC Criteria

April 24, 2014

First Posted (Estimate)

April 28, 2014

Study Record Updates

Last Update Posted (Estimate)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 116763
  • 2013-001918-15 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis A

Clinical Trials on Blood sampling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe