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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®

NCT ID: NCT02124785

Last Updated: 2015-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2019-07-31

Brief Summary

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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

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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.

Conditions

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Hepatitis A

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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HAV Group

Subjects who were previously vaccinated with Havrix in primary studies.

Group Type EXPERIMENTAL

Blood sampling

Intervention Type PROCEDURE

At Years 21 to 25 after their second vaccine dose.

Interventions

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Blood sampling

At Years 21 to 25 after their second vaccine dose.

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Wilrijk, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2013-001918-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

116763

Identifier Type: -

Identifier Source: org_study_id