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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®

Primary Purpose

Hepatitis A

Status

Withdrawn

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

Blood sampling

About this trial

This is an interventional prevention trial for Hepatitis A focused on measuring Long-term persistence, Havrix, Hepatitis A

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HAV Group

Arm Description

Subjects who were previously vaccinated with Havrix in primary studies.

Outcomes

Primary Outcome Measures

Immunogenicity with respect to components of the study vaccine in terms of anti-HAV seropositivity status and GMCs.

Secondary Outcome Measures

Occurrence of serious adverse events (SAEs).

Full Information

NCT ID

NCT02124785

First Posted

April 24, 2014

Last Updated

November 16, 2015

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT02124785

Brief Title

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®

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Withdrawn

Why Stopped

This study has been cancelled before initiation due to company's prioritisation decisions linked to resources restrictions.

Study Start Date

May 2015 (undefined)

Primary Completion Date

July 2019 (Anticipated)

Study Completion Date

July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis A

Keywords

Long-term persistence, Havrix, Hepatitis A

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HAV Group

Arm Type

Experimental

Arm Description

Subjects who were previously vaccinated with Havrix in primary studies.

Intervention Type

Procedure

Intervention Name(s)

Blood sampling

Intervention Description

At Years 21 to 25 after their second vaccine dose.

Primary Outcome Measure Information:

Title

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.

Secondary Outcome Measure Information:

Title

Occurrence of serious adverse events (SAEs).

Time Frame

During the entire study period (Year 21 to Year 25).

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

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®

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