NCT02124785

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®.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
1 year until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

4.2 years

First QC Date

April 24, 2014

Last Update Submit

November 16, 2015

Conditions

Hepatitis A

Keywords

Long-term persistenceHavrixHepatitis A

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Occurrence of serious adverse events (SAEs).

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

Study Arms (1)

HAV Group

EXPERIMENTAL

Subjects who were previously vaccinated with Havrix in primary studies.

Procedure: Blood sampling

Interventions

Blood samplingPROCEDURE

At Years 21 to 25 after their second vaccine dose.

HAV Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Wilrijk, 2610, Belgium

Location

MeSH Terms

Conditions

Hepatitis A

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2014

First Posted

April 28, 2014

Study Start

May 1, 2015

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

BE(1)