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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02135666
Other study ID # 117307
Secondary ID 2013-004586-13
Status Withdrawn
Phase Phase 4
First received May 8, 2014
Last updated November 16, 2015
Start date May 2015
Est. completion date October 2019

Study information

Verified date November 2015
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHPCzech Republic: State Institute for Drug Control
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the long-term persistence of immunity to hepatitis A and B in adults who were vaccinated 16-20 years earlier with the combined hepatitis A and hepatitis B vaccine, Twinrix.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2019
Est. primary completion date October 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

- A male or female who received two/three doses of Twinrix according to his/her group allocation in study HAB-084 (208127/084), and received no further dose of any hepatitis A and/or B vaccine since then.

- Written informed consent obtained from the subject.

Exclusion Criteria:

- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to study entry. Inhaled and topical steroids are allowed.

- Administration of long-acting immune-modifying drugs within six months prior to the study entry.

- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).

- Administration of any hepatitis A and/or B vaccine at any time since completion of the primary vaccination series in HAB-084 (208127/084) study, including a challenge dose of the study vaccine, as a part of the study procedures, during the long-term persistence phase.

- Documented history of hepatitis A or B disease since completion of the primary vaccination series in HAB-084 (208127/084) study.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

- Administration of immunoglobulins within six months prior to study entry.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Procedure:
Blood sampling
At Years 16 - 20 after first dose of the primary vaccination in HAB-084 (208127/084) study.

Locations

Country Name City State
Czech Republic GSK Investigational Site Hradec Kralove

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type Measure Description Time frame Safety issue
Primary Immunogenicity with respect to components of the study vaccine in terms of antibody titres At each long-term follow-up (LTFU) visit (16-20 years after the first dose of primary vaccination) No
Secondary Occurrence of Serious adverse events (SAEs) During the entire study period (Year 16-20) No
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