A phase IV, open, multicentre, multicountry study to evaluate the immune response to a challenge dose of GSK Biologicals’ Twinrix™ vaccine versus monovalent hepatitis A and B vaccines from different manufacturers in healthy and non-healthy adults aged > 41 years, approximately 48 months after primary vaccination in study 100382 (HAB-160). - HAB-168 BST 160

• Conditions: Healthy and non-healthy (including those taking medications) adults older than 41 years who participated in the primary vaccination study HAB-160 approximately 48 months ago.

• Registration Number: EUCTR2008-000526-39-BE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 333

Inclusion Criteria

•Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
•A male or female who completed the primary vaccination phase of the HAB-160 study.
•Written informed consent obtained from the subject.
•If the subject is female, she must be of non-childbearing potential, i.e., either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e., intrauterine contraceptive device; oral/long term hormonal contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam) for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after the vaccination.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the challenge dose, or planned use during the study period.
•History of any hepatitis A or hepatitis B vaccination or infection since the primary vaccination study.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., Oral/ axillary temperature <37.5°C) [37.0°C for Czech Republic only].
•Pregnant or lactating female.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified