Study to evaluate antibody persistence & immune memory in subjects vaccinated during adolescence with Twinrix™.

• Conditions: Adult subjects who received a primary vaccination course with Twinrix Adult following a two-dose schedule or Twinrix Junior following a three-dose schedule as adolescents (12-15 years) approximately 11 to 15 years ago.; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2008-006083-11-CZ
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-27
• Last Update Posted: 28 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

All subjects must satisfy the following criteria at entry into each of the time-points of the long-term follow-up phase:
•Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
•A male or female who received the complete primary vaccination course according to his/her group allocation in the primary study HAB-084.
•Written informed consent obtained from the subject.
All subjects must satisfy the following criteria at entry into the challenge dose phase:
•A male or female who received the complete primary vaccination course according to his/her group allocation in the primary study HAB-084.
•Subjects who participated in the long-term follow-up phase of the HAB-084 study and for whom the antibody concentrations were below 15 mIU/ml for anti-HAV antibodies and/ or 10 mIU/ml for anti-HBs antibodies at the last available follow-up time-points.
•Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
•Written informed consent obtained from the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the challenge dose phase of this study.
•If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) 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 241
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 each follow-up visit. If any apply at study entry, the subject must not be included at that long-term follow-up visit.
•Use of any investigational or non-registered product (drug or vaccine) since the last blood sampling visit.
•Administration of a hepatitis A, hepatitis B or hepatitis combination vaccine since the primary vaccination course of the study HAB-084.
•History of hepatitis A or hepatitis B infection.
•Administration of hepatitis A or hepatitis B immunoglobulins and/or any blood products within 3 months prior to blood sampling.
The following criteria should be checked before the challenge dose phase. If any apply, the subject must not be included in the challenge dose phase:
•Use of any investigational or non-registered product (drug or vaccine) within 30 days before the administration of the challenge dose or planned use during the study period outside the context of the study.
•Administration of a hepatitis A, hepatitis B or hepatitis combination vaccine between the primary vaccination course of the study HAB-084 and the challenge dose visit.
•History of hepatitis A or hepatitis B infection.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose. (For corticosteroids, this will mean prednisone, or equivalent, ? 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
•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 temperature <37.5°C/ Axillary temperature <37.5°C).
•Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the challenge dose or planned administration before the final blood sampling point (one month after the challenge dose).
•Pregnant or lactating female.

Study & Design

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