EUCTR2008-000526-39-CZ
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GlaxoSmithKline Biologicals
- Enrollment
- 333
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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