Immunisation of healthy adults with Twinrix Adult
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must satisfy the following criteria at entry into each of the long-term follow-up visits: •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 in the primary study HAB-028 (208127/021). •Written informed consent obtained from the subject. All subjects must satisfy the following criteria at entry into the challenge dose phase: •Subjects who the investigator believes that they can and will comply with the requirements of the protocol. •A male or female who received the complete primary vaccination course according to his/her group allocation in the primary study HAB-028 (208127/021). •Written informed consent obtained from the subject. •Subjects who participated in the LTFU phase of the HAB-028 (208127/021) study and for whom the antibody concentrations were below the cut-off (15 mIU/ml for anti-HAV antibodies, and/or below 10 mIU/ml for anti-HBs antibodies) at the last available follow-up time-point. •Female subjects of non-childbearing potential may be enrolled in the study. –Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause. •Female subjects of childbearing potential may be enrolled in the study, if the subject: – has practiced adequate contraception for 30 days prior to vaccination, and – has a negative pregnancy test on the day of vaccination, and – has agreed to continue adequate contraception for two months after the administration of the challenge dose. 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
Exclusion criteria: The following criteria should be checked before entry into each of the long-term follow-up visits. If any exclusion criterion applies, the subject must not be included in the study: •Use of any investigational or non-registered product (drug, vaccine or device) within 30 days prior to blood sampling. •Administration of a hepatitis A, hepatitis B or combined hepatitis A and B vaccine outside the study procedures, since the primary study HAB-028 (208127/021). •History of hepatitis A or hepatitis B infection since the primary study HAB-028 (208127/021). •Administration of hepatitis A or hepatitis B immunoglobulins and/or any blood products within three months prior to blood sampling. The following criteria should be checked before the challenge dose is administered. If any apply, the subject must not be included in the challenge dose phase: •Use of any investigational or non-registered product (drug, vaccine or device) within 30 days prior to study start or planned use during the study. •Administration of a hepatitis A, hepatitis B or combined hepatitis A and B vaccine between the last LTFU visit and the challenge dose visit. •History of hepatitis A or hepatitis B infection between the last LTFU visit and the challenge dose visit. •History of anaphylactic reactions following the administration of vaccines. •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. •Acute disease and/or fever at the time of enrolment. –Fever is defined as temperature = 37.5°C (99.5°F) on oral or axillary setting. –Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator. •Pregnant or lactating female. •Female planning to become pregnant or planning to discontinue contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate anti-HAV and anti-HBs antibody persistence at Years 16, 17, 18, 19 and 20 after a three-dose primary vaccination course with Twinrix Adult.;Secondary Objective: •To evaluate the immune response to a challenge dose of hepatitis A and/or B vaccine for subjects who became seronegative for anti-HAV antibodies and/or, whose anti-HBs antibody concentrations decreased below 10 mIU/ml during the follow-up period. •To evaluate the safety of a challenge dose of Engerix-B and/or Havrix in terms of unsolicited symptoms and serious adverse events (SAE). ;Primary end point(s): •Antibody persistence against the study vaccine antigen at each LTFU visit (Year 16-20): –Anti-HAV: percentage of seropositive subjects and GMCs. –Anti-HBs: percentage of seropositive subjects, subjects with anti-HBs concentrations =10 mIU/ml and GMCs. | — |
Countries
Belgium
Outcome results
None listed