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.
Conditions
Interventions
Trade Name: Twinrix Adult
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Hepatitis A (inactivated)
Concentration unit: ELISA unit/ml enzyme-linked immunosorbent assay unit/millitre
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the anti-HAV and anti-HBs immune memory (in terms of anti-HAV and anti-HBs immune response elicited by the challenge dose) in a population > 41 years of age (healthy and non-healthy), approximately 48 months after the first dose of the primary vaccination course.;Secondary Objective: To evaluate the long-term persistence elicited by Twinrix, Engerix-B /Havrix and HB VAX PRO /Vaqta, in terms of anti-HAV seropositivity rates and GMTs as well as anti-HBs seropositivity rates, seroprotection rates and GMTs at Month 48. To evaluate the immune response to the challenge dose, two weeks (Day 14) and one month (Day 30) after vaccination. To retrospectively evaluate all serious adverse events (SAEs) with causal relationship to vaccination or referring to hepatitis A or B infection from the previous study visit up to Month 48. To evaluate safety and reactogenicity of the challenge dose in terms of: solicited symptoms occurring during the 4-day (Day 0 to Day 3) follow-up period. unsolicited symptoms occurring during the 31-day (Day 0 to Day 30) follow-up period. all SAEs following the challenge dose administration. ;Primary end point(s): • Anti-HAV immune response to the challenge dose is defined as: ? Anti-HAV antibody titres >= 15 mIU/ml at one month post-challenge dose in subjects, seronegative at the pre-challenge time point. ? At least a 2-fold increase in anti-HAV antibody titres one month after the challenge dose, in subjects having anti-HAV antibody titres >= 100 mIU/ml at the pre-challenge time point ? or at least a 4-fold increase in anti-HAV antibody titres one month after the challenge dose, in seropositive subjects having anti-HAV antibody titres = 10 mIU/ml at one month post-challenge dose in subjects seronegative at the pre-challenge time point. ? At least a 4-fold increase in anti-HBs antibody titres, at one month post-challenge dose in subjects seropositive at the pre-challenge time point. | — |
Countries
Belgium, Czech Republic
Outcome results
None listed