Hepatitis A, Hepatitis B
Conditions
Keywords
Twinrix, Long-term follow-up, Persistence, Hepatitis A, Antibody, Immunity, Hepatitis B, Combination vaccine, Adult
Brief summary
The purpose of this study is to assess the long-term persistence of immunity to hepatitis A and B in adults who were vaccinated 16-20 years earlier with the combined hepatitis A and hepatitis B vaccine, Twinrix.
Interventions
PROCEDUREBlood sampling
At Years 16 - 20 after first dose of the primary vaccination in HAB-084 (208127/084) study.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female who received two/three doses of Twinrix according to his/her group allocation in study HAB-084 (208127/084), and received no further dose of any hepatitis A and/or B vaccine since then. * Written informed consent obtained from the subject.
Exclusion criteria
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to study entry. Inhaled and topical steroids are allowed. * Administration of long-acting immune-modifying drugs within six months prior to the study entry. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device). * Administration of any hepatitis A and/or B vaccine at any time since completion of the primary vaccination series in HAB-084 (208127/084) study, including a challenge dose of the study vaccine, as a part of the study procedures, during the long-term persistence phase. * Documented history of hepatitis A or B disease since completion of the primary vaccination series in HAB-084 (208127/084) study. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Administration of immunoglobulins within six months prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity with respect to components of the study vaccine in terms of antibody titres | At each long-term follow-up (LTFU) visit (16-20 years after the first dose of primary vaccination) |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of Serious adverse events (SAEs) | During the entire study period (Year 16-20) |
Countries
Czechia
Outcome results
None listed