Healthy volunteers (Vaccination against hepatitis A and hepatitis B in healthy adults) MedDRA version: 16.1 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: TwinrixTM Adult
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Hepatitis A (inactivated)
Current Sponsor code: HAV Antigen
Other descriptive name: HEPATITIS A VIRUS ANT
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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 180 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 |
|---|---|
| Main Objective: •To evaluate the persistence of anti-HBs antibodies in terms of seroprotection rate and geometric mean concentrations (GMCs), 16 to 20 years after the first vaccine dose. •To evaluate the persistence of anti-HAV antibodies in terms of seropositivity rate and GMCs, 16 to 20 years after the first vaccine dose. ;Secondary Objective: •Occurrence of serious adverse events (SAEs) related to study participation, or to the study vaccine administered in the primary study HAB-084 (208127/084), during the entire study period.;Primary end point(s): Immunogenicity with respect to components of the study vaccine in terms of antibody titres. ?Anti-HAV seropositivity status and Geometric Mean Concentration (GMC), ?Anti-HBs seropositivity status, seroprotection status and GMC. ;Timepoint(s) of evaluation of this end point: At each long-term follow-up (LTFU) visit (16-20 years after the first dose of primary vaccination). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Occurrence of Serious adverse events (SAEs). -Occurrence of SAEs related to study participation or to the study vaccine administered in the primary study HAB-084 (208127/084).;Timepoint(s) of evaluation of this end point: During the entire study period (Year 16-20). | — |
Countries
Belgium
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed