Evaluation of the long-term persistence of hepatitis A antibodies in healthy adults who were vaccinated 21-25 years earlier with GlaxoSmithKline (GSK) Biologicals’ hepatitis A vaccine, Havrix®.
- Conditions
- Healthy volunteers (Vaccination against hepatitis A in healthy adults)MedDRA version: 16.1Level: LLTClassification code 10052551Term: Hepatitis A virusSystem Organ Class: 100000004848Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2013-001918-15-BE
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
A male or female who received two doses of Havrix in study HAV-112 (208109/108) or HAV-123 (208109/114), and received no further booster dose since then.
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. return for follow-up visits).
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 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
• History of hepatitis A disease since completion of the primary vaccination series in studies HAV-112 (208109/108) or HAV-123 (208109/114).
• Administration of a hepatitis A vaccine at any time since completion of the primary vaccination series in studies HAV-112 (208109/108) or HAV-123 (208109/114) including a challenge dose of the study vaccine, as a part of the study procedures, during the long-term persistence phase.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
• Administration of hepatitis A immunoglobulins and/or any blood products and/or long-acting immune-modifying drugs within six months prior to study entry.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study entry. For corticosteroids, this will mean prednisone >=20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
• Administration of long-acting immune-modifying drugs within six months prior to study entry (e.g. infliximab).
• Concurrently participating in another clinical study, during the period starting 30 days before and ending 30 days after each study visit, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the persistence of anti-HAV antibodies in terms of seropositivity rate and geometric mean concentration (GMC), 21 to 25 years after the second vaccine dose.;Secondary Objective: Occurrence of serious adverse events (SAEs) related to study participation, or to the study vaccine administered in the primary studies HAV-112 (208109/108) or HAV-123 (208109/114), during the entire study period.;Primary end point(s): Immunogenicity with respect to components of the study vaccine in terms of anti-HAV seropositivity status and GMCs<br>-Anti-HAV seropositivity status and antibody concentrations;Timepoint(s) of evaluation of this end point: 21 to 25 years after the second vaccine dose
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Occurrence of serious adverse events (SAEs).<br>Occurrence of SAEs related to study participation or to the study vaccine administered in the primary studies HAV-112 (208109/108) or HAV-123 (208109/114);Timepoint(s) of evaluation of this end point: During the entire study period (Year 21 to Year 25)