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®.

• Register: EUCTR
• Last refreshed on: 17 August 2015
• Main ID: EUCTR2013-001918-15-BE
• Date of registration: 25/04/2014
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: 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®.
• Scientific title: A phase IV, open-label, single-centre study to assess the long-term persistence of hepatitis A antibodies in healthy adults, primed 21 to 25 years earlier with GSK Biologicals’ hepatitis A vaccine Havrix® (SB208109) in studies HAV-112 (208109/108) or HAV-123 (208109/114). - HAV-248
• Date of first enrolment: 28/04/2014
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001918-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1

Countries of recruitment

Belgium

Contacts

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

Key inclusion & exclusion criteria

Inclusion criteria:
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

Exclusion criteria:
• 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Healthy volunteers (Vaccination against hepatitis A in healthy adults)
MedDRA version: 16.1 Level: LLT Classification code 10052551 Term: Hepatitis A virus System Organ Class: 100000004848

Intervention(s)

Trade Name: Havrix 1440 Adult
Product Name: Havrix 1440 Adult
Product Code: HAV 1140
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Hepatitis A (inactivated)
Current Sponsor code: HAV Antigen
Other descriptive name: HEPATITIS A VIRUS ANTIGEN (INACTIVATED)
Concentration unit: ELISA unit/ml enzyme-linked immunosorbent assay unit/millitre
Concentration type: equal
Concentration number: 1440-

Primary Outcome(s)

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.

Timepoint(s) of evaluation of this end point: 21 to 25 years after the second vaccine dose

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.

Primary end point(s): Immunogenicity with respect to components of the study vaccine in terms of anti-HAV seropositivity status and GMCs
-Anti-HAV seropositivity status and antibody concentrations

Secondary Outcome(s)

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 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)

Secondary ID(s)

116763

Source(s) of Monetary Support

GlaxoSmithKline Biologicals