Immunogenicity and Persistence of GlaxoSmithKline (GSK) Biologicals' Havrix® in Healthy Adult Subjects Vaccinated at Infancy Under the Hepatitis A Universal Mass Vaccination (UMV) Program in Israel

NCT ID: NCT03183492

Last Updated: 2018-03-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-07
• Study Completion Date: 2019-01-28

Brief Summary

This study will evaluate the persistence, immunogenicity and safety of Havrix® (hepatitis A vaccine) in adults primed in infancy. The enrolled subjects will be assessed for circulating antibodies against hepatitis A and will also receive a challenge dose of Havrix Adult vaccine. In the present study, the anamnestic response will be assessed 30 days after the challenge dose.

Conditions

Hepatitis A

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HAV Group

Subjects who were vaccinated under UMV with 2 doses of Havrix® Junior at infancy and will receive a single challenge dose of Havrix Adult at Visit 1 (Day 1).

Group Type: EXPERIMENTAL

Havrix®

Intervention Type: BIOLOGICAL

One challenge dose of Havrix® administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Interventions

Havrix®

One challenge dose of Havrix® administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Intervention Type: BIOLOGICAL

Other Intervention Names

GSK Biologicals' inactivated hepatitis A vaccine

Eligibility Criteria

Inclusion Criteria

• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol
• Written informed consent obtained from the subject prior to performing any study specific procedure
• A male or female subject aged 18 to 19 years at the time of enrolment (up to but excluding the 20th birthday)
• Documented administration of 2 doses of Havrix® Junior in the second year of life
• Healthy subjects as established by medical history and clinical examination before entering into the study
• Female subjects of childbearing potential may be enrolled in the study, if the subject:

has practiced adequate contraception for 30 days prior to study vaccine administration, and has a negative pregnancy test on the day of vaccine administration, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study vaccine administration

Exclusion Criteria

• Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the dose of study vaccine (Day 29 to Day1), or planned use during the study period
• Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed
• Administration of long-acting immune-modifying drugs at any time during 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
• Administration of any hepatitis A vaccine dose, with the exception of the two doses of routine toddler vaccination for the subjects
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
• Planned enrolment in the Israel Defense Forces within 30 days of study enrolment or activity that would prohibit the subject to return for Visit 2
• Acute disease and/or fever at the time of enrolment Fever is defined as temperature ≥38.0°C / 100.4°F. The preferred location for measuring temperature in this study will be the oral cavity Subjects with a minor illness without fever may be enrolled at the discretion of the investigator
• Pregnant or lactating female
• Female planning to become pregnant or planning to discontinue contraceptive precautions

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

116762

Identifier Type: -

Identifier Source: org_study_id