Safety and Immunogenicity of a Paediatric Dose of Virosomal Hepatitis A Vaccine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2012-04-30

Brief Summary

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The primary purpose of the original study was to assess whether the protection afforded by the paediatric dose of Epaxal vaccine against hepatitis A was not inferior to the protection afforded by the standard dose of Epaxal. The aim of the follow-up phase was to perform a computer based modelling analysis of the long term protection afforded by the paediatric dose, and to compare this with the standard dose and also with an alternative hepatitis A vaccine (Havrix Junior).

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Detailed Description

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Conditions

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Hepatitis A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Epaxal 0.25 mL

Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6

Group Type EXPERIMENTAL

Epaxal 0.25 mL

Intervention Type BIOLOGICAL

12 IU hepatitis A antigen coupled to immunopotentiating reconstituted Influenza virosome (IRIV)

Epaxal 0.5 mL

Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6

Group Type ACTIVE_COMPARATOR

Epaxal 0.5 mL

Intervention Type BIOLOGICAL

24 IU hepatitis A antigen coupled to IRIV

Havrix Junior

Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6

Group Type ACTIVE_COMPARATOR

Havrix Junior 0.5 mL

Intervention Type BIOLOGICAL

720 EU hepatitis A antigen absorbed onto aluminum hydroxide

Interventions

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Epaxal 0.25 mL

12 IU hepatitis A antigen coupled to immunopotentiating reconstituted Influenza virosome (IRIV)

Intervention Type BIOLOGICAL

Epaxal 0.5 mL

24 IU hepatitis A antigen coupled to IRIV

Intervention Type BIOLOGICAL

Havrix Junior 0.5 mL

720 EU hepatitis A antigen absorbed onto aluminum hydroxide

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Original study:

* Males or females aged \>=12 months and 16 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject when applicable and from the parent/legal guardian of the subject. - Free of obvious health problems as established by medical history and/or clinical examination before entering the study.

Follow up phase:

* Subjects enrolled and randomized in the primary study and having received two doses of the study vaccine

Exclusion Criteria

* Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this means prednisone, or equivalent, \>=0.5 mg/kg/day. Inhaled and topical steroids were allowed.)
* Planned administration/administration of a vaccine not foreseen by the study protocol within 4 weeks prior to the first dose of study vaccine
* Previous vaccination against hepatitis A
* Seropositive for anti-HAV antibodies (\>=10 mIU/mL)
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness
* Acute disease at the time of enrolment

Minimum Eligible Age

12 Months

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes