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

A Phase II Open, Randomised, Controlled Study to Evaluate the Safety and Immunogenicity of a Paediatric Dose (0.25 mL) and the Standard Dose (0.5 mL) of Epaxal® With Reference to Havrix Junior® Healthy in Healthy Children and Adolescents (>=12 Months - 16 Years of Age) Using a 0/6 Month Schedule

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01405677

Enrollment

308

Registered

2011-07-29

Start date

2004-06-30

Completion date

2012-04-30

Last updated

2014-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis A

Keywords

Hepatitis A, Vaccination, Immunisation

Brief summary

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).

Interventions

BIOLOGICALEpaxal 0.25 mL

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

BIOLOGICALEpaxal 0.5 mL

24 IU hepatitis A antigen coupled to IRIV

BIOLOGICALHavrix Junior 0.5 mL

720 EU hepatitis A antigen absorbed onto aluminum hydroxide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Months to 16 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Individual anti-HAV titers	66 months post-booster	Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection

Secondary

Measure	Time frame	Description
Geometric mean titers	18, 30, 42, 54, 66 months post-booster	—
Seroprotection	18, 30, 42, 54, 66 months post-booster	Porportion of subjects who are seroprotected calculated at each time point where seroprotection is defined as \>=10 mIU/mL

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026