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

Phase 2

Completed

• Conditions: Hepatitis A
• Interventions: Biological: Epaxal 0.25 mL; Biological: Epaxal 0.5 mL; Biological: Havrix Junior 0.5 mL

• Registration Number: NCT01405677
• Lead Sponsor: Crucell Holland BV

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2011-07-28
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-07-29
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2013-12
• Last Update Submitted: 2014-07-28
• Last Update Posted: 2014-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 308

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epaxal 0.25 mL	Epaxal 0.25 mL	Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6
Epaxal 0.5 mL	Epaxal 0.5 mL	Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6
Havrix Junior	Havrix Junior 0.5 mL	Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6

Primary Outcome Measures

Name	Time	Method
Individual anti-HAV titers	54 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 Outcome Measures

Name	Time	Method
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
Geometric mean titers	18, 30, 42, 54, 66 months post-booster

Trial Locations

Locations (2)

Sint-Vincentiusziekenhuis; 🇧🇪 Antwerp, Belgium

Centre for the Evaluation of Vaccination, University of Antwerp; 🇧🇪 Antwerp, Belgium