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

Crucell

Status and phase: Completed; Phase 2

Conditions: Hepatitis A

Treatments: Biological: Havrix Junior 0.5 mL; Biological: Epaxal 0.25 mL; Biological: Epaxal 0.5 mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT01405677

EPA 001 FU

Details and patient eligibility

About

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).

Enrollment: 308 patients

Sex: All

Ages: 12 months to 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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308 participants in 3 patient groups

Epaxal 0.25 mL

Experimental group

Description:

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

Treatment:

Biological: Epaxal 0.25 mL

Epaxal 0.5 mL

Active Comparator group

Description:

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

Treatment:

Biological: Epaxal 0.5 mL

Havrix Junior

Active Comparator group

Description:

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

Treatment:

Biological: Havrix Junior 0.5 mL