A Study to Evaluate the Safety and Immunogenicity of the Hepatitis A Virus Vaccine HAVpur in Healthy Young Children

Study Overview
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Brief Summary
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This is a study to test whether vaccination with HAVpur Junior against hepatitis A provides protection that is non-inferior to the protection afforded by vaccination with Havrix 720 Junior.

Official Title
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A Phase IV Open, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of a Pediatric Presentation (0.25 ml) of the Virosomal Hepatitis A Virus (HAV) Vaccine HAVpur in Healthy Young Children Aged Between and Including 18 Months to 47 Months, Using a 0/6 Month Immunization Schedule

Conditions
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Hepatitis A

Intervention / Treatment
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* Biological: HAVpur Junior
* Biological: Havrix 720 Junior


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A male or female between (and including) 18 months to 47 months of age. Written informed consent obtained 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 Exclusion Criteria: Seropositive for anti-HAV antibodies (>=10 mIU/ml). 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, such as prednisone, or equivalent, >=0.5 mg/kg/day. Inhaled and local steroids are allowed.) Planned administration/ administration of a measles containing vaccine within 4 weeks prior to and after the first or booster dose of study vaccine. Previous vaccination against hepatitis A. 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

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 47 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HAVpur<br> | Biological: HAVpur Junior<br>* ≥12 International Units (IU) hepatitis A antigen coupled to virosomes, intramuscularly (i.m.), anterolateral thigh (M. vastus lateralis) or deltoid (M. deltoideus) Vaccination schedule: single doses at 0 and 6 months<br>|
| Active Comparator: Havrix<br> | Biological: Havrix 720 Junior<br>* ≥720 ELISA Units (EU) hepatitis A antigen adsorbed to aluminium hydroxide, intramuscularly (i.m.), anterolateral thigh (M. vastus lateralis) or deltoid (M. deltoideus) Vaccination schedule: single doses at 0 and 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection at Month 1 | Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration >=10 mIU/ml) | Month 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection at Month 6 | Proportion of subjects seroprotected (>=10 mIU/ml) | Month 6 | 
| Seroprotection at Month 7 | Proportion of subjects seroprotected (>=10 mIU/ml) | Month 7 | 
| Geometric Mean Concentrations (GMCs) | GMCs of anti-HAV antibodies will be measured from blood samples | Month 1 | 
| Geometric Mean Concentrations (GMCs) | GMCs of anti-HAV antibodies will be measured from blood samples | Month 6 | 
| Geometric Mean Concentrations (GMCs) | GMCs of anti-HAV antibodies will be measured from blood samples | Month 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis A, Vaccination, Immunity