Title
A Study to Evaluate the Safety and Immunogenicity of the Hepatitis A Virus Vaccine HAVpur in Healthy Young Children
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
Phase
Phase 4Lead Sponsor
CrucellStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Hepatitis AIntervention/Treatment
hepatitis a vaccine, inactivated ...Study Participants
251This 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.
≥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
≥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
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
| Event Type | Organ System | Event Term | HAVpur - First Vaccination | Havrix - First Vaccination | HAVPur - Second Vaccination | Havrix - Second Vaccination |
|---|
Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration >=10 mIU/ml)
Proportion of subjects seroprotected (>=10 mIU/ml)
Proportion of subjects seroprotected (>=10 mIU/ml)
GMCs of anti-HAV antibodies will be measured from blood samples
GMCs of anti-HAV antibodies will be measured from blood samples
GMCs of anti-HAV antibodies will be measured from blood samples
