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

Crucell

Status and phase

Completed

Phase 4

Conditions

Hepatitis A

Treatments

Biological: Havrix 720 Junior

Biological: HAVpur Junior

Study type

Interventional

Funder types

Industry

Identifiers

NCT01349829

EPA-V-A008

Details and patient eligibility

About

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.

Enrollment

251 patients

Sex

All

Ages

18 to 47 months old

Volunteers

Accepts Healthy Volunteers

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