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

Crucell Switzerland AGRehhagstr. 79CH-3018 BerneSwitzerland0 sites250 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sponsor

Crucell Switzerland AGRehhagstr. 79CH-3018 BerneSwitzerland

•1\.A male or female between (and including) 18 months to 47 months of age.
•2\.Written informed consent obtained from the parent/legal guardian of the subject.
•3\.Free of obvious health problems as established by medical history and/or clinical examination before entering the study.

•1\.Seropositive for anti\-HAV antibodies (\>/\=10 mIU/ml).
•2\.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.
•3\.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.)
•4\.Planned administration/ administration of a measles containing vaccine within 4 weeks prior to and after the first or booster dose of study vaccine.
•5\.Previous vaccination against hepatitis A.
•6\.Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
•7\.History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•8\.Major congenital defects or serious chronic illness.
•9\.Acute disease at the time of enrolment.

Not specified