Status:
COMPLETED
Safety and Immunogenicity of a Paediatric Dose of Virosomal Hepatitis A Vaccine
Lead Sponsor:
Crucell Holland BV
Conditions:
Hepatitis A
Eligibility:
All Genders
12-16 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT01405677
Start Date
June 1 2004
End Date
April 1 2012
Last Update
July 29 2014
Active Locations (2)
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1
Sint-Vincentiusziekenhuis
Antwerp, Belgium, B-2018
2
Centre for the Evaluation of Vaccination, University of Antwerp
Antwerp, Belgium, BE-2610