NCT01405677CompletedPhase 2
A Phase II Open, Randomised, Controlled Study to Evaluate the Safety and Immunogenicity of a Paediatric Dose (0.25 mL) and the Standard Dose (0.5 mL) of Epaxal® With Reference to Havrix Junior® Healthy in Healthy Children and Adolescents (>=12 Months - 16 Years of Age) Using a 0/6 Month Schedule
Crucell Holland BV4 sites in 1 country308 target enrollmentStarted: June 1, 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 308
- Locations
- 4
- Primary Endpoint
- Individual anti-HAV titers
Study Overview
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 standard dose of Epaxal. The aim of the follow-up phase was to perform a computer based modelling analysis of the long term protection afforded by the paediatric dose, and to compare this with the standard dose and also with an alternative hepatitis A vaccine (Havrix Junior).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 12 Months to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Individual anti-HAV titers
Time Frame: 54 months post-booster
Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection
Secondary Outcomes
- Seroprotection(18, 30, 42, 54, 66 months post-booster)
- Geometric mean titers(18, 30, 42, 54, 66 months post-booster)
Investigators
Study Sites (4)
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