Clinical trial NCT01405677: Safety and Immunogenicity of a Paediatric Dose of Virosomal Hepatitis A Vaccine
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis A
Keywords: Hepatitis A
Vaccination
Immunisation
Lead sponsor: Crucell Holland BV
Sponsor class: INDUSTRY
First posted: 2011-07-29
Enrollment: 308
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: Individual anti-HAV titers
timeFrame: 66 months post-booster
measure: Individual anti-HAV titers
timeFrame: 18 months post-booster
measure: Individual anti-HAV titers
timeFrame: 30 months post-booster
measure: Individual anti-HAV titers
timeFrame: 42 months post-booster
measure: Individual anti-HAV titers
timeFrame: 54 months post-booster
Secondary outcomes:
measure: Geometric mean titers
timeFrame: 18, 30, 42, 54, 66 months post-booster
measure: Seroprotection
timeFrame: 18, 30, 42, 54, 66 months post-booster
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Sint-Vincentiusziekenhuis
city: Antwerp
country: Belgium
facility: Centre for the Evaluation of Vaccination, University of Antwerp
Study officials:
affiliation: Universiteit Antwerpen
name: Pierre van Damme, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sint-Vincentiusziekenhuis
name: Andre Vertruyen, MD
role: PRINCIPAL_INVESTIGATOR
References: