Trial | NCT01405677  Report issue

Title

Safety and Immunogenicity of a Paediatric Dose of Virosomal Hepatitis A Vaccine
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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    308
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 Started
Jun 30
2004
Primary Completion
Apr 30
2012
Study Completion
Apr 30
2012
Last Update
Jul 29
2014
Estimate

Biological Epaxal 0.25 mL

12 IU hepatitis A antigen coupled to immunopotentiating reconstituted Influenza virosome (IRIV)

Biological Epaxal 0.5 mL

24 IU hepatitis A antigen coupled to IRIV

Biological Havrix Junior 0.5 mL

720 EU hepatitis A antigen absorbed onto aluminum hydroxide

Epaxal 0.25 mL Experimental

Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6

Epaxal 0.5 mL Active Comparator

Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6

Havrix Junior Active Comparator

Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6

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
No Results Posted