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

Hepatitis A Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405677
• Other study ID #: EPA 001 FU
• Status: Completed
• Phase: Phase 2
• First received: July 28, 2011
• Last updated: July 28, 2014
• Start date: June 2004
• Est. completion date: April 2012

Study information

• Verified date: December 2013
• Source: Crucell Holland BV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 16 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A

Intervention

Biological:
• Epaxal 0.25 mL
12 IU hepatitis A antigen coupled to immunopotentiating reconstituted Influenza virosome (IRIV)
• Epaxal 0.5 mL
24 IU hepatitis A antigen coupled to IRIV
• Havrix Junior 0.5 mL
720 EU hepatitis A antigen absorbed onto aluminum hydroxide

Locations

Country	Name	City	State
Belgium	Centre for the Evaluation of Vaccination, University of Antwerp	Antwerp
Belgium	Sint-Vincentiusziekenhuis	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Crucell Holland BV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Individual anti-HAV titers	Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection	66 months post-booster	No
Primary	Individual anti-HAV titers	Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection	18 months post-booster	No
Primary	Individual anti-HAV titers	Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection	30 months post-booster	No
Primary	Individual anti-HAV titers	Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection	42 months post-booster	No
Primary	Individual anti-HAV titers	Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection	54 months post-booster	No
Secondary	Geometric mean titers		18, 30, 42, 54, 66 months post-booster	No
Secondary	Seroprotection	Porportion of subjects who are seroprotected calculated at each time point where seroprotection is defined as >=10 mIU/mL	18, 30, 42, 54, 66 months post-booster	No