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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT01405677
First received: July 28, 2011
Last updated: December 18, 2012
Last verified: December 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Hepatitis A
 Biological: Epaxal 0.25 mL
Biological: Epaxal 0.5 mL
Biological: Havrix Junior 0.5 mL
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Crucell Holland BV:

Primary Outcome Measures:
  • Individual anti-HAV titers [ Time Frame: 66 months post-booster ] [ Designated as safety issue: No ]
    Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection

  • Individual anti-HAV titers [ Time Frame: 18 months post-booster ] [ Designated as safety issue: No ]
    Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection

  • Individual anti-HAV titers [ Time Frame: 30 months post-booster ] [ Designated as safety issue: No ]
    Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection

  • Individual anti-HAV titers [ Time Frame: 42 months post-booster ] [ Designated as safety issue: No ]
    Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection

  • Individual anti-HAV titers [ Time Frame: 54 months post-booster ] [ Designated as safety issue: No ]
    Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection


Secondary Outcome Measures:
  • Geometric mean titers [ Time Frame: 18, 30, 42, 54, 66 months post-booster ] [ Designated as safety issue: No ]
  • Seroprotection [ Time Frame: 18, 30, 42, 54, 66 months post-booster ] [ Designated as safety issue: No ]
    Porportion of subjects who are seroprotected calculated at each time point where seroprotection is defined as >=10 mIU/mL


Enrollment: 308
Study Start Date: June 2004
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epaxal 0.25 mL
Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6
 Biological: Epaxal 0.25 mL
12 IU hepatitis A antigen coupled to immunopotentiating reconstituted Influenza virosome (IRIV)
Active Comparator: Epaxal 0.5 mL
Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6
 Biological: Epaxal 0.5 mL
24 IU hepatitis A antigen coupled to IRIV
Active Comparator: Havrix Junior
Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6
 Biological: Havrix Junior 0.5 mL
720 EU hepatitis A antigen absorbed onto aluminum hydroxide

  Eligibility

Ages Eligible for Study:   12 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405677

Locations
Belgium
Centre for the Evaluation of Vaccination, University of Antwerp
Antwerp, Belgium, BE-2610
Sint-Vincentiusziekenhuis
Antwerp, Belgium, B-2018
Sponsors and Collaborators
Crucell Holland BV
Investigators
Principal Investigator: Pierre van Damme, MD Universiteit Antwerpen
Principal Investigator: Andre Vertruyen, MD Sint-Vincentiusziekenhuis
  More Information

No publications provided

Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01405677     History of Changes
Other Study ID Numbers: EPA 001 FU
Study First Received: July 28, 2011
Last Updated: December 18, 2012
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Crucell Holland BV:
Hepatitis A
Vaccination
Immunisation

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on June 17, 2013