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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT01405677
First received: July 28, 2011
Last updated: July 28, 2014
Last verified: December 2013
  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:


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
Study Completion Date: April 2012
Primary Completion Date: April 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 28, 2014
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 August 21, 2014