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 19, 2013
Last verified: December 2013

July 28, 2011
December 19, 2013
June 2004
July 2014   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01405677 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Hepatitis A
  • 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
  • Experimental: Epaxal 0.25 mL
    Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6
    Intervention: Biological: Epaxal 0.25 mL
  • Active Comparator: Epaxal 0.5 mL
    Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6
    Intervention: Biological: Epaxal 0.5 mL
  • Active Comparator: Havrix Junior
    Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6
    Intervention: Biological: Havrix Junior 0.5 mL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
308
December 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
12 Months to 16 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01405677
EPA 001 FU
Yes
Crucell Holland BV
Crucell Holland BV
Not Provided
Principal Investigator: Pierre van Damme, MD Universiteit Antwerpen
Principal Investigator: Andre Vertruyen, MD Sint-Vincentiusziekenhuis
Crucell Holland BV
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP