A Study to Evaluate the Safety and Immunogenicity of the Hepatitis A Virus Vaccine HAVpur in Healthy Young Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT01349829
First received: May 5, 2011
Last updated: October 25, 2013
Last verified: August 2013

May 5, 2011
October 25, 2013
March 2010
April 2011   (final data collection date for primary outcome measure)
Seroprotection at Month 1 [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration >=10 mIU/ml)
Same as current
Complete list of historical versions of study NCT01349829 on ClinicalTrials.gov Archive Site
  • Seroprotection at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Proportion of subjects seroprotected (>=10 mIU/ml)
  • Seroprotection at Month 7 [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
    Proportion of subjects seroprotected (>=10 mIU/ml)
  • Geometric Mean Concentrations (GMCs) [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
    GMCs of anti-HAV antibodies will be measured from blood samples
  • Geometric Mean Concentrations (GMCs) [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    GMCs of anti-HAV antibodies will be measured from blood samples
  • Geometric Mean Concentrations (GMCs) [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
    GMCs of anti-HAV antibodies will be measured from blood samples
  • Seroprotection at Months 6 and 7 [ Time Frame: Months 6 and 7 ] [ Designated as safety issue: No ]
    Proportion of subjects seroprotected (>=10 mIU/ml)
  • Seroprotection at Months 1, 6 and 7 [ Time Frame: Months 1, 6 and 7 ] [ Designated as safety issue: No ]
    Proportion of subjects seroprotected (>=20 mIU/ml)
  • Geometric mean concentrations (GMCs) [ Time Frame: Months 1, 6 and 7 ] [ Designated as safety issue: No ]
    GMCs of anti-HAV antibodies will be measured from blood samples
  • Solicited local and systemic adverse events [ Time Frame: For the 4 days following each vaccination ] [ Designated as safety issue: Yes ]
    Proportion of subjects experiencing local and systemic adverse events after primary and after booster vaccination in the two study groups
Not Provided
Not Provided
 
A Study to Evaluate the Safety and Immunogenicity of the Hepatitis A Virus Vaccine HAVpur in Healthy Young Children
A Phase IV Open, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of a Pediatric Presentation (0.25 ml) of the Virosomal Hepatitis A Virus (HAV) Vaccine HAVpur in Healthy Young Children Aged Between and Including 18 Months to 47 Months, Using a 0/6 Month Immunization Schedule

This is a study to test whether vaccination with HAVpur Junior against hepatitis A provides protection that is non-inferior to the protection afforded by vaccination with Havrix 720 Junior.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Hepatitis A
  • Biological: HAVpur Junior

    ≥12 International Units (IU) hepatitis A antigen coupled to virosomes, intramuscularly (i.m.), anterolateral thigh (M. vastus lateralis) or deltoid (M. deltoideus)

    Vaccination schedule: single doses at 0 and 6 months

  • Biological: Havrix 720 Junior

    ≥720 ELISA Units (EU) hepatitis A antigen adsorbed to aluminium hydroxide, intramuscularly (i.m.), anterolateral thigh (M. vastus lateralis) or deltoid (M. deltoideus)

    Vaccination schedule: single doses at 0 and 6 months

  • Experimental: HAVpur
    Intervention: Biological: HAVpur Junior
  • Active Comparator: Havrix
    Intervention: Biological: Havrix 720 Junior
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
251
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A male or female between (and including) 18 months to 47 months of age.
  • Written informed consent obtained 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

Exclusion Criteria:

  • Seropositive for anti-HAV antibodies (>=10 mIU/ml).
  • 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, such as prednisone, or equivalent, >=0.5 mg/kg/day.
  • Inhaled and local steroids are allowed.)
  • Planned administration/ administration of a measles containing vaccine within 4 weeks prior to and after the first or booster dose of study vaccine.
  • Previous vaccination against hepatitis A.
  • 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
18 Months to 47 Months
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01349829
EPA-V-A008
No
Crucell Holland BV
Crucell Holland BV
Not Provided
Principal Investigator: Daljit Singh, MD Dayanad Medical College and Hospital
Principal Investigator: Tejinder Singh, MD Christian Medical College and Hospital
Principal Investigator: Hemant Jain, MD Medical College and Chacha Nehru Bal Chikitsalay
Principal Investigator: Vardana Kumavat, MD Rajiv Ghandi Medical College
Crucell Holland BV
August 2013

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