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
  Purpose

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.


Condition Intervention Phase
Hepatitis A
Biological: HAVpur Junior
Biological: Havrix 720 Junior
Phase 4

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 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

Resource links provided by NLM:


Further study details as provided by Crucell Holland BV:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Enrollment: 251
Study Start Date: March 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HAVpur 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

Active Comparator: Havrix 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


  Eligibility

Ages Eligible for Study:   18 Months to 47 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01349829

Locations
India
Medical College and Chacha Nehru Bal Chikitsalay
Indore, Madhya Pradesh, India, 452001
Rajiv Ghandi Medical College
Thane, Maharashtra, India, 400 605
Christian Medical College and Hospital
Ludhiana, Punjab, India, 141008
Sponsors and Collaborators
Crucell Holland BV
Investigators
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
  More Information

No publications provided

Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01349829     History of Changes
Other Study ID Numbers: EPA-V-A008
Study First Received: May 5, 2011
Results First Received: October 25, 2013
Last Updated: October 25, 2013
Health Authority: India: Drugs Controller General of India

Keywords provided by Crucell Holland BV:
Hepatitis A
Vaccination
Immunity

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 28, 2014