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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01349829
Recruitment Status : Completed
First Posted : May 9, 2011
Results First Posted : December 17, 2013
Last Update Posted : December 17, 2013
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis A Biological: HAVpur Junior Biological: Havrix 720 Junior Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Seroprotection at Month 1 [ Time Frame: Month 1 ]
    Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration >=10 mIU/ml)


Secondary Outcome Measures :
  1. Seroprotection at Month 6 [ Time Frame: Month 6 ]
    Proportion of subjects seroprotected (>=10 mIU/ml)

  2. Seroprotection at Month 7 [ Time Frame: Month 7 ]
    Proportion of subjects seroprotected (>=10 mIU/ml)

  3. Geometric Mean Concentrations (GMCs) [ Time Frame: Month 1 ]
    GMCs of anti-HAV antibodies will be measured from blood samples

  4. Geometric Mean Concentrations (GMCs) [ Time Frame: Month 6 ]
    GMCs of anti-HAV antibodies will be measured from blood samples

  5. Geometric Mean Concentrations (GMCs) [ Time Frame: Month 7 ]
    GMCs of anti-HAV antibodies will be measured from blood samples


Eligibility Criteria
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Ages Eligible for Study:   18 Months to 47 Months   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01349829


Locations
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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
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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
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Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01349829    
Other Study ID Numbers: EPA-V-A008
First Posted: May 9, 2011    Key Record Dates
Results First Posted: December 17, 2013
Last Update Posted: December 17, 2013
Last Verified: August 2013
Keywords provided by Crucell Holland BV:
Hepatitis A
Vaccination
Immunity
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections