A Study to Evaluate the Safety and Immunogenicity of the Hepatitis A Virus Vaccine HAVpur in Healthy Young Children
Primary Purpose
Hepatitis A
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
HAVpur Junior
Havrix 720 Junior
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis A focused on measuring Hepatitis A, Vaccination, Immunity
Eligibility 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
Sites / Locations
- Medical College and Chacha Nehru Bal Chikitsalay
- Rajiv Ghandi Medical College
- Christian Medical College and Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HAVpur
Havrix
Arm Description
Outcomes
Primary Outcome Measures
Seroprotection at Month 1
Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration >=10 mIU/ml)
Secondary Outcome Measures
Seroprotection at Month 6
Proportion of subjects seroprotected (>=10 mIU/ml)
Seroprotection at Month 7
Proportion of subjects seroprotected (>=10 mIU/ml)
Geometric Mean Concentrations (GMCs)
GMCs of anti-HAV antibodies will be measured from blood samples
Geometric Mean Concentrations (GMCs)
GMCs of anti-HAV antibodies will be measured from blood samples
Geometric Mean Concentrations (GMCs)
GMCs of anti-HAV antibodies will be measured from blood samples
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01349829
Brief Title
A Study to Evaluate the Safety and Immunogenicity of the Hepatitis A Virus Vaccine HAVpur in Healthy Young Children
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 Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Crucell Holland BV
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis A
Keywords
Hepatitis A, Vaccination, Immunity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
251 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HAVpur
Arm Type
Experimental
Arm Title
Havrix
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
HAVpur Junior
Intervention Description
≥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
Intervention Type
Biological
Intervention Name(s)
Havrix 720 Junior
Intervention Description
≥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
Primary Outcome Measure Information:
Title
Seroprotection at Month 1
Description
Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration >=10 mIU/ml)
Time Frame
Month 1
Secondary Outcome Measure Information:
Title
Seroprotection at Month 6
Description
Proportion of subjects seroprotected (>=10 mIU/ml)
Time Frame
Month 6
Title
Seroprotection at Month 7
Description
Proportion of subjects seroprotected (>=10 mIU/ml)
Time Frame
Month 7
Title
Geometric Mean Concentrations (GMCs)
Description
GMCs of anti-HAV antibodies will be measured from blood samples
Time Frame
Month 1
Title
Geometric Mean Concentrations (GMCs)
Description
GMCs of anti-HAV antibodies will be measured from blood samples
Time Frame
Month 6
Title
Geometric Mean Concentrations (GMCs)
Description
GMCs of anti-HAV antibodies will be measured from blood samples
Time Frame
Month 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
47 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daljit Singh, MD
Organizational Affiliation
Dayanad Medical College and Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tejinder Singh, MD
Organizational Affiliation
Christian Medical College and Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hemant Jain, MD
Organizational Affiliation
Medical College and Chacha Nehru Bal Chikitsalay
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vardana Kumavat, MD
Organizational Affiliation
Rajiv Ghandi Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College and Chacha Nehru Bal Chikitsalay
City
Indore
State/Province
Madhya Pradesh
ZIP/Postal Code
452001
Country
India
Facility Name
Rajiv Ghandi Medical College
City
Thane
State/Province
Maharashtra
ZIP/Postal Code
400 605
Country
India
Facility Name
Christian Medical College and Hospital
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141008
Country
India
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety and Immunogenicity of the Hepatitis A Virus Vaccine HAVpur in Healthy Young Children
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