Back to resultsSafety and Immunogenicity of a Paediatric Dose of Virosomal Hepatitis A Vaccine
Primary Purpose
Hepatitis A
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Epaxal 0.25 mL
Epaxal 0.5 mL
Havrix Junior 0.5 mL
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis A focused on measuring Hepatitis A, Vaccination, Immunisation
Eligibility Criteria
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
Sites / Locations
- Sint-Vincentiusziekenhuis
- Centre for the Evaluation of Vaccination, University of Antwerp
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Epaxal 0.25 mL
Epaxal 0.5 mL
Havrix Junior
Arm Description
Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6
Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6
Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6
Outcomes
Primary Outcome Measures
Individual anti-HAV titers
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
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
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
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
Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection
Secondary Outcome Measures
Geometric mean titers
Seroprotection
Porportion of subjects who are seroprotected calculated at each time point where seroprotection is defined as >=10 mIU/mL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01405677
Brief Title
Safety and Immunogenicity of a Paediatric Dose of Virosomal Hepatitis A Vaccine
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Crucell Holland BV
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
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, Immunisation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
308 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epaxal 0.25 mL
Arm Type
Experimental
Arm Description
Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6
Arm Title
Epaxal 0.5 mL
Arm Type
Active Comparator
Arm Description
Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6
Arm Title
Havrix Junior
Arm Type
Active Comparator
Arm Description
Single intramuscular dose (M. deltoideus) given on Day 1 and at Month 6
Intervention Type
Biological
Intervention Name(s)
Epaxal 0.25 mL
Intervention Description
12 IU hepatitis A antigen coupled to immunopotentiating reconstituted Influenza virosome (IRIV)
Intervention Type
Biological
Intervention Name(s)
Epaxal 0.5 mL
Intervention Description
24 IU hepatitis A antigen coupled to IRIV
Intervention Type
Biological
Intervention Name(s)
Havrix Junior 0.5 mL
Intervention Description
720 EU hepatitis A antigen absorbed onto aluminum hydroxide
Primary Outcome Measure Information:
Title
Individual anti-HAV titers
Description
Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection
Time Frame
66 months post-booster
Title
Individual anti-HAV titers
Description
Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection
Time Frame
18 months post-booster
Title
Individual anti-HAV titers
Description
Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection
Time Frame
30 months post-booster
Title
Individual anti-HAV titers
Description
Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection
Time Frame
42 months post-booster
Title
Individual anti-HAV titers
Description
Real-time seroprotection analysis and computer modelling will be conducted up to 5 years post-booster to estimate long term seroprotection
Time Frame
54 months post-booster
Secondary Outcome Measure Information:
Title
Geometric mean titers
Time Frame
18, 30, 42, 54, 66 months post-booster
Title
Seroprotection
Description
Porportion of subjects who are seroprotected calculated at each time point where seroprotection is defined as >=10 mIU/mL
Time Frame
18, 30, 42, 54, 66 months post-booster
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre van Damme, MD
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andre Vertruyen, MD
Organizational Affiliation
Sint-Vincentiusziekenhuis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sint-Vincentiusziekenhuis
City
Antwerp
ZIP/Postal Code
B-2018
Country
Belgium
Facility Name
Centre for the Evaluation of Vaccination, University of Antwerp
City
Antwerp
ZIP/Postal Code
BE-2610
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Safety and Immunogenicity of a Paediatric Dose of Virosomal Hepatitis A Vaccine
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