Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults
Primary Purpose
Influenza, Orthomyxoviridae Infections
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
A/H5N1 inactivated, split-virion influenza virus
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, A/H5N1 strain, Orthomyxoviridae Infections, Influenza Pandemics
Eligibility Criteria
Inclusion Criteria:
- Aged 18 to 60 years on day of inclusion.
- Informed Consent Form signed.
- Able to attend all scheduled visits and to comply with all trial procedures.
- For a woman, inability to bear a child or negative urine pregnancy test.
- For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to and at least 4 weeks after each vaccination.
Exclusion Criteria:
- Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9).
- Febrile illness (oral temperature >= 37.5°C) on the day of inclusion.
- Breast-feeding.
- Previous vaccination with an avian flu vaccine.
- Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination.
- Planned participation in another clinical trial during the present trial period.
- Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
- Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders).
- Current alcohol or drug abuse that may interfere with the subject's ability to comply with trial procedures.
- Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response.
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
- Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
- Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
To provide information concerning the immunogenicity of A/H5N1 inactivated, split-virion influenza virus vaccine
Secondary Outcome Measures
Full Information
NCT ID
NCT00545701
First Posted
October 15, 2007
Last Updated
January 10, 2014
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00545701
Brief Title
Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company
4. Oversight
5. Study Description
Brief Summary
The trial is a Phase II, open-label trial in healthy subjects aged 18 to 60 years to support the immunogenicity data from previous clinical studies.
Objectives:
To describe the immune response 21 days after each vaccination.
To describe the safety profiles following each vaccination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Orthomyxoviridae Infections
Keywords
Influenza, A/H5N1 strain, Orthomyxoviridae Infections, Influenza Pandemics
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
A/H5N1 inactivated, split-virion influenza virus
Intervention Description
0.5 mL, Intramuscular
Primary Outcome Measure Information:
Title
To provide information concerning the immunogenicity of A/H5N1 inactivated, split-virion influenza virus vaccine
Time Frame
Day 42 post-vaccination 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 18 to 60 years on day of inclusion.
Informed Consent Form signed.
Able to attend all scheduled visits and to comply with all trial procedures.
For a woman, inability to bear a child or negative urine pregnancy test.
For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to and at least 4 weeks after each vaccination.
Exclusion Criteria:
Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9).
Febrile illness (oral temperature >= 37.5°C) on the day of inclusion.
Breast-feeding.
Previous vaccination with an avian flu vaccine.
Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination.
Planned participation in another clinical trial during the present trial period.
Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy.
Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders).
Current alcohol or drug abuse that may interfere with the subject's ability to comply with trial procedures.
Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response.
Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Adelaide
Country
Australia
City
Queensland
Country
Australia
12. IPD Sharing Statement
Links:
URL
http://www.sanofipasteur.com
Description
Related Info
Learn more about this trial
Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults
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