Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine
April 16, 2012 updated by: Sanofi
Safety and Immunogenicity of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine in Healthy Adults
Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity using adjuvants were initiated.
The present study is part of this endeavor.
It is primarily a formulation/dose-finding study with a secondary aim at generating safety and immunogenicity data for the final formulation for the development of a pre-pandemic vaccine.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Biological: Monovalent subvirion H5N1 influenza vaccine
- Biological: Monovalent subvirion H5N1 influenza vaccine
- Biological: Monovalent subvirion H5N1 influenza vaccine
- Biological: Monovalent subvirion H5N1 influenza vaccine
- Biological: Monovalent subvirion H5N1 influenza vaccine
- Biological: Monovalent subvirion H5N1 influenza vaccine
- Biological: Monovalent subvirion H5N1 influenza vaccine
- Biological: Monovalent subvirion H5N1 influenza vaccine
- Biological: Physiological saline
Detailed Description
This is a Phase I, observer-blinded, randomized, controlled multicenter, dose-finding study in adult subjects.
All vaccines will be administered as a two-dose schedule in (H5N1) immunologically-naïve adults.
Immunogenicity and safety will be evaluated after each injection.
Study Type
Interventional
Enrollment (Actual)
375
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92103
-
-
Florida
-
South Miami, Florida, United States, 33143
-
-
Missouri
-
Springfield, Missouri, United States, 65802
-
-
Ohio
-
Cincinnati, Ohio, United States, 45219
-
Cincinnati, Ohio, United States, 45227
-
-
Tennessee
-
Knoxville, Tennessee, United States, 37920
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria :
- Healthy adult aged 18 to 40 years on the day of inclusion.
- Provides signed informed consent prior to study procedures.
- Able to attend all scheduled visits and comply with all trial procedures.
- For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to the first vaccination, until at least 4 weeks after last vaccination.
Exclusion Criteria :
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the standard-dose Fluzone® vaccine or to a vaccine containing any of the same substances
- For a woman of child-bearing potential, known pregnancy or positive serum/urine pregnancy test
- Breast feeding woman
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the (first) trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, oral, parenteral, or inhaled steroids
- Has an acute or chronic medical illness or any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or would interfere with the evaluation of responses or render the subject unable to meet the requirements of the protocol
- Known or suspected current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
- History of receipt of blood or immunoglobulin or other blood-derived products within the 3 months prior to enrollment in this study 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 preceding or following any trial vaccination
- Known Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C seropositivity
- Personal or family history of Guillain-Barré Syndrome
- Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
- Active neoplastic disease or a history of any hematologic malignancy
- Previous participation in a pandemic flu trial
- History of H5N1 infection or exposure to presumed/confirmed H5N1 human/animal cases
- Known seizure/epilepsy history and/or taking anti-seizure medication
- Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study.
- Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
|
0.5 mL, IM, 2 injections, Formulation 1
0.5 mL, IM, 2 injections, Formulation 2
0.5 mL, IM, 2 injections, Formulation 3
0.5 mL, IM, 2 injections, Formulation 4
0.5 mL, IM, 2 injections, Formulation 5
0.5 mL, IM, 2 injections, Formulation 6
0.5 mL, IM, 2 injections, Comparator 1
0.5 mL, IM, 2 injections, Comparator 2
|
|
Experimental: 2
|
0.5 mL, IM, 2 injections, Formulation 1
0.5 mL, IM, 2 injections, Formulation 2
0.5 mL, IM, 2 injections, Formulation 3
0.5 mL, IM, 2 injections, Formulation 4
0.5 mL, IM, 2 injections, Formulation 5
0.5 mL, IM, 2 injections, Formulation 6
0.5 mL, IM, 2 injections, Comparator 1
0.5 mL, IM, 2 injections, Comparator 2
|
|
Experimental: 3
|
0.5 mL, IM, 2 injections, Formulation 1
0.5 mL, IM, 2 injections, Formulation 2
0.5 mL, IM, 2 injections, Formulation 3
0.5 mL, IM, 2 injections, Formulation 4
0.5 mL, IM, 2 injections, Formulation 5
0.5 mL, IM, 2 injections, Formulation 6
0.5 mL, IM, 2 injections, Comparator 1
0.5 mL, IM, 2 injections, Comparator 2
|
|
Experimental: 4
|
0.5 mL, IM, 2 injections, Formulation 1
0.5 mL, IM, 2 injections, Formulation 2
0.5 mL, IM, 2 injections, Formulation 3
0.5 mL, IM, 2 injections, Formulation 4
0.5 mL, IM, 2 injections, Formulation 5
0.5 mL, IM, 2 injections, Formulation 6
0.5 mL, IM, 2 injections, Comparator 1
0.5 mL, IM, 2 injections, Comparator 2
|
|
Experimental: 5
|
0.5 mL, IM, 2 injections, Formulation 1
0.5 mL, IM, 2 injections, Formulation 2
0.5 mL, IM, 2 injections, Formulation 3
0.5 mL, IM, 2 injections, Formulation 4
0.5 mL, IM, 2 injections, Formulation 5
0.5 mL, IM, 2 injections, Formulation 6
0.5 mL, IM, 2 injections, Comparator 1
0.5 mL, IM, 2 injections, Comparator 2
|
|
Experimental: 6
|
0.5 mL, IM, 2 injections, Formulation 1
0.5 mL, IM, 2 injections, Formulation 2
0.5 mL, IM, 2 injections, Formulation 3
0.5 mL, IM, 2 injections, Formulation 4
0.5 mL, IM, 2 injections, Formulation 5
0.5 mL, IM, 2 injections, Formulation 6
0.5 mL, IM, 2 injections, Comparator 1
0.5 mL, IM, 2 injections, Comparator 2
|
|
Active Comparator: 7
|
0.5 mL, IM, 2 injections, Formulation 1
0.5 mL, IM, 2 injections, Formulation 2
0.5 mL, IM, 2 injections, Formulation 3
0.5 mL, IM, 2 injections, Formulation 4
0.5 mL, IM, 2 injections, Formulation 5
0.5 mL, IM, 2 injections, Formulation 6
0.5 mL, IM, 2 injections, Comparator 1
0.5 mL, IM, 2 injections, Comparator 2
|
|
Active Comparator: 8
|
0.5 mL, IM, 2 injections, Formulation 1
0.5 mL, IM, 2 injections, Formulation 2
0.5 mL, IM, 2 injections, Formulation 3
0.5 mL, IM, 2 injections, Formulation 4
0.5 mL, IM, 2 injections, Formulation 5
0.5 mL, IM, 2 injections, Formulation 6
0.5 mL, IM, 2 injections, Comparator 1
0.5 mL, IM, 2 injections, Comparator 2
|
|
Placebo Comparator: 9
|
0.5 mL, IM, 2 injections
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To provide information concerning the safety after primary administration of A/H1N1 vaccine
Time Frame: 6 months post-vaccination
|
6 months post-vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
April 22, 2008
First Submitted That Met QC Criteria
April 22, 2008
First Posted (Estimate)
April 23, 2008
Study Record Updates
Last Update Posted (Estimate)
April 17, 2012
Last Update Submitted That Met QC Criteria
April 16, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUF04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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