Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine
NCT ID: NCT00664417
Last Updated: 2012-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
375 participants
INTERVENTIONAL
2008-04-30
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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1
Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 1
2
Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 2
3
Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 3
4
Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 4
5
Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 5
6
Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 6
7
Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 1
8
Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 2
9
Physiological saline
0.5 mL, IM, 2 injections
Interventions
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Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 1
Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 2
Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 3
Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 4
Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 5
Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 6
Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 1
Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 2
Physiological saline
0.5 mL, IM, 2 injections
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
40 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Sanofi Pasteur, Inc.
Locations
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San Diego, California, United States
South Miami, Florida, United States
Springfield, Missouri, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Knoxville, Tennessee, United States
Countries
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Related Links
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Related Info
Other Identifiers
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FUF04
Identifier Type: -
Identifier Source: org_study_id
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