Study of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00664417 |
Recruitment Status :
Completed
First Posted : April 23, 2008
Last Update Posted : April 17, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Influenza Orthomyxoviridae Infections | Biological: Monovalent subvirion H5N1 influenza vaccine Biological: Physiological saline | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 375 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Safety and Immunogenicity of Different Formulations of an Intramuscular A/H5N1 Inactivated, Split Virion Influenza Adjuvanted Vaccine in Healthy Adults |
Study Start Date : | April 2008 |
Actual Primary Completion Date : | September 2009 |
Actual Study Completion Date : | August 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 1 |
Experimental: 2 |
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 2 |
Experimental: 3 |
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 3 |
Experimental: 4 |
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 4 |
Experimental: 5 |
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 5 |
Experimental: 6 |
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 6 |
Active Comparator: 7 |
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 1 |
Active Comparator: 8 |
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 2 |
Placebo Comparator: 9 |
Biological: Physiological saline
0.5 mL, IM, 2 injections |
- To provide information concerning the safety after primary administration of A/H1N1 vaccine [ Time Frame: 6 months post-vaccination ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664417
United States, California | |
San Diego, California, United States, 92103 | |
United States, Florida | |
South Miami, Florida, United States, 33143 | |
United States, Missouri | |
Springfield, Missouri, United States, 65802 | |
United States, Ohio | |
Cincinnati, Ohio, United States, 45219 | |
Cincinnati, Ohio, United States, 45227 | |
United States, Tennessee | |
Knoxville, Tennessee, United States, 37920 |
Study Director: | Medical Monitor | Sanofi Pasteur, Inc. |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00664417 |
Other Study ID Numbers: |
FUF04 |
First Posted: | April 23, 2008 Key Record Dates |
Last Update Posted: | April 17, 2012 |
Last Verified: | April 2012 |
Influenza A/H5N1 Orthomyxoviridae Infections Influenza Pandemics |
Influenza, Human Influenza in Birds Orthomyxoviridae Infections Infections Respiratory Tract Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |