A Study of Different Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly
NCT ID: NCT00952276
Last Updated: 2011-10-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
548 participants
INTERVENTIONAL
2009-10-31
2011-03-31
Brief Summary
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Primary Objectives:
* To describe the immunogenicity of the candidate vaccines after a single injection.
* To describe the safety of the candidate vaccines after a single injection.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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A/H1N1 Vaccine Group 1
Participants will receive A/H1N1 vaccine formulation 1 (with adjuvant)
Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant
0.5 mL, Intramuscular on Day 0
A/H1N1 Vaccine Group 2
Participants will receive A/H1N1 vaccine formulation 2 (with adjuvant)
Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant
0.5 mL, Intramuscular on Day 0
A/H1N1 Vaccine Group 3
Participants will receive A/H1N1 vaccine formulation 3
Monovalent Subvirion A/H1N1 influenza vaccine
0.5 mL, Intramuscular on Day 0
A/H1N1 Vaccine Group 4
Participants will receive A/H1N1 vaccine formulation 4
Monovalent Subvirion A/H1N1 influenza vaccine
0.5 mL, Intramuscular on Day 0
Placebo Group 5
Participants will receive a placebo vaccine
Normal saline solution
0.5 mL, Intramuscular on Day 0
Interventions
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Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant
0.5 mL, Intramuscular on Day 0
Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant
0.5 mL, Intramuscular on Day 0
Monovalent Subvirion A/H1N1 influenza vaccine
0.5 mL, Intramuscular on Day 0
Monovalent Subvirion A/H1N1 influenza vaccine
0.5 mL, Intramuscular on Day 0
Normal saline solution
0.5 mL, Intramuscular on Day 0
Eligibility Criteria
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Inclusion Criteria
* Informed consent has been signed and dated
* Able to attend all scheduled visits and comply with all trial procedures
* For a woman of child-bearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination, until at least 4 weeks after last vaccination.
Exclusion Criteria
* Currently breastfeeding a child
* 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
* Receipt of any vaccine in the 4 weeks preceding the trial vaccination, except for the inactivated seasonal influenza vaccine, within two weeks preceding trial vaccination
* Planned receipt of any vaccine prior to the Day 42 blood sample
* Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B antigen, or Hepatitis C
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
* Self reported thrombocytopenia contraindicating intramuscular (IM) vaccination
* Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
* Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
* Chronic illness that in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
* Employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator
* Previous participation in a swine-origin A/H1N1 pandemic flu trial except if performed in 1976
* Any confirmed case of influenza (including swine-origin A/H1N1 Influenza) since March 2009
* Febrile illness (temperature ≥ 100.4°F \[≥ 38.0°C \]) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination
* Personal or family history of Guillain-Barré syndrome
* Active neoplastic disease or a history of any hematologic malignancy
* 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
* Any Grade 1, 2, or 3 liver function values (Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), and Alkaline phosphatase) observed in blood sample taken at Screening
* Any Grade 2 or Grade 3 laboratory abnormalities in blood sample taken at Screening
* Receipt of any monovalent 2009 pandemic H1N1 vaccine.
18 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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Anaheim, California, United States
Fountain Valley, California, United States
South Miami, Florida, United States
Springfield, Missouri, United States
Rochester, New York, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Grove City, Pennsylvania, United States
Jefferson Hills, Pennsylvania, United States
Warwick, Rhode Island, United States
Jackson, Tennessee, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Springville, Utah, United States
Countries
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Related Links
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Related Info
Other Identifiers
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UTN: U1111-1111-4882
Identifier Type: -
Identifier Source: secondary_id
FUF16
Identifier Type: -
Identifier Source: org_study_id