A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age
NCT ID: NCT01258595
Last Updated: 2016-05-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
300 participants
INTERVENTIONAL
2010-11-30
2011-04-30
Brief Summary
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Primary Objective:
* To describe the immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine (TIV) compared to TIV.
* To describe the safety profile of High-Dose Trivalent Inactivated Influenza Vaccine, as assessed by solicited adverse reactions collected for 7 days post-vaccination, and unsolicited adverse events (including Serious Adverse Events and Adverse Events of Special Interests) collected between Visit 1 and Visit 2
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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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High-Dose Trivalent Inactivated Influenza Vaccine
High-Dose Trivalent Inactivated Influenza Vaccine
0.5 mL Intramuscular
Trivalent Inactivated Influenza Vaccine
Trivalent Inactivated Influenza Vaccine
0.5 mL, Intramuscular
Interventions
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High-Dose Trivalent Inactivated Influenza Vaccine
0.5 mL Intramuscular
Trivalent Inactivated Influenza Vaccine
0.5 mL, Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent form has been signed and dated
* Medically stable
* Able to attend all scheduled visits and to comply with all trial procedures
* For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination
Exclusion Criteria
* Currently breastfeeding a child
* Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
* Planned participation in another clinical trial during the present trial period
* Planned receipt of any vaccine in the 4 weeks following the trial vaccination (prior to the Visit 2 blood draw)
* Receipt of seasonal or pandemic influenza vaccine in the past 6 months
* Receipt of blood or blood-derived products in the past 3 months
* Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the standard-dose Trivalent Inactivated Influenza Vaccine or a vaccine containing any of the same substances
* Known or suspected 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
* Neoplastic disease or any hematologic malignancy
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
* Personal history of Guillain-Barré Syndrome
* Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
* Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
* Identified as 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 (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator
50 Years
64 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Idaho Falls, Idaho, United States
Columbia, Maryland, United States
Ellicott City, Maryland, United States
Missoula, Montana, United States
Cleveland, Ohio, United States
Countries
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Related Links
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Related Info
Other Identifiers
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UTN: U1111-1113-3648
Identifier Type: OTHER
Identifier Source: secondary_id
FIM09
Identifier Type: -
Identifier Source: org_study_id
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