A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age
Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Influenza
Intervention: High-Dose Trivalent Inactivated Influenza Vaccine (Biological); Trivalent Inactivated Influenza Vaccine (Biological)
Phase: Phase 2
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Sanofi Pasteur Inc.
Summary
The aim of the study is to generate data on key parameters associated with assessment of
influenza vaccines in individuals 50-64 years of age
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
Clinical Details
Official title: Safety and Immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Secondary outcome: Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
Detailed description:
Participants will be randomized to receive one dose of either High-Dose Trivalent
Inactivated Influenza Vaccine or Trivalent Inactivated Influenza Vaccine. They will be
followed up for safety for one month post-vaccination.
Eligibility
Minimum age: 50 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Aged 50 to 64 years (inclusive) on the day of vaccination
- 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:
- Known pregnancy, or a positive urine pregnancy test
- 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
Locations and Contacts
Idaho Falls, Idaho 83404, United States
Columbia, Maryland 21045, United States
Ellicott City, Maryland 21042, United States
Missoula, Montana 59802, United States
Cleveland, Ohio 44122, United States
Additional Information
Starting date: November 2010
Last updated: September 19, 2011
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