Clinical trial NCT01258595: A Study of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age
Official title: Safety and Immunogenicity of High-Dose Trivalent Inactivated Influenza Vaccine in Adults 50 to 64 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza
Trivalent Inactivated Influenza Vaccine
High-Dose Trivalent Inactivated Influenza Vaccine
Influenza vaccines
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-12-13
Enrollment: 300
Sex: ALL
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

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 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

Primary outcomes:
measure: Geometric Mean Titers (GMTs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine.
timeFrame: Day 0 and Day 28 post-vaccination
measure: Geometric Mean of Individual Titer Ratios (GMTRs) of Vaccine Antibodies Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
timeFrame: Day 0 and Day 28 Post-vaccination
measure: Percentage of Participants With Seroconversion After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
timeFrame: Day 0 and Day 28 post-vaccination
measure: Percentage of Participants With Seroprotection Before and After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
timeFrame: Day 0 and Day 28 post vaccination
Secondary outcomes:
measure: Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either Fluzone® High-Dose or Fluzone® Vaccine
timeFrame: Day 0 through Day 7 post-vaccination
Other outcomes:
Locations:
city: Idaho Falls
country: United States
state: Idaho
city: Columbia
country: United States
state: Maryland
city: Ellicott City
country: United States
state: Maryland
city: Missoula
country: United States
state: Montana
city: Cleveland
country: United States
state: Ohio
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: