Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects
Immunogenicity and Safety of The Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Standard Fluzone® in Ambulatory Elderly Subjects
1 other identifier
interventional
817
1 country
17
Brief Summary
As a result of the safety and immunogenicity data generated from earlier dose-ranging studies, the present formulation has been selected for further development in the elderly. Primary Objective: To compare the immunogenicity in subjects receiving investigational Fluzone with those of subjects receiving standard Fluzone®. Secondary Objectives: Immunogenicity: To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®. Safety: To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2006
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 16, 2006
CompletedFirst Posted
Study publicly available on registry
October 17, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
September 13, 2011
CompletedApril 18, 2012
April 1, 2012
9 months
October 16, 2006
July 14, 2011
April 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
The serological determinations of total anti-influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.
Pre-vaccination and Day 28 post-vaccination
Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
Seroprotection was defined as a post-vaccination Hemagglutinin inhibition (HAI) antibody titer ≥ 40
Day 28 post-vaccination
Secondary Outcomes (2)
Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine.
Pre- and Day 28 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Day 0 up to 7 days post-vaccination
Study Arms (2)
Fluzone Intradermal (ID) Vaccine Group
EXPERIMENTALParticipants received a dose of Fluzone Intradermal (ID) Influenza Vaccine
Fluzone Intramuscular (IM) Vaccine Group
ACTIVE COMPARATORParticipants received a dose of Fluzone Intramuscular (IM) Influenza Vaccine.
Interventions
0.1 mL, Intradermal
Eligibility Criteria
You may qualify if:
- Aged ≥ 65 years on the day of vaccination.
- Informed consent form signed.
- Medically stable (Subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease, congestive cardiac disorders or hypothyroidism, as long as their symptoms/signs are controlled).
- Able to attend all scheduled visits and to comply with all trial procedures.
You may not qualify if:
- Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to the standard-dose Fluzone® vaccine or a vaccine containing the same substances (the list of vaccine components is included in the Investigator's Brochure).
- Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
- Systemic corticosteroid therapy as follows:
- Continuous use with a dosage equivalent to \> 15 mg/day of oral prednisone for 90 days preceding vaccination
- Sporadic use with a dose of \> 40 mg/day of oral prednisone for \> 14 days in the 90 days preceding vaccination.
- Note: Use of topical or inhalant corticosteroids is acceptable.
- Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, as well as subjects who have a history of neoplastic disease and who have been disease-free for ≥ 5 years).
- Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
- Receipt of blood or blood-derived products in the past 3 months.
- Vaccination against influenza in the past 6 months.
- Any vaccination in the 4 weeks preceding the trial vaccination.
- Vaccination planned in the 4 weeks following the trial vaccination.
- Participation in another clinical trial in the 4 weeks preceding trial vaccination.
- Planned participation in another clinical trial during the present trial period. Concomitant participation in an observational trial (not involving drugs, vaccines, or medical devices) is acceptable.
- Chronic illness at a stage that could interfere with trial conduct or completion.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (17)
Unknown Facility
Alabaster, Alabama, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Fountain Valley, California, United States
Unknown Facility
Pinellas Park, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Springfield, Missouri, United States
Unknown Facility
Brooklyn, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Bensalem, Pennsylvania, United States
Unknown Facility
Grove City, Pennsylvania, United States
Unknown Facility
Johnstown, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Fort Worth, Texas, United States
Unknown Facility
Galveston, Texas, United States
Unknown Facility
Layton, Utah, United States
Unknown Facility
South Jordan, Utah, United States
Unknown Facility
Norfolk, Virginia, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2006
First Posted
October 17, 2006
Study Start
September 1, 2006
Primary Completion
June 1, 2007
Study Completion
September 1, 2008
Last Updated
April 18, 2012
Results First Posted
September 13, 2011
Record last verified: 2012-04