Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects
Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Orthomyxoviridae Infection; Influenza; Myxovirus Infection
Intervention: Split, Inactivated, Trivalent Influenza Vaccine (Biological); Split, Inactivated, Trivalent 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
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: 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.Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
Secondary outcome: Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine.Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Known current HIV, hepatitis B (HBsAg) or hepatitis C infection or seropositivity.
- Known thrombocytopenia or bleeding disorder contraindicating IM vaccination.
- Subject deprived of freedom by an administrative or court order, or in an emergency
setting, or hospitalized without his/her consent.
- Acute illness and febrile illness with a temperature ≥ 38. 0°C [or 100. 4°F]) 72 hours
before or on the day of inclusion.
- Received antibiotics therapy within 72 hours preceding the trial vaccination.
- Received any allergy shots in the 7-day period preceding trial vaccination and/or
scheduled to receive any allergy shots in the 7-day period after trial vaccination.
- Any condition, which in the opinion of the investigator would pose a health risk to
the participant.
Locations and Contacts
Alabaster, Alabama, United States
Tucson, Arizona, United States
Fountain Valley, California, United States
Pinellas Park, Florida, United States
Chicago, Illinois, United States
Springfield, Missouri, United States
Brooklyn, New York, United States
New York, New York, United States
Bensalem, Pennsylvania, United States
Grove City, Pennsylvania, United States
Johnstown, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Fort Worth, Texas, United States
Galveston, Texas, United States
Layton, Utah, United States
South Jordan, Utah, United States
Norfolk, Virginia, United States
Additional Information
Starting date: September 2006
Last updated: April 13, 2012
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