Clinical trial NCT00388583: Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Orthomyxoviridae Infection
Influenza
Myxovirus Infection
Keywords: Influenza
Orthomyxoviruses
Inactivated Split-virion influenza vaccine
Elderly.
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-10-17
Enrollment: 817
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Pre-vaccination and Day 28 post-vaccination
measure: Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
timeFrame: Day 28 post-vaccination
Secondary outcomes:
measure: Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine.
timeFrame: Pre- and Day 28 post-vaccination
measure: Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine
timeFrame: Day 0 up to 7 days post-vaccination
Other outcomes:
Locations:
city: Alabaster
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Fountain Valley
country: United States
state: California
city: Pinellas Park
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Springfield
country: United States
state: Missouri
city: Brooklyn
country: United States
state: New York
city: New York
country: United States
state: New York
city: Bensalem
country: United States
state: Pennsylvania
city: Grove City
country: United States
state: Pennsylvania
city: Johnstown
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Fort Worth
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: Layton
country: United States
state: Utah
city: South Jordan
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: