Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects

NCT ID: NCT00388583

Last Updated: 2012-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 817 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-09-30

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.

Conditions

Orthomyxoviridae Infection; Influenza; Myxovirus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Fluzone Intradermal (ID) Vaccine Group

Participants received a dose of Fluzone Intradermal (ID) Influenza Vaccine

Group Type: EXPERIMENTAL

Split, Inactivated, Trivalent Influenza Vaccine

Intervention Type: BIOLOGICAL

0.1 mL, Intradermal

Fluzone Intramuscular (IM) Vaccine Group

Participants received a dose of Fluzone Intramuscular (IM) Influenza Vaccine.

Group Type: ACTIVE_COMPARATOR

Split, Inactivated, Trivalent Influenza Vaccine

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Interventions

Split, Inactivated, Trivalent Influenza Vaccine

0.1 mL, Intradermal

Intervention Type: BIOLOGICAL

Split, Inactivated, Trivalent Influenza Vaccine

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

Fluzone; Fluzone® 2006/2007 Formulation

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

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

Countries

United States

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

FID04

Identifier Type: -

Identifier Source: org_study_id