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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00388583
First received: October 16, 2006
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Orthomyxoviridae Infection
Influenza
Myxovirus Infection
Biological: Split, Inactivated, Trivalent Influenza Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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. [ Time Frame: Pre-vaccination and Day 28 post-vaccination ] [ Designated as safety issue: No ]
    The serological determinations of total anti-influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.

  • Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine. [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]
    Seroprotection was defined as a post-vaccination Hemagglutinin inhibition (HAI) antibody titer ≥ 40


Secondary Outcome Measures:
  • Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine. [ Time Frame: Pre- and Day 28 post-vaccination ] [ Designated as safety issue: No ]
    The serological determinations of total anti influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.

  • Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine [ Time Frame: Day 0 up to 7 days post-vaccination ] [ Designated as safety issue: No ]

    Solicited injection site reactions: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus.

    Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.



Enrollment: 817
Study Start Date: September 2006
Study Completion Date: September 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluzone Intradermal (ID) Vaccine Group
Participants received a dose of Fluzone Intradermal (ID) Influenza Vaccine
Biological: Split, Inactivated, Trivalent Influenza Vaccine
0.1 mL, Intradermal
Other Name: Fluzone
Active Comparator: Fluzone Intramuscular (IM) Vaccine Group
Participants received a dose of Fluzone Intramuscular (IM) Influenza Vaccine.
Biological: Split, Inactivated, Trivalent Influenza Vaccine
0.5 mL, Intramuscular
Other Name: Fluzone® 2006/2007 Formulation

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388583

Locations
United States, Alabama
Alabaster, Alabama, United States
United States, Arizona
Tucson, Arizona, United States
United States, California
Fountain Valley, California, United States
United States, Florida
Pinellas Park, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Missouri
Springfield, Missouri, United States
United States, New York
Brooklyn, New York, United States
New York, New York, United States
United States, Pennsylvania
Bensalem, Pennsylvania, United States
Grove City, Pennsylvania, United States
Johnstown, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, Texas
Fort Worth, Texas, United States
Galveston, Texas, United States
United States, Utah
Layton, Utah, United States
South Jordan, Utah, United States
United States, Virginia
Norfolk, Virginia, United States
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00388583     History of Changes
Other Study ID Numbers: FID04
Study First Received: October 16, 2006
Results First Received: July 14, 2011
Last Updated: April 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Influenza
Orthomyxoviruses
Inactivated Split-virion influenza vaccine
Elderly.

Additional relevant MeSH terms:
Communicable Diseases
Infection
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014