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Influenza Vaccine Revaccination in Ambulatory Elderly Subjects

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00775450
First received: October 16, 2008
Last updated: August 10, 2011
Last verified: August 2011
History of Changes
  Purpose

This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years.

Primary Objective:

To describe the safety profile for all subjects.

Secondary Objective:

To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.


Condition Intervention Phase
Influenza
Orthomyxovirus Infection
Myxovirus Infection
 Biological: Influenza Virus Vaccine USP Trivalent Types A and B
 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: Safety and Immunogenicity of Revaccination With Influenza Vaccine in Ambulatory Elderly Subjects Previously Vaccinated With Fluzone ID, Fluzone HD, and Fluzone® IM

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection [ Time Frame: Days 0 through 7 post vaccination ] [ Designated as safety issue: No ]
    Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.


Secondary Outcome Measures:
  • Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection [ Time Frame: Day 0 and Day 28 post-vaccination ] [ Designated as safety issue: No ]
    Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.

  • Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine [ Time Frame: Days 0 and 28 post-vaccination ] [ Designated as safety issue: No ]
    Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28.

  • Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine [ Time Frame: Day 28 post vaccination ] [ Designated as safety issue: No ]
    Seroconversion was defined as either a pre-vaccination hemagglutinin inhibition (HAI) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre- vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post vaccination.


Enrollment: 807
Study Start Date: October 2008
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1a: Fluzone ID After Fluzone ID Biological: Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
Other Name: Fluzone
Experimental: Group 1b: Fluzone IM After Fluzone ID Biological: Influenza Virus Vaccine USP Trivalent Types A and B
0.5 mL, Intramuscular
Other Name: Fluzone
Active Comparator: Group 2a: Fluzone IM After Fluzone IM Biological: Influenza Virus Vaccine USP Trivalent Types A and B
0.5 mL, Intramuscular
Other Name: Fluzone
Experimental: Group 2b: Fluzone ID After Fluzone IM Biological: Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
Other Name: Fluzone
Active Comparator: Group 3: Fluzone HD After Fluzone HD Biological: Influenza Virus Vaccine USP Trivalent Types A and B
0.5 mL, Intramuscular
Other Name: Fluzone

Detailed Description:

Subjects who previously participated in study FID29 will be invited to participate in this revaccination study. They will be assigned to 1 of 3 groups based on the group they were previously randomized to and the vaccine received in study FID29.

  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
  • Enrolled in and completed study FID29 and received the correct vaccine for the group to which they were randomized
  • Informed consent form signed and dated
  • Able to attend all scheduled visits and to comply with all trial procedures
  • Subject is medically stable.

Exclusion Criteria :

  • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
  • Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
  • Current alcohol abuse 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, that might interfere with the assessment of immune response
  • Receipt of any vaccination in the 4 weeks preceding the trial vaccination
  • Planned receipt of any vaccine in the 4 weeks following the trial vaccination
  • Known human immunodeficiency virus (HIV), hepatitis B (HBs) antigen, or Hepatitis C seropositivity.
  • Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine
  • Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
  • 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).
  • Personal or family history of Guillain-Barré Syndrome.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775450

  Show 28 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Monitor, Sanofi Pasteur Inc.
ClinicalTrials.gov Identifier: NCT00775450     History of Changes
Other Study ID Numbers: FID21
Study First Received: October 16, 2008
Results First Received: July 14, 2011
Last Updated: August 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Influenza
Orthomyxovirus Infection
Inactivated Split-virion influenza vaccine
Elderly

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

ClinicalTrials.gov processed this record on May 19, 2013