ClinicalTrials.gov
ClinicalTrials.gov Menu

Influenza Vaccine Revaccination in Ambulatory Elderly Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00775450
Recruitment Status : Completed
First Posted : October 20, 2008
Results First Posted : August 11, 2011
Last Update Posted : December 31, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

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 or disease Intervention/treatment Phase
Influenza Orthomyxovirus Infection Myxovirus Infection Biological: Influenza Virus Vaccine USP Trivalent Types A and B Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 807 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]
    Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.


Secondary Outcome Measures :
  1. 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 ]
    Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.

  2. 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 ]
    Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28.

  3. 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 ]
    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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00775450


  Show 28 Study Locations
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00775450     History of Changes
Other Study ID Numbers: FID21
First Posted: October 20, 2008    Key Record Dates
Results First Posted: August 11, 2011
Last Update Posted: December 31, 2013
Last Verified: December 2013

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Influenza
Orthomyxovirus Infection
Inactivated Split-virion influenza vaccine
Elderly

Additional relevant MeSH terms:
Infection
Communicable Diseases
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs