Influenza Vaccine Revaccination in Ambulatory Elderly Subjects

Safety and Immunogenicity of Revaccination With Influenza Vaccine in Ambulatory Elderly Subjects Previously Vaccinated With Fluzone ID, Fluzone HD, and Fluzone® IM

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.

Study Overview

• Status: Completed
• Conditions: Influenza; Myxovirus Infection; Orthomyxovirus Infection
• Intervention / Treatment: Biological: Influenza Virus Vaccine USP Trivalent Types A and B; Biological: Influenza Virus Vaccine USP Trivalent Types A and B

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
• Enrollment (Actual): 807
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Hoover, Alabama, United States, 35216
    • Mobile, Alabama, United States, 36608
  • Arizona
    • Chandler, Arizona, United States, 85224
    • Mesa, Arizona, United States, 85213
    • Phoenix, Arizona, United States, 85014
    • Tucson, Arizona, United States, 85710
  • California
    • Fountain Valley, California, United States, 92708
    • San Diego, California, United States, 92103
  • Connecticut
    • Milford, Connecticut, United States, 06460
  • Florida
    • Pembroke Pines, Florida, United States, 33024
    • Pinellas Park, Florida, United States, 33781
  • Illinois
    • Chicago, Illinois, United States, 60610
  • Kansas
    • Wichita, Kansas, United States, 67207
  • Missouri
    • Kansas City, Missouri, United States, 64114
    • Springfield, Missouri, United States, 65802
    • St. Louis, Missouri, United States, 63110
  • North Carolina
    • Cary, North Carolina, United States, 27518
    • Raleigh, North Carolina, United States, 27609
  • Ohio
    • Cincinnati, Ohio, United States, 45249
  • Pennsylvania
    • Bensalem, Pennsylvania, United States, 19020
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
  • South Carolina
    • Mt. Pleasant, South Carolina, United States, 29464
  • Texas
    • Fort Worth, Texas, United States, 76107
    • Galveston, Texas, United States, 77555
  • Utah
    • Salt Lake City, Utah, United States, 84121
    • Salt Lake City, Utah, United States, 84109
    • West Jordan, Utah, United States, 84088
  • Wisconsin
    • Marshfield, Wisconsin, United States, 54449

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / 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 Names: Fluzone; Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.5 mL, Intramuscular; Other Names: Fluzone
Experimental: Group 1b: Fluzone IM After Fluzone ID	Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.1 mL, Intradermal; Other Names: Fluzone; Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.5 mL, Intramuscular; Other Names: Fluzone
Active Comparator: Group 2a: Fluzone IM After Fluzone IM	Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.1 mL, Intradermal; Other Names: Fluzone; Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.5 mL, Intramuscular; Other Names: Fluzone
Experimental: Group 2b: Fluzone ID After Fluzone IM	Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.1 mL, Intradermal; Other Names: Fluzone; Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.5 mL, Intramuscular; Other Names: Fluzone
Active Comparator: Group 3: Fluzone HD After Fluzone HD	Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.1 mL, Intradermal; Other Names: Fluzone; Biological: Influenza Virus Vaccine USP Trivalent Types A and B; 0.5 mL, Intramuscular; Other Names: Fluzone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection	Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.	Days 0 through 7 post vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection	Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.	Day 0 and Day 28 post-vaccination
Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine	Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28.	Days 0 and 28 post-vaccination
Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine	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.	Day 28 post vaccination

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: October 16, 2008
• First Submitted That Met QC Criteria: October 16, 2008
• First Posted (Estimate): October 20, 2008

Study Record Updates

• Last Update Posted (Estimate): December 31, 2013
• Last Update Submitted That Met QC Criteria: December 5, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Elderly; Influenza; Inactivated Split-virion influenza vaccine; Orthomyxovirus Infection
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Influenza, Human; Orthomyxoviridae Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: FID21