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

April 13, 2012 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

817

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Alabaster, Alabama, United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • Fountain Valley, California, United States
    • Florida
      • Pinellas Park, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Missouri
      • Springfield, Missouri, United States
    • New York
      • Brooklyn, New York, United States
      • New York, New York, United States
    • Pennsylvania
      • Bensalem, Pennsylvania, United States
      • Grove City, Pennsylvania, United States
      • Johnstown, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • Texas
      • Fort Worth, Texas, United States
      • Galveston, Texas, United States
    • Utah
      • Layton, Utah, United States
      • South Jordan, Utah, United States
    • Virginia
      • Norfolk, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Fluzone
Biological: Split, Inactivated, Trivalent Influenza Vaccine
0.5 mL, Intramuscular
Other Names:
  • Fluzone® 2006/2007 Formulation
Active Comparator: Fluzone Intramuscular (IM) Vaccine Group
Participants received a dose of Fluzone Intramuscular (IM) Influenza Vaccine.
Biological: Split, Inactivated, Trivalent Influenza Vaccine
0.1 mL, Intradermal
Other Names:
  • Fluzone
Biological: Split, Inactivated, Trivalent Influenza Vaccine
0.5 mL, Intramuscular
Other Names:
  • Fluzone® 2006/2007 Formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The serological determinations of total anti-influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.
Pre-vaccination and Day 28 post-vaccination
Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine.
Time Frame: Day 28 post-vaccination
Seroprotection was defined as a post-vaccination Hemagglutinin inhibition (HAI) antibody titer ≥ 40
Day 28 post-vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The serological determinations of total anti influenza antibodies were performed using an Hemagglutinin inhibition (HAI) test.
Pre- and Day 28 post-vaccination
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

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

Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Day 0 up to 7 days post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

October 16, 2006

First Submitted That Met QC Criteria

October 16, 2006

First Posted (Estimate)

October 17, 2006

Study Record Updates

Last Update Posted (Estimate)

April 18, 2012

Last Update Submitted That Met QC Criteria

April 13, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FID04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Influenza

Clinical Trials on Split, Inactivated, Trivalent Influenza Vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe