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A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination

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ClinicalTrials.gov Identifier: NCT00835926
Recruitment Status : Completed
First Posted : February 4, 2009
Results First Posted : October 26, 2009
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

To describe the safety during days 0 to 21 following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years.

To describe the immune response at 21 days following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.


Condition or disease Intervention/treatment Phase
Influenza Biological: Influenza virus vaccine Phase 4

Detailed Description:
Safety will be assessed throughout the trial period. Using antigens provided by Aventis Pasteur Inc., pre- and post-vaccination serum antibody titers for each of the three vaccine strains will be measured.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® 2003/2004
Study Start Date : July 2003
Actual Primary Completion Date : September 2003
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Fluzone® Vaccine Group 1
Participants aged 18 to 59 years at enrollment - Fluzone® Group
Biological: Influenza virus vaccine
0.5 mL, Intramuscular
Other Name: Fluzone®
Experimental: Fluzone® Vaccine Group 2
Participants aged 60 years and older at enrollment - Fluzone® Group
Biological: Influenza virus vaccine
0.5 mL, Intramuscular
Other Name: Fluzone®



Primary Outcome Measures :
  1. Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-Vaccination With Fluzone® [ Time Frame: Days 0 to 3 Post-vaccination ]

    Solicited injection site reactions: Erythema, bruising, induration, and Pain at injection site.

    Solicited systemic reaction: Fever (temperature), chills, rash, headache, cough, runny nose, nausea, vomiting, diarrhea, malaise, myalgia, and arthralgia


  2. Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Before and After Vaccination With Fluzone® [ Time Frame: Day 0 and Day 21 Post-vaccination ]
    Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.

  3. Percentage of Participants With a ≥ 4-Fold Rise in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® [ Time Frame: Day 21 Post-vaccination ]
    Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay.

  4. Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titers ≥ 40 Post-Vaccination With Fluzone® [ Time Frame: Day 21 Post-vaccination ]
    Hemagglutination inhibition antibodies is a measure of the serum antibody to the influenza virus in the vaccine as determined by the hemagglutinin inhibition (HAI) assay



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Age of 18 years or greater.
  • Ambulatory.
  • In reasonably good health as assessed by the investigator.
  • Available for duration of the study (21 days + 2d).
  • Willing and able to meet protocol requirements.
  • Willing and able to give informed consent.

Exclusion Criteria :

  • Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
  • An acute illness with or without fever (temperature >100.4°F) in the 72 hours preceding enrollment in the trial.
  • Clinically significant findings in vital signs (including temperature >100.4°F) or review of systems.
  • Self-reported history of severe adverse event to any influenza vaccine.
  • Vaccination against influenza in the 6 months preceding enrollment in the study.
  • Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.
  • Participation in any other experimental drug or vaccine trial within the 30 days preceding enrollment into the study.
  • Immunosuppressive therapy including long-term (> 2 weeks) systemic corticosteroids or cancer therapy within the past 3 months or ongoing.
  • Receipt of blood or blood products within the 3 months preceding enrollment in the study.
  • Diabetes
  • Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine (e.g., existing severe chronic illness such as pulmonary disorders, cardiovascular disorders, chronic blood disorders, etc.).
  • Person deprived of freedom by an administrative or court order (having legal or medical guardian).
  • For women of childbearing age, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.

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): NCT00835926


Locations
United States, Virginia
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00835926     History of Changes
Other Study ID Numbers: GRC16
First Posted: February 4, 2009    Key Record Dates
Results First Posted: October 26, 2009
Last Update Posted: April 14, 2016
Last Verified: April 2016

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Influenza
Fluzone®

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