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A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination
This study has been completed.
First Received: January 27, 2009   Last Updated: February 3, 2009   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00835926
  Purpose

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 Intervention Phase
Influenza
Biological: Influenza virus vaccine (Fluzone®)
Phase IV

MedlinePlus related topics: Flu
Drug Information available for: Fluvirin Influenza Vaccines
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: Safety and Immunogenicity of Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® 2003/2004

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of Fluzone® (2003/2004) vaccine. [ Time Frame: 21days post-vaccination ] [ Designated as safety issue: No ]
  • To provide information concerning the safety after administration of Fluzone® (2003/2004) vaccine. [ Time Frame: 4 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]

Enrollment: 121
Study Start Date: July 2003
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Fluzone Group
Biological: Influenza virus vaccine (Fluzone®)
0.5 mL, Intramuscular

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835926

Locations
United States, Virginia
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi Pasteur Inc. ( Medical Monitor )
Study ID Numbers: GRC16
Study First Received: January 27, 2009
Last Updated: February 3, 2009
ClinicalTrials.gov Identifier: NCT00835926     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Sanofi-Aventis:
influenza

Study placed in the following topic categories:
Fluconazole
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

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

ClinicalTrials.gov processed this record on May 07, 2009