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Trial to Describe the Safety and Immunogenicity of Fluzone®

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. Identifier: NCT00524940
Recruitment Status : Completed
First Posted : September 5, 2007
Results First Posted : March 30, 2009
Last Update Posted : April 14, 2016
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

Objective 1:To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere (NH) 2007-2008 formulation.

Objective 2: To describe the immunogenicity, of Fluzone, inactivated, split virion influenza vaccine NH 2007-2008 formulation.

Objective 3: Serum Collection - To submit remaining available sera to Center for Biologics Evaluation and research (CBER) for further analysis by the Food and Drug Administration (FDA), the Center for Disease Control and Prevention (CDC), and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.

Condition or disease Intervention/treatment Phase
Influenza Biological: Inactivated, Split-Virion Influenza Virus Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2007-2008 Formulation (Intramuscular Route)
Study Start Date : August 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Study Group Biological: Inactivated, Split-Virion Influenza Virus
0.5 mL, Intramuscular
Other Name: Fluzone®

Primary Outcome Measures :
  1. Solicited Injection Site and Solicited Systemic Reactions Post-vaccination. [ Time Frame: 0-3 days post-vaccination and entire study duration ]
    Information concerning the safety of Fluzone® vaccine 2007-2008 formulation.

  2. Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination. [ Time Frame: 21 days post-vaccination ]
    GMTs and their 95% Confidence Interval are presented for each of the 3 antigens in the Fluzone® Vaccine 2007-2008 formulation.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Participant aged 18 years or older on the day of inclusion.
  • Participant able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
  • Participant is in good health as assessed by the investigator.
  • Participant willing and able to meet protocol requirements.
  • Participant willing and able to give informed consent.
  • For a woman, inability to bear a child or negative serum/urine pregnancy test.

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 ≥ 99.5 °F oral) in the 72 hours preceding enrollment in the trial.
  • Clinically significant findings in vital signs (including temperature ≥ 99.5 °F oral) on review of systems.
  • Self-reported history of severe adverse event to any influenza vaccine.
  • Laboratory-confirmed influenza infection or 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 2.
  • Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study.
  • Immunocompromising or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 6 months.
  • Receipt of blood or blood products within the 3 months preceding enrollment in the study.
  • Diabetes mellitus requiring pharmacological control.
  • Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
  • Person deprived of freedom by an administrative or court order (having legal or medical guardian).
  • For women of childbearing potential, a positive urine pregnancy test, breast feeding, or not using a medically approved form of contraception for the duration of the trial.
  • Current alcohol or drug use that may interfere with the subject's ability to comply with trial procedures.
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
  • Prior personal 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 identifier (NCT number): NCT00524940

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United States, Virginia
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
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Study Director: Medical Director Sanofi Pasteur Inc
Additional Information:
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Responsible Party: Sanofi Pasteur, a Sanofi Company Identifier: NCT00524940    
Other Study ID Numbers: GRC37
First Posted: September 5, 2007    Key Record Dates
Results First Posted: March 30, 2009
Last Update Posted: April 14, 2016
Last Verified: April 2016
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Inactivated Split-virion influenza vaccine
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases