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Phase IV Trial to Determine the Safety and Immunogenicity of the WHO Formulation of the 2006-2007 Fluzone® Vaccine

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ClinicalTrials.gov Identifier: NCT00389532
Recruitment Status : Completed
First Posted : October 19, 2006
Results First Posted : March 30, 2009
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE October 18, 2006
First Posted Date  ICMJE October 19, 2006
Results First Submitted Date  ICMJE February 24, 2009
Results First Posted Date  ICMJE March 30, 2009
Last Update Posted Date April 14, 2016
Study Start Date  ICMJE October 2006
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2014)
  • Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination [ Time Frame: 0-3 days post-vaccination ]
    Percentage of Participants with Solicited Injection Site or Systemic Reaction(s) within 0-3 days after vaccination with Fluzone® (2006-2007 formulation)
  • Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition Antibodies Pre-vaccination and Post-vaccination [ Time Frame: 21 days post-vaccination ]
    GMTs and their 95% confidence intervals for each of the 3 antigens in the Fluzone® vaccine (2006-2007 formulation) pre-vaccination and 21 days post-vaccination.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00389532 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase IV Trial to Determine the Safety and Immunogenicity of the WHO Formulation of the 2006-2007 Fluzone® Vaccine
Official Title  ICMJE Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity of Fluzone® Influenza Virus Vaccine (2006-2007 Formulation)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE Biological: Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)
Influenza vaccine
Other Name: 2006-2007 Fluzone® vaccine
Study Arms  ICMJE
  • Experimental: 1
    aged 19 to 59 years
    Intervention: Biological: Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)
  • Experimental: 2
    aged ≥ 60 years
    Intervention: Biological: Influenza Virus Vaccine (2006-2007 Fluzone® vaccine)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2008)
116
Original Enrollment  ICMJE
 (submitted: October 18, 2006)
120
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 reasonably 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 3.
  • Vaccination planned in the 4 weeks following Fluzone® vaccination at Visit 1.
  • 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 abuse of alcohol or drug addiction 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00389532
Other Study ID Numbers  ICMJE GRC35
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc
PRS Account Sanofi
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP