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Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT00845429
Recruitment Status : Completed
First Posted : February 18, 2009
Results First Posted : December 17, 2012
Last Update Posted : December 19, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE February 13, 2009
First Posted Date  ICMJE February 18, 2009
Results First Submitted Date  ICMJE November 17, 2012
Results First Posted Date  ICMJE December 17, 2012
Last Update Posted Date December 19, 2012
Study Start Date  ICMJE October 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2012)
  • Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. [ Time Frame: Days 0 and 21 post-vaccination ]
  • Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. [ Time Frame: Day 21 post-vaccination ]
    Seroprotection was defined as a titer ≥ 40 1/dil, and determined in participants with a valid serology result for the particular Flu strain, including results reported as less than lower limit of quantitation (LLOQ)
  • Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine. [ Time Frame: Day 21 post-vaccination ]
    Seroconversion: For participants with a Day 0 pre-vaccination titer < 10 (1/dil), titer ≥ 40 (1/dil) on Day 21. Significant Increase: For participants with a Day 0 pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of titer on Day 21.
Original Primary Outcome Measures  ICMJE
 (submitted: February 13, 2009)
To provide information concerning the immunogenicity of cell-based influenza vaccine [ Time Frame: 21 days post-vaccination ]
Change History Complete list of historical versions of study NCT00845429 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2012)
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine. [ Time Frame: Day 0 up to Day 7 post-vaccination ]
Solicited Injection Site Reactions: Pain, erythema or redness, swelling, ecchymosis, and induration. Solicited Systemic Reactions: Fever (temperature), headache, malaise, myalgia, and rigors.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2009)
To provide information concerning the safety of cell-based influenza vaccine [ Time Frame: 21 days post-vaccination and entire study period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects
Official Title  ICMJE Immunogenicity of Two Dosages of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine Administered in Healthy Adult Subjects Aged 18 to 49 Years
Brief Summary

Primary Objective:

To describe the immune response to a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.

Secondary Objective:

To describe the safety following a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.

Detailed Description This is a multi-center study in healthy adult subjects. All subjects will receive a single dose of one of the influenza vaccine formulations and will provide blood samples for immunogenicity assessment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Influenza
  • Orthomyxoviruses
  • Myxovirus Infection
Intervention  ICMJE
  • Biological: Influenza virus vaccine - cell based (2007-2008 Formulation)
    0.5 mL, Intramuscular
  • Biological: Influenza virus vaccine - cell-based (2007-2008 Formulation)
    1.0 mL, Intramuscular
  • Biological: Influenza virus vaccine (2007-2008 Formulation)
    0.5 mL, Intramuscular
    Other Name: Fluzone® (2007-2008 formulation)
Study Arms  ICMJE
  • Experimental: Group 1: Standard-dose Cell-based Influenza Vaccine
    Participants will receive a single dose of standard-dose cell-based influenza virus vaccine.
    Intervention: Biological: Influenza virus vaccine - cell based (2007-2008 Formulation)
  • Experimental: Group 2: High-dose Cell-based Influenza Vaccine
    Participants will receive a single dose of high-dose cell-based influenza virus vaccine.
    Intervention: Biological: Influenza virus vaccine - cell-based (2007-2008 Formulation)
  • Active Comparator: Group 3: Licensed Fluzone® Influenza Vaccine
    Participants will receive a single dose of licensed Fluzone® influenza vaccine.
    Intervention: Biological: Influenza virus vaccine (2007-2008 Formulation)
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: November 17, 2012)
729
Original Actual Enrollment  ICMJE
 (submitted: February 13, 2009)
734
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria :

  • Healthy male or female subject, aged ≥ 18 to < 50 years on the day of inclusion
  • Informed consent form signed
  • Able to attend all scheduled visits and to comply with all trial procedures
  • For a woman of childbearing potential: a negative urine pregnancy test and documented use of an effective method of contraception or abstinence for at least four weeks pre vaccination and up until three weeks post-vaccination

Exclusion Criteria :

  • Subject currently breast-feeding.
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Prior participation in the Phase I trial of FLU INTERPAN (PER.C6) vaccine (study GCE01).
  • 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 except the use of topical or inhalant corticosteroids
  • Systemic hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
  • Chronic illness at a stage that could interfere with trial conduct or completion (chronic illness may include, but is not limited to, cardiac, renal or auto-immune disorders, or diabetes).
  • Receipt of blood or blood-derived products in the 3 months preceding vaccination.
  • Receipt of any vaccination in the 4 weeks preceding vaccination, or planned receipt of any vaccination in the 4 weeks following the trial vaccination.
  • History of influenza infection (confirmed either clinically, serologically or microbiologically) within the 6 months preceding vaccination.
  • Previous vaccination against influenza (in the 6 months preceding the trial vaccination).
  • Planned receipt of any other 2007-2008 influenza vaccine.
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
  • History of Guillain-Barré syndrome
  • Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures
  • Any other condition which in the opinion of the investigator would pose a health risk to the participant or interfere with the evaluation of the vaccine.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (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 NCT00845429
Other Study ID Numbers  ICMJE GCE03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date December 2012

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