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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00845429
First received: February 13, 2009
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Influenza
Orthomyxoviruses
Myxovirus Infection
Biological: Influenza virus vaccine - cell based (2007-2008 Formulation)
Biological: Influenza virus vaccine - cell-based (2007-2008 Formulation)
Biological: Influenza virus vaccine (2007-2008 Formulation)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity of Two Dosages of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine Administered in Healthy Adult Subjects Aged 18 to 49 Years

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. [ Time Frame: Day 21 post-vaccination ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    Solicited Injection Site Reactions: Pain, erythema or redness, swelling, ecchymosis, and induration.

    Solicited Systemic Reactions: Fever (temperature), headache, malaise, myalgia, and rigors.



Enrollment: 729
Study Start Date: October 2007
Study Completion Date: November 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: Standard-dose Cell-based Influenza Vaccine
Participants will receive a single dose of standard-dose cell-based influenza virus vaccine.
Biological: Influenza virus vaccine - cell based (2007-2008 Formulation)
0.5 mL, Intramuscular
Experimental: Group 2: High-dose Cell-based Influenza Vaccine
Participants will receive a single dose of high-dose cell-based influenza virus vaccine.
Biological: Influenza virus vaccine - cell-based (2007-2008 Formulation)
1.0 mL, Intramuscular
Active Comparator: Group 3: Licensed Fluzone® Influenza Vaccine
Participants will receive a single dose of licensed Fluzone® influenza vaccine.
Biological: Influenza virus vaccine (2007-2008 Formulation)
0.5 mL, Intramuscular
Other Name: Fluzone® (2007-2008 formulation)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00845429

Locations
United States, Alabama
Hoover, Alabama, United States, 35216
Mobile, Alabama, United States, 36608
United States, Arizona
Tucson, Arizona, United States, 85710
United States, Connecticut
Milford, Connecticut, United States, 06460
United States, Florida
Pinellas Park, Florida, United States, 33781
United States, Illinois
Chicago, Illinois, United States, 60610
United States, Kansas
Wichita, Kansas, United States, 67207
United States, Missouri
Kansas City, Missouri, United States, 64114
Springfield, Missouri, United States, 65802
United States, North Carolina
Cary, North Carolina, United States, 27518
Raleigh, North Carolina, United States, 27609
United States, Ohio
Cincinnati, Ohio, United States, 45249
United States, Pennsylvania
Bensalem, Pennsylvania, United States, 19020
United States, Rhode Island
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Mt Pleasant, South Carolina, United States, 29464
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00845429     History of Changes
Other Study ID Numbers: GCE03
Study First Received: February 13, 2009
Results First Received: November 17, 2012
Last Updated: December 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Influenza
Orthomyxoviruses
Split-virion inactivated influenza vaccine
cell-based vaccine
Adults

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

ClinicalTrials.gov processed this record on November 23, 2014