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

December 13, 2012 updated by: Sanofi

Immunogenicity of Two Dosages of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine Administered in Healthy Adult Subjects Aged 18 to 49 Years

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

729

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Hoover, Alabama, United States, 35216
      • Mobile, Alabama, United States, 36608
    • Arizona
      • Tucson, Arizona, United States, 85710
    • Connecticut
      • Milford, Connecticut, United States, 06460
    • Florida
      • Pinellas Park, Florida, United States, 33781
    • Illinois
      • Chicago, Illinois, United States, 60610
    • Kansas
      • Wichita, Kansas, United States, 67207
    • Missouri
      • Kansas City, Missouri, United States, 64114
      • Springfield, Missouri, United States, 65802
    • North Carolina
      • Cary, North Carolina, United States, 27518
      • Raleigh, North Carolina, United States, 27609
    • Ohio
      • Cincinnati, Ohio, United States, 45249
    • Pennsylvania
      • Bensalem, Pennsylvania, United States, 19020
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
    • South Carolina
      • Mt Pleasant, South Carolina, United States, 29464

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Fluzone® (2007-2008 formulation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Day 21 post-vaccination
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.
Day 21 post-vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 up to Day 7 post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

February 13, 2009

First Submitted That Met QC Criteria

February 13, 2009

First Posted (Estimate)

February 18, 2009

Study Record Updates

Last Update Posted (Estimate)

December 19, 2012

Last Update Submitted That Met QC Criteria

December 13, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCE03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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