Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects
Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Influenza; Orthomyxoviruses; Myxovirus Infection
Intervention: Influenza virus vaccine - cell based (2007-2008 Formulation) (Biological); Influenza virus vaccine - cell-based (2007-2008 Formulation) (Biological); Influenza virus vaccine (2007-2008 Formulation) (Biological)
Phase: Phase 2
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Sanofi Pasteur Inc.
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens.Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination. Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine.
Secondary outcome: Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine.
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
Minimum age: 18 Years.
Maximum age: 49 Years.
Gender(s): Both.
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.
Locations and Contacts
Hoover, Alabama 35216, United States
Mobile, Alabama 36608, United States
Tucson, Arizona 85710, United States
Milford, Connecticut 06460, United States
Pinellas Park, Florida 33781, United States
Chicago, Illinois 60610, United States
Wichita, Kansas 67207, United States
Kansas City, Missouri 64114, United States
Springfield, Missouri 65802, United States
Cary, North Carolina 27518, United States
Raleigh, North Carolina 27609, United States
Cincinnati, Ohio 45249, United States
Bensalem, Pennsylvania 19020, United States
Warwick, Rhode Island 02886, United States
Mt Pleasant, South Carolina 29464, United States
Additional Information
Starting date: October 2007
Last updated: December 13, 2012
|
