Clinical trial NCT00845429: Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Orthomyxoviruses
Myxovirus Infection
Keywords: Influenza
Orthomyxoviruses
Split-virion inactivated influenza vaccine
cell-based vaccine
Adults
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-02-18
Enrollment: 729
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens.
timeFrame: Days 0 and 21 post-vaccination
measure: Percentage of Participants With Seroprotection to Each of the Influenza Vaccine Antigen Before and Post-vaccination.
timeFrame: Day 21 post-vaccination
measure: Percentage of Participants Achieving Seroconversion or Significant Increase at Day 21 Following Vaccination With Influenza Vaccine.
timeFrame: Day 21 post-vaccination
Secondary outcomes:
measure: Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With Influenza Vaccine.
timeFrame: Day 0 up to Day 7 post-vaccination
Other outcomes:
Locations:
city: Hoover
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Milford
country: United States
state: Connecticut
city: Pinellas Park
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Wichita
country: United States
state: Kansas
city: Kansas City
country: United States
state: Missouri
city: Springfield
country: United States
state: Missouri
city: Cary
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Bensalem
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Mt Pleasant
country: United States
state: South Carolina
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: