DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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.


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.


Minimum age: 18 Years. Maximum age: 49 Years. Gender(s): Both.


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


- 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


- 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


- Planned receipt of any other 2007-2008 influenza vaccine.

- Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM)


- 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

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017