Study of Quadrivalent Influenza Vaccine Among Adults

Condition(s) targeted: Influenza

Intervention: Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative (Biological); Investigational Trivalent Inactivated Influenza Vaccine, No Preservative (Biological); Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative (Biological); Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi Pasteur, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Sanofi Pasteur Inc.

The aim of the study is to evaluate a prototype quadrivalent influenza vaccine (QIV), the licensed 2010-2011 trivalent influenza vaccine (TIV) containing the primary B strain, and the investigational TIV containing the alternate B strain in adult subjects. Primary Objective:

- To demonstrate non-inferiority of antibody responses to QIV compared with licensed

2010-2011 TIV (containing the primary B strain) and investigational TIV (containing the alternate B strain) as assessed by geometric mean titer (GMT) ratios for each of the four virus strains separately among subjects 65 years of age and older Observational Objective:

- To describe the safety profiles of TIV among subjects 18 years of age and older and QIV

in subjects 65 years and older, as assessed by solicited injection site and systemic adverse events (AEs) collected for 7 days post-vaccination, unsolicited adverse events collected from 21 days post-vaccination, and adverse events of special interest and serious adverse events (SAEs) collected from Visit 1 to Visit 2.

Official title: Safety and Immunogenicity Trial Among Adults Administered Quadrivalent Influenza Vaccine

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older.

Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older.

Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older

Detailed description: All participants will receive a single dose of their assigned vaccine during Visit 1. They will be followed up for safety and immunogenicity through Day 21 post-vaccination (Visit 2)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria:

- Subject is 18 years of age or older on the day of inclusion.

- Informed consent form (ICF) has been signed and dated.

- Able to attend all scheduled visits and to comply with all trial procedures.

- For a woman of childbearing potential, use of an effective method of contraception or

abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks post-vaccination. Exclusion criteria:

- Known pregnancy, or a positive urine pregnancy test.

- Currently breastfeeding a child.

- History of serious adverse reaction to any influenza vaccine.

- Receipt of any vaccine in the 4 weeks preceding the trial vaccination.

- Planned receipt of any vaccine between Visit 1 and Visit 2.

- Participation in another interventional clinical trial investigating a vaccine, drug,

medical device, or medical procedure in the 4 weeks preceding the first study vaccination or during the course of the study.

- Receipt of any influenza vaccine since 01 August 2010 (including 2009 H1N1 monovalent

vaccine).

- Known systemic hypersensitivity to any of the vaccine components, or history of a

life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances.

- Receipt of blood or blood-derived products in the past 3 months, which might

interfere with assessment of the immune response.

- Thrombocytopenia, bleeding disorder, or receipt of anticoagulants contraindicating

intramuscular vaccination.

- Any condition that in the opinion of the Investigator would pose a health risk to the

subject if enrolled or could interfere with the evaluation of the vaccine.

- Personal history of Guillain-Barré Syndrome (GBS).

- Known or suspected congenital or acquired immunodeficiency; or receipt of

immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).

- Any chronic illness that, in the opinion of the Investigator, is not well controlled

or that may interfere with trial conduct or completion or with assessment of adverse events.

- Known seropositivity for human immunodeficiency virus (HIV), hepatitis B, or

hepatitis C.

- Deprived of freedom by an administrative or court order, or in an emergency setting,

or hospitalized involuntarily.

- Current alcohol or drug use that, in the opinion of the Investigator, might interfere

with the ability to comply with trial procedures.

- Identified as employees of the Investigator or study center, with direct involvement

in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i. e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.

Hoover, Alabama 35216, United States

South Miami, Florida 33143, United States

Springfield, Missouri 65802, United States

New York, New York 10004, United States

Rochester, New York 14609, United States

Cincinnati, Ohio 45249, United States

Allentown, Pennsylvania 18102, United States

Bensalem, Pennsylvania 19020, United States

Warwick, Rhode Island 02866, United States

Mt. Pleasant, South Carolina 29464, United States

Nashville, Tennessee 37212, United States

San Antonio, Texas 78229, United States

Starting date: October 2010
Last updated: September 13, 2013