Study of Intradermal Quadrivalent Influenza Vaccine in Adults Aged 18 Through 64 Years

Condition(s) targeted: Influenza

Intervention: Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation (Biological); Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal (Biological); Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal (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 demonstrate safety and immunogenicity of the quadrivalent influenza intradermal (QIV-ID) vaccine compared to the trivalent influenza vaccine (TIV) containing the B strain from the primary (Yamagata) lineage (TIV-ID1) and the trivalent influenza vaccine containing B strain from the alternate (Victoria) lineage (TIV-ID2) vaccines in producing protection against four strains of influenza virus. Primary Objective:

- To demonstrate that QIV-ID induces an immune response (as assessed by hemagglutination

inhibition (HAI) geometric mean titers (GMTs) and seroconversion rates) that is non-inferior to responses induced by TIV-ID1 and TIV-ID2 for the 4 virus strains at 28 days post-vaccination. Secondary Objectives:

- To demonstrate that each B strain in QIV-ID induces an immune response (as assessed by

HAI GMTs and seroconversion rates) that is superior to the response induced by the TIV-ID that does not contain the corresponding B strain.

- To describe the rate of post-vaccination seroprotection induced by QIV-ID and TIV-ID.

- To describe post-vaccination immunogenicity stratified by age (18-49 years and 50-64

years), race, ethnicity, gender, previous vaccination status, and baseline seropositivity status.

- To describe the safety profile for subjects who receive QIV-ID and TIV-ID.

Observational Objectives:

- To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 2 or

Grade 3 solicited systemic reactions combined

- To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 3

solicited injection site reactions combined.

Official title: Immunogenicity and Safety Trial of Quadrivalent Influenza Vaccine Administered by Intradermal Route in Adult Subjects Aged 18 Through 64 Years

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 the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route

Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route

Secondary outcome:

Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route

Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route

Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route

Detailed description: All participants will receive a single dose of their assigned vaccine on Day 0. A subset of the participants will be assessed for immunologic response on Day 0 before vaccination and Day 28 after vaccination. All subjects will be monitored for safety for up to 6 months after vaccination.

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Aged 18 through 64 years 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.

Exclusion Criteria:

- Subject is pregnant, or lactating, or of childbearing potential (to be considered of

non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination)

- Participation at the time of trial enrollment (or in the 4 weeks preceding the trial

vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure

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

receipt of any vaccine in the 4 weeks following trial vaccination

- Vaccination against influenza in the past 6 months

- Receipt of immune globulins, blood or blood-derived products in the past 3 months

- 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)

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

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

- History of thrombocytopenia

- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion

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

or hospitalized involuntarily

- Current alcohol abuse or drug addiction

- Chronic illness that, in the opinion of the investigator, is at a stage where it

might interfere with trial conduct or completion

- Identified as an Investigator or employee of the Investigator or trial center with

direct involvement in the proposed trial, or identified as an immediate family member (i. e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed trial

- Personal or family history of Guillain-Barré Syndrome

- Neoplastic disease or any hematologic malignancy (except localized skin or prostate

cancer that is stable at the time of vaccination in the absence of therapy, and subjects who have a history of neoplastic disease and who have been disease free for ≥ 5 years.

Hoover, Alabama 35216, United States

Huntsville, Alabama 35802, United States

Chandler, Arizona 85224, United States

Mesa, Arizona 85213, United States

Phoenix, Arizona 85020, United States

Tucson, Arizona 85704, United States

Chula Vista, California 91911, United States

Sacramento, California 95816, United States

San Diego, California 92103, United States

Milford, Connecticut 06460, United States

Coral Gables, Florida 33134, United States

Melbourne, Florida 32935, United States

Pinellas Park, Florida 33781, United States

South Miami, Florida 33143, United States

Boise, Idaho 83642, United States

Iowa City, Iowa 52242, United States

Overland Park, Kansas 66212, United States

Wichita, Kansas 67207, United States

Kansas City, Missouri 64114, United States

Springfield, Missouri 65802, United States

St. Louis, Missouri 63104, United States

Omaha, Nebraska 68134, United States

Binghamton, New York 13901, United States

Rochester, New York 14609, United States

Rochester, New York 14621, United States

Allentown, Pennsylvania 18102, United States

Bensalem, Pennsylvania 19020, United States

Warwick, Rhode Island 02886, United States

Mt. Pleasant, South Carolina 29464, United States

Dakota Dunes, South Dakota 57049, United States

Austin, Texas 78745, United States

Fort Worth, Texas 76107, United States

Fort Worth, Texas 76135, United States

San Angelo, Texas 76904, United States

Salt Lake City, Utah 84109, United States

Salt Lake City, Utah 84121, United States

West Jordan, Utah 84088, United States

Marshfield, Wisconsin 54449, United States

Related publications:

Gorse GJ, Falsey AR, Ozol-Godfrey A, Landolfi V, Tsang PH. Safety and immunogenicity of a quadrivalent intradermal influenza vaccine in adults. Vaccine. 2015 Feb 25;33(9):1151-9. doi: 10.1016/j.vaccine.2015.01.025. Epub 2015 Jan 19.

Starting date: October 2012
Last updated: April 20, 2015