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Study of Quadrivalent Influenza Vaccine Among Children

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative (Biological); Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative (Biological); Quadrivalent 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.

Summary

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 (B1), and the investigational TIV containing the alternate B (B2) strain in children. 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 children aged 6 months to less than 9 years of age Secondary Objective: To demonstrate superiority of antibody responses to each B strain in QIV compared with antibody titers following vaccination with the TIV that does not contain the corresponding B strain, as assessed by GMT ratios and seroconversion rates. Observational Objective: To describe the safety profile of QIV among subjects 6 months to less than 9 years of age, 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.

Clinical Details

Official title: Safety and Immunogenicity Among Children 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 A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants

Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All Participants

Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All Participants

Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months.

Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years.

Detailed description: Participants will receive a single dose of their assigned vaccine during Visit 1. For those requiring two doses of influenza vaccine, as per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of the assigned vaccine will be administered at Visit 2. All participants will be followed up for safety (up to 6 months post final vaccination) and for immunogenicity up to Day 28 post-vaccination (Visit 2 or Visit 3, as appropriate).

Eligibility

Minimum age: 6 Months. Maximum age: 8 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject is 6 months to < 9 years of age on the day of inclusion.

- Parent/guardian is willing and able to attend scheduled visits and to comply with the

study procedures during the entire duration of the study.

- Subject is in reasonably good health as assessed by the Investigator.

- Informed consent is granted by the parent(s) or other legally acceptable

representative; assent by subjects 7 to < 9 years of age.

- For subjects 6 months to < 24 months of age, born at full term of pregnancy (≥ 37

weeks) and with a birth weight ≥ 2. 5 kg (5. 5 lbs). Exclusion Criteria:

- History of allergy to egg proteins or any constituents of the vaccine.

- History of serious adverse reaction to any influenza vaccine.

- Any vaccination scheduled between Visit 1 and Visit 2 (or Visit 1 and Visit 3 for

those requiring two doses).

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

- 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.

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

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.

- 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).

- Personal or immediate family history of congenital immune deficiency.

- Personal developmental delay, neurologic disorder, or seizure disorder.

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

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

- Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.

- Receipt of blood or blood-derived products (including immunoglobulin therapy) in the

past 3 months, which might interfere with assessment of the immune response.

- 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 of the employees or the Investigator.

Locations and Contacts

Dothan, Alabama 36305, United States

Chandler, Arizona 85224, United States

Chandler, Arizona 85225, United States

Mesa, Arizona 85203, United States

Mesa, Arizona 85213, United States

Scottsdale, Arizona 85258, United States

Little Rock, Arkansas 72205, United States

Los Angeles, California 90036, United States

San Diego, California 92103, United States

San Diego, California 92108, United States

Colorado Spring, Colorado 80922, United States

Denver, Colorado 80239, United States

Ridgefield, Connecticut 06877, United States

Boca Raton, Florida 33432, United States

Jacksonville, Florida 32216, United States

Melbourne, Florida 32935, United States

Miami Beach, Florida 33141, United States

Ponte Vedra, Florida 32081, United States

Sarasota, Florida 34231, United States

Sarasota, Florida 34239, United States

South Miami, Florida 33143, United States

Marietta, Georgia 30625, United States

Arkansas City, Kansas 67005, United States

Newton, Kansas 67114, United States

Overland Park, Kansas 66202, United States

Wichita, Kansas 67205, United States

Wichita, Kansas 67207, United States

Bardstown, Kentucky 40004, United States

Crestview Hills, Kentucky 41017, United States

Lexington, Kentucky 40509, United States

Metairie, Louisiana 70006, United States

Columbia, Maryland 21045, United States

Kansas City, Missouri 64114, United States

St. Louis, Missouri 63141, United States

Las Vegas, Nevada 89104, United States

Binghamton, New York 13901, United States

Cary, North Carolina 27518, United States

Akron, Ohio 44311, United States

Cleveland, Ohio 44121, United States

Columbus, Ohio 43212, United States

Portland, Oregon 97203, United States

Pittsburgh, Pennsylvania 15227, United States

Pittsburg, Pennsylvania 15220, United States

Scranton, Pennsylvania 18510, United States

Warwick, Rhode Island 02886, United States

Barnwell, South Carolina 26812, United States

Mount Pleasant, South Carolina 29464, United States

Clarksville, Tennessee 37043, United States

Kingsport, Tennessee 37664, United States

Austin, Texas 78705, United States

Fort Worth, Texas 76107, United States

Ft. Worth, Texas 76135, United States

Houston, Texas 77074, United States

Katy, Texas 77450, United States

Layton, Utah 84041, United States

Murray, Utah 84107, United States

Orem, Utah 84057, United States

Provo, Utah 84604, United States

Salt Lake City, Utah 84121, United States

Salt Lake City, Utah 84124, United States

Salt Lake City, Utah 84109, United States

South Jordan, Utah 84095, United States

West Jordan, Utah 84088, United States

Charlottesville, Virginia 22902, United States

Midlothian, Virginia 23113, United States

Williamsburg, Virginia 23185, United States

Marshfield, Wisconsin 54449, United States

Additional Information

Starting date: November 2010
Last updated: June 16, 2015

Page last updated: August 20, 2015

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