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