Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
4363 participants
INTERVENTIONAL
2010-11-30
2012-02-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group 1: Licensed 2010-2011 TIV
Participants will receive the Licensed 2010-2011 Trivalent Influenza Vaccine containing the primary B strain.
Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative
0.25 mL (6 to 35 months) or 0.5 mL (3 to \<9 years), Intramuscular
Group 2: Investigational TIV
Participants will receive the Investigational Trivalent Influenza Vaccine containing the alternate B strain
Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative
0.25 mL (6 to 35 months) or 0.5 mL (3 to \<9 years), Intramuscular
Group 3: Investigational QIV
Participants will receive the investigational Quadrivalent Influenza Vaccine
Quadrivalent Influenza Vaccine, No Preservative
0.25 mL (6 to 35 months), or 0.5 mL(3 to \<9 years), Intramuscular
Interventions
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Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative
0.25 mL (6 to 35 months) or 0.5 mL (3 to \<9 years), Intramuscular
Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative
0.25 mL (6 to 35 months) or 0.5 mL (3 to \<9 years), Intramuscular
Quadrivalent Influenza Vaccine, No Preservative
0.25 mL (6 to 35 months), or 0.5 mL(3 to \<9 years), Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
6 Months
8 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Dothan, Alabama, United States
Chandler, Arizona, United States
Chandler, Arizona, United States
Mesa, Arizona, United States
Mesa, Arizona, United States
Scottsdale, Arizona, United States
Little Rock, Arkansas, United States
Los Angeles, California, United States
San Diego, California, United States
San Diego, California, United States
Colorado Spring, Colorado, United States
Denver, Colorado, United States
Ridgefield, Connecticut, United States
Boca Raton, Florida, United States
Jacksonville, Florida, United States
Melbourne, Florida, United States
Miami Beach, Florida, United States
Ponte Vedra, Florida, United States
Sarasota, Florida, United States
Sarasota, Florida, United States
South Miami, Florida, United States
Marietta, Georgia, United States
Arkansas City, Kansas, United States
Newton, Kansas, United States
Overland Park, Kansas, United States
Wichita, Kansas, United States
Wichita, Kansas, United States
Bardstown, Kentucky, United States
Crestview Hills, Kentucky, United States
Lexington, Kentucky, United States
Metairie, Louisiana, United States
Columbia, Maryland, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Binghamton, New York, United States
Cary, North Carolina, United States
Akron, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Scranton, Pennsylvania, United States
Warwick, Rhode Island, United States
Barnwell, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Clarksville, Tennessee, United States
Kingsport, Tennessee, United States
Austin, Texas, United States
Fort Worth, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Katy, Texas, United States
Layton, Utah, United States
Murray, Utah, United States
Orem, Utah, United States
Provo, Utah, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
South Jordan, Utah, United States
West Jordan, Utah, United States
Charlottesville, Virginia, United States
Midlothian, Virginia, United States
Williamsburg, Virginia, United States
Marshfield, Wisconsin, United States
Countries
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References
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Greenberg DP, Robertson CA, Landolfi VA, Bhaumik A, Senders SD, Decker MD. Safety and immunogenicity of an inactivated quadrivalent influenza vaccine in children 6 months through 8 years of age. Pediatr Infect Dis J. 2014 Jun;33(6):630-6. doi: 10.1097/INF.0000000000000254.
Related Links
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Related Info
Other Identifiers
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UTN: U1111-1114-3713
Identifier Type: OTHER
Identifier Source: secondary_id
QIV04
Identifier Type: -
Identifier Source: org_study_id
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