Safety and Immunogenicity of Three Influenza Vaccines in Children Aged 4 Years Old to Less Than 18 Years Old
NCT ID: NCT01992107
Last Updated: 2015-12-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
2333 participants
INTERVENTIONAL
2013-11-30
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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QIVc (≥4 to <18 years)
Subjects received one or two doses of QIVc-Quadrivalent Cell-based Influenza Vaccine recommended for 2013-2014 season
QIVc
Novartis Investigational Quadrivalent Vaccine
TIV1c (≥4 to <18 years)
Subjects received one or two doses of TIV1c (Trivalent Inactivated Cell-based Influenza Vaccine containing one strain from B lineage ("B1" strain) recommended for 2013-2014 season
TIV1c
Licensed Influenza Vaccine
TIV2c (≥4 to <18 years)
Subjects received one or two doses of TIV2c (Trivalent Inactivated Cell-based Influenza Vaccine containing B strain from the alternate lineage ("B2" strain) recommended for 2013-2014
TIV2c
Novartis Investigational Vaccine
Interventions
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QIVc
Novartis Investigational Quadrivalent Vaccine
TIV1c
Licensed Influenza Vaccine
TIV2c
Novartis Investigational Vaccine
Eligibility Criteria
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Inclusion Criteria
2. Individual who had a parent or guardian who could give written informed consent after understanding the nature of the study and comply with study procedures and were available for follow-up.
3. If the individual was of an age where, according to local regulations, informed assent is required, that individual had provided assent to participate in the study.
Exclusion Criteria
2. Subjects with contraindications to receive influenza vaccine
4 Years
18 Years
ALL
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Vaccines
Role: STUDY_CHAIR
Novartis Vaccines
Locations
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Huntsville, Alabama, United States
Mobile, Alabama, United States
Chandler, Arizona, United States
Mesa, Arizona, United States
Mesa, Arizona, United States
Harrisburg, Arkansas, United States
Jonesboro, Arkansas, United States
Anaheim, California, United States
Anaheim, California, United States
Downey, California, United States
Garden Grove, California, United States
Modesto, California, United States
Paramount, California, United States
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
Santa Rosa, California, United States
West Covina, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Denver, Colorado, United States
Thornton, Colorado, United States
Boca Raton, Florida, United States
Lake Mary, Florida, United States
Melbourne, Florida, United States
Miami Beach, Florida, United States
Opa-locka, Florida, United States
Pinellas Park, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Woodstock, Georgia, United States
Boise, Idaho, United States
Peoria, Illinois, United States
Mishawaka, Indiana, United States
Council Bluffs, Iowa, United States
Newton, Kansas, United States
Wichita, Kansas, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Metairie, Louisiana, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Bellevue, Nebraska, United States
Fremont, Nebraska, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Binghamton, New York, United States
Wilmington, North Carolina, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Dayton, Ohio, United States
Kettering, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Erie, Pennsylvania, United States
Erie, Pennsylvania, United States
Hermitage, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Upper Saint Clair, Pennsylvania, United States
Anderson, South Carolina, United States
Charleston, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Bristol, Tennessee, United States
Jefferson City, Tennessee, United States
Lebanon, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Fort Worth, Texas, United States
Round Rock, Texas, United States
San Angelo, Texas, United States
San Antonio, Texas, United States
Draper, Utah, United States
Layton, 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
Burke, Virginia, United States
Charlottesville, Virginia, United States
Countries
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References
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Hartvickson R, Cruz M, Ervin J, Brandon D, Forleo-Neto E, Dagnew AF, Chandra R, Lindert K, Mateen AA. Non-inferiority of mammalian cell-derived quadrivalent subunit influenza virus vaccines compared to trivalent subunit influenza virus vaccines in healthy children: a phase III randomized, multicenter, double-blind clinical trial. Int J Infect Dis. 2015 Dec;41:65-72. doi: 10.1016/j.ijid.2015.11.004. Epub 2015 Nov 14.
Other Identifiers
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V130_03
Identifier Type: -
Identifier Source: org_study_id