Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
NCT ID: NCT04074928
Last Updated: 2022-01-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2414 participants
INTERVENTIONAL
2019-09-06
2020-09-03
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
Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
QIVc
Previously vaccinated subjects received a 0.5 mL intramuscular dose of QIVc on Day 1; not previously vaccinated subjects received a 0.5 mL intramuscular dose of QIVc on Day 1 and Day 29.
Comparator QIV
Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV
Previously vaccinated subjects received a dose of Comparator QIV on Day 1; not previously vaccinated subjects received a dose of Comparator QIV on Day 1 and Day 29. Subjects 6 months through 35 months of age received a 0.25 mL intramuscular dose of Comparator QIV; subjects 36 months through 47 months of age received a 0.5 mL intramuscular dose of Comparator QIV.
Interventions
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QIVc
Previously vaccinated subjects received a 0.5 mL intramuscular dose of QIVc on Day 1; not previously vaccinated subjects received a 0.5 mL intramuscular dose of QIVc on Day 1 and Day 29.
Comparator QIV
Previously vaccinated subjects received a dose of Comparator QIV on Day 1; not previously vaccinated subjects received a dose of Comparator QIV on Day 1 and Day 29. Subjects 6 months through 35 months of age received a 0.25 mL intramuscular dose of Comparator QIV; subjects 36 months through 47 months of age received a 0.5 mL intramuscular dose of Comparator QIV.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Individuals whose parent(s)/Legally Acceptable Representative (LAR) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
* Individuals who can comply with study procedures including follow-up
* Individual is in generally good health as per the Investigator's medical judgement
Exclusion Criteria
* History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study
* A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis
* Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study
* Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.
6 Months
47 Months
ALL
Yes
Sponsors
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Seqirus
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Program Director
Role: STUDY_DIRECTOR
Seqirus
Locations
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84035 CCR Research
Mobile, Alabama, United States
84040 Southland Clnical Research Center
Anaheim, California, United States
84044 Premier Health Research Center
Downey, California, United States
84028 Orange County Research Institute
Ontario, California, United States
84029 Center for Clinical Trials
Paramount, California, United States
84012 Benchmark Research
Sacramento, California, United States
84006 California Research Foundation
San Diego, California, United States
84001 Acevedo Clincal Research Associates
Miami, Florida, United States
84005 Sunshine Research Center
Opa-locka, Florida, United States
84052 Tekton Research
Chamblee, Georgia, United States
84036 Advanced Clinical Research
Meridian, Idaho, United States
84027 Heartland Research Associates
El Dorado, Kansas, United States
84020 Heartland Research Associates
Newton, Kansas, United States
84014 Heartland Research Associates
Wichita, Kansas, United States
84026 Heartland Research Associates
Wichita, Kansas, United States
84041 Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States
84009 Bluegrass Clinical Research Inc.
Louisville, Kentucky, United States
84008 Meridian Clinical Research
Baton Rouge, Louisiana, United States
84046 ACC Pediatric Research
Haughton, Louisiana, United States
84004 Benchmark Research
Metairie, Louisiana, United States
84022 Med Pharmics
Metairie, Louisiana, United States
84053 MedPharmics
Gulfport, Mississippi, United States
84051 Office of Craig A. Spiegel
Bridgeton, Missouri, United States
84016 Center for Pharmaceutical Research
Kansas City, Missouri, United States
84037 Meridian Clinical Research
Norfolk, Nebraska, United States
84017 Meridian Clinical Research
Omaha, Nebraska, United States
84033 Med Pharmics
Albuquerque, New Mexico, United States
84013 Regional Clinical Research
Binghamton, New York, United States
84045 Dayton Clinical
Dayton, Ohio, United States
84003 PriMed Clinical Research
Dayton, Ohio, United States
84015 Meridian Clinical Research
Dakota Dunes, South Dakota, United States
84032 Clinical Research Associates
Nashville, Tennessee, United States
84007 Benchmark Research
Austin, Texas, United States
84023 Ventavia Research Group
Fort Worth, Texas, United States
84042 Universtiy of North Texas Health Science Center
Fort Worth, Texas, United States
84043 Benchmark Research
Fort Worth, Texas, United States
84047 Ventavia Research Group
Houston, Texas, United States
84011 West Houston Clinical Research
Houston, Texas, United States
84019 Ventavia Research Group
Keller, Texas, United States
84021 Benchmark Research
San Angelo, Texas, United States
84002 Tekton Research
San Antonio, Texas, United States
84025 Pediatric Healthcare of NW Houston
Tomball, Texas, United States
84018 Tanner Clinic
Layton, Utah, United States
84050 JBR Clinical Research Group
Salt Lake City, Utah, United States
84048 J. Lewis Research/Foothill Family Clinic South
Salt Lake City, Utah, United States
84031 Advanced Clinical Research
West Jordan, Utah, United States
84039 Pediatric Research of Charlottesville
Charlottesville, Virginia, United States
Countries
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References
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Essink BJ, Heeringa M, Jeanfreau RJ, Finn D, Matassa V, Edelman J, Hohenboken M, Molrine D. Safety and Immunogenicity of Cell-Based Quadrivalent Influenza Vaccine: A Randomized Trial. Pediatrics. 2022 Nov 1;150(5):e2022057509. doi: 10.1542/peds.2022-057509.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-002785-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V130_10
Identifier Type: -
Identifier Source: org_study_id
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