Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine (QIV) in Children Previously Vaccinated in Trial V118_05
NCT ID: NCT02255409
Last Updated: 2023-03-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
607 participants
INTERVENTIONAL
2014-10-31
2016-01-31
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
SINGLE
Study Groups
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aQIV
Adjuvanted Quadrivalent Subunit Influenza
Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
1 dose 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months
QIV
Non-Adjuvanted Quadrivalent Subunit Influenza
non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
1 dose 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months
Interventions
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Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
1 dose 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months
non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
1 dose 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months
Eligibility Criteria
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Inclusion Criteria
2. Individuals who give written informed consent, who can comply with study procedures, and who are available for follow-up
Exclusion Criteria
2. Subjects with contraindications to receive influenza vaccine.
3. Please contact the site for additional eligibility criteria.
12 Months
84 Months
ALL
Yes
Sponsors
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Seqirus
INDUSTRY
Responsible Party
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Locations
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San Diego, California, United States
San Gabriel, California, United States
Colorado Springs, Colorado, United States
Melbourne, Florida, United States
Augusta, Kansas, United States
Newton, Kansas, United States
Louisville, Kentucky, United States
Metairie, Louisiana, United States
Bellevue, Nebraska, United States
Binghamton, New York, United States
Dayton, Ohio, United States
Austin, Texas, United States
Fort Worth, Texas, United States
San Angelo, Texas, United States
Tomball, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Espoo, , Finland
Helsinki, , Finland
Helsinki, , Finland
Järvenpää, , Finland
Kokkola, , Finland
Pori, , Finland
Tampere, , Finland
Turku, , Finland
Vantaa, , Finland
Countries
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Other Identifiers
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2014-002599-95
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V118_05E1
Identifier Type: -
Identifier Source: org_study_id
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