Safety and Immunogenicity of a Four Influenza Vaccines in Children Ages 6 Months Old to Less Than 48 Months Old
NCT ID: NCT02035696
Last Updated: 2018-07-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
671 participants
INTERVENTIONAL
2013-12-31
2014-12-31
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
QUADRUPLE
Study Groups
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TIVc-High Dose
Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine
Trivalent influenza vaccine (TIVc)
TIVc-Full Dose
Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine
Trivalent influenza vaccine (TIVc)
TIVc- Half Dose
Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine
Trivalent influenza vaccine (TIVc)
TIVe
Subjects (6 to \<48 months old) received two doses of TIVe vaccine(IM/0.25mL -for ages 6 to \<36 months and IM/ 0.5 mL -for ages 36 to \<48 months)
Trivalent influenza vaccine-licensed
Licensed influenza vaccine
Interventions
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Trivalent influenza vaccine (TIVc)
Trivalent influenza vaccine-licensed
Licensed influenza vaccine
Eligibility Criteria
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Inclusion Criteria
* Individual who has a parent or guardian that can give written informed consent after understanding the nature of the study and are available for follow-up
Exclusion Criteria
* Subjects with contraindications to receive influenza vaccine
6 Months
48 Months
ALL
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Seqirus
INDUSTRY
Responsible Party
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Locations
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Site 116
Phoenix, Arizona, United States
Site 119
Tucson, Arizona, United States
Site 109
Little Rock, Arkansas, United States
Site 112
Long Beach, California, United States
Site 113
Ontario, California, United States
Site 117
San Diego, California, United States
Site 114
West Covina, California, United States
Site 107
Thornton, Colorado, United States
Site 111
Miami, Florida, United States
Site 108
Miami Beach, Florida, United States
Site 121
Gainesville, Georgia, United States
Site 101
Omaha, Nebraska, United States
Site 104
Omaha, Nebraska, United States
Site 105
Omaha, Nebraska, United States
Site 106
Omaha, Nebraska, United States
Site 103
Youngstown, Ohio, United States
Site 102
Charleston, South Carolina, United States
Site 115
Houston, Texas, United States
Site 110
Salt Lake City, Utah, United States
Site 118
St. George, Utah, United States
Site 120
Spokane, Washington, United States
Site 502
Kuopio, , Finland
Site 506
Tampere, , Finland
Site 302
City of Muntinlupa, , Philippines
Site 301
Manila, , Philippines
Site 201
Bangkok, , Thailand
Site 202
Bangkok, , Thailand
Countries
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Other Identifiers
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2013-002081-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V58P16
Identifier Type: -
Identifier Source: org_study_id
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