A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years
NCT ID: NCT02212106
Last Updated: 2015-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
402 participants
INTERVENTIONAL
2014-09-30
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
TRIPLE
Study Groups
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bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
Comparator Quadrivalent Influenza Virus Vaccine
The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
Comparator Quadrivalent Influenza Virus Vaccine
Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
Interventions
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bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
Comparator Quadrivalent Influenza Virus Vaccine
Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The subject's parent or guardian to provide written informed consent and be willing and able to adhere to all protocol requirements.
* In good health, as determined by medical history and a targeted physical examination (if warranted).
Exclusion Criteria
* Clinical signs of significant active infection or an elevated oral temperature at study entry.
* A clinically significant medical or psychiatric condition.
* A history of seizures or febrile convulsions or Guillain-Barré syndrome.
* Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
* Vaccination with a licensed vaccine within 14 days preceding study entry, or planning to be vaccinated with another licensed vaccine before the study exit evaluation.
* Currently receiving systemic glucocorticoid therapy (excluding intra-articular, topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry.
* Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of the study vaccine.
* Currently receiving treatment with warfarin or other anticoagulants.
5 Years
8 Years
ALL
Yes
Sponsors
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Seqirus
INDUSTRY
Responsible Party
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Principal Investigators
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bioCSL Pty Ltd Clinical Program Director
Role: STUDY_DIRECTOR
Seqirus
Locations
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Site 286
Los Angeles, California, United States
Site 289
Boise, Idaho, United States
Site 287
St Louis, Missouri, United States
Site 285
Binghamton, New York, United States
Site 290
Durham, North Carolina, United States
Site 281
Raleigh, North Carolina, United States
Site 280
Winston-Salem, North Carolina, United States
Site 284
Charleston, South Carolina, United States
Site 283
Austin, Texas, United States
Site 282
Fort Worth, Texas, United States
Site 288
San Angelo, Texas, United States
Countries
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Other Identifiers
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2015-000175-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSLCT-USF-10-69
Identifier Type: -
Identifier Source: org_study_id
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