A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine in a Pediatric Population
NCT ID: NCT00959049
Last Updated: 2017-05-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1474 participants
INTERVENTIONAL
2009-09-30
2010-05-31
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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Afluria Cohort A
Age 6 months to \< 3 years
CSL's Influenza Virus Vaccine (Afluria)
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Afluria Cohort B
Age 3 to \< 9 years
CSL's Influenza Virus Vaccine (Afluria)
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Afluria Cohort C
Age 9 to \< 18 years
CSL's Influenza Virus Vaccine (Afluria)
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Fluzone Cohort A
Age 6 months to \< 3 years
Influenza Virus Vaccine (Fluzone)
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Fluzone Cohort B
Age 3 to \< 9 years
Influenza Virus Vaccine (Fluzone)
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Fluzone Cohort C
Age 9 to \< 18 years
Influenza Virus Vaccine (Fluzone)
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Interventions
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CSL's Influenza Virus Vaccine (Afluria)
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Influenza Virus Vaccine (Fluzone)
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
Eligibility Criteria
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Inclusion Criteria
* For participants aged ≥ 6 months to \< 9 years, born after a normal gestation period (between 36 and 42 weeks).
* Females of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrollment.
Exclusion Criteria
6 Months
17 Years
ALL
Yes
Sponsors
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Seqirus
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Director Vaccines
Role: STUDY_DIRECTOR
Seqirus
Locations
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Chandler, Arizona, United States
Harrisburg, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Mountain Home, Arkansas, United States
Melbourne, Florida, United States
Bardstown, Kentucky, United States
Omaha, Nebraska, United States
Binghamton, New York, United States
Elmira, New York, United States
Cincinnati Children's Hospital Medical Center- Division of Infectious Disease
Cincinnati, Ohio, United States
Warr Acres, Oklahoma, United States
UPMC / Community Medicine Inc
Greenville, Pennsylvania, United States
Pediatric Associates of Latrobe
Latrobe, Pennsylvania, United States
Pediatric Alliance Greentree Division
Pittsburgh, Pennsylvania, United States
South Hills Pediatrics
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, 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
Burke, Virginia, United States
Vienna, Virginia, United States
Countries
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References
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Brady RC, Hu W, Houchin VG, Eder FS, Jackson KC, Hartel GF, Sawlwin DC, Albano FR, Greenberg M. Randomized trial to compare the safety and immunogenicity of CSL Limited's 2009 trivalent inactivated influenza vaccine to an established vaccine in United States children. Vaccine. 2014 Dec 12;32(52):7141-7. doi: 10.1016/j.vaccine.2014.10.024. Epub 2014 Oct 29.
Other Identifiers
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CSLCT-USF-07-36
Identifier Type: -
Identifier Source: org_study_id
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