A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA
NCT ID: NCT00958243
Last Updated: 2018-05-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
473 participants
INTERVENTIONAL
2009-08-31
2010-04-30
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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Placebo
Placebo
Placebo
Placebo
CSL425 (7.5 mcg)
7.5 mcg of hemagglutinin antigen per dose
CSL's 2009 H1N1 Influenza Vaccine (CSL425)
0.25 mL intramuscular injection on Day 0 and Day 21
CSL425 (15 mcg)
15 mcg of hemagglutinin antigen per dose
CSL's 2009 H1N1 Influenza Vaccine (CSL425)
0.5 mL intramuscular injection on Day 0 and Day 21
Interventions
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CSL's 2009 H1N1 Influenza Vaccine (CSL425)
0.5 mL intramuscular injection on Day 0 and Day 21
CSL's 2009 H1N1 Influenza Vaccine (CSL425)
0.25 mL intramuscular injection on Day 0 and Day 21
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* For children \< 3 years of age at the time of first vaccination, born at or after 36 weeks gestation.
Exclusion Criteria
6 Months
9 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
Melbourne, Florida, United States
Bardstown, Kentucky, United States
Metairie, Louisiana, United States
Omaha, Nebraska, United States
Austintown, Ohio, United States
Cincinnati, Ohio, United States
Latrobe, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Austin, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Murray, Utah, United States
Countries
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Other Identifiers
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CSLCT-CAL-09-62
Identifier Type: -
Identifier Source: org_study_id
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