At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Multicenter, Observer-Blinded, Noninferiority Study to Evaluate the Immunogenicity and Safety of a Seqirus Quadrivalent Inactivated Influenza Virus Vaccine (Seqirus QIV) With a US-Licensed 2015-2016 Quadrivalent Inactivated Comparator Influenza Vaccine (Comparator QIV) in a Pediatric Population 5 Through 17 Years of Age
In Brief
A Phase 3 clinical trial evaluating Seqirus QIV and Comparator QIV for Influenza, Human. Completed, enrolled 2,278 participants across 32 sites.
Detailed Summary
This is a study to assess the immune (antibody) response and safety of a Seqirus split virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US licensed 2015/2016 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric population 5 through 17 years of age.
Study Details
Timeline
Interventions
Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe. The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.
The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe. The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.