At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Open-Label Trial to Compare the Immunogenicity of Cell Culture-Based and Recombinant Unadjuvanted Quadrivalent Influenza Vaccines to Conventional Egg-Based Unadjuvanted Quadrivalent Influenza Vaccines Among Healthcare Personnel Aged 18-64 Years
In Brief
A Phase 4 clinical trial evaluating Flublok, Flucelvax, and 3 other interventions for Influenza. Completed, enrolled 944 participants across 2 sites.
Detailed Summary
This randomized, open-label trial will assess humoral and cell-mediated immune responses to cell culture-based and recombinant unadjuvanted quadrivalent influenza vaccines compared to conventional egg-based unadjuvanted quadrivalent standard dose (15µg of HA per strain) influenza vaccines among persons aged 18-64 years. The trial will be conducted at two sites in the United States during two influenza seasons (2018-19 and 2019-20). Stratified enrollment procedures will be used to enroll a mix of participants based on age.
Study Details
Timeline
Interventions
0.5 mL intramuscular dose of Flublok
0.5 mL intramuscular dose of Flucelvax
0.5 mL intramuscular dose of Fluarix
0.5 mL intramuscular dose of Fluzone
0.5 mL intramuscular dose of Fluzone