Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518577
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Immunogenicity of Influenza Vaccinations
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Measuring Immunity Against Circulating Influenza Viruses Randomized Immunogenicity Study Among US Adults Aged 18-64 Years Comparing Two Approved Influenza Vaccines
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a randomized immunogenicity study in an enrolled cohort with active surveillance for influenza-like illness ILI During this study participants will be randomly assigned to receive an approved cell culture-based influenza vaccine Flucelvax versus a licensed comparator influenza vaccine Flublok or Fluzone Blood samples from participants will be collected for measurement of biomarkers of immune response at baseline visit 1 day 1 post-vaccination visit 2 day 29 and post-season visit 3 day 181 Participants will be asked if they wish to also provide saliva specimens at baseline visit 1 day 1 post-vaccination visit 2 day 29 and post-season visit 3 day 181 Serum and peripheral blood mononuclear cells PBMC and plasma samples will be isolated from whole blood and tested for biomarkers of vaccine immunogenicity and duration of antibody responses
Participants will receive electronic surveys via email or text message weekly asking about changes in health status and new ILI symptoms those reporting illness may be asked to provide a respiratory swab for laboratory testing for influenza and other respiratory viruses and up to 2 additional blood draws acute 10 days after symptom onset and convalescent 28 days after acute visit if lab-confirmed positive for influenza
Participants will receive electronic surveys via email or text message weekly asking about changes in health status and new ILI symptoms those reporting illness may be asked to provide a respiratory swab for laboratory testing for influenza and other respiratory viruses and up to 2 additional blood draws acute 10 days after symptom onset and convalescent 28 days after acute visit if lab-confirmed positive for influenza
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None