Ignite Creation Date:
2024-07-17 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-27
Brief Title:
Lot Consistency Study of COVID-19 and Influenza Combination Vaccine
Sponsor:
Novavax
Organization:
Novavax
Study Overview
Official Title:
A Phase 3 Randomized Observer-Blinded Study to Compare the Safety and Immunogenicity of 3 Lots of SARS-CoV-2 rS Nanoparticle and Trivalent Hemagglutinin Nanoparticle Influenza Combination Vaccine With Matrix M Adjuvant in Participants 65 Years of Age
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIC
Brief Summary:
The goal of Phase 3 Study is Comparing the Safety and Immune Response of Three Batches of a COVID-19 and Flu Combination Vaccine in Seniors Aged 65
Detailed Description:
This is a randomized Phase 3 study comparing the safety and immunogenicity of 3 different lots of Novavax coronavirus disease 2019 COVID-19 and influenza combination CIC vaccine in terms of wild-type influenza hemagglutinin inhibition HAI antibody responses to 3 vaccine-homologous influenza strains ie 2 influenza A strains and an influenza B-Victoria lineage strain and 1 IM dose of Fluzone HD in terms of the neutralizing antibody NAb responses to the homologous severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 strain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None