Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06291857
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-03-01
Brief Title:
A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine
Sponsor:
Novavax
Organization:
Novavax
Study Overview
Official Title:
A Randomized Observer-Blinded Active-Controlled Study to Evaluate the Safety and Immunogenicity of a COVID-19 Influenza Combination Nanoparticle Vaccine and a Standalone Trivalent Nanoparticle Influenza Hemagglutinin Vaccine in Participants 65 Years of Age
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
The goal of this Phase 3 study is to compare the effectiveness safety and side effects of the CIC vaccine with approved flu vaccines and the Novavax COVID-19 Vaccine with adjuvant
Detailed Description:
This is a large study to test how well a new combination vaccine for COVID-19 and influenza the CIC vaccine works in adults 65 and older compared to other vaccines The study will check if the CIC vaccine triggers a similar or better immune response measured by antibody levels than the Fluzone High-Dose influenza vaccine and the Novavax COVID-19 vaccine It will also test a new standalone flu vaccine tNIV to see if it works as well as Fluzone High-Dose
The study has two parts
Part 1 will include up to 4950 adults and will test how well both CIC and tNIV vaccines trigger an immune response and track side effects
Part 2 will include up to 3000 adults to further monitor the safety of both vaccines
The study has two parts
Part 1 will include up to 4950 adults and will test how well both CIC and tNIV vaccines trigger an immune response and track side effects
Part 2 will include up to 3000 adults to further monitor the safety of both vaccines
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