Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-03 @ 11:01 PM
Study NCT ID:
NCT06482359
Status:
WITHDRAWN
Last Update Posted:
2025-03-11
First Post:
2024-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lot Consistency Study of COVID-19 and Influenza Combination Vaccine
Sponsor:
Novavax
Organization:
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:
WITHDRAWN
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
It was decided to not move forward with the study.
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 (i.e., 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:
True
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?: