Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409663
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-05-08
Brief Title:
Phase 3 Strain Change Study for SARS-CoV-2 rS Vaccines
Sponsor:
Novavax
Organization:
Novavax
Study Overview
Official Title:
A Phase 3 Open-Label Single-Arm Study to Evaluate the Safety and Immunogenicity of a JN1 Subvariant SARS CoV-2 rS Vaccine
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
COVID-19
Brief Summary:
Phase 3 study assessing the safety and effectiveness of a single dose of a SARS-CoV-2 nanoparticle vaccine NVX CoV2705 adjuvanted with Matrix-M in previously vaccinated adults About 100 participants will receive the vaccine and be monitored for safety and immune response for up to 35 days post-vaccination
Detailed Description:
This is a Phase 3 open-label single arm study to evaluate the safety and immunogenicity of a single dose of a JN1 subvariant severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 recombinant r spike S protein nanoparticle vaccine SARS-CoV-2 rS adjuvanted with Matrix-M NVX CoV2705 in previously vaccinated adults
Approximately 100 participants will be enrolled to receive a single dose of NVX CoV2705 on Day 0 and remain on study for immunogenicity and safety data collection up to 35 days post-vaccination
Approximately 100 participants will be enrolled to receive a single dose of NVX CoV2705 on Day 0 and remain on study for immunogenicity and safety data collection up to 35 days post-vaccination
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?:
None
Is an FDA AA801 Violation?:
None