Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05925127
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2023-06-27
Brief Title:
Phase 23 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS Vaccines
Sponsor:
Novavax
Organization:
Novavax
Study Overview
Official Title:
A Phase 23 Randomized Double-Blind Study to Evaluate the Safety and Immunogenicity of Different Booster Dose Levels of Monovalent SARS-CoV-2 rS Vaccines in Adults 50 Years Previously Vaccinated With COVID-19 mRNA Vaccines
Status:
ACTIVE_NOT_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:
This is a Phase 23 randomized double-blind study to evaluate the safety and immunogenicity of different booster dose levels of the monovalent severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 recombinant r spike S protein nanoparticle SARS-CoV-2 rS vaccines with Matrix-M adjuvant NVX-CoV2373 prototype Wuhan vaccine with Matrix-M adjuvant or NVX-CoV2601 Omicron XBB15 subvariant vaccine with Matrix-M adjuvant
Detailed Description:
The ongoing COVID-19 pandemic has reached a stage where it is necessary to stablish the framework for periodic national vaccination campaignsThe present study aims to investigate the safety and immunogenicity of different booster dose levels of monovalent and bivalent vaccines in adults 50 years of age who have already been immunized with 3 doses of a COVID-19 prototype or bivalent licensed mRNA vaccine The Boosters of investigational products will be administered 90 days after the participants received their third dose of a COVID-19 prototype or bivalent licensed mRNA vaccine
Approximately 1980 participants 50 years of age who have received a regimen of 3 doses of a coronavirus disease 2019COVID-19 vaccine the last vaccine could have been a bivalent licensed mRNA vaccine will be included in this study The last COVID-19 vaccine dose should have been administered 90 days prior to Day 0
Approximately 1800 participants will be randomly assigned in a 122221 ratio to receive NVX-CoV2373 or NVC-CoV2601 in a double-blinded fashion into 1 of 6 monovalent vaccine groups vaccine groups A to G Following completion of enrollment into the 6 monovalent vaccine groups 180 participants will be enrolled in vaccine group G to receive a bivalent licensed mRNA vaccine in an open-label fashion
Approximately 1980 participants 50 years of age who have received a regimen of 3 doses of a coronavirus disease 2019COVID-19 vaccine the last vaccine could have been a bivalent licensed mRNA vaccine will be included in this study The last COVID-19 vaccine dose should have been administered 90 days prior to Day 0
Approximately 1800 participants will be randomly assigned in a 122221 ratio to receive NVX-CoV2373 or NVC-CoV2601 in a double-blinded fashion into 1 of 6 monovalent vaccine groups vaccine groups A to G Following completion of enrollment into the 6 monovalent vaccine groups 180 participants will be enrolled in vaccine group G to receive a bivalent licensed mRNA vaccine in an open-label fashion
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