Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05875701
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2023-05-16
Brief Title:
Phase 3 Study of Novavax Vaccines as Booster Dose After mRNA Vaccines
Sponsor:
Novavax
Organization:
Novavax
Study Overview
Official Title:
A Phase 3 Study to Evaluate the Immunogenicity and Safety of Novavax COVID-19 Vaccines as Second or Subsequent Booster After mRNA Vaccines in Individuals 18 to 49 Years of Age
Status:
COMPLETED
Status Verified Date:
2024-03
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:
This is an open-label Phase 3 study evaluating the immunogenicity and safety of Novavax vaccines with Matrix-M adjuvant ancestral strain NVX-CoV2373 and an alternative strain andor multivalent Novavax vaccine as booster doses following a series of primary and booster doses of authorizedapproved mRNA vaccines followed by a single booster dose of NVX-CoV2373 in the Novavax 2019nCoV-307 study NCT05463068
Detailed Description:
This Phase 3 study investigates the immunogenicity and safety of Novavaxs NVX-CoV2373 vaccine including its Matrix-M adjuvant as an additional booster dose for adults aged 18 to 49 Participants must have already received both their primary mRNA vaccine series and at least one booster dose of the same type All participants were previously enrolled in Study 307 NCT05463068 where they received either their primary mRNA vaccines with or without an additional mRNA booster followed by a single NVX-CoV2373 booster
The study involves up to 300 volunteers who will receive a single dose of the Novavax vaccine 5 micrograms of recombinant spike protein antigen and 50 micrograms of Matrix-M adjuvant on Day 1
The study involves up to 300 volunteers who will receive a single dose of the Novavax vaccine 5 micrograms of recombinant spike protein antigen and 50 micrograms of Matrix-M adjuvant on Day 1
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