Ignite Creation Date:
2024-05-06 @ 6:01 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05519839
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2022-08-26
Brief Title:
A Study to Evaluate the Safety and Immunogenicity of COVID-19 and Influenza Combination Vaccine
Sponsor:
Novavax
Organization:
Novavax
Study Overview
Official Title:
A Phase 2 Randomized Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 rS Nanoparticle and Quadrivalent Hemagglutinin Nanoparticle Influenza Combination Vaccine With Matrix-M Adjuvant in Healthy Participants 50 to 80 Years of Age
Status:
COMPLETED
Status Verified Date:
2024-07
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 randomized observer-blinded Phase 2 study evaluating the safety and immunogenicity of a severe acute respiratory syndrome coronavirus 2 SARSCoV2 recombinant spike rS SARS-CoV-2 rS nanoparticle and quadrivalent hemagglutinin HA nanoparticle influenza vaccine qNIV combination vaccine with Matrix-M adjuvant this combination vaccine
Detailed Description:
The study will enroll approximately 2300 1520 in Part 1 and 800 in Part 2 healthy based on history and physical examination adult male and female participants 50 to 80 years of age inclusive targeting participants who must have completed a primary vaccination series against SARS-CoV-2 with an authorized COVID-19 vaccine and fulfill national recommendations for hisher age and morbidity category with receipt of secondlast dose of authorized vaccine with or without boosterss 3 months prior to enrollment Randomization will be stratified by age 50 to 65 or 65 to 80 years to distribute the proportions of each age stratum evenly across vaccine groups
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