Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04922788
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-11-04
First Post:
2021-06-08
Brief Title:
Study to Evaluate the Safety Immunogenicity and Efficacy of Nanocovax Vaccine Against COVID-19
Sponsor:
Nanogen Pharmaceutical Biotechnology Joint Stock Company
Organization:
Nanogen Pharmaceutical Biotechnology Joint Stock Company
Study Overview
Official Title:
a Phase 3 Adaptive Multicenter Randomized Double-blind Placebo-controlled Study to Evaluate the Safety Immunogenicity and Efficacy of the Nanocovax Vaccine Against COVID-19 in Volunteer Subjects 18 Years of Age and Older
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-11
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:
The purpose of this study is to evaluate the safety immunogenicity and efficacy of Nanocovax vaccine in volunteer subjects 18 years of age and older
Detailed Description:
This is a phase 3 adaptive multicenter randomized double-blind placebo control study to evaluate the safety immunogenicity and efficacy of the Nanocovax vaccine against COVID-19 in volunteer subjects 18 years of age and older
Age stratified as 18-45 45-60 and 60 years of age
The assessment of immunogenicity will be further expanded in a subset of Phase 3 1000 participants
Randomly assigned to vaccine or placebo group with a ratio of 21 2 subjects injected with Nanocovax 25 mcg 1 subject injected with placebo
Age stratified as 18-45 45-60 and 60 years of age
The assessment of immunogenicity will be further expanded in a subset of Phase 3 1000 participants
Randomly assigned to vaccine or placebo group with a ratio of 21 2 subjects injected with Nanocovax 25 mcg 1 subject injected with placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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