Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04649021
Status:
COMPLETED
Last Update Posted:
2022-05-10
First Post:
2020-11-17
Brief Title:
Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine BNT162b2 in Chinese Healthy Population
Sponsor:
BioNTech SE
Organization:
BioNTech SE
Study Overview
Official Title:
Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine BNT162b2 in Chinese Healthy Population A Phase II Randomized Placebo-controlled Observer-blinded Study
Status:
COMPLETED
Status Verified Date:
2022-05
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:
None
Brief Summary:
This is a phase II randomized placebo-controlled observer-blinded study of the safety and immunogenicity of SARS-CoV-2 messenger RNA mRNA vaccine BNT162b2 in Chinese healthy population After randomization the trial for each participant will last for approximately 13 months Screening period is 2 weeks prior to randomization Day -14 to Day 0 and two doses of either SARS-CoV-2 vaccine BNT162b2 or placebo will be given intramuscularly IM separated by 21 days
Detailed Description:
None
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