Viewing Study NCT04649021



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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