Ignite Creation Date:
2024-05-06 @ 6:21 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05630352
Status:
WITHDRAWN
Last Update Posted:
2024-03-18
First Post:
2022-11-22
Brief Title:
A Study to Learn About Bivalent COVID-19 RNA Vaccine Candidates in Healthy Infants and Children
Sponsor:
BioNTech SE
Organization:
BioNTech SE
Study Overview
Official Title:
A MASTER PROTOCOL TO INVESTIGATE THE SAFETY TOLERABILITY AND IMMUNOGENICITY OF BIVALENT BNT162b2 RNA-BASED VACCINE CANDIDATES IN HEALTHY INFANTS AND CHILDREN
Status:
WITHDRAWN
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Bivalent vaccine no longer epidemiologically relevant
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 clinical trial is to learn about the safety and immune responses of the study vaccine called a bivalent BNT162b2 Omicron containing vaccine in healthy infants and children Sub study A of this clinical trial will test up to four different dose levels of the vaccine in infants who are under 6 months of age and have not previously received a coronavirus vaccination
This will be a 3- dose primary series of the study vaccine with each dose separated by 8 weeks
This will be a 3- dose primary series of the study vaccine with each dose separated by 8 weeks
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None