Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646744
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Safety Study About the mRNA Vaccines Against COVID-19 in Children PEDIVACOV-HCSC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety Study About the mRNA Vaccines Against COVID-19 in Pediatric Patients PEDIVACOV-HCSC
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEDIVACOV-HCSC
Brief Summary:
Drugs side effects in children need to be evaluated in a different way because of their constant growth and body changes
The use of COVID-19 vaccines mRNA vaccines is worldwide spread as a safety measure against the pandemic
Although clinical trials have shown that vaccines are safe in the general population specific real-life monitoring is needed to address the special situation that applies to children
The use of COVID-19 vaccines mRNA vaccines is worldwide spread as a safety measure against the pandemic
Although clinical trials have shown that vaccines are safe in the general population specific real-life monitoring is needed to address the special situation that applies to children
Detailed Description:
Drug-related side effects are an important health problem causing an increase in health costs Most of the related research is focused on the adult population therefore evidence in pediatric patients is scarse This situation remains true in the clinical trials of the mRNA vaccines against COVID-19 with most studies suggesting the need of a greater follow up and specific research that address the pediatric population Even though vaccines seem to be a safe and effective ways to protect the population against the COVID-19 pandemic more information is needed regarding the safety profile for pediatrics in the short and long term
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None