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Safety Study About the mRNA Vaccines Against COVID-19 in Pediatric Patients (PEDIVACOV-HCSC)
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.
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.
Age
5 - 12 years
Sex
ALL
Healthy Volunteers
Yes
Fundacion para Investigación Biomedica Hospital Clinico San Carlos
Madrid, Spain
Start Date
March 8, 2022
Primary Completion Date
March 3, 2023
Completion Date
March 3, 2023
Last Updated
October 17, 2024
2,100
ACTUAL participants
mRNA COVID-19 vaccine
BIOLOGICAL
Lead Sponsor
Ana Belen Rivas Paterna
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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