NCT06646744

Safety Study About the mRNA Vaccines Against COVID-19 in Children (PEDIVACOV-HCSC)

Safety Study About the mRNA Vaccines Against COVID-19 in Pediatric Patients (PEDIVACOV-HCSC)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,100 (actual)
• Sponsor: Ana Belen Rivas Paterna · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• COVID-19 Vaccine Adverse Reaction

Interventions

Type	Name	Description
BIOLOGICAL	mRNA COVID-19 vaccine	Children will be vaccinated according to standard local procedure

Timeline

• Start date: 2022-03-08
• Primary completion: 2023-03-03
• Completion: 2023-03-03
• First posted: 2024-10-17
• Last updated: 2024-10-17

Locations

1 site across 1 country: Spain