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

Ana Belen Rivas Paterna

Status

Completed

Conditions

COVID-19 Vaccine Adverse Reaction

Treatments

Biological: mRNA COVID-19 vaccine

Study type

Observational

Funder types

Other

Identifiers

NCT06646744

PEDIVACOV-HCSC

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,100 patients

Sex

All

Ages

5 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients of both sexes between 5 and 12 years old.
Pediatric patients with data included in the Clinico San Carlos' Hospital available for consultation.
Acceptance by the parents/legal guardians for the participation and follow up.

Exclusion criteria