Clinical trial NCT06646744: Safety Study About the mRNA Vaccines Against COVID-19 in Children (PEDIVACOV-HCSC)
Official title: Safety Study About the mRNA Vaccines Against COVID-19 in Pediatric Patients (PEDIVACOV-HCSC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Vaccine Adverse Reaction
Keywords: COVID19 vaccine
Pharmacovigilance
Drug-Related Side Effects and Adverse Reactions
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 2100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the pediatric patients (between 5-12 years old) vaccinated in the Clinico San Carlos' Hospital

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.

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.

Eligibility criteria: 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:

* None

Primary outcomes:
measure: Incidence of vaccine side effects
timeFrame: 10 days, 1 month and 6 months after vaccination
Secondary outcomes:
measure: Vaccine side effects
timeFrame: 10 days, 1 month and 6 months after vaccination
measure: Time to vaccine side effect
timeFrame: 10 days, 1 month and 6 months after vaccination
measure: Causality of side effects
timeFrame: 10 days, 1 month and 6 months after vaccination
measure: Severity of side effects
timeFrame: 10 days, 1 month and 6 months after vaccination
measure: Vaccine and drug interactions
timeFrame: 10 days, 1 month and 6 months after vaccination
measure: Vaccine reactogenicity
timeFrame: 10 days, 1 month and 6 months after vaccination
measure: Perceived quality of the vaccination system
timeFrame: 10 days, 1 month and 6 months after vaccination
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fundacion para Investigación Biomedica Hospital Clinico San Carlos
Study officials:
References:
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