Safety Study About the mRNA Vaccines Against COVID-19 in Children (PEDIVACOV-HCSC)
- Registration Number
- NCT06646744
- Lead Sponsor
- Ana Belen Rivas Paterna
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2100
- 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.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Vaccinated children mRNA COVID-19 vaccine Children between 5 and 12 years old vaccinated with 2 doses of an approved mRNA vaccione against COVID-19.
- Primary Outcome Measures
Name Time Method Incidence of vaccine side effects 10 days, 1 month and 6 months after vaccination Incidence of vaccine side effects
- Secondary Outcome Measures
Name Time Method Vaccine side effects 10 days, 1 month and 6 months after vaccination Clinical description of side effects that occurre during follow up
Time to vaccine side effect 10 days, 1 month and 6 months after vaccination Clinical description of side effect according to the time of appearance
Causality of side effects 10 days, 1 month and 6 months after vaccination Evaluation of the causality by using the modified Karch-Lasagna modified scale
Severity of side effects 10 days, 1 month and 6 months after vaccination Evaluation of the severity using de Venulet criteria and the spanish pharmacovigilance system
Vaccine and drug interactions 10 days, 1 month and 6 months after vaccination Evaluation of the possible interaction between the vaccines and regularly prescribed drugs
Vaccine reactogenicity 10 days, 1 month and 6 months after vaccination Evaluation of the difference reactogenicity between the first and second vaccine dose by recording the side effect appearance after each dose.
Perceived quality of the vaccination system 10 days, 1 month and 6 months after vaccination Evaluation of the parents perceived quality of the vaccination system
Trial Locations
- Locations (1)
Fundacion para Investigación Biomedica Hospital Clinico San Carlos
🇪🇸Madrid, Spain