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.
Study Type
OBSERVATIONAL
Enrollment
2,100
Children will be vaccinated according to standard local procedure
Fundacion para Investigación Biomedica Hospital Clinico San Carlos
Madrid, Spain
Incidence of vaccine side effects
Incidence of vaccine side effects
Time frame: 10 days, 1 month and 6 months after vaccination
Vaccine side effects
Clinical description of side effects that occurre during follow up
Time frame: 10 days, 1 month and 6 months after vaccination
Time to vaccine side effect
Clinical description of side effect according to the time of appearance
Time frame: 10 days, 1 month and 6 months after vaccination
Causality of side effects
Evaluation of the causality by using the modified Karch-Lasagna modified scale
Time frame: 10 days, 1 month and 6 months after vaccination
Severity of side effects
Evaluation of the severity using de Venulet criteria and the spanish pharmacovigilance system
Time frame: 10 days, 1 month and 6 months after vaccination
Vaccine and drug interactions
Evaluation of the possible interaction between the vaccines and regularly prescribed drugs
Time frame: 10 days, 1 month and 6 months after vaccination
Vaccine reactogenicity
Evaluation of the difference reactogenicity between the first and second vaccine dose by recording the side effect appearance after each dose.
Time frame: 10 days, 1 month and 6 months after vaccination
Perceived quality of the vaccination system
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Evaluation of the parents perceived quality of the vaccination system
Time frame: 10 days, 1 month and 6 months after vaccination