COVID-19 Vaccine Adverse Reaction
Conditions
Keywords
COVID19 vaccine, Pharmacovigilance, Drug-Related Side Effects and Adverse Reactions
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.
Interventions
BIOLOGICALmRNA COVID-19 vaccine
Children will be vaccinated according to standard local procedure
Sponsors
Ana Belen Rivas Paterna
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of vaccine side effects | 10 days, 1 month and 6 months after vaccination | Incidence of vaccine side effects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 side effects | 10 days, 1 month and 6 months after vaccination | Clinical description of side effects that occurre during follow up |
| 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 |
| 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 |
Countries
Spain
Outcome results
None listed