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OpenTrials
Completed

NCT Number: NCT06646744

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

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.

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Key information

Conditions

COVID-19 Vaccine Adverse Reaction Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundacion para Investigación Biomedica Hospital Clinico San Carlos

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mRNA COVID-19 Vaccine

Biological

Children will be vaccinated according to standard local procedure

Primary outcomes

  1. Incidence of vaccine side effects

    Time frame: 10 days, 1 month and 6 months after vaccination

    Incidence of vaccine side effects

Secondary outcomes

  1. Vaccine side effects

    Time frame: 10 days, 1 month and 6 months after vaccination

    Clinical description of side effects that occurre during follow up

  2. Time to vaccine side effect

    Time frame: 10 days, 1 month and 6 months after vaccination

    Clinical description of side effect according to the time of appearance

  3. Causality of side effects

    Time frame: 10 days, 1 month and 6 months after vaccination

    Evaluation of the causality by using the modified Karch-Lasagna modified scale

  4. Severity of side effects

    Time frame: 10 days, 1 month and 6 months after vaccination

    Evaluation of the severity using de Venulet criteria and the spanish pharmacovigilance system

  5. Vaccine and drug interactions

    Time frame: 10 days, 1 month and 6 months after vaccination

    Evaluation of the possible interaction between the vaccines and regularly prescribed drugs

  6. Vaccine reactogenicity

    Time frame: 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.

  7. Perceived quality of the vaccination system

    Time frame: 10 days, 1 month and 6 months after vaccination

    Evaluation of the parents perceived quality of the vaccination system

Sponsors and collaborators

Lead sponsor

Ana Belen Rivas Paterna

Other

Registry information

Official study title

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

Acronym: PEDIVACOV-HCSC

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 17, 2024
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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