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

October 16, 2024 updated by: Ana Belen Rivas Paterna

Safety Study About the mRNA Vaccines Against COVID-19 in Pediatric Patients (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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

2100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Fundacion para Investigación Biomedica Hospital Clinico San Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All the pediatric patients (between 5-12 years old) vaccinated in the Clinico San Carlos' Hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vaccinated children
Children between 5 and 12 years old vaccinated with 2 doses of an approved mRNA vaccione against COVID-19.
Biological: mRNA COVID-19 vaccine
Children will be vaccinated according to standard local procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of vaccine side effects
Time Frame: 10 days, 1 month and 6 months after vaccination
Incidence of vaccine side effects
10 days, 1 month and 6 months after vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccine side effects
Time Frame: 10 days, 1 month and 6 months after vaccination
Clinical description of side effects that occurre during follow up
10 days, 1 month and 6 months after vaccination
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
10 days, 1 month and 6 months after vaccination
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
10 days, 1 month and 6 months after vaccination
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
10 days, 1 month and 6 months after vaccination
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
10 days, 1 month and 6 months after vaccination
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.
10 days, 1 month and 6 months after vaccination
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
10 days, 1 month and 6 months after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ana Belen Rivas Paterna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2022

Primary Completion (Actual)

March 3, 2023

Study Completion (Actual)

March 3, 2023

Study Registration Dates

First Submitted

October 15, 2024

First Submitted That Met QC Criteria

October 16, 2024

First Posted (Actual)

October 17, 2024

Study Record Updates

Last Update Posted (Actual)

October 17, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEDIVACOV-HCSC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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