CoVacU18-Study: retrospective cohort study to evaluate safety and tolerability of COVID-19 vaccines in children under 18 years of age

• Conditions: mRNA-vaccines against COVID-19 (BNT162b2 Comirnaty; BNT162b2 Comirnaty Original/Omicron BA.1; BTN162b2 Comirnaty Original/Omicron BA.4-5; mRNA-1273 Spikevax; mRNA-1273-214 Spikevax Bivalent Original/Omicron BA.1; Spikevax Bivalent Original/Omicron BA.4-5)

• Registration Number: DRKS00031994
• Lead Sponsor: Helios Universitätsklinikum Wuppertal, Zentrum für Kinder- und Jugendmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-02
• Study Completion: 2024-03-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 3228

Inclusion Criteria

Received at least one COVID-19-vaccination with an mRNA-vaccine before 18 years of age
Written informed consent of parent or legal representatives to allow anonymized web-based survey

Exclusion Criteria

COVID-19-vaccination exclusively before October 1, 2021
Vaccination with others than mRNA-vaccines against COVID-19
COVID-19-vaccination at the age of 18 and older

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of symptoms after COVID-19-vaccination with an mRNA-vaccine categorized into 11 groups (injection-site symptoms, any symptoms of respiratory, cardiovascular, musculoskeletal, gastrointestinal tract or nervous system, general reaction and fever, changes of skin and lymph nodes, any symptoms of the ear, neck or throat, psychological symptoms, susceptibility for infections) and stratified by age group, sex, dosage, COVID-19-vaccine (BNT162b, mRNA-1273) and comorbidities. Period of observation more than 90 days after first COVID-19 vaccination.

Secondary Outcome Measures

Name	Time	Method
- determine risk factors for occurence of vaccination-related symptoms after mRNA-vaccination against COVID-19<br>-Probability of self-reported categorized symptoms after COVID-19-vaccination with an mRNA-vaccine compared to Non-SARS-CoV2-vaccinations. <br>-retrospective estimation of the incidence of SARS-CoV2-infections, -COVID-19-related hospitalisations and complications among the study population