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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031994

Enrollment

20000

Registered

2023-06-02

Start date

2023-05-24

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mRNA-vaccines against COVID-19 (BNT162b2 Comirnaty

Interventions

Group 1: Parents or legal representatives of children who received at least one COVID-19 vaccination with an mRNA-vaccination before the age of 18 years, are going to be surveyed about vaccination rea

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

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

Countries

Germany

Contacts

Public ContactCho-Ming Chao

Helios Universitätsklinikum Wuppertal, Zentrum für Kinder- und Jugendmedizin

Cho-Ming.Chao@helios-gesundheit.de0202-896 3840

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026