Survey of side effects after vaccination (Comirnaty, BNT162b2) against COVID-19 in Children below 5 Years in Germany

Survey of side effects after vaccination (Comirnaty, BNT162b2) against COVID-19 in Children below 5 Years in Germany - CoVacU5

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00028759

Enrollment

10000

Registered

2022-04-05

Start date

2022-04-14

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

vaccination side effects

Interventions

Group 1: Children who were below 5 years of age at the timepoint of first COVID-19 vaccination (BNT162b2)

Eligibility

Sex/Gender

All

Age

0 Years to 5 Years

Inclusion criteria

Inclusion criteria: -Informed consent of parents legal representatives to allow anonymized web-based survey - Children below 5 years of age who have received at least one vaccination against SARS-CoV2

Exclusion criteria

Exclusion criteria: - Children older than 5 years of age - Children without vaccination against SARS-CoV2

Design outcomes

Primary

Measure	Time frame
Symptoms occurring after the first, second or third COVID-19 vaccination (BNT162b2), stratified by dosage used	—

Secondary

Measure	Time frame
- Overview of used BNT162b2 vaccine dosage according to age group - Investigation of risk factors for occurrence of vaccination-related symptoms or side effects - retrospective estimation of the incidence of COVID-19 diagnosis, -COVID-19-related hospitalisations and complications among the study population	—

Countries

Germany

Contacts

Public ContactCho-Ming Chao

Klinik und Poliklinik für Kinder-und Jugendmedizin, Universitätsmedizin Rostock

cho-ming.chao@med.uni-rostock.de+49 381-494-7003

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 6, 2026