Trial document




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  DRKS00028759

Trial Description

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Title

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

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Trial Acronym

CoVacU5

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Survey in parents regarding safety and side effects of the mRNA vaccine (BNT162b2 ) against COVID-19 in children below 5 years who were vaccinated (off-label use) in Germany. The aim of this study is to systematically describe potential side effects of the mRNA-vaccine (BNT162b2) in this age group.

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Brief Summary in Scientific Language

A retrospective parental survey-based cohort study on mRNA vaccine (BNT162b2) against COVID-19 as off-label use in Germany. The primary aim of the study is to systematically assess parental self-reported symptoms of side-effects and safety of the vaccine.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

Not envisioned due to the short-term organisation of the current study. Statistical analysis plan will be shared at the time of publication of results as a supplementary document.

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Organizational Data

  •   DRKS00028759
  •   2022/04/05
  •   [---]*
  •   yes
  •   Approved
  •   A2022-0065, Ethik-Kommission an der Medizinischen Fakultät der Universität Rostock
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   vaccination side effects
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Interventions/Observational Groups

  •   Children who were below 5 years of age at the timepoint of first COVID-19 vaccination (BNT162b2)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

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

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2022/04/14
  •   10000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   0   Years
  •   5   Years
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Additional 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

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Exclusion Criteria

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

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Addresses

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    • Klinik und Poliklinik für Kinder-und Jugendmedizin, Universitätsmedizin Rostock
    • Mr.  PD, MD, PhD  Cho-Ming  Chao 
    • Ernst-Heydemann-Straße 8
    • 18057  Rostock
    • Germany
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    • Klinik und Poliklinik für Kinder-und Jugendmedizin, Universitätsmedizin Rostock
    • Mr.  PD, MD, PhD  Cho-Ming  Chao 
    • Ernst-Heydemann-Straße 8
    • 18057  Rostock
    • Germany
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    • Klinik und Poliklinik für Kinder-und Jugendmedizin, Universitätsmedizin Rostock
    • Mr.  PD, MD, PhD   Cho-Ming  Chao 
    • Ernst-Heydemann-Straße 8
    • 18057  Rostock
    • Germany
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    end of 1:1-Block address contact public-contact
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Sources of Monetary or Material Support

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    • Klinik und Poliklinik für Kinder-und Jugendmedizin, Universitätsmedizin Rostock
    • Mr.  PD, MD, PhD  Cho-Ming  Chao 
    • Ernst-Heydemann-Straße 8
    • 18057  Rostock
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   [---]*
  •   [---]*
  •   2022/05/09
  •   8167
  •   8167
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Trial Publications, Results and other Documents

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