Trial document



drksid header

  DRKS00024800

Trial Description

start of 1:1-Block title

Title

Safety profile of COVID-19 vaccines and the comparison to COVID-19 symptomatology

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

ImpfSurv

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

https://www.charite.de/service/klinische_studien_detail/item/studien_detail/impfsurv/

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Vaccination course, course of a COVID-19 disease, as well as long-term consequences of a Corona infection are to be compared with the vaccination reactions of vaccinated and health impairments of non-vaccinated persons.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Vaccination course, course of a COVID-19 disease, as well as long-term consequences of a Corona infection are to be compared with the vaccination reactions of vaccinated and health impairments of non-vaccinated persons. For this purpose, an online vaccination-survival questionnaire is used in this observational study, which records physical complaints after vaccination, COVID-19 disease and general complaints.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

No

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00024800
  •   2021/04/26
  •   [---]*
  •   yes
  •   Approved
  •   EA1/057/21, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   3000242  (Zenrales Studienregister der Charité)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Z20.8 -  Contact with and exposure to other communicable diseases
  •   U07.1 -  Emergency use of U07.1
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Longitudinal observational study without intervention with the aim of building a database of symptoms of COVID-19 vaccination or COVID-19 disease or general complaints of subjects not vaccinated against or not suffering from COVID-19 at baseline and over the course of two years.

    All subjects between 18 and 105 years of age who provided written informed consent will be included.

    Implementation: study participants will complete an online survey. The first survey of all subjects will be conducted at the time of the subject's initial voluntary enrollment via the online survey. Follow-up: In the form of a follow-up survey, interviews are conducted monthly for the first 6 months after the initial survey and then every 3 months for a period of 2 years. 




end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The primary objective parameter is to assess adverse vaccination reactions in COVID-19 vaccinated individuals compared to the adverse health effects in COVID-19 diseased and non-diseased individuals, respectively. The target parameter will be collected using a newly developed online questionnaire.  

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

All other analyses involving predictors influencing vaccination responses or general or health impairments resulting from COVID-19 disease are exploratory.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2021/04/26
  •   7800
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   105   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Included in the study are:
- Subjects 18 years of age and older  
- Subjects who have received COVID-19 vaccination and have not had COVID-19. 
- Subjects who have received COVID-19 vaccination and have had COVID-19. 
- Subjects who had COVID-19 and were not vaccinated 
- Subjects who have not had COVID-19 disease.
- Ability to give consent and signed informed consent form.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Subjects without an understanding of the German language will be excluded from the study.  Participants will also be excluded if they are participating or have participated in another (clinical) study that has not been completed 3 months prior to study participation.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Charité - Universitätsmedizin Berlin
    • 10117  Berlin
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie Charité – Universitätsmedizin Berlin
    • Mr.  Prof. Dr.  Harald  Matthes 
    • Luisenstraße 57
    • 10117  Berlin
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie Charité – Universitätsmedizin Berlin
    • Mr.  Maximilian  Hinse 
    • Luisenstr. 57
    • 10117  Berlin
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Software AG
    • 64297  Darmstadt
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.