Trial document
DRKS00024800
Trial Description
Title
Safety profile of COVID-19 vaccines and the comparison to COVID-19 symptomatology
Trial Acronym
ImpfSurv
URL of the Trial
https://www.charite.de/service/klinische_studien_detail/item/studien_detail/impfsurv/
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.
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.
Do you plan to share individual participant data with other researchers?
No
Description IPD sharing plan:
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Organizational Data
- DRKS00024800
- 2021/04/26
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- yes
- Approved
- EA1/057/21, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
Secondary IDs
- 3000242 (Zenrales Studienregister der Charité)
Health Condition or Problem studied
- Z20.8 - Contact with and exposure to other communicable diseases
- U07.1 - Emergency use of U07.1
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.
Characteristics
- Non-interventional
- Observational study
- Single arm study
- Open (masking not used)
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- Uncontrolled/Single arm
- Other
- Single (group)
- N/A
- N/A
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.
Secondary Outcome
All other analyses involving predictors influencing vaccination responses or general or health impairments resulting from COVID-19 disease are exploratory.
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2021/04/26
- 7800
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- 105 Years
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.
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.
Addresses
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- Charité - Universitätsmedizin Berlin
- 10117 Berlin
- Germany
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- 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-contactstart of 1:1-Block address contact scientific-contact- +49 (30) – 36501699
- +49 (30) – 450 529 902
- harald.matthes at charite.de
- https://epidemiologie.charite.de/
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- Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie Charité – Universitätsmedizin Berlin
- Mr. Maximilian Hinse
- Luisenstr. 57
- 10117 Berlin
- Germany
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- +49 (30) – 450 529 902
- maximilian.hinse at charite.de
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Sources of Monetary or Material Support
-
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- Software AG
- 64297 Darmstadt
- Germany
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Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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