Population-based study on efficacy and safety of a booster COVID-19 vaccinatio

Phase 1

• Conditions: SARS-CoV-2 infection prevention; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-005094-28-AT
• Lead Sponsor: Medical University of Vienna, Department for Internal Medicine III, Division of Rheumatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-25
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

1.Are =18 years on the day of screening
2.Have an understanding of the study, agree to its provisions, and give written informed consent before study entry
3.Have received two doses of SARS-CoV-2 vaccines (Moderna, Biontech/Pfizer or Astra Zeneca) or one dose of Johnson and Johnson SARS-CoV-2 vaccine according to recommendations in the label and/or national guidelines at least 6 months before study entry
4.Have the technical requirements to complete online questionnaires (Smartphone)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2500

Exclusion Criteria

Subjects will be excluded from participation in this study if they:
1.Had grade 3 adverse effects from the vaccination reported
2.Any other contraindication to any of the vaccine compounds

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified