Same as above

Phase 1

• Conditions: The aim is to study primarily effectiveness as well as safety of citizens being vaccinated with one of the SARS-CoV2 vaccines being applied in the Danish COVID-19 vaccine programme. Whereas ongoing phase III trials are reporting vaccine efficacy in defined study populations, the effectiveness of these vaccines – and in particular the durability hereof - once introduced into the general population is presently unknown, and the focus of intense research and public health interest.; MedDRA version: 23.1Level: LLTClassification code 10084465Term: COVID-19 vaccinationSystem Organ Class: 100000004865; Therapeutic area: Health Care [N] - Environment and Public Health [N06]

• Registration Number: EUCTR2020-006003-42-DK
• Lead Sponsor: CHIP - Rigshospitalet - University of Copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-21
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

1.Written informed consent obtained before any trial related procedures are performed
2.Male or female eligible for SARS-CoV-2 immunization (as defined by SST in the national vaccination plan)
3.The subject must be willing and able to comply with trial protocol (re-visits and biological samples)

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 5000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5000

Exclusion Criteria

1.Male and female under the age of 18
2.Any subgroup of individuals for which the vaccines are contra-indicated
3.Previous SARS-CoV-2 vaccination

Study & Design

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