SARS-CoV-2 immune response

Phase 1

• Conditions: immune response to COVDI-19 vaccination; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-001202-30-NL
• Lead Sponsor: Diakonessenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-16
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Before and after COVID-19 vaccination
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

< 18 years old

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: immune response after COVID-19 vaccination;Secondary Objective: Not applicable;Primary end point(s): 1 year after final vaccination dose;Timepoint(s) of evaluation of this end point: 1 year after final vaccination dose

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): immune response 3 weeks, 3 months and 1 year after final vaccination;Timepoint(s) of evaluation of this end point: immune response 3 weeks, 3 months and 1 year after final vaccination