Same as above

Phase 1

• Conditions: The primary objective of the study is to assess if the SARS-CoV-2 vaccine Johnson & Johnson/Janssen results in change in number and activation of platelets and anti-PF4 level. As well as to compare whether the Johnson & Johnson/Janssen vaccine is causing a greater activation of platelets and anti-PF4 than the mRNA vaccines.The Danish Medicines Agency has approved the vaccine from Johnson & Johnson/Janssen for use in Denmark, however it is not currently part of the national vaccine programme.; MedDRA version: 23.1Level: LLTClassification code 10084465Term: COVID-19 vaccinationSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2021-003188-90-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: 2021-06-11
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

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/Tilvalgsordningen)
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 1000
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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
Specific for the Johnson & Johnson vaccine:
4.Experience of a serious allergic reaction after injection of any other vaccine
5.Serious infection with high fever (> 38 0C)
A temporary postponement of the vaccination is allowed, when participant has been well for at least 48 hours. Mild fever or upper airway infection like a cold is not a problem
6.Problems with bleeding or bruising, or use of anticoagulant medicine (to prevent blood clots)
7.Immunodeficiency or use of medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants or cancer medicines)

Study & Design

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