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A Phase IV Vaccine Study Under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2 (COVID-19) Vaccines.

NCT06360744 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-04-11

No results posted yet for this study

Summary

A phase IV study to assess if the SARS-CoV-2 vaccine from Johnson \& Johnson/Janssen (J\&J) results in change in number and activation of platelets and anti-PF4 Level. As well as compare whether the vaccine is causing a greater activation of platelets and anti-PF4 than the mRNA vaccines.

The Danish Medicines Agency has approved the vaccine from J\&J for use in Denmark, however it is not currently part of the national vaccine programme.

The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls. A sub-study will be embedded within this master protocol addressing basic and translational research questions requiring additional sampling of biological material (under separate participant informed consent).

Conditions

  • SARS CoV 2 Infection

Interventions

BIOLOGICAL

Johnson & Johnson

Vaccination with the Johnson \& Johnson vaccine which is NOT part of the Danish National Government programme

Sponsors & Collaborators

  • Ministry of the Interior and Health, Denmark

    collaborator OTHER_GOV

  • Jens D Lundgren, MD

    lead OTHER

Principal Investigators

  • Jens Lundgren, Professor · Rigshospitalet, Denmark

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-05
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06360744 on ClinicalTrials.gov