Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360744
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2021-07-01
Brief Title:
A Phase IV Vaccine Study Under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2 COVID-19 Vaccines
Sponsor:
Jens D Lundgren MD
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
A Phase IV Vaccine Study Under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2 COVID-19 Vaccines ENFORCE PLUS
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A phase IV study to assess if the SARS-CoV-2 vaccine from Johnson JohnsonJanssen JJ 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 JJ 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
The Danish Medicines Agency has approved the vaccine from JJ 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
Detailed Description:
Participants will have 3 specific study visits and will hereafter be followed for 2 years after the vaccination with regular visits after 3 6 12 and 24 month In this way the participants will be offered an extra close follow up on vaccine effectiveness
Safety data will be collected at study visits until 3 months after the first vaccination with additional safety data collected under this protocol during the first month after vaccination
Research samples will be collected at each study visit during the two-year follow-up
Safety data will be collected at study visits until 3 months after the first vaccination with additional safety data collected under this protocol during the first month after vaccination
Research samples will be collected at each study visit during the two-year follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None