A Phase IV Vaccine Study Under the National Cohort Study... | NCT06360744

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

NCT06360744

Sponsor

Jens D Lundgren, MD

Status

Completed

Last Update Posted

Apr 11, 2024Actual

Enrollment

25Actual

Phase

Phase 4

Conditions

SARS CoV 2 Infection

Interventions

Johnson & Johnson

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 5, 2021Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Jul 1, 2021

First Submission Date that Met QC Criteria

Apr 10, 2024

First Posted Date

Apr 11, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2024

Last Update Posted Date

Apr 11, 2024Actual

Name	Class
Ministry of the Interior and Health, Denmark	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vaccine Johnson and Johnson/Janssen Covid-19 vaccine	Other	Johnson & Johnson/Janssen Covid-19 vaccine.	Biological: Johnson & Johnson

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Johnson & Johnson	Biological	Vaccination with the Johnson & Johnson vaccine which is NOT part of the Danish National Government programme	Vaccine Johnson and Johnson/Janssen Covid-19 vaccine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of the J& J vaccine	To clarify whether vaccination with the J&J vaccine leads to changes in the number and activation of platelets as well as anti-PF4 level and to compare whether the J&J vaccine causes a stronger activation of platelets as well as an increase in anti-PF4 antibodies compared to mRNA vaccines. Included is also questionnaires	The change from base-line to after 24 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Male and female under the age of 18
Any subgroup of individuals for which the vaccine is contra-indicated
Previous SARS-CoV-2 vaccination

Specific for the Johnson & Johnson vaccine:
Experience of a serious allergic reaction after injection of any other vaccine
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
Problems with bleeding or bruising, or use of anticoagulant medicine (to prevent blood clots)
Immunodeficiency or use of medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants or cancer medicines)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus Universitetshospital, Skejby		Aarhus	Aarhus N	8200	Denmark
Aalborg Universitetshospital Syd

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

ID	Term
D000086663	COVID-19 Vaccines
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products