ACAM2000® Myopericarditis Registry | NCT01395082

Studies
ACAM2000® Myopericarditis Registry

NCT01395082

Sponsor

Emergent BioSolutions

Status

Completed

Last Update Posted

Mar 18, 2024Actual

Enrollment

24Actual

Phase

Not provided

Conditions

Myocarditis
Pericarditis

Interventions

Not provided

Countries

United States

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

ID	Type	Description	Link
U1111-1120-1721	Other Identifier	WHO

Status Module

Record Verification Date

Mar 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

Apr 2011

Primary Completion Date

Feb 4, 2019Actual

Completion Date

Feb 4, 2019Actual

First Submitted Date

Jul 13, 2011

First Submission Date that Met QC Criteria

Jul 13, 2011

First Posted Date

Jul 15, 2011Estimated

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

Mar 15, 2024

Last Update Posted Date

Mar 18, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this registry is to study the natural history of vaccination-related myocarditis and pericarditis and to assess possible risk factors for these conditions.

Primary Objective:

- To document the natural history of confirmed, probable, suspected, and subclinical myocarditis and pericarditis (myopericarditis) following ACAM2000® vaccination.

Other Pre-defined Objective:

- To look for potential predictive factors for the prognosis of myopericarditis following ACAM2000® vaccination.

Detailed Description

All participants will have received previous vaccination with ACAM2000 but will not receive any vaccination as part of the registry. All participants enrolled in the registry will be followed for 2 up to 5 years (depending on whether there are persisting signs and symptoms of myopericarditis).

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Entire registry group		Participants with potential myopericarditis cases referred to the Registry

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of confirmed, probable, suspected, and subclinical cases of myopericarditis, categorized by time since vaccination		2 years after enrollment or after the last symptoms or positive findings

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
The natural history of myopericarditis in terms of time to resolution or change in status of myopericarditis and the pattern of changes in status of myopericarditis		2 years after enrollment or after the last symptoms or positive findings

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals who are current or former members of the active duty, Reserve, or National Guard, from any branch of service
Documented vaccination with ACAM2000® vaccine
Meet one of the case definitions for suspect, probable, confirmed or subclinical myopericarditis.

Exclusion Criteria:

Individuals not meeting at least one of the case definitions for myopericarditis will not be entered into the Registry.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Eligible participants will have received previous vaccination with ACAM2000® but will not receive any vaccination as part of the registry.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Director	Emergent BioSolutions	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		San Diego	California	92106	United States

Condition Browse Module

MeSH Terms

ID	Term
D009205	Myocarditis
D010493	Pericarditis
D014615	Vaccinia

Ancestor Terms

ID	Term
D009202	Cardiomyopathies
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D011213	Poxviridae Infections

Browse Leaves

Not provided

Browse Branches

Not provided