Safety Surveillance Study of ACAM2000® Vaccinia Vaccine | NCT00927719

Studies
Safety Surveillance Study of ACAM2000® Vaccinia Vaccine

NCT00927719

Sponsor

Emergent BioSolutions

Status

Completed

Last Update Posted

Mar 18, 2024Actual

Enrollment

897,227Actual

Phase

Not provided

Conditions

Smallpox

Interventions

ACAM2000® smallpox vaccine

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

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

Dec 2008

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Dec 31, 2017Actual

First Submitted Date

Jun 24, 2009

First Submission Date that Met QC Criteria

Jun 24, 2009

First Posted Date

Jun 25, 2009Estimated

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 14, 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

This is an enhanced safety surveillance study that will occur within the military Service Member population.

Primary Objective:

To evaluate the rates of suspected, probable, and confirmed myocarditis and/or pericarditis in temporal association with ACAM2000® vaccination.

Secondary Objectives:

To evaluate the rates of cardiovascular adverse events in temporal association with ACAM2000® vaccination.
To evaluate the rates of neurological adverse events in temporal association with ACAM2000® vaccination.

Detailed Description

The Armed Forces Health Surveillance Activity (AFHSA) will perform comprehensive health surveillance through the operation of the Defense Medical Surveillance System (DMSS). Demographic and medical information gathered within monthly reports from the DMSS will be collected from approximately 100,000 to 200,000 military Service Members who received the ACAM2000® smallpox vaccine.

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

897,227Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ACAM2000® vaccinia vaccine Cohort		Participants had received ACAM2000®, vaccinia virus Smallpox vaccine.	Biological: ACAM2000® smallpox vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ACAM2000® smallpox vaccine	Biological	Previous vaccination, no vaccine is administered in this study.	ACAM2000® vaccinia vaccine Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To provide information concerning the safety following vaccination with ACAM2000® vaccinia vaccine		Entire study duration

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria :

Male and female military personnel >= 17 years of age.
Have received the ACAM2000® smallpox vaccine.

Exclusion Criteria :

Not applicable.

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

Participants that had received ACAM2000®, vaccinia virus Smallpox vaccine.

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
		Twentynine Palms	California	92278	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34454787	Derived	Decker MD, Garman PM, Hughes H, Yacovone MA, Collins LC, Fegley CD, Lin G, DiPietro G, Gordon DM. Enhanced safety surveillance study of ACAM2000 smallpox vaccine among US military service members. Vaccine. 2021 Sep 15;39(39):5541-5547. doi: 10.1016/j.vaccine.2021.08.041. Epub 2021 Aug 26.

ID	Term
D011213	Poxviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections