Safety Surveillance Study of ACAM2000® Vaccinia Vaccine
A Phase IV Enhanced Safety Surveillance Study of ACAM2000® in Military Personnel
1 other identifier
observational
897,227
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2008
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 24, 2009
CompletedFirst Posted
Study publicly available on registry
June 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedMarch 18, 2024
March 1, 2024
9.1 years
June 24, 2009
March 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To provide information concerning the safety following vaccination with ACAM2000® vaccinia vaccine
Entire study duration
Study Arms (1)
ACAM2000® vaccinia vaccine Cohort
Participants had received ACAM2000®, vaccinia virus Smallpox vaccine.
Interventions
Previous vaccination, no vaccine is administered in this study.
Eligibility Criteria
Participants that had received ACAM2000®, vaccinia virus Smallpox vaccine.
You may qualify if:
- Male and female military personnel \>= 17 years of age.
- Have received the ACAM2000® smallpox vaccine.
You may not qualify if:
- Not applicable.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Unknown Facility
Twentynine Palms, California, 92278, United States
Unknown Facility
Fort Campbell North, Kentucky, 42223, United States
Unknown Facility
Fort Bliss, Texas, 79906, United States
Unknown Facility
Fort Hood, Texas, 76544, United States
Related Publications (1)
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.
PMID: 34454787DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Emergent BioSolutions
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2009
First Posted
June 25, 2009
Study Start
December 1, 2008
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
March 18, 2024
Record last verified: 2024-03