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Assessment of Myocarditis After Replication-Deficient Smallpox Immunization

NCT05513313 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2350

Last updated 2023-12-14

No results posted yet for this study

Summary

This is a prospective observational phase IV study of a novel, replication-deficient smallpox vaccine that has been recently been approved by FDA. The purpose of this study is to determine if there are any abnormalities detected by electrocardiographic testing and/or blood tests within 35 days of receiving the second dose of smallpox vaccine either alone or co-administered with other vaccines that may/may not be suggestive of myopericarditis.

Conditions

  • Myopericarditis
  • Small Pox

Interventions

BIOLOGICAL

JYNNEOS

smallpox vaccine

Sponsors & Collaborators

  • United States Naval Medical Center, San Diego

    collaborator FED

  • C.R.Darnall Army Medical Center

    collaborator FED

  • Womack Army Medical Center

    lead FED

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2029-03-31
Primary Completion
2029-03-31
Completion
2033-10-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05513313 on ClinicalTrials.gov