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VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection

StatusEnrolling by Invitation
PhaseNot specified
Started
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Record History

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  1. Primary completion date: Aug 2026 to Aug 2027
    • Study completion date: Aug 2027 to Aug 2028
    v14
  2. Primary completion date: Aug 2025 to Aug 2026
    • Study completion date: Aug 2025 to Aug 2027
    • Secondary endpoints: details revised at 1 of 1 entry
    v13
  3. 5 versions Re-verified since Jul 26, 2022, no change to tracked fieldsv8-v12
  4. Primary and study completion dates: Aug 2021 to Aug 2025v7
  5. Lead sponsor: Cangene Corporation to Emergent BioSolutions
    • Primary completion date: Aug 2018 to Aug 2021
    • Study completion date: Feb 2019 to Aug 2021
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Aug 2017 to Aug 2018
    • Study completion date: Feb 2018 to Feb 2019
    v5
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Suspended to Enrolling by Invitationv3 Show 8 more changesShow less
    • Study completion date: Feb 2018
    • Interventions: CNJ-016 (Biological) to VIGIV (Biological)
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoint revised
    • Primary endpoint revised
    • Study description expanded, about 8 words
    • Study arms: 0 to 1
    • Study title expanded, about 1 word
  4. Trial status: Enrolling by Invitation to Suspended Sponsor's reason: Enrolment is temporarily on hold due to transfer of ethical oversight from BioMed IRB to a different central IRB.
    • Eligibility criteria shortened, about 15 words
    • Study description expanded, about 29 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a post-marketing study to verify the clinical benefits of VIGIV \[CNJ-016, Vaccinia Immune Globulin Intravenous (Human), sterile solution\] in the resolution of complications resulting from smallpox vaccination in eligible patients treated with VIGIV.
Trial Details
NCT Number NCT01374984
Lead Sponsor Emergent BioSolutions
Collaborators: Centers for Disease Control and Prevention
Conditions
(from sponsor)		 Complication of Smallpox Vaccination
Related terms Smallpox
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov