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Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jul 2026 → Jul 2027
See other at-risk trials from University of California, Davis

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jul 2026 to Jul 2027v16
  2. Primary and study completion dates: Jul 2025 to Jul 2026v15
  3. Enrollment target: 90 to 75
    • Primary completion date: Mar 1, 2025 to Jul 2025
    • Study completion date: Mar 2, 2025 to Jul 2025
    v14
  4. Primary completion date: Mar 1, 2024 to Mar 1, 2025
    • Study completion date: Mar 2, 2024 to Mar 2, 2025
    v13
  5. Primary completion date: Sep 1, 2022 to Mar 1, 2024
    • Study completion date: Sep 2, 2022 to Mar 2, 2024
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Study Status, Referencesv11
  2. Primary completion date: Sep 1, 2021 to Sep 1, 2022
    • Study completion date: Sep 2, 2021 to Sep 2, 2022
    • Study description revised
    v10
  3. Re-verified, no change to tracked fieldsv9
  4. Primary completion date: Sep 1, 2019 to Sep 1, 2021
    • Study completion date: Mar 1, 2020 to Sep 2, 2021
    v8
  5. Phase: Not applicable to Phase 2
    • Primary completion date: Jun 5, 2026 to Sep 1, 2019
    • Study completion date: Jun 5, 2026 to Mar 1, 2020
    • Study description expanded, about 2 words
    v7
  6. Primary and study completion dates: Apr 2018 to Jun 5, 2026v6
  7. Re-verified, no change to tracked fieldsv5
  8. Primary and study completion dates: Jun 2017 to Apr 2018
    • Study sites: 2 to 1
    v4
  9. Primary and study completion dates: Jun 2016 to Jun 2017v3
  10. Trial status: Active, Not Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary completion date: Aug 2015 to Jun 2016
    • Study sites: 1 to 2
    • Study completion date: Jun 2016
    • Start date: Dec 2014
    • Collaborators shortened, about 5 words
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Persons without a spleen are susceptible to potentially lethal infections from certain bacteria, with pneumococcus being the most prevalent. Vaccines are provided to help protect against these infections, though they do not so with certainty. Trauma patients who sustain an injury to their spleen currently have three treatment options available for the treating surgeon - nonoperative management, embolization, or removal of the spleen. The purpose of this study is to investigate the antibody response to pneumococcal vaccine in patients undergoing these modes of therapy.
Trial Details
NCT Number NCT02232191
Lead Sponsor University of California, Davis
Conditions
(from sponsor)		 Asplenia
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov