A Study to Assess the Safety of Live Intranasal Sendai Virus Vaccine in Children and Toddlers

StatusSuspended
PhasePhase 1
Started

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Record History

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  1. Primary completion date: Jan 2026 to Jan 2027
    • Study completion date: Jan 2027 to Jan 2028
    v41
  2. Primary completion date: Jan 2025 to Jan 2026
    • Study completion date: Jan 2026 to Jan 2027
    v40
  3. Re-verified, no change to tracked fieldsv39
  4. Trial status: Active, Not Recruiting to Suspended Sponsor's reason: voluntary Hold because of COVID-19, all participants were off study prior to the hold.
    • Primary completion date: Jan 2023 to Jan 2025
    • Study completion date: Jan 2024 to Jan 2026
    v38
  5. 2 versions Re-verified since Jun 7, 2021, no change to tracked fieldsv36-v37
Show 34 earlier versionsHide 34 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v35
  2. Primary completion date: Jan 2020 to Jan 2023
    • Study completion date: Jan 2020 to Jan 2024
    v34
  3. Primary and study completion dates: Dec 2019 to Jan 2020v33
  4. Primary and study completion dates: Nov 2019 to Dec 2019v32
  5. Primary and study completion dates: Jun 2019 to Nov 2019v31
  6. Primary and study completion dates: Jun 30, 2019 to Jun 2019v30
  7. Start date: Mar 2005 to May 5, 2005
    • Primary and study completion dates: Jun 2019 to Jun 30, 2019
    v29
  8. Primary and study completion dates: Jun 2017 to Jun 2019
    • Eligibility criteria revised
    v28
  9. 2 versions Re-verified since Jun 17, 2016, no change to tracked fieldsv26-v27
  10. Study sites: 2 to 1v25
  11. Eligibility criteria expanded, about 97 words
    • Site contacts updated at 2 of 2 sites
    v24
  12. 2 versions Re-verified since Feb 24, 2015, no change to tracked fieldsv22-v23
  13. Primary and study completion dates: Jun 2014 to Jun 2017v21
  14. Re-verified, no change to tracked fieldsv20
  15. Enrollment target: 30 to 54v19
  16. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    v18
  17. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v17
  18. Primary and study completion dates: Jun 2013 to Jun 2014
    • Study sites: 1 to 2
    • Collaborators shortened, about 5 words
    v16
  19. Eligibility criteria revisedv15
  20. Primary and study completion dates: Jun 2012 to Jun 2013v14
  21. Primary and study completion dates: Jun 2011 to Jun 2012v13
  22. Study description expanded, about 76 wordsv12
  23. Re-verified, no change to tracked fieldsv11
  24. Trial status: Suspended to Recruiting
    • Site details revised
    v10
  25. Primary completion date: Jun 2011
    • Study completion date: Apr 2009 to Jun 2011
    v9
  26. Study arms: 0 to 1v8
  27. Sponsor's reason: Clinical Hold issued by the FDA pending completion of additional laboratory testing of the vaccine requested by the FDA
    • Collaborators expanded, about 5 words
    v7
  28. Trial status: Recruiting to Suspended
    • Study completion date: Apr 2008 to Apr 2009
    • Site details revised
    v6
  29. Study completion date: Apr 2006 to Apr 2008v5
  30. Study completion date: Apr 2006v4
  31. Re-verified, no change to tracked fieldsv3
  32. Trial status: Suspended to Recruiting
    • Site details revised
    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.
Croup is an illness of young children that is caused by a virus. With this illness, the child has fever, cough, and hoarseness. Although the illness usually gets better in 2 to 4 days, some children may be admitted to the hospital and a few infants may require an intervention to help their breathing. This illness is most often caused by a virus called parainfluenza virus type 1, but it can be caused by other viruses. The experimental vaccine that is being investigated in this study is intended to try to prevent croup caused by parainfluenza virus type 1. Currently, there are no vaccines to prevent this virus, or medications available to treat the illness once infection has occurred. This research study is testing a new experimental live-virus vaccine that is given by placing liquid drops in the nose. The Sendai virus is very similar to the virus that causes croup, but it has never been found to cause illness in people. Previous studies in animals have shown that the vaccine provided protection against the croup virus, and did not cause illness. Many people have been exposed to the Sendai virus, but no one has been known to develop illness. Several healthy adults have been given the Sendai virus vaccine being studied, and they did not experience any serious side effects or illness.
Trial Details
NCT Number NCT00186927
Lead Sponsor St. Jude Children's Research Hospital
Conditions
(from sponsor)		 Parainfluenza, Respiratory Viral Infections
Related terms Paramyxoviridae Infections
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov