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

StatusSuspended
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Notable

    Primary completion date: Jan 2026 to Jan 2027

    Completion date: Jan 2027 to Jan 2028

    Study Statusv41

  2. Notable

    Primary completion date: Jan 2025 to Jan 2026

    Completion date: Jan 2026 to Jan 2027

    Study Statusv40

  3. Minor

    Study Status

    Re-verified, no change to tracked fields

    v39

  4. Stopped

    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; Completion date: Jan 2024 to Jan 2026

    Study Statusv38

  5. Minor

    2 amendments

    2 re-verifications since 2021-06-07, no change to tracked fields

    v36-v37

Show 34 earlier versions

  1. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised

    Study Status, Contacts/Locationsv35

  2. Notable

    Primary completion date: Jan 2020 to Jan 2023

    Completion date: Jan 2020 to Jan 2024

    Study Statusv34

  3. Minor

    Primary and study completion dates: Dec 2019 to Jan 2020

    Study Statusv33

  4. Minor

    Primary and study completion dates: Nov 2019 to Dec 2019

    Study Statusv32

  5. Minor

    Primary and study completion dates: Jun 2019 to Nov 2019

    Study Statusv31

  6. Minor

    Primary and study completion dates: Jun 30, 2019 to Jun 2019

    Study Statusv30

  7. Notable

    Start date: Mar 2005 to May 5, 2005

    Primary and study completion dates: Jun 2019 to Jun 30, 2019

    Study Status, Oversightv29

  8. Notable

    Primary and study completion dates: Jun 2017 to Jun 2019

    Eligibility criteria revised

    Show what changed: Eligibility criteria
    [...] e contact (i.e. stay in the same room in daycare) less than 624 months of age if same room contact is expected within 14 da [...]

    Study Status, Eligibilityv28

  9. Minor

    2 amendments

    2 re-verifications since 2016-06-17, no change to tracked fields

    v26-v27

  10. Minor

    Study sites: 2 to 1

    Study Status, Contacts/Locationsv25

  11. Minor

    Eligibility criteria expanded, about 97 words

    Site contacts updated at 2 of 2 sites

    Show what changed: Eligibility criteria
    Inclusion Criteria; Parent or legal guardian willing and able to give informed consent and comply with study requirements Child is greater than or equal to one year of age orand less than six years of age Adequate blood, liver and kidney [...] xclusion Criteria: History of allergy to eggs or gentamicin Child has no historyHistory of lung disease, asthma, and hospitalization for respirator [...] kle cell disease, or any other serious underlying condition FamilyChildren memberwho withhave a family history of primary immunodeficiency or lack history of maternal or paternal immune status Height or weight less t [...] [...]

    Study Status, Outcome Measures, Eligibility, Contacts/Locationsv24

  12. Minor

    2 amendments

    2 re-verifications since 2015-02-24, no change to tracked fields

    v22-v23

  13. Notable

    Primary and study completion dates: Jun 2014 to Jun 2017

    Study Status, Referencesv21

  14. Minor

    Study Status

    Re-verified, no change to tracked fields

    v20

  15. Notable

    Enrollment target: 30 to 54

    Study Status, Study Designv19

  16. Notable

    Trial status: Active, Not Recruiting to Recruiting

    Site details revised at 2 of 2 sites

    Study Status, Study Design, Arms and Interventions, Contacts/Locationsv18

  17. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised at 2 of 2 sites

    Study Status, Contacts/Locationsv17

  18. Notable

    Primary and study completion dates: Jun 2013 to Jun 2014

    Study sites: 1 to 2; Collaborators shortened, about 5 words

    Show what changed: Collaborators
    National Institutes of Health (NIH)

    Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locationsv16

  19. Minor

    Eligibility criteria revised

    Show what changed: Eligibility criteria
    Inclusion Criteria; Child is greater than or equal to one year of age or less thenthan six years of age Adequate blood, liver and kidney function [...]

    Study Identification, Study Status, Sponsor/Collaborators, Outcome Measures, Eligibilityv15

  20. Notable

    Primary and study completion dates: Jun 2012 to Jun 2013

    Study Statusv14

  21. Notable

    Primary and study completion dates: Jun 2011 to Jun 2012

    Study Statusv13

  22. Minor

    Study description expanded, about 76 words

    Show what changed: Study description
    The main aim of the study is to assess the tolerance and safety of escalating doses of intranasal Sendai virus in children and toddlers. The secondary objective of the study is to assess the magnitude and duration of the immune response elicited by intranasal Sendai virus. Responses between seroposi [...]

    Study Status, Study Descriptionv12

  23. Minor

    Study Status

    Re-verified, no change to tracked fields

    v11

  24. Notable

    Trial status: Suspended to Recruiting

    Site details revised

    Study Status, Contacts/Locationsv10

  25. Minor

    Primary completion date: Jun 2011

    Completion date: Apr 2009 to Jun 2011

    Study Status, Sponsor/Collaborators, Outcome Measuresv9

  26. Minor

    Study arms: 0 to 1

    Study Status, Arms and Interventionsv8

  27. Minor

    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

    Show what changed: Collaborators
    National Institutes of Health (NIH)

    Study Identification, Study Status, Sponsor/Collaborators, Arms and Interventions, Outcome Measuresv7

  28. Stopped

    Trial status: Recruiting to Suspended

    Completion date: Apr 2008 to Apr 2009; Site details revised

    Study Status, Contacts/Locationsv6

  29. Minor

    Completion date: Apr 2006 to Apr 2008

    Study Status, Oversight, Study Designv5

  30. Minor

    Completion date: Apr 2006

    Study Statusv4

  31. Minor

    Study Status

    Re-verified, no change to tracked fields

    v3

  32. Notable

    Trial status: Suspended to Recruiting

    Site details revised

    Study Status, Contacts/Locations, Referencesv2

  1. Minor

    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 Parainfluenza, Respiratory Viral Infections
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov