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

Paused · Phase 1

Conditions studied: Parainfluenza, Respiratory Viral Infections

In brief

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.

Key facts

Study ID: NCT00186927
Run by: St. Jude Children's Research Hospital
People needed: 54
Starts: 2005-05-05
Expected to finish: 2028-01-01
Last updated by the study team: 2026-03-30

Who can join

Age: 1 and older, up to 6. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

History of allergy to eggs or gentamicin
History of lung disease, asthma, and hospitalization for respiratory illness, immunodeficiency, sickle cell disease, or any other serious underlying condition
Children who have a family history of primary immunodeficiency or lack history of maternal or paternal immune status
Height or weight less than 5th percentile
Upper respiratory tract infection (URI) or household member with URI
Evidence of developmental delay or evolving neurological disorders
Household member or daycare contact (i.e. stay in the same room in daycare) less than 24 months of age if same room contact is expected within 14 days of vaccination or 7 days after booster, or prior to evidence of vaccine clearance
Immunodeficient household members or other close contacts if same room contact is expected within 14 days of vaccination or 7 days after booster, or prior to evidence of vaccine clearance
Current use of investigational or immunosuppressive drugs (e.g., steroids)
Current use of antibiotics or antivirals

Where it is running

St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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