Status:
SUSPENDED
A Study to Assess the Safety of Live Intranasal Sendai Virus Vaccine in Children and Toddlers
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Parainfluenza
Respiratory Viral Infections
Eligibility:
All Genders
12-6 years
Phase:
PHASE1
Brief Summary
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 m...
Detailed 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 magnitud...
Eligibility Criteria
Inclusion
- 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 and less than six years of age
- Adequate blood, liver and kidney function
- Has not or will not receive other vaccinations within 30 days of receiving study vaccine
- Exclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
May 5 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00186927
Start Date
May 5 2005
End Date
January 1 2027
Last Update
February 19 2025
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105