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A Study to Assess the Safety of Live Intranasal Sendai Virus Vaccine in Children and Toddlers - NCT00186927-38105(Clinical Trial 129391)



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City:  Memphis
State:  
TN
Zip Code: 38105
Conditions: Parainfluenza - Respiratory Viral Infections
Purpose: 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.
Study summary: 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 seropositive and seronegative children will be compared. This study also tests the safety and immunogenicity of a booster vaccination at the highest dose tolerated during primary immunization dose-escalation.
Criteria: Inclusion Criteria; - Child is greater than or equal to one year of age or less then 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 - Child has no history of lung disease, asthma, and hospitalization for respiratory illness, immunodeficiency, sickle cell disease, or any other serious underlying condition - Family member with primary immunodeficiency - Height or weight less than 5th percentile - Upper respiratory infection (URI) or household member with URI - Household member or daycare contact less than 24 months - Household member or close contact with immunodeficiency - Use of investigational or immunosuppressive drugs, antibiotics or antivirals
Study is available at: St. Jude Children's Research Hospital
Memphis, TN 38105
United States

Primary Contact:
Jerry L Shenep, MD
Email: info@stjude.org
Phone: 866-278-5833

Secondary Contact:
Jerry L Shenep, MD
Email: info@stjude.org
Phone: 1-866-278-5833
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 21, 2011
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