|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
4 March 2013 |
|
Main ID: |
NCT00186927 |
|
Date of registration:
|
12/09/2005 |
|
Primary sponsor: |
|
|
Public title:
|
A Study to Assess the Safety of Live Intranasal Sendai Virus Vaccine in Children and Toddlers
|
|
Scientific title:
|
A Phase I Study of Unmodified Live Intranasal Sendai Virus Vaccine in Children and Toddlers: Assessment of Safety and Immunogenicity |
|
Date of first enrolment:
|
March 2005 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00186927 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Elisabeth Adderson, MD |
|
Address:
|
|
|
Telephone:
|
1-866-278-5833 |
|
Email:
|
info@stjude.org |
|
Affiliation:
|
|
|
|
Name:
|
Elisabeth Adderson, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
St. Jude Children's Research Hospital |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria;
- Child is greater than or equal to one year of age or 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
- 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
Age minimum:
12 Months
Age maximum:
6 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Parainfluenza
|
|
Respiratory Viral Infections
|
|
Intervention(s)
|
|
Biological: Sendai virus vaccine
|
|
Primary Outcome(s)
|
|
To determine if a child's body responds to the presence of the Sendai virus by making proteins in the blood called antibodies that can find and kill the croup virus
[Time Frame: 6 months after enrollment complete; enrollment is projected to extend into 2012]
|
|
To determine if giving live Sendai virus (in the form of a vaccine) to children through their nose is safe (causes no serious illness)
[Time Frame: 6 months after enrollment complete; enrollment is projected to extend into 2012]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|