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A Multicenter, Randomized Dose Response Study of the Safety, Clinical and Immune Responses of Dryvax Administered to Children 2 to 5 Years of Age
Some information in the following documents is exempt from disclosure under Federal statutes and has been redacted.
Requesting IRB: |
Harbor UCLA Medical Center |
Study Summary: |
This study proposed to evaluate the potency, dose and safety of vaccinia virus vaccine (Dryvax) administered to children in the event there is a smallpox terrorist event. The objective of this study was to evaluate the safety and the rate of clinical and immune responses with stockpiled Dryvax vaccine when administered to children 2-5 years of age. It was to have been evaluated undiluted and at a 1:5 dilution, with 5 skin punctures; additionally, the safety of semi-occlusive dressings to limit self-inoculation and secondary transmission would have been evaluated. Revaccination of non-responders would have helped define the value of a second dose. The vaccine take and immune response rate would have been compared between pediatric subjects in the two study groups and by comparisons with results from similar trials conducted in adults. |
Funding Source: |
National Institute of Allergy and Infectious Diseases/National Institutes of Health |
Expert Reports
Correspondence/applcication
IRB and principal investigator
- Harbor-UCLA Medical Center
- Cincinnati Children's Hispital Medical Center
- Kaiser Permanente
Other
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