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Sponsored by: |
MedImmune LLC |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00767416 |
The primary objective of this study is to describe the safety and tolerability of three doses of MEDI-559 at 10:5 FFU when administered to healthy RSV seronegative children 1 to <12 months.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Biological: MEDI-559 Other: Placebo |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, and Viral Shedding of MEDI-559, a Live Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus in Healthy 1 to <12 Month-Old Children |
Estimated Enrollment: | 320 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
MEDI-559
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Biological: MEDI-559
Cohort 1 (5 to <12 months): N=80 MEDI-559 at 105 FFU at 0, 2, and 4 months N=80 Placebo at 0, 2, and 4 months
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2: Experimental
MEDI-559
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Biological: MEDI-559
Cohort 2 (1 to <3 months): N=80 MEDI-559 at 105 FFU at 0, 2, and 4 months N=80 Placebo at 0, 2, and 4 months
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Placebo: Placebo Comparator
Placebo
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Other: Placebo
frozen preparation filled into 0.5 ml; each 0.2 ml dose contains sucrose phosphate buffer.
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The primary objective of this study is to describe the safety and tolerability of three doses of MEDI-559 at 10:5 FFU when administered to healthy RSV seronegative children 1 to <12 months of age and to healthy infants 1 to <3 months of age regardless of baseline serostatus.
Ages Eligible for Study: | 5 Months to 11 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michele Jordan | 301-398-4167 | |
Contact: Mark Eickhoff | 301-398-5038 |
United States, Arkansas | |
Arkansas Pediatric Research Division | Recruiting |
Bentonville, Arkansas, United States, 72712 | |
Contact: Elise Campion 479-273-5437 elisecampion.chirp@yahoo.com | |
Principal Investigator: Bryan Harvey, M.D. | |
United States, Kentucky | |
IGLU | Recruiting |
Lexington, Kentucky, United States, 40503 | |
Contact: Carol Rush 859-277-6516 simonrn@iglou.com | |
Principal Investigator: Simon, M.D. |
Study Director: | Raburn Mallory, M.D. | MedImmune LLC |
Responsible Party: | MedImmune LLC ( Raburn Mallory, MD ) |
Study ID Numbers: | MI-CP147 |
Study First Received: | October 3, 2008 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00767416 |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Healthy |