MEDI-559
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 <24 Month-Old Children
Sponsor study identifier
interventional
116
2 countries
76
Study Start
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2011
Actual (reported)Study Completion
December 2011
Actual (reported)The primary objective of this study is to describe the 28-day post-final dose safety and tolerability of three doses of MEDI-559 at 10\^5 FFU when administered to healthy RSV seronegative children 1 to \<24 months of age.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
October 3, 2008
Actual (reported)October 7, 2008
Actual (reported)December 2011
Actual (reported)December 2011
Actual (reported)Incidence of solicited symptoms after Dose 1
Solicited symptoms are predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms for this study include: fever \>100.4°F (\>38.0 °C) regardless of route, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/Fussiness, oropharyngeal irritation (laryngitis), epistaxis
Through Day 28 after each dose
Incidence of solicited symptoms after Dose 2
Solicited symptoms are predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms for this study include: fever \>100.4°F (\>38.0 °C) regardless of route, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/Fussiness, oropharyngeal irritation (laryngitis), epistaxis
Through Day 28 after each dose
Incidence of solicited symptoms after Dose 3
Solicited symptoms are predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms for this study include: fever \>100.4°F (\>38.0 °C) regardless of route, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/Fussiness, oropharyngeal irritation (laryngitis), epistaxis
Incidence of MEDI-559 shedding
Day 7-10 after Dose 1, 2, and 3
Incidence of MEDI-559 shedding
Day 12-18 after Dose 1, 2, and 3
Incidence of MEDI-559 shedding
Day 28-34 post Dose 1, 2, and 3
Post-vaccination seroresponse against RSV
Day 28 post final dose
Phenotypic stability of recovered vaccine-type virus
Day 7-10 post any dose
MEDI-559
Placebo
Cohort 1 (5 to \<24 months): N=80 MEDI-559 at 10\^5 FFU at 0, 2, and 4 months; frozen preparation filled into 0.5 ml luer slip-tip syringes. Each 0.2 ml dose contains 10\^5 FFU MEDI-559 in a sucrose phosphate glutamate buffer.
Cohort 1 (5 to \< 24 months); N = 80 placebo at 0, 2, and 4 months; frozen preparation filled into 0.5 ml luer slip-tip syringes. Each 0.2 ml dose contains sucrose phosphate buffer.
Research Site
Greenville, Alabama, 36037, United States
Research Site
Huntsville, Alabama, 35802, United States
Research Site
Mobile, Alabama, 36608, United States
Research Site
Conway, Arkansas, 72034, United States
Research Site
Little Rock, Arkansas, 72202, United States
Research Site
Little Rock, Arkansas, 72205, United States
Research Site
Anaheim, California, 92804, United States
Malkin E, Yogev R, Abughali N, Sliman J, Wang CK, Zuo F, Yang CF, Eickhoff M, Esser MT, Tang RS, Dubovsky F. Safety and immunogenicity of a live attenuated RSV vaccine in healthy RSV-seronegative children 5 to 24 months of age. PLoS One. 2013 Oct 29;8(10):e77104. doi: 10.1371/journal.pone.0077104. eCollection 2013.
Joseph Sliman, M.D.
MedImmune LLC
116 participants (actual enrollment reported by the registry).
First Submitted
October 3, 2008
First Posted
October 7, 2008
Study Start
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
Through Day 28 after each dose
Incidence of adverse events (AEs) after Dose 1
As defined by the ICH Guideline for Good Clinical Practice, an AE is: Any untoward medical occurrence in a participant or clinical investigations subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Through Day 28 after each dose
Incidence of AEs after Dose 2
As defined by the ICH Guideline for Good Clinical Practice, an AE is: Any untoward medical occurrence in a participant or clinical investigations subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Through Day 28 after each dose
Incidence of AEs after Dose 3
As defined by the ICH Guideline for Good Clinical Practice, an AE is: Any untoward medical occurrence in a participant or clinical investigations subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Through Day 28 after each dose
Incidence of medically-attended lower respiratory illnesses (MA-LRIs) after Dose 1
An MA-LRI is defined as a health care provider confirmed diagnosis of any one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, apnea
Through Day 28 after each dose
Incidence of MA-LRIs after Dose 2
An MA-LRI is defined as a health care provider confirmed diagnosis of any one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, apnea
Through Day 28 after each dose
Incidence of MA-LRIs after Dose 3
An MA-LRI is defined as a health care provider confirmed diagnosis of any one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, apnea
Through Day 28 after each dose
Incidence of SAEs
An SAE is any adverse event that results in any of the following outcomes: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital anomaly/birth defect (in the offspring of a subject); an important medical event that may not result in death, threaten life or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, it may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
Administration of Dose 1 (Day 0) through Day 28 post final dose
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Research Site
Cypress, California, 90630, United States
Research Site
Downey, California, 90241, United States
Research Site
Huntington Beach, California, 92647, United States
Research Site
Lakewood, California, 90712, United States
Research Site
Long Beach, California, 90806, United States
Research Site
Los Angeles, California, 90015, United States
Research Site
Los Angeles, California, 90024, United States
Research Site
Paramount, California, 90723, United States
Research Site
San Diego, California, 92103, United States
Research Site
Santa Ana, California, 92705, United States
Research Site
Thornton, Colorado, 80223, United States
Research Site
Hartford, Connecticut, 06106, United States
Research Site
Washington D.C., District of Columbia, 20058, United States
Research Site
Miami, Florida, 33142, United States
Research Site
Miami, Florida, 33155, United States
Research Site
Orange City, Florida, 32763, United States
Research Site
Tampa, Florida, 33606, United States
Research Site
Dalton, Georgia, 30721, United States
Research Site
Chicago, Illinois, 60614, United States
Research Site
Fishers, Indiana, 46037, United States
Research Site
New Albany, Indiana, 47150, United States
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South Bend, Indiana, 46601, United States
Research Site
Ames, Iowa, 50010, United States
Research Site
Bardstown, Kentucky, 40004, United States
Research Site
Lexington, Kentucky, 40503, United States
Research Site
Lexington, Kentucky, 40509, United States
Research Site
Louisville, Kentucky, 40202, United States
Research Site
Louisville, Kentucky, 40207, United States
Research Site
Paducah, Kentucky, 42003, United States
Research Site
Metarie, Louisiana, 70006, United States
Research Site
Fredrick, Maryland, 21215, United States
Research Site
Boston, Massachusetts, 02111, United States
Research Site
Fall River, Massachusetts, 02724, United States
Research Site
Bridgeton, Missouri, 63044, United States
Research Site
Kansas City, Missouri, 64132, United States
Research Site
Omaha, Nebraska, 68131, United States
Research Site
Omaha, Nebraska, 68134, United States
Research Site
Brooklyn, New York, 11219, United States
Research Site
Endwell, New York, 13760, United States
Research Site
Stony Brook, New York, 11794, United States
Research Site
Syracuse, New York, 13210, United States
Research Site
Cleveland, Ohio, 44109, United States
Research Site
Cleveland, Ohio, 44121, United States
Research Site
Huber Heights, Ohio, 45424, United States
Research Site
Norman, Oklahoma, 73071, United States
Research Site
Tulsa, Oklahoma, 74127, United States
Research Site
Warwick, Rhode Island, 02886, United States
Research Site
Spartanburg, South Carolina, 29303, United States
Research Site
Franklin, Tennessee, 37067, United States
Research Site
Jackson, Tennessee, 38305, United States
Research Site
Johnson City, Tennessee, 37604, United States
Research Site
Kingsport, Tennessee, 37660, United States
Research Site
Corpus Christi, Texas, 78414, United States
Research Site
Houston, Texas, 77036, United States
Research Site
Houston, Texas, 77055, United States
Research Site
San Angelo, Texas, 76904, United States
Research Site
San Antonio, Texas, 78205, United States
Research Site
San Antonio, Texas, 78229, United States
Research Site
San Antonio, Texas, 78258, United States
Research Site
Tomball, Texas, 77375, United States
Research Site
Layton, Utah, 84041, United States
Research Site
St. George, Utah, 84790, United States
Research Site
Syracuse, Utah, 84075, United States
Research Site
Charlottesville, Virginia, 22902, United States
Research Site
Colonial Heights, Virginia, 23834, United States
Research Site
Midlothian, Virginia, 23113, United States
Research Site
Richmond, Virginia, 23219, United States
Research Site
Walla Walla, Washington, 99362, United States
Research Site
Caguas, 00726, Puerto Rico
Primary Completion
December 2011
Actual (reported)Study Completion
December 2011
Actual (reported)Last Updated
July 20, 2016
Record last verified: 2016-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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