Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age
NCT ID: NCT00493285
Last Updated: 2012-07-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
49 participants
INTERVENTIONAL
2007-07-31
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
MEDI-534 at 10\^4 TCID50 at 0, 2, and 4 months (Nasal spray)
MEDI-534
Multiple doses of MEDI-534 or Placebo at 10\^4 TCID50
2
MEDI-534 at 10\^5 TCID50 at 0, 2, and 4 months (Nasal Spray)
MEDI-534
Multiple doses of MEDI-534 or Placebo at 10 \^5 TCID50.
3
MEDI-534 at 10\^6 TCID50 at 0, 2, and 4 months (Nasal Spray)
MEDI-534
Multiple doses of MEDI-534 or Placebo at 10\^6 TCID50.
Interventions
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MEDI-534
Multiple doses of MEDI-534 or Placebo at 10\^4 TCID50
MEDI-534
Multiple doses of MEDI-534 or Placebo at 10 \^5 TCID50.
MEDI-534
Multiple doses of MEDI-534 or Placebo at 10\^6 TCID50.
Eligibility Criteria
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Inclusion Criteria
* Subject is seronegative to both RSV and PIV3 at screening
* Subject was the product of normal full term pregnancy (defined as \>36 weeks gestation)
* Subject is in general good health
* Subject's legal representative is available by telephone
* Written informed consent and HIPAA authorization (if applicable) obtained from the subject's legal representative
* Subject's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator
* Subject is available to complete the follow-up period, which will be through the end of RSV season (provisionally defined as 01/Apr for the United States) or 180 days after the final dose of study vaccine, whichever is later
* Subject's legal representative must be willing and able to bring the subject to the study site for evaluation of respiratory illness in accordance with the protocol
Exclusion Criteria
* Moderate or severe nasal congestion that in the investigator's opinion could prevent intranasal delivery of vaccine
* Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt through the protocol-specified blood collection 28 days after each study vaccine dosing, except that infrequent use of over-the-counter medications such as pain relievers are permitted according to the judgment of the investigator
* Any current or expected receipt of immunosuppressive agents including steroids (2 mg/kg per day of prednisone or its equivalent, or equal to or greater than 20 mg/day if the subject weighs \>10 kg, given daily or on alternate days for equal to or greater than 14 days); children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for equal to or greater than 30 days; the use of topical steroids is permitted according to the judgment of the investigator
* History of receipt of blood transfusion or expected receipt through 30 days following final study vaccine dosing
* History of receipt of immunoglobulin products or expected receipt through 30 days after study vaccine dosing
* Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 30 days after final study vaccine dosing
* Receipt of any live virus vaccine (excluding rotavirus vaccine) within 28 days prior to randomization or expected receipt within a 28-day window around any study vaccine dose
* Receipt of any inactivated (i.e., non-live) vaccine or rotavirus vaccine within 14 days prior to randomization or expected receipt within a 14-day window around any study vaccine dose
* Known or suspected immunodeficiency, including HIV
* Living in the same home or enrolled in the same classroom at day care with infants \<24 months of age (only one child per household may be enrolled into the study)
* Contact with pregnant caregiver
* A household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 30 days after any study vaccine dose
* A household contact who is a health care provider in contact with immunocompromised patients or who is a day care provider for infants under the age of 6 months
* History of allergic reaction to any component of the study vaccine
* Previous medical history, or evidence, of an intercurrent or chronic illness that, in the opinion of the investigator, may compromise the safety of the subject
* Known or suspected active or chronic hepatitis infection
* History of medical diagnosis of asthma, reactive airway disease, wheezing requiring medication, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically confirmed apnea, hospitalization for respiratory illness or mechanical ventilation
* Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study
* Any condition that, in the opinion of the investigator, might interfere with study vaccine evaluation
6 Months
23 Months
ALL
Yes
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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MedImmune LLC
Principal Investigators
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Elissa Malkin, D.O.
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Arkansas Pediatric Research Division
Conway, Arkansas, United States
Arkansas Pediatric Clinic
Little Rock, Arkansas, United States
THe Children's Hospital
Aurora, Colorado, United States
Miami Children's Hospital
Miami, Florida, United States
Pediatric Partners
Palm Beach Gardens, Florida, United States
North Georgia Clinical Research Center
Dalton, Georgia, United States
University Consultants in Allergy and Immunology
Chicago, Illinois, United States
Children's Memorial Hospital
Chicago, Illinois, United States
University of Maryland, Baltimore
Baltimore, Maryland, United States
Tufts-New England Medical Center
Boston, Massachusetts, United States
Craig A. Spiegel, MD
Bridgeton, Missouri, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
United Medical Associates
Binghamton, New York, United States
Withrop University Hospital
Mineola, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
University Hospitals case Medical Center
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
St. Vincent Mercy Medical Center Mercy Children's Hospital
Toledo, Ohio, United States
Primary Physicians Research, Inc.
Pittsburgh, Pennsylvania, United States
Sanford Children's Specialty Clinic
Sioux Falls, South Dakota, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Health Science Center of Houston Medical School
Houston, Texas, United States
Bear Care Pediatrics
Ogden, Utah, United States
Copperview Medical Center
South Jordan, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Advanced Pediatrics
Vienna, Virginia, United States
Rockwood Clinic Research Center
Spokane, Washington, United States
Marshall University Joan C. Edwards School of Medicine
Huntington, West Virginia, United States
West Virginia University Health Science Center
Morgantown, West Virginia, United States
Countries
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References
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Bernstein DI, Malkin E, Abughali N, Falloon J, Yi T, Dubovsky F; MI-CP149 Investigators. Phase 1 study of the safety and immunogenicity of a live, attenuated respiratory syncytial virus and parainfluenza virus type 3 vaccine in seronegative children. Pediatr Infect Dis J. 2012 Feb;31(2):109-14. doi: 10.1097/INF.0b013e31823386f1.
Other Identifiers
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MI-CP149
Identifier Type: -
Identifier Source: org_study_id