Study to Evaluate the Safety of MEDI-534 Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3) in Healthy Children
NCT ID: NCT00345670
Last Updated: 2008-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
120 participants
INTERVENTIONAL
2006-06-30
2007-05-31
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
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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1
MEDI-534
MEDI-534
10:4 TCID50 of MEDI-534 intranasal spray Study Day 0
2
MEDI-534
MEDI-534
10:5 TCID50 of MEDI-534 intranasal spray Study Day 0
3
MEDI-534
MEDI-534
10:6 TCID50 of MEDI-534; intranasal spray
Interventions
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MEDI-534
10:4 TCID50 of MEDI-534 intranasal spray Study Day 0
MEDI-534
10:5 TCID50 of MEDI-534 intranasal spray Study Day 0
MEDI-534
10:6 TCID50 of MEDI-534; intranasal spray
Eligibility Criteria
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Inclusion Criteria
* In general good health
* Seropositive for RSV (enzyme-linked immunosorbent assay \[ELISA\] titer \> 12 U/ml) and PIV3 (hemagglutination-inhibition \[HAI\] titer \> 1:8)
* Subject's parent/legal representative available by telephone
* Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) obtained from the subject's parent/legal representative
* Ability of the subject's parent/legal representative to understand and comply with the requirements of the protocol as judged by the investigator
* Ability to complete the follow-up period of 6 months following dosing as required by the protocol
Exclusion Criteria
* Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt of such therapy through the protocol-specified blood collection 28-35 days after study vaccine dosing
* Any current or expected receipt of systemic immunosuppressive agents including steroids; children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for less than or equal to 30 days
* Receipt of blood transfusion within 7 months prior to randomization or expected receipt through 35 days after study vaccine dosing
* Receipt of immunoglobulin products within 11 months prior to randomization or expected receipt through 35 days after study vaccine dosing
* Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 180 days after study vaccine dosing
* Receipt of any other live virus vaccine within 30 days prior to randomization or expected receipt through the protocol-specified blood collection 28-35 days after study vaccine dosing
* Receipt of any inactivated (i.e., non-live) vaccine within 14 days prior to randomization or expected receipt through the protocol-specified blood collection 28-35 days after study vaccine dosing
* History of Guillain-Barré syndrome
* Known or suspected immunodeficiency, including HIV
* Known or suspected acute or chronic hepatitis infection
* Living at home or attending day care with children less than or equal to 24 months of age
* Contact with pregnant caregiver
* Household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 30 days after study vaccine dosing
* History of hypersensitivity to kanamycin or other aminoglycoside antibiotics (gentamicin, tobramycin, etc)
* Previous medical history, or evidence, of chronic illness may compromise the safety of the subject
* At screening any of the following laboratory tests outside of the laboratory normal range: complete blood count (CBC) with differential and platelet count, AST, ALT, blood urea nitrogen (BUN), creatinine, or other abnormal laboratory value in the screening panel that, in the opinion of the principal investigator, is considered to be clinically significant or may potentially compromise the safety of the subject during the conduct of the study
* History of medically confirmed diagnosis of asthma, reactive airway disease, or chronic obstructive pulmonary disease (COPD)
* Passive primary household smoking
* Family member or household contact who is an employee of the research center with the conduct of the study
* Any condition that, in the opinion of the investigator, might interfere with study vaccine evaluation
1 Year
9 Years
ALL
Yes
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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MedImmune LLC
Principal Investigators
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Margarita M Gomez, M.D.
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Edinger Medical Group
Fountain Valley, California, United States
Heart of America Research
Shawnee, Kansas, United States
Heart of America Research
Topeka, Kansas, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States
Cincinnati Children's Hospital Medical Center, Division of Infectious Disease
Crestview Hills, Kentucky, United States
University of Maryland Pediatric Ambulatory Center
Baltimore, Maryland, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
Regional Clinical Research, Inc.
Binghamton, New York, United States
Children's Hospital at Montefiore; Montefiore Medical Center
The Bronx, New York, United States
Pediatric Associates of Mt. Carmel, Inc.
Cincinnati, Ohio, United States
Primary Physicians Research, Inc.
Pittsburgh, Pennsylvania, United States
University Physicians Internal Medicine
Huntington, West Virginia, United States
Countries
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References
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Gomez M, Mufson MA, Dubovsky F, Knightly C, Zeng W, Losonsky G. Phase-I study MEDI-534, of a live, attenuated intranasal vaccine against respiratory syncytial virus and parainfluenza-3 virus in seropositive children. Pediatr Infect Dis J. 2009 Jul;28(7):655-8. doi: 10.1097/INF.0b013e318199c3b1.
Other Identifiers
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MI-CP130
Identifier Type: -
Identifier Source: org_study_id