- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00345670
Study to Evaluate the Safety of MEDI-534 Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3) in Healthy Children
September 2, 2008 updated by: MedImmune LLC
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, and Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy RSV and PIV3 Seropositive 1-9 Year-Old Children
This is a randomized, double-blind, placebo-controlled, dose-escalation, Phase 1, multi-center study to evaluate the safety, tolerability, immunogenicity, and viral shedding of MEDI-534 in healthy children 1-9 years of age who are seropositive for respiratory syncytial virus (RSV) and parainfluenza virus type 3 (PIV3) at screening.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a randomized, double-blind, placebo-controlled, dose-escalation Phase 1 multi-center study to evaluate the safety, tolerability, immunogenicity, and viral shedding of MEDI-534 in healthy children 1-9 years of age who are seropositive for RSV and PIV3 at screening.
MEDI-534 will be administered at dosage levels of 10:4 TCID50, 10:5 TCID50, or 10:6 TCID50 to three cohorts of subjects in a staggered, step-wise fashion.
A single dose of study vaccine (MEDI-534 or matched volume of vehicle placebo) will be administered on Study Day 0 by nasal spray, one-half dose into each nostril.
The target sample size is 120 subjects randomized 1:1 (MEDI-534 to placebo), with 40 subjects in each of three cohorts.
Randomization will be stratified by site.
This study will enroll during the RSV off season at multiple sites in the United States and Chile.
Study Type
Interventional
Enrollment
120
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Fountain Valley, California, United States, 92708
- Edinger Medical Group
-
-
Kansas
-
Shawnee, Kansas, United States, 66216
- Heart of America Research
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Topeka, Kansas, United States, 66614
- Heart of America Research
-
-
Kentucky
-
Bardstown, Kentucky, United States, 40004
- Kentucky Pediatric/Adult Research
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Crestview Hills, Kentucky, United States, 41017
- Cincinnati Children's Hospital Medical Center, Division of Infectious Disease
-
-
Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Pediatric Ambulatory Center
-
-
Nebraska
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Omaha, Nebraska, United States, 68134
- Meridian Clinical Research, LLC
-
-
New York
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Binghamton, New York, United States, 13901
- Regional Clinical Research, Inc.
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Bronx, New York, United States, 10467
- Children's Hospital at Montefiore; Montefiore Medical Center
-
-
Ohio
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Cincinnati, Ohio, United States, 45245
- Pediatric Associates of Mt. Carmel, Inc.
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15241
- Primary Physicians Research, Inc.
-
-
West Virginia
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Huntington, West Virginia, United States, 25701-3655
- University Physicians Internal Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 9 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female aged 1 through 9 years old
- 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 fever and/or respiratory illness (e.g., cough or sore throat) within 7 days prior to randomization
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
MEDI-534
|
10:4 TCID50 of MEDI-534 intranasal spray Study Day 0
10:5 TCID50 of MEDI-534 intranasal spray Study Day 0
10:6 TCID50 of MEDI-534; intranasal spray
|
EXPERIMENTAL: 2
MEDI-534
|
10:4 TCID50 of MEDI-534 intranasal spray Study Day 0
10:5 TCID50 of MEDI-534 intranasal spray Study Day 0
10:6 TCID50 of MEDI-534; intranasal spray
|
EXPERIMENTAL: 3
MEDI-534
|
10:4 TCID50 of MEDI-534 intranasal spray Study Day 0
10:5 TCID50 of MEDI-534 intranasal spray Study Day 0
10:6 TCID50 of MEDI-534; intranasal spray
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To describe the safety and tolerability of 1-9 year old RSV and PIV3 seropositive children
Time Frame: Day 28
|
Day 28
|
Reactogenicity evaluations (REs) from administration of study vaccine through 28 days post-dosing
Time Frame: Day 28 post final vaccination
|
Day 28 post final vaccination
|
Adverse events (AEs) from administration of study vaccine through 28 post-dosing
Time Frame: Day 28 post final vaccination
|
Day 28 post final vaccination
|
Serious adverse events (SAEs) from administration of study vaccine through 28 days post-dosing
Time Frame: Day 180
|
Day 180
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To describe the immunogenicity and viral shedding of MEDI-534
Time Frame: Days 3, 7, 14 days (± 1 day) and 28 35 days after study vaccine dosing as well as at any unscheduled study visits.
|
Days 3, 7, 14 days (± 1 day) and 28 35 days after study vaccine dosing as well as at any unscheduled study visits.
|
The viral shedding of MEDI-534 will be assessed by the absence or presence of vaccine-type virus from nasal swab and nasal wash samples
Time Frame: Days 3, 7, 14 days (± 1 day) and 28 35 days after study vaccine dosing as well as at any unscheduled study visits.
|
Days 3, 7, 14 days (± 1 day) and 28 35 days after study vaccine dosing as well as at any unscheduled study visits.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Margarita M Gomez, M.D., MedImmune LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Study Completion (ACTUAL)
May 1, 2007
Study Registration Dates
First Submitted
June 27, 2006
First Submitted That Met QC Criteria
June 27, 2006
First Posted (ESTIMATE)
June 28, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
September 3, 2008
Last Update Submitted That Met QC Criteria
September 2, 2008
Last Verified
September 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MI-CP130
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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