Status:
COMPLETED
Study to Evaluate the Safety of MEDI-534 Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3) in Healthy Children
Lead Sponsor:
MedImmune LLC
Conditions:
Healthy
Eligibility:
All Genders
1-9 years
Phase:
PHASE1
Brief Summary
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 chi...
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 child...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00345670
Start Date
June 1 2006
End Date
May 1 2007
Last Update
September 3 2008
Active Locations (12)
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1
Edinger Medical Group
Fountain Valley, California, United States, 92708
2
Heart of America Research
Shawnee, Kansas, United States, 66216
3
Heart of America Research
Topeka, Kansas, United States, 66614
4
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States, 40004