Study to Evaluate the Safety of MEDI-534 Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3) in Healthy Children

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00345670

Run by

MedImmune LLC

People needed

120

Starts

2006-06-01

Expected to finish

2007-05-01

Last updated by the study team

2008-09-03

Who can join

Age: 1 and older, up to 9. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.