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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Edinger Medical Group
Fountain Valley, California, United States
Heart of America Research
Shawnee, Kansas, United States
Heart of America Research
Topeka, Kansas, United States
To describe the safety and tolerability of 1-9 year old RSV and PIV3 seropositive children
Time frame: Day 28
Reactogenicity evaluations (REs) from administration of study vaccine through 28 days post-dosing
Time frame: Day 28 post final vaccination
Adverse events (AEs) from administration of study vaccine through 28 post-dosing
Time frame: Day 28 post final vaccination
Serious adverse events (SAEs) from administration of study vaccine through 28 days post-dosing
Time frame: Day 180
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.
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.
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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
...and 2 more locations