Respiratory Synctial Virus Clinical Trial
Official title:
A Phase I Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) Recombinant Fusion (F) Nanoparticle Vaccine, With or Without Aluminum Adjuvant, in Healthy Subjects 24 to <72 Months of Age
This is a randomized, observer-blind, irrelevant comparator-controlled trial in male and
female subjects ≥24 months of age and <72 months of age. Subjects will be without
symptomatic chronic cardiopulmonary disease, including recurrent wheezing. Subjects will be
screened for seropositivity to RSV in a qualified serum microneutralization (MN) assay and
will be excluded if titers for either RSV/A or RSV/B are <1:16 (4 log2).
Treatments will comprise an IM dose of saline placebo or RSV F vaccine on Day 0 and an IM
dose of RSV F vaccine or a licensed hepatitis A vaccine on Day 28. Hepatitis A vaccine (and
in one group placebo) will be used to maintain the study blind; all subjects will receive a
complete course of hepatitis A vaccine as a study benefit.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention