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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
32
University of Calgary, Alberta Children's Hospital
Calgary, Alberta, Canada
Dalhousie University, IWK Health Centre- Canadian Center for Vaccinology
Halifax, Nova Scotia, Canada
Aggarwal and Associates
Brampton, Ontario, Canada
Medicore Research, Inc
Greater Sudbury, Ontario, Canada
Numbers and percentages of subjects with solicited local and systemic AEs.
Solicited local and systemic AEs over the 7 days post injection; and all AES, solicited and unsolicited, including adverse changes in clinical laboratory parameters, over 56 days post- first injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year.
Time frame: Up to Day 392
Immunogenicity as assessed by serum IgG antibody levels specific for the F protein antigen as detected by enzyme-linked immunosorbent assay (ELISA) providing a standardized ELISA Unit (EU) reasout based on a standard reference sample.
Derived/ calculated endpoints based on these data will include: Geometric mean EU (GMEU) Geometric mean ratio (GMR) Seroresponse rate (SRR)
Time frame: Up to Day 392
Epitope-specific immune responses to the RSV F protein antigen measured by serum titers in a competition ELISA assay using known-efficacious prophylactic antibody preparation, or in vitro neutralization assays using at least one prototype RSV/A and RSV/B
Derived/ calculated endpoints based on these data will include: Geometric mean EU (GMEU) Geometric mean ratio (GMR) Seroconversion rate (SCR) Seroresponse rate (SRR)
Time frame: Up to Day 392
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