NCT02296463

A Phase I Randomized, Observer-Blinded, Dose-Ranging Study in Healthy Subjects 24 to <72 Months of Age

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 24 Months – 72 Months
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Respiratory Synctial Virus

Interventions

Type	Name	Description
BIOLOGICAL	RSV F Vaccine with adjuvant (0.5mL injection)
BIOLOGICAL	RSV F Vaccine (0.5mL injection)
BIOLOGICAL	Hepatitis A Vaccine (0.5mL injection)
BIOLOGICAL	Placebo (0.5mL injection)

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-09-01
• Completion: 2016-04-01
• First posted: 2014-11-20
• Last updated: 2016-04-28

Locations

4 sites across 1 country: Canada