NCT02593071

Safety and Immunogenicity of the RSV-F Vaccine in Older Adults Previously Treated With the Same Vaccine or Placebo in the Prior Year.

A Phase II Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) Recombinant F Nanoparticle Vaccine in Healthy Older Adult Subjects Previously Treated With the Same Vaccine, or Placebo, in the Prior Year; and to Estimate the Incidence Rate of RSV Disease and Vaccine Efficacy in Subjects Based on Their RSV F Vaccine Experience Over Two Consecutive Years.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,330 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

This study will enroll subjects who received the RSV F vaccine or placebo in the earlier study (RSV-E-201, Year 1) and re-randomize them to receive either vaccine or placebo in a second season. This design will permit evaluation of the safety and immunogenicity of revaccination in a second RSV season, and the safety and immunogenicity of revaccination over two years.

Conditions

• Respiratory Syncytial Virus (RSV)

Interventions

Type	Name	Description
BIOLOGICAL	RSV-F Vaccine
BIOLOGICAL	Phosphate Buffer Placebo

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2015-10-30
• Last updated: 2022-05-27

Locations

10 sites across 1 country: United States