drugset / Trial / NCT02593071

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

NCT02593071

Phase 2 Completed 1330 enrolled Novavax
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2015-10
Primary completion
2016-11
Completion
2016-11

Drugs

EvaluationDrugModalityDoseRoute
Subject RSV F vaccine Vaccine 0.5 ml