drugset / Trial / NCT02926430

A Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Vaccinations of Ad26.RSV.preF One Year Apart in Adults Aged 60 Years and Older in Stable Health

NCT02926430

Phase 1 Completed 73 enrolled Janssen Vaccines & Prevention B.V.
RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to assess the safety and tolerability of 2 single doses of either 5\*10\^10 viral particles (vp) or 1\*10\^11 vp of Ad26.RSV.preF, administered intramuscularly to elderly adults given approximately 12 months apart.

Timeline

Start
2016-11-08
Primary completion
2018-03-14
Completion
2019-01-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Ad26.RSV.preF Vaccine 5e+10 vg Intramuscular
Subject Ad26.RSV.preF Vaccine 1e+11 vg Intramuscular

Indications

No indication recorded.