drugset / Trial / NCT03334695

An Exploratory Study to Evaluate the Prophylactic Efficacy of a Single Immunization of Ad26.RSV.preF Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy 18 to 50 Year-old Adults

NCT03334695

Phase 2 Completed 64 enrolled Janssen Vaccines & Prevention B.V.
RandomizedParallel-groupDouble-blindPrevention

Summary

The purpose of this study is to assess a trend for the prophylactic efficacy of a single dose of 1\*10\^11 virus particles (vp) of adenovirus serotype 26 respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) administered intramuscularly to adults aged 18-50 years in the respiratory syncytial virus (RSV) challenge model in terms of reduction of nasal wash viral load compared to placebo.

Timeline

Start
2017-10-16
Primary completion
2018-07-10
Completion
2018-11-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Ad26.RSV.preF Vaccine 1e+11 unknown Intramuscular

Indications

No indication recorded.