drugset / Trial / NCT03303625

A Study to Evaluate the Safety, Tolerability and Immunogenicity of an Investigational RSV Vaccine Candidate (Ad26.RSV.preF) in Adults 18 to 50 Years of Age, and RSV-seropositive Toddlers 12 to 24 Months of Age

NCT03303625

Phase 1/2 Completed 48 enrolled Janssen Vaccines & Prevention B.V.
RandomizedParallel-groupQuadruple-blindOther

Summary

The purpose of this study is to assess the safety and tolerability of an intramuscular regimen of two doses (1\*10\^11 viral particles \[vp\]) of an investigational respiratory syncytial virus (RSV) vaccine candidate (adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F protein \[pre-F\] \[Ad26.RSV.preF\]) in adults aged 18 to 50 years and RSV-seropositive toddlers aged 12 to 24 months.

Timeline

Start
2017-11-29
Primary completion
2020-04-21
Completion
2020-04-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Ad26.RSV.preF Vaccine 0.25 ml Intramuscular
Subject Ad26.RSV.preF Vaccine 0.5 ml Intramuscular
Subject Ad26.RSV.preF Vaccine 5e+10 unknown Intramuscular
Subject Ad26.RSV.preF Vaccine 1e+11 unknown Intramuscular