drugset / Trial / NCT01893554

Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in Infants and Children

NCT01893554 ↗

RandomizedParallel-groupQuadruple-blindPrevention

Summary

Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children around the world. This study will evaluate the safety and immune response to a RSV vaccine in three groups of participants: healthy children who have already had an RSV infection (RSV seropositive), healthy infants and children who have not already had an RSV infection (RSV seronegative), and healthy younger infants who have not been screened for prior RSV infection.

Timeline

Start
2013-06-01
Primary completion
2023-04-26
Completion
2023-04-26

Drugs

EvaluationDrugModalityDoseRoute
Subject RSV ΔNS2 Δ1313 I1314L Vaccine Vaccine 100000 unknown Intranasal
Subject RSV ΔNS2 Δ1313 I1314L Vaccine Vaccine 1e+06 unknown Intranasal