drugset
drugset / Trial / NCT03596801

Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children

NCT03596801 ↗

Phase 1 Completed 60 enrolled National Institute of Allergy and Infectious Diseases (NIAID)
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of a single dose of recombinant, live-attenuated respiratory syncytial virus (RSV) vaccines (RSV 6120/∆NS1 or RSV 6120/F1/G2/∆NS1) in RSV-seropositive children 12 to 59 months of age and RSV-seronegative infants and children 6 to 24 months of age.

Timeline

Start
2018-06-29
Primary completion
2024-04-25
Completion
2024-04-25

Drugs

EvaluationDrugModalityDoseRoute
Subject RSV 6120/F1/G2/∆NS1 Vaccine 100000 unknown Intranasal
Subject RSV 6120/F1/G2/∆NS1 Vaccine 630957 unknown Intranasal
Subject RSV 6120/∆NS1 Vaccine 100000 unknown Intranasal
Subject RSV 6120/∆NS1 Vaccine 1e+06 unknown Intranasal

Indications

respiratory syncytial virus infectious disease