At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 45 enrolled
Drug / intervention
RSV 6120/∆NS2/1030s +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, RSV 6120/∆NS2/1030s, Lot RSV#012A, Delivered as Nose Drops to RSV-Seropositive Children 12 to 59 Months of Age and RSV-Seronegative Infants and Children 6 to 24 Months of Age
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Dec 29, 2017·Updated Dec 11, 2024
In Brief
A Phase 1 clinical trial evaluating RSV 6120/∆NS2/1030s and Placebo for RSV Infection. Completed, enrolled 45 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of a single dose of a recombinant, live-attenuated respiratory syncytial virus (RSV) vaccine (RSV 6120/∆NS2/1030s) in RSV-seropositive children 12 to 59 months of age and RSV-seronegative infants and children 6 to 24 months of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRSV Infection
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
Enrollment StartOct 2017
First PostedDec 2017
Primary CompletionNov 2019
Study CompletionMay 2021
TodayJul 2026
First PostedDec 29, 2017
Enrollment StartOct 13, 2017
Primary CompletionNov 22, 2019
Study CompletionMay 31, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.5 years ago
Interventions
RSV 6120/∆NS2/1030sbiological
Delivered as nose drops
Placebobiological
Delivered as nose drops