At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
D46/NS2/N/ΔM2-2-HindIII +1 morebiological
Likely dose
D46/NS2/N/ΔM2-2-HindIII 0.5mlfrom 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, D46/NS2/N/ΔM2-2-HindIII, Lot RSV#011B, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Apr 5, 2017·Updated Feb 8, 2022
In Brief
A Phase 1 clinical trial evaluating D46/NS2/N/ΔM2-2-HindIII and Placebo for Respiratory Syncytial Virus Infections. Completed, enrolled 32 participants across 10 sites.
Detailed Summary
The purpose of this study was to evaluate the safety, infectivity, and immunogenicity of a single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in RSV-seronegative infants and children 6 to 24 months of age. This study was a companion study to CIR 313.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartApr 2017
Primary CompletionMay 2018
TodayJul 2026
First PostedApr 5, 2017
Enrollment StartApr 6, 2017
Primary CompletionMay 25, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.2 years ago
Interventions
D46/NS2/N/ΔM2-2-HindIIIbiological
10\^5 plaque-forming units (PFU) per 0.5ml vaccine; administered as nose drops
Placebobiological
Isotonic diluent; administered as nose drops