At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 33 enrolled
Drug / intervention
RSV LID ΔM2-2 1030s vaccine +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, LID ΔM2-2 1030s, Lot RSV#010A, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jun 9, 2016·Updated Aug 27, 2018
In Brief
A Phase 1 clinical trial evaluating RSV LID ΔM2-2 1030s vaccine and Placebo for Respiratory Syncytial Virus Infections. Completed, enrolled 33 participants across 8 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 6 to 24 months of age. This study was a companion study to CIR 311.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2016
Enrollment StartJul 2016
Primary CompletionJul 2017
TodayJul 2026
First PostedJun 9, 2016
Enrollment StartJul 15, 2016
Primary CompletionJul 7, 2017
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 10.1 years ago
Interventions
RSV LID ΔM2-2 1030s vaccinebiological
10\^5.0 PFU; administered as nose drops
Placebobiological
Isotonic diluent, administered as nose drops