At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 81 enrolled
Drug / intervention
RSV LID/ΔM2-2/1030s +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 Ib 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 and Children 6 to 24 Months of Age
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 20, 2020·Updated Aug 22, 2025
In Brief
A Phase 1 clinical trial evaluating RSV LID/ΔM2-2/1030s and Placebo for RSV Infection. Completed, enrolled 81 participants across 3 sites.
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, LID/ΔM2-2/1030s, in RSV-seronegative infants and children 6 to 24 months of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRSV Infection
CountriesUnited States
CollaboratorsSanofi Pasteur, a Sanofi Company
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedAug 2020
Enrollment StartMar 2022
Primary CompletionApr 2024
TodayJul 2026
First PostedAug 20, 2020
Enrollment StartMar 16, 2022
Primary CompletionApr 18, 2024
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.9 years ago
Interventions
RSV LID/ΔM2-2/1030sbiological
10\^5 plaque-forming units (PFU); administered as nose drops
Placebobiological
Administered as nose drops