CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 65 enrolled
Drug / intervention
RSV ΔNS2/Δ1313/I1314L +2 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.

Search/NCT03227029
NCT03227029Phase 1Completed
CompareCT.gov

Randomized Phase I Study of the Infectivity, Safety, and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jul 24, 2017·Updated Apr 22, 2022

In Brief

A Phase 1 clinical trial evaluating RSV ΔNS2/Δ1313/I1314L, RSV 276, and 1 other intervention for Respiratory Syncytial Virus Infections. Completed, enrolled 65 participants across 12 sites.

Detailed Summary

The purpose of this study was to evaluate the infectivity, safety, and immunogenicity of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 when delivered as nose drops to RSV-seronegative infants 6 to 24 months of age. This study was a companion study to Center for Immunization Research (CIR) 321.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJul 24, 2017
Enrollment StartSep 22, 2017
Primary CompletionDec 19, 2019
Study CompletionOct 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.9 years ago

Interventions

RSV ΔNS2/Δ1313/I1314Lbiological

10\^6 plaque-forming units (PFU); administered as nose drops

RSV 276biological

10\^5 PFU; administered as nose drops

Placebobiological

Isotonic diluent, administered as nose drops