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Evaluating the Infectivity, Safety, and Immunogenicity of Recombinant Live-Attenuated RSV Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants 6 to 24 Months of Age

NCT03227029 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2022-04-22

Study results available
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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.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

RSV ΔNS2/Δ1313/I1314L

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

BIOLOGICAL

RSV 276

10\^5 PFU; administered as nose drops

BIOLOGICAL

Placebo

Isotonic diluent, administered as nose drops

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Coleen Cunningham, MD · Children's Health Center, DUMC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-22
Primary Completion
2019-12-19
Completion
2020-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03227029 on ClinicalTrials.gov