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Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age

NCT03916185 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-02-21

Study results available
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Summary

The purpose of this study was to evaluate the safety and immunogenicity of a single dose of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines, RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, and RSV 276, in RSV-seronegative children 6 to 24 months of age.

Conditions

  • Respiratory Syncytial Virus (RSV)

Interventions

BIOLOGICAL

RSV ΔNS2/Δ1313/I1314L Vaccine

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

BIOLOGICAL

RSV 6120/ΔNS2/1030s Vaccine

10\^5 plaque-forming units (PFU); administered as nose drops

BIOLOGICAL

RSV 276 Vaccine

10\^5 plaque-forming units (PFU); administered as nose drops

BIOLOGICAL

Placebo

Administered as nose drops

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Coleen Cunningham, MD · University of California, Irvine

  • Ruth Karron, MD · Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHSPH)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-20
Primary Completion
2024-01-22
Completion
2024-04-25
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 NCT03916185 on ClinicalTrials.gov