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Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, in RSV-Seronegative Infants and Children 6 to 24 Months of Age

NCT04520659 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2025-08-22

Study results available
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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.

Conditions

  • RSV Infection

Interventions

BIOLOGICAL

RSV LID/ΔM2-2/1030s

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

BIOLOGICAL

Placebo

Administered as nose drops

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Ruth A. Karron, MD · 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
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-16
Primary Completion
2024-04-18
Completion
2024-04-18
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 NCT04520659 on ClinicalTrials.gov