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Evaluating the Infectivity, Safety, and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (D46/NS2/N/ΔM2-2-HindIII) in RSV-Seronegative Infants 6 to 24 Months of Age

NCT03102034 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-02-08

Study results available
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Summary

The purpose of this study was to evaluate the safety, infectivity, and immunogenicity of a single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in RSV-seronegative infants and children 6 to 24 months of age.

This study was a companion study to CIR 313.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

D46/NS2/N/ΔM2-2-HindIII

10\^5 plaque-forming units (PFU) per 0.5ml vaccine; 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

  • Elizabeth (Betsy) J. McFarland, MD · University of Colorado School of Medicine and Children's Hospital Colorado, Pediatric Infectious Diseases

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
2017-04-06
Primary Completion
2018-05-25
Completion
2018-05-25
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 NCT03102034 on ClinicalTrials.gov