MedTrace Logo

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

NCT02890381 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-11-05

Study results available
· View outcomes & findings →

Summary

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

This study was a companion study to CIR 312.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

RSV LID cp ΔM2-2 Vaccine

10\^5 plaque-forming units (PFUs); 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
2016-10-05
Primary Completion
2017-04-24
Completion
2017-04-24

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 NCT02890381 on ClinicalTrials.gov