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Study of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children

NCT04444284 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-06-29

No results posted yet for this study

Summary

This study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as drops in the nose. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 15 and 59 months who are seropositive to RSV.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

Investigational RSV vaccine MV-012-968 (Dosage 1)

Single dose administered intranasally on Day 1

BIOLOGICAL

Investigational RSV vaccine MV-012-968 (Dosage 2)

Single dose administered intranasally on Day 1

OTHER

Placebo

Single dose administered intranasally on Day 1

BIOLOGICAL

Investigational RSV vaccine MV-012-968 (Dosage 3)

Single dose administered intranasally on Day 1

Sponsors & Collaborators

  • Meissa Vaccines, Inc.

    lead INDUSTRY

Principal Investigators

  • Oliver Medzihradsky, MD MPH MS · Meissa Vaccines, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
15 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-09
Primary Completion
2021-05-07
Completion
2021-05-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04444284 on ClinicalTrials.gov