MedTrace Logo

Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months

NCT04909021 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2022-08-02

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 a nasal spray. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 6 and 24 months who are seronegative to RSV.

Conditions

  • Respiratory Syncytial Virus (RSV)

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

BIOLOGICAL

Investigational RSV vaccine MV-012-968 (Dosage 3; single-dose)

Single dose administered intranasally on Day 1

BIOLOGICAL

Investigational RSV vaccine MV-012-968 (Dosage 3; two-dose)

Single dose administered intranasally on Day 1, followed by an identical dose administered intranasally at the Day 29 study visit

OTHER

Placebo (single-dose)

Single dose administered intranasally on Day 1

OTHER

Placebo (two-dose)

Single dose administered intranasally on Day 1, followed by an identical dose administered intranasally at the Day 29 study visit

Sponsors & Collaborators

  • Meissa Vaccines, Inc.

    lead INDUSTRY

Principal Investigators

  • Jay Lieberman, MD · Meissa Vaccines, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-06-03
Primary Completion
2023-10-31
Completion
2023-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04909021 on ClinicalTrials.gov