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Study of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation Phase 1b Study to Evaluate the Safety and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Seropositive Young Children

NCT04444284•Meissa Vaccines, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

1 - 4 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Children aged 15-59 months
•2. Good health based on history, physical examination and medical record review, without evidence or suspicion of chronic disease
•3. Seropositive to RSV, as defined by serum neutralizing antibody titer above the threshold described in the study Analytical Plan
•4. Written informed consent provided by parent(s)/guardian(s)

Exclusion Criteria

•1. Known or suspected chronic illness, particularly cardiopulmonary (including asthma or reactive airways disease), metabolic, hepatic, renal, or infectious (including recurrent or chronic sinusitis)
•2. Known or suspected immunodeficiency
•3. Household or close contact with anyone ≤ 6 months of age or with immunocompromised individual(s)
•4. Nasal obstruction (including due to anatomic/structural causes, acute or chronic rhinosinusitis, or other causes)
•5. Receipt of immunoglobulins, monoclonal antibodies and/or any blood products, or ribavirin within 3 months prior to study inoculation, or planned during study period
•6. Receipt of an investigational RSV vaccine at any time
•7. Any other condition that, in the judgment of the investigator, would be a risk to participant's safety and/or may interfere with study procedures or interpretation of results

Locations (3)

Meridian Clinical Research

Norfolk, Nebraska, United States

Meridian Clinical Research

Omaha, Nebraska, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Key Dates

Start Date

June 9, 2020

Primary Completion Date

May 7, 2021

Completion Date

May 7, 2021

Last Updated

June 29, 2021

Enrollment

ACTUAL participants

Conditions

Respiratory Syncytial Virus Infections

Interventions

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

BIOLOGICAL

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

BIOLOGICAL

Placebo

OTHER

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

BIOLOGICAL

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

NCT07220109

Respiratory Syncytial Virus Infections

View study

RECRUITINGPHASE2

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

NCT07092865

Respiratory Syncytial Virus Infections

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

Genotype and Disease Burden of RSV in Older Vietnamese Adults (RSV: Respiratory Syncytial Virus )

An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children

Evaluating the Benefits of RSV Maternal Vaccination Using a Scottish National Dataset