Status:
COMPLETED
Study of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children
Lead Sponsor:
Meissa Vaccines, Inc.
Conditions:
Respiratory Syncytial Virus Infections
Eligibility:
All Genders
15-59 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- Key
- Children aged 15-59 months
- Good health based on history, physical examination and medical record review, without evidence or suspicion of chronic disease
- Seropositive to RSV, as defined by serum neutralizing antibody titer above the threshold described in the study Analytical Plan
- Written informed consent provided by parent(s)/guardian(s)
- Key
Exclusion
- Known or suspected chronic illness, particularly cardiopulmonary (including asthma or reactive airways disease), metabolic, hepatic, renal, or infectious (including recurrent or chronic sinusitis)
- Known or suspected immunodeficiency
- Household or close contact with anyone ≤ 6 months of age or with immunocompromised individual(s)
- Nasal obstruction (including due to anatomic/structural causes, acute or chronic rhinosinusitis, or other causes)
- Receipt of immunoglobulins, monoclonal antibodies and/or any blood products, or ribavirin within 3 months prior to study inoculation, or planned during study period
- Receipt of an investigational RSV vaccine at any time
- 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
Key Trial Info
Start Date :
June 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04444284
Start Date
June 9 2020
End Date
May 7 2021
Last Update
June 29 2021
Active Locations (3)
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1
Meridian Clinical Research
Norfolk, Nebraska, United States, 68701
2
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
3
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229