Study Details

A study is being conducted to evaluate an investigational nasal spray vaccine that may help prevent RSV.

 

We are currently enrolling healthy toddlers between the ages of 6 - 18 months.

 

Your toddler will receive either 1-2 nasal vaccine administrations or a placebo (a medically inactive substance).

 

Participation is voluntary.

    Symptoms of RSV

    RSV is a virus (germ) that can cause breathing problems in infants and children. Symptoms of infection with RSV may include:

     

    • Fever
    • Runny nose
    • Sore throat
    • Ear infection
    • Cough
    • Croup (barky cough with hoarseness)

     

    RSV can cause serious lung infections, such as pneumonia.


    At this time, there is no approved vaccine to prevent RSV illness.

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    Study Overview

    The study is being done to look at the safety (side effects) and antibody (germ fighters) response of toddlers using two different doses of an experimental vaccine versus placebo (a medically inactive substance) against a virus called respiratory syncytial virus (RSV).  The vaccine will be given by nasal spray as one or two administrations. This study will tell us how safe and strong the different doses of vaccine were during the study.

     

    Your child will be in the study for about 12 months.

     

    There will be about six scheduled visits when your child is seen by the clinical research staff.

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    Centers for Disease Control and Prevention. Respiratory Syncytial Virus (RSV): Symptoms and Care. https://www.cdc.gov/rsv/about/symptoms.html. Accessed August 2019.

    Shi T, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a systematic review and modelling study. Lancet 2017; 390: 946–58.

    Obando-Pacheco P, et al. Respiratory Syncytial Virus Seasonality: A Global Overview. The Journal of Infectious Diseases, 217(9), 1356–1364. doi:10.1093/infdis/jiy056

     

     

    MAT-US-2105466 V1 Expiration Date: 06/23/23