Purpose of this Study
Participants may be able to join if they are children ages 5 to 17 who are at high risk for RSV disease. If enrolled, they will receive one dose of either the study vaccine or a placebo and will be followed for 2 years. The study includes clinic visits, blood draws, health reviews, and one telehealth visit to monitor safety and learn how well the vaccine works.
Who Can Participate?
Eligibility
Participants may be able to join if they are children ages 5 to 17 with certain chronic medical conditions that increase the risk of severe RSV illness. These conditions include cystic fibrosis, asthma requiring treatment, other lung diseases, Down syndrome, neuromuscular disorders, cerebral palsy, congenital heart disease, sickle cell disease, and stable HIV infection.
Age Range
5-17
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing whether an RSV vaccine is safe, well tolerated, and able to help the immune system protect against RSV in children ages 5 to 17 who are at high risk for RSV disease. Researchers want to learn how well the vaccine produces an immune response and helps prevent infection.
Locations
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A PHASE 3 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND
IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS VACCINE IN
CHILDREN AT HIGH RISK OF RSV DISEASE
IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS VACCINE IN
CHILDREN AT HIGH RISK OF RSV DISEASE
Principal Investigator
Michael
Smith
Protocol Number
PRO00121136
Phase
III
Enrollment Status
Open to Enrollment