Comparing the Safety and Immune Response of Two Pneumococcal Vaccines in Young Children

In this study, we want to learn whether a new vaccine (PG4) is safe and helps protect kids against pneumococcal disease. We will compare a single dose of PG4 with a single dose of the currently available pneumococcal vaccine to see the level of protection provided and how the body responds to each vaccine.


Why this Research Matters

Vaccines help protect people from infections by training the immune system to recognize and fight germs. This study is comparing two vaccines that help protect kids against a bacteria called Streptococcus pneumoniae (S. pneumoniae). The currently used pneumococcal vaccine protects against 20 types of S. pneumoniae. The study vaccine, PG4, is designed to protect against those same types plus 5 more types that may cause serious illness in children. If your child joins this study, they will be randomly assigned to receive either PG4 or the currently used pneumococcal vaccine, like flipping a coin. Your child will be in the study for about 6 months. During this time, you will have one phone call with the study team, and your child will come to two study visits at Children's Hospital Colorado. During the study visits, we will ask questions about your child's health and do a physical exam. We will also take their temperature and collect blood samples. You will be paid for each study visit your child completes.


Who can Participate

Child and Teen

Your child may be able to join this study if they are between 15 months and 5 years old. Children 15 to 23 months old may be able to join if they have already received at least 2 doses of a pneumococcal vaccine. Children 2 to 5 years old may be able to join if they have received some, all, or no pneumococcal vaccines in the past. Your child may not be able to join if they have ever had a serious reaction to a vaccine. The study team will review all study requirements with you if you are interested in your child participating.


Study ID

Protocol Number: 26-0260

More information available at ClinicalTrials.gov: NCT07660198


Compensation Information

Compensation
Study Payment: Compensation provided.

Meet the Team

Image of Principal Investigator

Eric Simoes, MD

Principal Investigator