A Study to Learn How a New Pneumococcal Vaccine Works in Healthy Infants

In this study, we want to learn how safe a new pneumococcal vaccine is and how well it works to protect infants against pneumococcal disease. We will compare the new vaccine with the pneumococcal vaccine currently used in children, Prevnar 20® (20vPnC).


Why this Research Matters

Vaccines help protect people from infections by training the immune system to notice and fight off germs. This study is comparing two vaccines that help protect against a germ called Streptococcus pneumoniae (S. pneumoniae). This germ can cause illnesses such as pneumonia (a lung infection), meningitis (an infection of the lining around the brain and spinal cord), and ear infections. The pneumococcal vaccine currently used in children (20vPnC) protects against 20 types of S. pneumoniae. The new vaccine (PG4) protects against 25 types. There are two groups in this study so that we can compare how well the new PG4 vaccine works compared to the current vaccine. If your baby joins the study, they will take part for about 18 months and have six study visits at Children's Hospital Colorado and one phone call visit. The study vaccine will be given as an injection in your baby's thigh at four of the study visits. During the in-person visits, we will also check your baby's temperature, do physical exams, ask questions about their health, and collect a small blood sample. You will be paid for all study visits your baby takes part in.


Who can Participate

Child and Teen

Your baby may be able to join this study if they are 2 months old, have not yet received a pneumococcal vaccine, and are considered healthy by the study doctor. The study team will review other requirements to decide if your baby is eligible to join this study.


Study ID

Protocol Number: 26-0161

More information available at ClinicalTrials.gov: NCT07629440


Compensation Information

Compensation
Study Payment: Compensation provided.

Meet the Team

Image of Principal Investigator

Eric Simoes, MD

Principal Investigator