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).
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.
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.
Protocol Number: 26-0161
More information available at ClinicalTrials.gov: NCT07629440
Principal Investigator