In this study we want to learn more about how safe and how well a new vaccine works against invasive pneumococcal disease (IPD) in babies.
IPD is an illness caused by a germ called pneumococcus. There are many different strains of this germ that cause humans to get sick. The current vaccine used to prevent IPD only protects against 20 strains of pneumococcus. The new vaccine for IPD aims to protect against 31 different strains. This study is the first time the new vaccine will be tested in babies. There are two groups in this study so that we can compare how well the current vaccine (PCV20) works compared to the new vaccine (VAX-31). Your baby will be randomly assigned to receive either PCV20 or VAX-31, like flipping a coin. If your baby joins this study, they will come to 7 study visits at Children's Hospital Colorado over the course of about 2 years. Your baby will get a total of 4 shots of either PCV20 or VAX-31 at 4 study visits. We will ask you to take their temperature and record any reactions for 7 days after they receive each shot. At some study visits we will also use a needle to take a blood sample from your baby. You will be paid for all the study visits that your baby takes part in.
Your baby may be able to join this study if they were born full term and are currently between 42 and 89 days old. If you are interested in your baby joining our study, please reach out and we will see if they meet all requirements and that it is safe for them to join.
Protocol Number: 25-0133
Principal Investigator