What can I expect during this study?
If you are eligible for the study and choose to participate, you will be randomly assigned (like flipping a coin) to 1 of 2 study groups:
Receives the investigational study vaccine (V116) at Visit 1.
Receives a dose of an approved pneumococcal vaccine (Pneumovax23®) at Visit 1. You will have 5 visits that occur over approximately 6 months. At least 2 visits will be in person, and some will occur by a telephone call with the study staff.
Depending on when you start the study and the location of your study site, you may be enrolled in the immunogenicity follow-up and/or the PBMC sub-studies. Sub-study participants remain in the study for an additional 6-18 months and return to the study clinic every 6 months for 1-3 additional in-person visits. The study doctor will discuss sub-study participation with you.
Tests and examinations include your medical history, body temperature, blood samples, physical examinations, and keeping a diary at home of your temperature and any side effects.
Participation is voluntary and you can withdraw from the study for any reason at any time.
For more information, including the possible risks and benefits of participation, please contact us