What Is Pneumococcal Disease?
Pneumococcal disease is an illness caused by certain germs (bacteria), called Streptococcus pneumoniae. These germs can cause serious infections in the ears, nose, lungs, blood, or brain. Vaccines help the body fight infections due to diseases like pneumococcal disease, and may help prevent serious illness. New vaccines must be tested to show that they work.

What Is a Clinical Study?
A clinical trial is a type of research designed to learn more about how our bodies respond to drugs, vaccines, or other medical products. Most new treatments and vaccines must be tested in clinical trials before they can be approved by government agencies. These agencies want to be sure that the new treatments and vaccines are safe and that they work. If a new treatment or vaccine has not been approved, it is known as experimental. Researchers look at the results of many clinical trials to understand which drugs and vaccines work and how they work. It takes lots of people in many trials all around the world to advance medical science. Regulations and policies have been developed to ensure studies are conducted according to strict scientific and ethical principles. Before a clinical study can begin, an independent review board such as an Institutional Review Board (IRB) or ethics committee (EC) must review and approve the study. This is to help protect the rights, safety, and well-being of research participants.

What Is the Purpose of This Study?
The STRIDE-4 study is testing an investigational study vaccine (V116) to see if it can help protect against pneumococcal disease. This trial will compare V116 to Pneumovax23® (pneumococcal vaccine, polyvalent (23-valent), also known as PPSV23). Pneumovax23® is approved for preventing pneumococcal disease in some countries but may not be approved in your country.
This study will:
• Evaluate the safety of V116
• Compare different lots of V116 to see if they work the same
• See how well different lots of V116 work and how the body responds to them compared to Pneumovax23®

Who Can Take Part in This Study?
You may be able to take part in this study if you are 18-49 years of age and:
• Have not previously received a pneumococcal vaccine or haven’t had one since childhood
• Have not had a positive test (culture) for pneumococcal disease within the last 3 years
• If you are a female able to have children, you are not currently pregnant or breastfeeding, and agree not to breastfeed or become pregnant for at least 6 weeks after receiving the study vaccination
Additional requirements apply, which the study doctor can discuss with you.

What Can I Expect During This Study?
If you qualify for the study, you will be randomly assigned (like pulling names from a hat) to 1 of 4 study groups. Three groups will receive a dose of the investigational study vaccine, and 1 group will receive a dose of Pneumovax23®. Your participation in the study will last about 6 months, and you will visit the study center twice. You will also have 3 telephone call visits with the study staff.
Tests and exams during this study include your medical history, body temperature, blood samples, a physical exam, and keeping a diary at home of your temperature and any side effects. The study vaccines and study-related tests will be provided at no cost. You may also be reimbursed for study travel and related expenses. Participation is voluntary, and you may withdraw from the study for any reason at any time.

For more information, including the possible risks and benefits of participation, please contact: 786-772-0510

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