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 study or trial is a type of research designed to learn more about how our bodies respond to medicines, 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 medicines 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 that studies are conducted according to strict scientific and ethical principles. Before a clinical study can begin, an independent review board called an ethics committee (EC) must review 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-10 study is testing an investigational study vaccine (V116) to see if it can help protect against pneumococcal disease. This study is testing V116 in adults 50 years of age and older who have not previously received any pneumococcal vaccine. This study will compare V116 to Pneumovax23® (pneumococcal 23-valent vaccine).
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 and see how well the vaccine works and how your body responds to it.
Who can take part in this study?
You may be able to take part in this study if you are aged 50 or older and:
• have not previously received any pneumococcal vaccine
• 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.