In a vaccine research study, people help doctors find ways to improve health. Each vaccine research study seeks to answer specific scientific questions and find better ways to prevent disease. Vaccines have to go through research studies before they can be approved for public use. A vaccine research study follows a plan that is reviewed and approved before it can begin. This review ensures that the research study follows safety guidelines.
Vaccine research studies are important because they help us understand whether a potential vaccine may provide more coverage and protection to vaccines we use now. We can also learn what the benefits and risks are.
About the NeXXstep Study
The NeXXstep Study is a vaccine research study for children, which will evaluate an investigational pneumococcal vaccine compared with an approved pneumococcal vaccine. We want to learn about the safety and potential coverage of the investigational vaccine.
What is the investigational vaccine?
The investigational vaccine contains the same base ingredients as the approved pneumococcal vaccine, but it targets 20 types of pneumococcal germs instead of 13. It is given by injection into the thigh in the same way as the approved vaccine.
Your child will receive either the approved vaccine or the investigational vaccine, not both. Neither you, nor your doctor will know which vaccination your child is receiving. This is to make sure the results of the vaccine research study cannot be influenced by anyone.
Are there any risks or benefits to taking part?
You will have the chance to review with the study team the most likely risks or discomforts expected from this study before agreeing to have your child participate.
The health and well-being of every child that takes part will be monitored. What we learn from the NeXXstep Study may benefit children in the future, by reducing the risk of pneumococcal disease.