Frequently Asked Questions
Clinical Research Information
What is a clinical research study?
Clinical research studies are designed to test the safety and effectiveness of investigational drugs. These studies must follow government regulations and must be approved and monitored by an institutional review board or ethics committee in order to protect the safety and rights of study participants. All personal information provided is kept entirely confidential.
Is participation in a clinical research study voluntary?
Yes, choosing to participate in any clinical research study is completely voluntary. You are always free to stop or withdraw at any time for any reason without consequences, penalty, or effect on your future medical care.
What is informed consent?
The informed consent process will explain: the purpose of the study, the study design and procedures, what is expected of a study participant, the possible benefits and risks of participation, and how you and your child’s personal information is used and protected.
Every eligible study participant’s caregiver takes part in the informed consent process, which ensures that the potential participant’s caregivers can have their questions answered and understand everything involved in the study to help them make an informed decision about participation. Participation in any clinical study is completely voluntary, and you may stop at any time for any reason.
If you choose to enroll your child, all study-related information will be clarified in the Informed Consent Form (ICF), which the study doctor will provide and explain to you. You will be asked to review and sign the ICF to indicate that you are willing to have your child take part in the study.
What is a clinical research study?
The pneumococcal vaccine study is sponsored by Astellas Pharma Global Development, Inc. (APGD) and is being conducted by doctors and medical specialists at study locations in the United States.
What is the investigational drug?
The study drug being investigated is called ASP3772. It is designed to provide protection against more than 13 types of bacteria that cause pneumococcal disease. The study drug is administered as a shot into the outer thigh muscle, similar to the 3 doses of PCV13 vaccine your child previously received.
What are the risks involved in participating in this study?
As with any medication, there may be side effects associated with the study drug. And it is possible that the investigational drug may not work for some participants. The effectiveness of the study drug will be monitored after administration. If the study doctor determines it necessary, your child may receive an additional booster shot of the PCV13 vaccine to ensure your child is protected. If your child is eligible and you decide to participate, the study staff will discuss the risks and potential benefits with you in full detail.
Why would someone consider participating in this clinical study?
Clinical studies are essential to the development of improved preventive options for pneumococcal disease in children. By choosing to enroll your child in the pneumococcal vaccine study, you are helping to advance scientific knowledge and assisting the medical community in researching the safety and effectiveness of the study drug, a potential new option for protecting against pneumococcal disease.
Throughout the study, eligible participants and caregivers will receive at no cost:
- All study-related drugs
- Close care and monitoring from a team of medical professionals
- Reimbursement for your time and travel costs may also be available