Pneumococcal Vaccine for Toddlers

Pneumococcal (pronounced “noo-muh-KOK-uhl”) disease is an infection that is caused by the bacteria Streptococcus pneumoniae, or pneumococcus. There are more than 90 known strains of pneumococcus that can cause serious illnesses, including pneumonia and bacterial meningitis.

Immunizations, also known as vaccines, protect humans from getting sick from certain diseases. The Centers for Disease Control (CDC) recommend you take preventive action against pneumococcal disease by vaccinating your children before the age of two.

About the Pneumococcal Vaccine

Currently, the CDC recommends that all children under the age of two be vaccinated for pneumococcal disease.

Typically, children receive a series of 4 doses of the Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine), or PCV13, vaccine. PCV13 provides protection against 13 strains of pneumococcus; however, researchers are currently investigating ways to improve protection against additional strains of the bacteria.

An investigational vaccine called ASP3772 is being tested in this study. The study drug may provide protection against more than 13 types of pneumococcal bacteria. The study drug is a vaccine and is administered as an injection, similar to the PCV13 vaccination. For this study, the safety and effectiveness of the investigational vaccine will be monitored. Your child will also receive close care and monitoring during participation. If needed, a booster of PCV13 may be provided to ensure your child is protected.

Additional Resources:

CDC Pneumococcal Vaccination Information
Prevnar 13 Information

About the Study

Our team of medical professionals is evaluating an investigational vaccine designed to provide protection against different strains of pneumococcus.

Currently, the standard vaccine, Prevnar 13®, or PCV13, protects against 13 strains. The investigational vaccine being studied is may provide toddlers protection against more than 13 strains of the bacteria that cause pneumococcal disease. The main purpose of this pneumococcal vaccine study for toddlers ages 12 to 15 months is to determine the effectiveness and strength of the investigational vaccine.

If you choose to enroll your child in the study and your child is deemed eligible, participation will last for 6 months and include 4 visits. Your child will receive the investigational drug at the first visit and be scheduled for 3 follow-up visits at 1 week, 1 month, and 6 months following treatment.

Why Should My Child Participate?

By choosing to enroll your child in the pneumococcal vaccine study, you are helping to advance development of an investigational drug for prevention of pneumococcal disease.

Qualified participants will receive at no cost:

Research study medication that may provide protection against more than 13 strains of pneumococcal bacteria

Close care and monitoring from a local study doctor

Reimbursement for study and parent/caregiver travel expenses

Does My Child Qualify for the Study?

Only a study doctor can determine if your child meets the eligibility criteria. To qualify, potential study participants must:

12-15 months

Be between the ages of approximately 12 and 15 months

3 doses

Have received 3 doses of the infant series of PCV13 vaccinations

2+ months

Received the last PCV13 dose more than 2 months prior to the study

For more information and to see if your child qualifies, contact the doctor who provided information about the study to you.

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.

Study Information

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

Thank you for your interest in the Pneumococcal Vaccine Study for Toddlers.

For more information and to see if you qualify, call the doctor’s office that previously provided you with information about this study.