Meningitis Vaccine Booster Study – Healthy Teens Ages 15-17

STUDY BASICS

Are you the parent of a healthy teen aged 15-17? Did your child receive a meningitis vaccine in the past 4-6 years? Your child may be able to participate in a research study to find out if an investigational meningitis booster vaccine is safe and effective for protecting against different types of meningococcus germs. Compensation is provided.

STUDY PURPOSE

Meningitis is inflammation of the lining around the brain and spinal cord. The most common cause of meningitis is an infection, which can lead to symptoms ranging from mild to severe. Existing meningitis vaccines can reduce the risk of becoming infected with meningitis, but may not protect against all types of meningococcus germs.

 

The purpose of this study is to learn more about the safety and immune response of an investigational new meningitis vaccine called MenABCWY when given as a booster dose in healthy teens who previously received a meningitis vaccine. A booster dose is an additional dose of vaccine designed to "boost" the immune system’s original response to the vaccine. The MenABCWY vaccine used in this research study was developed based on two approved meningitis vaccines, but has not been approved by the U.S. Food and Drug Administration (FDA). 

COULD THIS STUDY BE RIGHT FOR YOUR CHILD?

• Ages 15-17
• Received a standard meningitis vaccine in the past 4-6 years
• Willing to complete an e-diary throughout the duration of the study
• Able and willing to undergo blood draws
• If female, not pregnant

WHAT PARTICIPANTS CAN EXPECT

This study will take up to 12 months to complete. Participants will be randomly assigned (like the flip of a coin) to one of two study groups. Some participants will receive the investigational MenABCWY vaccine and some will receive an already-approved vaccine (individual MenACWY and Men B vaccines). Both groups will receive an injection in the arm three separate times. Participants will also be asked to complete questionnaires and an e-diary, and have blood draws and physical exams.