Why Participate?
Before a potential vaccine can be approved, it must first be tested in a series of clinical trials, or research studies. Clinical trials are an essential step in the process of developing new vaccines, and they are not possible without the participation of volunteers.
The results from this study will help us learn more about the safety and effectiveness of the two study vaccines, and may help to provide better protection against meningitis for people in the future.
As an eligible participant, you or your adolescent will receive the study vaccines and related tests at no cost. Additionally, you may be eligible for compensation and/or reimbursement.
About The Study
This study is evaluating the effectiveness of two meningitis vaccines when given together. In this study, researchers will determine if the meningitis vaccines Bexsero and Menveo are as effective against meningitis germ types A, B, C, W, and Y when given together as they are when given separately. All participants will receive four total injections: two doses of Bexsero, one dose of Menveo, and one dose of placebo (an injection with no active ingredient). This study will enroll about 945 teens and young adults in the United States.
What To Expect
If you or your adolescent are eligible for this study and decide to participate, here's what you can expect:
- You or your adolescent will be randomly assigned to one of three groups. Neither you nor the study doctor will know which has been assigned. One third of participants will initially receive Bexsero and placebo, one third will initially receive Menveo and a placebo, and one third will initially receive Bexsero and Menveo.
- You or your adolescent will receive the first two injections on the same day you enter the study. You or your adolescent will receive a third injection about two months later, and a fourth injection about one month after the third. You or your adolescent will need to remain at the study site for about 30 minutes after each injection so the study team can monitor for any reactions.
- You or your adolescent will need to attend at least 12 study visits over about 15 months. 5 of these visits will be in the clinic, and 7 will be over the phone. You or your adolescent will also be asked to track any symptoms or side effects in an electronic diary (e-diary). The study team will show you how to use this.
The Study Vaccines
Bexsero is a vaccine that helps to protect against the meningitis B germ. In the US, it is already approved by the FDA for people who are 10 to 25 years of age.
Menveo is a vaccine that helps to protect against meningitis A, C, W and Y germs. In the US, it is approved by the FDA for people who are 2 months to 55 years of age.
Bexsero and Menveo are considered investigational in this study because they have not yet been approved to give in combination to healthy adolescents or adults. In a previous study of healthy infants, Bexsero and Menveo were found to be well-tolerated and effective when given together.
What Is Meningitis?
Meningitis is an infection of the brain or spinal cord caused by different types of a germ called Neisseria meningitidis A, B, C, W and Y. Anyone can get meningitis, but is more common in teenagers, young children, and infants.
Symptoms of meningitis include headache, fever, and neck stiffness. Symptoms often develop rapidly and require urgent treatment. If left untreated, meningitis can lead to hearing loss, learning and behavior problems, severe brain damage, and even death.
FAQs
How long will I be in the study?
Your participation in the study will last about 15 months.
What are the possible side effects?
All vaccines have the potential to cause unwanted side effects. Common side effects of Bexsero and Menveo include pain, swelling, or redness at the injection site, muscle or joint pain, nausea, or headache. The study doctor will discuss all possible risks and benefits of participating in this study with you before you join the study.
What if this study is not right for me?
You can choose to leave this study at any time, for any reason. Choosing to leave the study will not affect your future medical care.
Have these vaccines been studied in people before?
Yes. Bexsero and Menveo were found to be well-tolerated and effective when given independently along with other vaccine antigens, including Diphtheria, Tetanus, and acellular Pertussis (DTPa). Results from a previous study of healthy infants showed that Bexsero and Menveo were well-tolerated and effective when given concomitantly (in combination). This is the first time Bexsero and Menveo will be given concomitantly to healthy adolescents and young adults.
Are there other meningitis vaccines available?
Yes, there are other meningitis vaccines that may be appropriate for you if you choose not to participate in this study. The vaccine Trumenba ® has been approved to prevent meningococcal group B infections, and the vaccines Menactra ® , MenQuadfi ® , and Menomune ® have been approved to prevent type ACWY infections. The study doctor will discuss all available options with you and answer any questions you may have.
Does it cost anything to participate?
No, it does not cost anything to participate in this study. Payment for completing study visits, or reimbursement for study-related expenses (like travel) may be available. Please ask your study team for more information.
