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Find Another Clinical Study

Healthy Children 10 to 12 Years Old for Meningitis Vaccine Study

What is the purpose of this study?

This is a research study, sometimes known as a clinical study or trial, to learn more about an investigational research vaccine (shot) not approved by the FDA (Food and Drug Administration) that might prevent meningococcal disease (caused by bacteria which can lead to meningitis, an infection of the fluid surrounding the brain and spinal cord). Other vaccines approved by the FDA will be given as part of the study.

Who can participate?

Healthy children 10 to 12 years old may be eligible to participate.

Ages

From 10 To 12 years old

Conditions

Healthy Infants, Children and Adolescent Studies
Vaccines

What is involved?

The study lasts for approximately 14 months and includes 6 study visits and 1 follow-up phone call. Here are some of the procedures:

Your child will:

Have a physical exam
Have blood draws
Will receive either the study vaccine or placebo (inactive salt pill) and the FDA-approved Tdap and Menactra® vaccines

You will:

Provide your child’s medical history
Complete an electronic diary about your child’s health status
Be called to review your child’s health status as a follow-up

What are the benefits?

Your child will benefit from receiving the licensed vaccines Tdap and Menactra®, as part of the study. Also, your child may be protected from meningococcus B as result of the study. In addition, other children may benefit from the information learned from this study.

Will I get all the facts about the study?

You will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until a parent or guardian has signed this form.