What will happen in the study?
Study participants will receive 1 dose of the study vaccine by nose drops. There are at least 8 clinic visits and 2 follow-up phone calls during a 6-month period. Here are some of the things that will happen in this study:
You/your child will:
- Be asked about your child’s health and any medicines he/she takes
- Have a physical exam including temperature, pulse, blood pressure, length and weight measurements
- Have a blood draw at two visits
- Have nasal swabs done during at least 6 of the study visits
- Receive either study vaccine or placebo (decided by chance – like flipping a coin, with 4 participating children receiving vaccine for every 1 child receiving placebo)
(This a nasal vaccine and will be given as drops into your child’s nose.)
- Complete a memory aid (or diary card) for 14 days after your child receives the study vaccine to record your child’s temperature and any symptoms he/she may have
You will be given a consent form and study handouts that will give you details about the study. A member of the study staff will review the consent form with you and answer all of your questions.