Study for Healthy Children 15 to 59 Months Old

Why are we doing this research?

Cincinnati Children’s is doing a research study, sometimes known as a clinical trial or clinical study, to learn if an experimental nasal RSV vaccine is safe and to see how children’s germ-fighting abilities respond to the vaccine. Respiratory syncytial virus, or RSV, is a common respiratory virus that can be very serious for infants and older adults. It is a leading cause of hospitalization for infants.

Who can participate?

Healthy children 15 months to 59 months of age may be eligible to participate.

Conditions

  • Healthy Babies Children and Teens
  • Vaccines

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.

What are the good things that can happen from this research?

Being in this research study will not help your child right now. When we finish the study, we hope that we will know more about the study vaccine and how it may help prevent RSV in children in the future.

What are the bad things that can happen from this research?

Possible risks and discomforts will be discussed with those interested in learning more about the study.

Will you/your child be paid to be in this research study?

Participants may receive up to $700 for time and effort.

Contact

Contact Us.To see if your child qualifies, go to
www.is.gd/rsvresearch, or contact:
Gamble Program for Clinical Studies
513-636-7699
gambleprogram@cchmc.org
Infectious Diseases
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039

Study Doctor

Paul Spearman, MD
Infectious Diseases
Cincinnati Children’s Hospital Medical Center