Vaccine Study for Healthy Infants and Children 6 to 23 Months Old
What is the purpose of the study?
The Gamble Program for Clinical Studies at Cincinnati Children's is conducting a research study for an experimental nasal spray vaccine that may prevent two common viruses (RSV and ParaFlu). These viruses frequently cause croup and pneumonia.
Who will be included in the study?
Healthy infants and children 6 to 23 months of age may be eligible to participate.
What is involved?
This study will last approximately 12 months. The following is a list of procedures that will take place during the study:
- Physical exam with review of medical history and medication
- 13 study visits; some involving collection of blood & nasal wash samples
- 3 doses of study vaccine given as nasal droplets (1 of 3 strengths) or placebo (inactive liquid)
- Completion of a diary card after each vaccination
- Approximately 8 follow-up telephone calls
What are the benefits?
It is possible that the vaccine may provide protection against the viruses, RSV (Respiratory Syncytial Virus) and Paraflu (Parainfluenza). However, there may be no direct benefit from being in this study. Participation in studies like this contributes to learning more about improving child health.
Will I Get all the facts about the study?
Parents interested in having their child participate 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/guardian has signed this form.
What are the risks?
The risks of participation include possible reactions to the vaccine-the common ones being fussiness and mild fever. Also, there may be temporary discomfort from the blood collection and nasal washes. A full explanation of the risks is included in the consent form.
What is the compensation?
Parents will receive up to $550 for time and travel with an additional $300 in gift cards.
Who should I contact for more information?
Gamble Program for Clinical Studies
Cincinnati Children's Hospital Medical Center
gambleprogram@cchmc.org –Study Line: 513-636-7699
