Healthy Infants 1 to 3 Months and 6 to 12 Months Old Needed for Vaccine Study
What is the purpose of this study?
Cincinnati Children's is conducting a research study to evaluate an experimental nasal droplet vaccine that may prevent Paraflu, a common virus that frequently causes croup and pneumonia.
Who will be included in this study?
Healthy infants 1 to 3 months and 6 to 12 months old may be eligible to participate.
What is involved?
The following is an outline of the visits and procedures included in this study:
- Screening Visit
- Medical history
- Physical exam
- Nasal wash and a possible blood draw
Three Vaccine Visits Physical exam Blood draw at vaccine visit 1 only Study vaccine or placebo (harmless liquid) Diary card to completeNine follow-up visits Physical exam Some visits include a blood draw and nasal washFollow-up telephone calls Approximately 4 calls during the studyWhat are the benefits?
It is possible that the vaccine may provide protection against Paraflu. 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 or guardian has signed this form.
What are the risks?
The risks of participation include possible reactions to the vaccine, including fussiness and mild fever. 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 pay?
Parents may receive up to $515 for time and travel and an additional $300 in gift cards.
Who should I contact for more information?
Gamble Program for Clinical Studies
Cincinnati Children's Hospital Medical Center
3333 Burnet Ave., Cincinnati, OH 45229-3039
Study Line: 513-636-7699
gambleprogram@cchmc.org
