What is the purpose of this study?
The purpose of this study is to evaluate the safety and effectivenss
of an investigational DTPa-HepB-IPV vaccine, which contains vaccines
against diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis.
Who will be included in the study?
Healthy infants aged 6 to 12 weeks who have not yet received any
vaccines and meet other necessary study criteria will be included in
this study.
What is involved?
This study lasts for 10 months and includes 3 visits. The following
is a list of procedures that will take place during the study:
During the three visits (at 2, 4, and 6 months of age)
- A complete physical exam, medical history, and temperature will be
taken.
- The study vaccine will be administered if your child is randomly
chosen to receive it.
- Routine vaccines will be administered.
- There will be a 30 minute wait after the vaccinations.
For four days after each visit parents will:
- Obtain information daily including child's temperature, redness or
swelling around the injection site, and general health.
- Share the information obtained with the study personnel when they
call approximately 4 days after each of the 3 vaccination visits.
Study personnel will make telephone calls to parents at 32 days and
at 6 months after the final vaccination visit.
What are the benefits?
Your child may develop protection against diptheria, tetanus,
pertussis, hepatitis B, polio, Haemophilus influenzae type b, and
pneumococcal disease. If my child is randomized to the group that
receives the investigational DTPa-HepB-IPV vaccine, your child will
receive only 3 injections instead of 5.
Clinical studies are essential in finding new and improved treatments
and diagnostic tools. Your child may receive no direct benefit from
participating in this study.
Will I get all of the facts?
Parents interested in having their child participate will be given a
consent form that thoroughly explains all of the details of the study.
It goes over all of the procedures, the risks, the benfits, the
compensation, 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 and, if of age,
the child has given at minimum his/her verbal agreement.
What are the risks?
All side effects and risks will be discussed in detail during the
consent process.
What is the compensation?
Parents will receive a $20.00 travel compensation for each study
visit. Participants who complete the study will receive a $50.00 gift
certifcate to a local toy store. Those who do not complete the study
will be compensated for the portion they do.
There is no charge for the vaccinations that will be given at each
visit.
Who should I contact for more information?
Lori Ann McKenna, R.N.
The Gamble Program for Clinical Studies/Division of Infectious Disease
Cincinnati Children's Hospital Medical Center
3333 Burnet Ave MLC 7017
Cincinnati, OH 45229-3039
513-636-7699
mckp5l@chmcc.org
Useful Links
http://www.cdc.gov/nip/
