Trial Information
Summary: Safety of a fifth dose of Diphtheria Tetanus Acellular Pertussis Vaccine (DTaP) in children who had an extensive local reaction after the fourth DTaP dose (Revaccination Study)
Summary:
Diphtheria, tetanus, and pertussis are infections that still exist
in the world and may cause outbreaks of disease if children are not
vaccinated. A vaccine, DTaP, is a childhood immunization, given in
a series of 5 injections, that protects children against all three
of these infections. Approximately 2% of children have a large area
of swelling at the vaccination site after the 4th and/or 5th dose
of DTaP. There may also be redness and pain. The reactions go away
in a few days. It is not known if a child who had a reaction after
dose 4 is more likely to again react to the 5th dose. It is also
not known if reactions are more common with some DTaP vaccines than
other vaccines. Different DTaP vaccines contain different amounts
of vaccine parts. There are currently three DTaP vaccines approved
by the FDA for use in the U.S.
There are three main purposes for this study:
- to determine rates and severity of swelling after a 5th dose of
DTaP in children who were reported by their parents or health care
providers to have had a bad local reaction after dose 4;
- to compare rates of swelling among two different DTaP vaccines;
and
- to compare antibody levels (proteins that fight germs) in the
blood of children who had reactions to those who did not have
swelling reactions
Subjects will have two study visits, the first for a blood
sample and to receive their 5th dose of DTaP which is required for
entry into school. The second visit will be solely for a blood
sample. This information will help doctors find out why children
have these reactions, and also, if one vaccines is more likely to
cause this severe swelling reactions. Subjects will receive
reimbursement for their participation.
Eligibility:
Children of either sex and any race between the ages of 4 to 6
years will be eligible to enroll as cases if the parent or their
medical practitioner were concerned that they had experienced an
extensive local reaction after the 4th dose of a DTaP vaccine, and
if they have not yet received their 5th DTaP booster dose.
|
Contact:
Nancy Bouvier, MSN, CPNP
Stanford University School of Medicine
Department of Pediatric Infectious Diseases
300 Pasteur Dr., Room G312
Stanford, CA 94305-5208
Telephone: 650-498-7284
Fax: 650-725-8040
Email:
|
|
If you would like to learn more about participating in this study, please send an e-mail message using the form below.
Please note: A number of commercial online services display an error message after you click on Send. Please be assured that your message has been received.
This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.
Trial listings updated: June 1, 2008 at 5:43:36 AM
