Status:
COMPLETED
A Comparison of One Versus Two Doses of Influenza Vaccine in Children 5-8 Years of Age
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Influenza
Eligibility:
All Genders
5-8 years
Phase:
NA
Brief Summary
The purpose of the study was to find out if children 5 through 8 years of age who are getting influenza vaccine for the first time should get one or two doses.
Detailed Description
Currently, two doses of influenza vaccine are recommended for children younger than 9 years receiving influenza vaccine for the first time. While the scientific support for 2 doses of vaccine in infan...
Eligibility Criteria
Inclusion
- Immunocompetent children who are at least 5 and no more than 8 years of age on the date of the first vaccination.
- Parents able to give informed consent and child available for all study visits.
- Family able to understand and comply with planned study procedures.
- Family must have telephone accessibility.
Exclusion
- Previous receipt of influenza vaccine of any kind (shot or nasal spray).
- Active cancer or blood system abnormalities such as leukemia.
- Immunocompromising illnesses or current receipt of immunosuppressive agents
- Allergy to eggs or egg protein, or to gentamicin (an antibiotic that is present in trace amounts in the vaccine).
- Any acute or chronic condition that (in the opinion of the investigator) would render vaccination unsafe or would interfere with the evaluation of responses.
- Temporary
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00158665
Start Date
August 1 2004
End Date
December 1 2004
Last Update
October 13 2017
Active Locations (1)
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1
Group Health Research Institute
Seattle, Washington, United States, 98101