A Comparison of One Versus Two Doses of Influenza Vaccine in Children 5-8 Years of Age
Recruitment status was Active, not recruiting
The purpose of the study is 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Comparison of One Versus Two Doses of Influenza Vaccine in Children Aged 5-8 Years of Age Receiving Influenza Vaccine for the First Time|
- Immunogenicity of one dose vs two doses of influenza vaccine.
- Overall reactogenicity of influenza vaccine in one dose vs two doses.
|Study Start Date:||August 2004|
|Estimated Study Completion Date:||December 2004|
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 infants and toddlers is sound, the need for 2 doses of vaccine for adequate immunogenicity in older children is less certain. If the immunogenicity of a one-dose vaccine regimen is comparable to a two-dose regimen, then one dose would be preferable for reasons of safety, practicality and economics, and would reduce a major barrier to vaccination in this injection-adverse age group. This study will compare the immunogenicity and reactogenicity of one versus two doses of influenza vaccine in children aged 5 to 8 years old receiving influenza vaccine for the first time. All children enrolled in the study will receive two doses of vaccine, and the immune response after one dose of vaccine will be compared to the immune response after two doses of vaccine.
|United States, Washington|
|Group Health Research Institute|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Lisa A Jackson, MD, MPH||Group Health Cooperative|