A Comparison of One Versus Two Doses of Influenza Vaccine in Children 5-8 Years of Age
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.
|Study Design:||Endpoint Classification: 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|
- Comparison of antibody response after 1 dose of influenza vaccine with that after 2 doses of influenza vaccine. [ Time Frame: Blood samples were obtained at 3 time points, before dose 1 of vaccine, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeks after dose 2 of vaccine. ] [ Designated as safety issue: No ]
- To describe and compare the safety profile after 1 and 2 doses of vaccine. [ Time Frame: Study diaries were kept from the day of vaccination daily for the 4 days after vaccination. ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2004|
|Study Completion Date:||December 2004|
|Primary Completion Date:||December 2004 (Final data collection date for primary outcome measure)|
Experimental: Subjects receiving vaccine
2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine 4 weeks apart.
Biological: 2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine
2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine
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 compared 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 received two doses of vaccine, and the immune response after one dose of vaccine was 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|