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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
280
2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine
Group Health Research Institute
Seattle, Washington, United States
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.
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.
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