Healthy Clinical Trial
Official title:
A Prospective, Open-label, Phase II, Multi-center Study of the Safety, Tolerability and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A and B, Live Cold-adapted (CAIV-T) in Healthy Children, Aged 6 to 17 Years
The study was designed to determine the number of doses of CAIV-T required to effectively immunize children and adolescents in the 6 to 17 year age group.
This was a phase II, prospective, open-label, multicenter, outpatient study designed to
evaluate the safety, tolerability, and immunogenicity of one or two doses of CAIV-T in
children and adolescents between 6 and 17 years of age. Subjects were allocated to one of
three study groups according to age at the time of enrollment: study group one consisted of
subjects between 6 and 9 years of age, group two of subjects 10 to 12 years of age, and
group three of subjects 13 to 17 years of age.
Approximately 450 subjects (ie, 150 subjects per age group) participated in the study and
were scheduled to receive two intranasal doses of CAIV-T separated by 35 ± 7 days in an
open-label manner.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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