To Asses the Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)
Too see percentage of subjects with HI titer \>= 1:40, 28 days after two doses in infants and children (6 months-8 years old) and one dose in children 9-11 years old for each strain.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
SINGLE
Enrollment
405
Flubio (Influenza HA) Vaccine The vaccine will be given intramuscularly.
Jatinegara Primary Health Center
Jakarta, Jakarta Special Capital Region, Indonesia
Primary School of SDN 01 Kampung Melayu
Jakarta, Jakarta Special Capital Region, Indonesia
To asses the immunogenicity of Flubio vaccine 28 days after 2 doses immunization in infants and children (6 months-8 years of age) and 1 dose immunization in children (9-11 years of age)
Percentage of subjects with anti HI titer \>=1:40
Time frame: 2 months
To describe the seroconversion after 2 doses of Flubio vaccine in infants and children (6 months-8 years old)
Percentage subjects with increasing antibody titer \>=4 times
Time frame: 2 months
To describe seroconversion after 1 dose of Flubio vaccine in children (9-11 years old)
Percentage of subjects with transition of seronegative to seropositive
Time frame: 1 months
To asses the safety of Flubio vaccine
Local and Systemic Reaction following immunization
Time frame: 1-2 months
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