This study is to assess protectivity and safety of Quadrivalent Influenza Vaccine in Indonesian Population
To describe the protectivity rate of Quadrivalent Influenza HA vaccine 28 days after immunization in Indonesian population. To describe immunogenicity of quadrivalent Influenza HA vaccine in all subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
810
1 or 2 doses of Quadrivalent Influenza Vaccine depends on age
1 dose of Trivalent Influenza Vaccine
Garuda Primary Health Center
Bandung, West Java, Indonesia
Ibrahim Adjie Primary Health Center
Bandung, West Java, Indonesia
Puter Primary Health Center
Bandung, West Java, Indonesia
Percentage of subjects with an anti-influenza titer >= 1:40 HI units
The anti-influenza antibody serological response
Time frame: 28 days after the last dose immunization
Geometric Mean Titer (GMT)
GMT in all subjects; comparison of GMT between one dose of quadrivalent and trivalent influenza HA vaccine in subjects 9-40 years old; and comparison of GMT between each batch number of quadrivalent influenza HA vaccine in subjects 9-40 years old
Time frame: 28 days
Percentage of subjects with increasing antibody titer >= 4 times
Percentage of subjects with increasing antibody titer \>= 4 times: in all subjects; comparison between one dose of quadrivalent and trivalent influenza HA vaccine in subjects 9-40 years old; and comparison between each batch number of quadrivalent influenza HA vaccine in subjects 9-40 years old
Time frame: 28 days
Percentage of subjects with transition of seronegative to seropositive
Percentage of subjects with transition of seronegative to seropositive: in all subjects; comparison between one dose of quadrivalent and trivalent influenza HA vaccine in subjects 9-40 years old; and comparison between each batch number of quadrivalent influenza HA vaccine in subjects 9-40 years old
Time frame: 28 days
Percentage of subjects with at least one immediate reaction
Immediate reaction (local reaction or systemic event)
Time frame: 30 minutes after each vaccination
Percentage of subjects with at least one of these adverse events
At least one of these adverse events, expected or not
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Time frame: within 72 hours, between 72 hours to 28 days after vaccination
Serious adverse event after vaccination
Serious adverse event occurring from inclusion until 28 days after vaccination.
Time frame: 28 days
Comparison adverse events between quadrivalent and trivalent influenza HA vaccine.
Adverse events occuring until 28 days after vaccination
Time frame: 28 days
Comparison of adverse events between each batch number of quadrivalent influenza HA vaccine.
Adverse events occuring until 28 days after vaccination
Time frame: 28 days