Quadrivalent Influenza Vaccine
Biological1 or 2 doses of Quadrivalent Influenza Vaccine depends on age
Other names: QIV
NCT Number: NCT03336593
This study is to assess protectivity and safety of Quadrivalent Influenza Vaccine in Indonesian Population
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Notify Me6 month–40 year
All sexes
Interventional
Phase 2
Garuda Primary Health Center, Bandung, West Java, Indonesia
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Subjects 9 - 40 Years of Age:
Inclusion criteria
for Subjects 6 Months - 8 Years of Age:
Exclusion criteria
1 or 2 doses of Quadrivalent Influenza Vaccine depends on age
Other names: QIV
1 dose of Trivalent Influenza Vaccine
Other names: TIV
Time frame: 28 days after the last dose immunization
The anti-influenza antibody serological response
Time frame: 28 days
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: 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: 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: 30 minutes after each vaccination
Immediate reaction (local reaction or systemic event)
Time frame: within 72 hours, between 72 hours to 28 days after vaccination
At least one of these adverse events, expected or not
Time frame: 28 days
Serious adverse event occurring from inclusion until 28 days after vaccination.
Time frame: 28 days
Adverse events occuring until 28 days after vaccination
Time frame: 28 days
Adverse events occuring until 28 days after vaccination
PT Bio Farma
Industry
A Bridging Study to Assess Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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