Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population
- Conditions
- Safety Issues
- Interventions
- Biological: Quadrivalent Influenza VaccineBiological: Trivalent Influenza Vaccine
- Registration Number
- NCT03336593
- Lead Sponsor
- PT Bio Farma
- Brief Summary
This study is to assess protectivity and safety of Quadrivalent Influenza Vaccine in Indonesian Population
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 810
Not provided
- Subject concomitantly enrolled or scheduled to be enrolled in another trial
- Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature >= 37.5 C )
- Known history of allergy to egg and or chicken protein or any component of the vaccines
- History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
- Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks).
- Pregnancy & Lactation (Adult)
- Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
- Subject already immunized with influenza vaccine within 1 year.
- Subjects receive any vaccination within 1 month before and after immunization of Quadrivalent Influenza Vaccine.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description QIV batch 2 Quadrivalent Influenza Vaccine 1 dose of 0.5 ml of quadrivalent influenza vaccine batch 2 QIV (subjects 6-35 months) Quadrivalent Influenza Vaccine 2 dose of 0.25 ml of quadrivalent influenza vaccine QIV (subjects 3-8 years) Quadrivalent Influenza Vaccine 2 dose of 0.5 ml of quadrivalent influenza vaccine QIV batch 1 Quadrivalent Influenza Vaccine 1 dose of 0.5 ml of quadrivalent influenza vaccine batch 1 QIV batch 3 Quadrivalent Influenza Vaccine 1 dose of 0.5 ml of quadrivalent influenza vaccine batch 3 Trivalent Influenza Vaccine Trivalent Influenza Vaccine 1 dose of 0.5 ml of trivalent influenza vaccine
- Primary Outcome Measures
Name Time Method Percentage of subjects with an anti-influenza titer >= 1:40 HI units 28 days after the last dose immunization The anti-influenza antibody serological response
- Secondary Outcome Measures
Name Time Method Percentage of subjects with increasing antibody titer >= 4 times 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
Percentage of subjects with at least one immediate reaction 30 minutes after each vaccination Immediate reaction (local reaction or systemic event)
Geometric Mean Titer (GMT) 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
Serious adverse event after vaccination 28 days Serious adverse event occurring from inclusion until 28 days after vaccination.
Percentage of subjects with transition of seronegative to seropositive 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
Comparison adverse events between quadrivalent and trivalent influenza HA vaccine. 28 days Adverse events occuring until 28 days after vaccination
Percentage of subjects with at least one of these adverse events within 72 hours, between 72 hours to 28 days after vaccination At least one of these adverse events, expected or not
Comparison of adverse events between each batch number of quadrivalent influenza HA vaccine. 28 days Adverse events occuring until 28 days after vaccination
Trial Locations
- Locations (3)
Ibrahim Adjie Primary Health Center
🇮🇩Bandung, West Java, Indonesia
Garuda Primary Health Center
🇮🇩Bandung, West Java, Indonesia
Puter Primary Health Center
🇮🇩Bandung, West Java, Indonesia