Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population

Study Overview
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Brief Summary
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This study is to assess protectivity and safety of Quadrivalent Influenza Vaccine in Indonesian Population

Detailed Description
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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

Official Title
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A Bridging Study to Assess Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population

Conditions
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Safety Issues

Intervention / Treatment
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* Biological: Quadrivalent Influenza Vaccine
* Biological: Trivalent Influenza Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Subjects 9 - 40 Years of Age: Healthy Properly informed about the study and having signed the informed consent form Subject/Parent will commit themselves to comply with the instructions of the investigator and the schedule of the trial. Inclusion Criteria for Subjects 6 Months - 8 Years of Age: Healthy Parents have been informed properly regarding the study and signed the informed consent form Parents will commit themselves to comply with the instructions of the investigator and the schedule of the trial Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects 9- 40 years of age: Experimental, randomized, double blind bridging study Subjects 6 months - 8 years of age: Experimental, open labeled bridging study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QIV batch 1<br>1 dose of 0.5 ml of quadrivalent influenza vaccine batch 1 | Biological: Quadrivalent Influenza Vaccine<br>* 1 or 2 doses of Quadrivalent Influenza Vaccine depends on age<br>* Other names: QIV;|
| Experimental: QIV batch 2<br>1 dose of 0.5 ml of quadrivalent influenza vaccine batch 2 | Biological: Quadrivalent Influenza Vaccine<br>* 1 or 2 doses of Quadrivalent Influenza Vaccine depends on age<br>* Other names: QIV;|
| Experimental: QIV batch 3<br>1 dose of 0.5 ml of quadrivalent influenza vaccine batch 3 | Biological: Quadrivalent Influenza Vaccine<br>* 1 or 2 doses of Quadrivalent Influenza Vaccine depends on age<br>* Other names: QIV;|
| Active Comparator: Trivalent Influenza Vaccine<br>1 dose of 0.5 ml of trivalent influenza vaccine | Biological: Trivalent Influenza Vaccine<br>* 1 dose of Trivalent Influenza Vaccine<br>* Other names: TIV;|
| Experimental: QIV (subjects 6-35 months)<br>2 dose of 0.25 ml of quadrivalent influenza vaccine | Biological: Quadrivalent Influenza Vaccine<br>* 1 or 2 doses of Quadrivalent Influenza Vaccine depends on age<br>* Other names: QIV;|
| Experimental: QIV (subjects 3-8 years)<br>2 dose of 0.5 ml of quadrivalent influenza vaccine | Biological: Quadrivalent Influenza Vaccine<br>* 1 or 2 doses of Quadrivalent Influenza Vaccine depends on age<br>* Other names: QIV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with an anti-influenza titer >= 1:40 HI units | The anti-influenza antibody serological response | 28 days after the last dose immunization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 28 days | 
| Percentage of subjects with at least one immediate reaction | Immediate reaction (local reaction or systemic event) | 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 | 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. | 28 days | 
| Comparison adverse events between quadrivalent and trivalent influenza HA vaccine. | Adverse events occuring until 28 days after vaccination | 28 days | 
| Comparison of adverse events between each batch number of quadrivalent influenza HA vaccine. | Adverse events occuring until 28 days after vaccination | 28 days |