Safety Issues
Conditions
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
Interventions
BIOLOGICALQuadrivalent Influenza Vaccine
1 or 2 doses of Quadrivalent Influenza Vaccine depends on age
BIOLOGICALTrivalent Influenza Vaccine
1 dose of Trivalent Influenza Vaccine
Sponsors
PT Bio Farma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
The study for subjects 9-40 years of age is randomized, double blind study. While the study for subjects 6 months-8 years of age is open labeled study.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
6 Months to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
| Percentage of subjects with at least one immediate reaction | 30 minutes after each vaccination | Immediate reaction (local reaction or systemic event) |
| 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 |
| Serious adverse event after vaccination | 28 days | Serious adverse event occurring from inclusion until 28 days after vaccination. |
| Comparison adverse events between quadrivalent and trivalent influenza HA vaccine. | 28 days | Adverse events occuring until 28 days after vaccination |
| Comparison of adverse events between each batch number of quadrivalent influenza HA vaccine. | 28 days | Adverse events occuring until 28 days after vaccination |
Countries
Indonesia
Outcome results
None listed