Status:
COMPLETED
Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population
Lead Sponsor:
PT Bio Farma
Conditions:
Safety Issues
Eligibility:
All Genders
6-40 years
Phase:
PHASE2
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 subj...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2018
Estimated Enrollment :
810 Patients enrolled
Trial Details
Trial ID
NCT03336593
Start Date
November 21 2017
End Date
November 30 2018
Last Update
April 2 2019
Active Locations (3)
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1
Garuda Primary Health Center
Bandung, West Java, Indonesia
2
Ibrahim Adjie Primary Health Center
Bandung, West Java, Indonesia
3
Puter Primary Health Center
Bandung, West Java, Indonesia