Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population
Tahapan Penelitian : Complete
Sponsor:
PT Bio Farma
Mitra Pelaksana:
RSHS/UNPAD
No Registry
INA-3PTS6EX
Tanggal Input Registry : 13-07-2018
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 09-10-2017 |
| Outcome Primer | To assess the protectivity rate of Quadrivalent Influenza HA vaccine 28 days after immunization in Indonesian population |
| Outcome Skunder | o To describe immunogenicity of quadrivalent Influenza HA vaccine in all subjects o To assess the safety of quadrivalent Influenza HA vaccine in all subjects o To evaluate immunogenicity and safety one dose of quadrivalent influenza HA vaccine compare to trivalent Influenza HA vaccine in group 9-40 years of age o To evaluate immunogenicity and safety in three consecutive batches of quadrivalent Influenza HA vaccine in group 9-40 years of age. |
| Descriptive Information | |
| Judul Penelitian Popular | Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population |
| Judul Penelitian Ilmiah | Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population |
| Jenis Penelitian | Interventional |
| Intervensi | 9-40 years old: 1 dose of Quadrivalent Influenza Vaccine 6 months - 8 years old: 2 dose of Quadrivalent Influenza Vaccine |
| Jumlah Subyek Penelitian | 810 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: 1. Healthy 2. Parents/subjects properly informed about the study and having signed the informed consent form 3. Subject/Parent will commit themselves to comply with the instructions of the investigator and the schedule of the trial.Exclusion Criteria: 1. Subject concomitantly enrolled or scheduled to be enrolled in another trial 2. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature 37.5C ) 3. Known history of allergy to egg and or chicken protein or any component of the vaccines 4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection 5. 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). 6. Pregnancy & Lactation (Adult) 7. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives 8. Subject already immunized with influenza vaccine within 1 year. 9. Subjects receive any vaccination within 1 month before and after immunization of Quadrivalent Influenza Vaccine. |
| Administrative Information | |
| Nomor Persetujuan Etik | 887/UN6.C.10/PN/2017 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | QIV0217 |
| Contact Person | Dr. Meita Dhamayanti, dr.,Sp.A(K).,MKes. |