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To Asses the Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)
Too see percentage of subjects with HI titer >= 1:40, 28 days after two doses in infants and children (6 months-8 years old) and one dose in children 9-11 years old for each strain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine | Experimental | Vaccine Flubio (Influenza HA) vaccine 2 doses for infants and children (6 months - 8 years old) 1 doses for children (9-11 years old) The vaccine will be given intramuscularly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccine | Biological | Flubio (Influenza HA) Vaccine The vaccine will be given intramuscularly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To asses the immunogenicity of Flubio vaccine 28 days after 2 doses immunization in infants and children (6 months-8 years of age) and 1 dose immunization in children (9-11 years of age) | Percentage of subjects with anti HI titer >=1:40 | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the seroconversion after 2 doses of Flubio vaccine in infants and children (6 months-8 years old) | Percentage subjects with increasing antibody titer >=4 times | 2 months |
| To describe seroconversion after 1 dose of Flubio vaccine in children (9-11 years old) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernie Endyarni, MD | Department of Child Health, School of Medicine, University of Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jatinegara Primary Health Center | Jakarta | Jakarta Special Capital Region | Indonesia | |||
| Primary School of SDN 01 Kampung Melayu |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29551225 | Derived | Soedjatmiko S, Medise BE, Gunardi H, Sekartini R, Satari HI, Hadinegoro SR, Bachtiar NS, Sari RM. Immunogenicity and safety of a Trivalent Influenza HA vaccine in Indonesian infants and children. Vaccine. 2018 Apr 12;36(16):2126-2132. doi: 10.1016/j.vaccine.2018.02.114. Epub 2018 Mar 16. |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Percentage of subjects with transition of seronegative to seropositive |
| 1 months |
| To asses the safety of Flubio vaccine | Local and Systemic Reaction following immunization | 1-2 months |
| Jakarta |
| Jakarta Special Capital Region |
| Indonesia |