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This study is to assess protectivity and safety of Quadrivalent Influenza Vaccine in Indonesian Population
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QIV batch 1 | Experimental | 1 dose of 0.5 ml of quadrivalent influenza vaccine batch 1 |
|
| QIV batch 2 | Experimental | 1 dose of 0.5 ml of quadrivalent influenza vaccine batch 2 |
|
| QIV batch 3 | Experimental | 1 dose of 0.5 ml of quadrivalent influenza vaccine batch 3 |
|
| Trivalent Influenza Vaccine | Active Comparator | 1 dose of 0.5 ml of trivalent influenza vaccine |
|
| QIV (subjects 6-35 months) | Experimental | 2 dose of 0.25 ml of quadrivalent influenza vaccine |
|
| QIV (subjects 3-8 years) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent Influenza Vaccine | Biological | 1 or 2 doses of Quadrivalent Influenza Vaccine depends on age |
|
| 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 |
| 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 |
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Inclusion Criteria for Subjects 9 - 40 Years of Age:
Inclusion Criteria for Subjects 6 Months - 8 Years of Age:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meita Dhamayanti | Hasan Sadikin General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Garuda Primary Health Center | Bandung | West Java | Indonesia | |||
| Ibrahim Adjie Primary Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37616221 | Derived | Fadlyana E, Dhamayanti M, Tarigan R, Prodjosoewojo S, Rahmadi AR, Sari RM, Rusmil K, Kartasasmita CB. Immunogenicity and safety of Quadrivalent Influenza HA vaccine compared with Trivalent Influenza HA vaccine and evaluation of Quadrivalent Influenza HA vaccine batch-to-batch consistency in Indonesian children and adults. PLoS One. 2023 Aug 24;18(8):e0281566. doi: 10.1371/journal.pone.0281566. eCollection 2023. | |
| 31862195 |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Subjects 9- 40 years of age: Experimental, randomized, double blind bridging study Subjects 6 months - 8 years of age: Experimental, open labeled bridging study
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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.
2 dose of 0.5 ml of quadrivalent influenza vaccine
|
|
| Trivalent Influenza Vaccine | Biological | 1 dose of Trivalent Influenza Vaccine |
|
|
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 |
| Bandung |
| West Java |
| Indonesia |
| Puter Primary Health Center | Bandung | West Java | Indonesia |
| Derived |
| Dhamayanti M, Tarigan R, Fadlyana E, Prasetyo D, Amalia N, Rusmil VK, Sari RM, Bachtiar NS, Rusmil K, Kartasasmita CB. Immunogenicity and safety of Quadrivalent Influenza HA vaccine in Indonesian children: An open-labeled, bridging, clinical study. Vaccine. 2020 Jan 29;38(5):993-1000. doi: 10.1016/j.vaccine.2019.12.008. Epub 2019 Dec 17. |