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Also known as pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| 1: 10 ug, 14 days | EXPERIMENTAL | - |
| 2: 5 ug, 28 days | EXPERIMENTAL | - |
| 3: 10 ug, 28 days | EXPERIMENTAL | - |
| 4: 15 ug, 28days | EXPERIMENTAL | - |
| No.1: 1.25 ug | EXPERIMENTAL | - |
| No.2: 2.5 ug | EXPERIMENTAL | - |
| No.3: 5.0 ug | EXPERIMENTAL | - |
| No. 4: 10 ug | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| pandemic influenza vaccine (H5N1 strain NIBRG-14) | BIOLOGICAL | two-dose regimen with 14 days apart: 5 microgram per dose |
Inclusion Criteria: * Healthy adults aged 18-60 years old * Be able to show legal identity card for the sake of recruitment * Be able to understand and sign the informed consent. Exclusion Criteria: * Woman： Who breast-feeding or planning to become pregnant during the 56 days of study participati...
It is an investigational vaccine developed by Sinovac Biotech, Ltd (ticker SVA) for the prevention of pandemic influenza. It is based on the H5N1 strain NIBRG-14 and is designed to protect against pandemic influenza. It is a vaccine modality and is not approved; it remains in clinical development.
It is used for the prevention of pandemic influenza caused by the H5N1 strain. The vaccine is intended to stimulate an immune response against pandemic influenza in healthy adult volunteers. It is investigational and has been studied in completed clinical trials, not as an approved product.
Sinovac Biotech, Ltd, which trades under the ticker SVA, is the developer of the pandemic influenza vaccine (H5N1 strain NIBRG-14). The company conducted the clinical development of this investigational vaccine for pandemic influenza prevention.
The pandemic influenza vaccine is in Phase 2 development. One completed Phase 2 trial and one completed Phase 1 trial have been conducted. It is an investigational vaccine and is not approved for use. The Phase 2 trial enrolled 402 participants, and the Phase 1 booster-dose trial enrolled 57 participants.
Two completed trials have studied the pandemic influenza vaccine: NCT00535665, a Phase 2 trial of an inactivated pandemic influenza vaccine with 402 participants, and NCT00660257, a Phase 1 trial of a booster dose of an inactivated, adjuvanted whole-virion pandemic influenza (H5N1) vaccine with 57 participants. Both trials are completed.
Yes, pandemic influenza vaccine (H5N1 strain NIBRG-14) is another name for the pandemic influenza vaccine developed by Sinovac Biotech, Ltd. The NIBRG-14 designation refers to the specific H5N1 strain used in this investigational vaccine for pandemic influenza prevention.