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Focetria · 2 trials · 5 indications
Geometric mean hemagglutination inhibition (HI) titer = GMT
The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with HIV infection. The percentage of subjects that reached seroprotection in comparison to the pre-vaccination result are presented by visit. Seroprotection was defined as HI titer ≥40.
The primary objective of this study was to help determine the ideal strategy of vaccination against pandemic H1N1 influenza in subjects with invasive solid tumors/hematologic neoplasms. Comparisons were made by vaccine group using differences in the percentage of subjects with seroconversion/significant increase and were presented with 95% confidence intervals.
The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with chronic diseases (chronic cardiac diseases, chronic pulmonary diseases and diabetes mellitus).
The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with chronic diseases (chronic cardiac diseases, chronic pulmonary diseases and diabetes mellitus). Comparisons were made by vaccine group using ratios of immunogenicity data and were presented with 95% confidence intervals.
The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with chronic diseases (chronic cardiac diseases, chronic pulmonary diseases and diabetes mellitus). The percentage of subjects that reached seroconversion or had a significant increase in comparison to the pre-vaccination result were presented by visit. Seroconversion or a significant increase was defined as HI titer ≥40 in subjects with negative results at pre-vaccination (HI titer \<10) or an increase of at least 4 times in HI titer for individuals with positive results at pre-vaccination (HI titer \>10) at Day 22 and Day 43 in comparison to the pre-vaccination result.
The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with chronic diseases (chronic cardiac diseases, chronic pulmonary diseases and diabetes mellitus). Comparisons were made by vaccine group using differences in the percentage of subjects with seroprotection and were presented with 95% confidence intervals.
The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with chronic diseases (chronic cardiac diseases, chronic pulmonary diseases and diabetes mellitus). Comparisons were made by vaccine group using differences in the percentage of subjects with seroconversion/significant increase and were presented with 95% confidence intervals.
| Arm | Type | Description |
|---|---|---|
| HIV-1 Infected Subjects Receiving Vaccine with Adjuvant | EXPERIMENTAL | Each subject received two doses of vaccine with adjuvant (Focetria®), the first on Study Day 1, and the second on Study Day 22 |
| HIV-1 Infected Subjects Receiving Vaccine without Adjuvant | EXPERIMENTAL | Each subject received two doses of vaccine without adjuvant (Begrivac®), the first on Study Day 1, and the second on Study Day 22 |
| Healthy Subjects Receiving Vaccine with Adjuvant | EXPERIMENTAL | Each subject received two doses of vaccine with adjuvant (Focetria®), the first on Study Day 1, and the second on Study Day 22 |
| Healthy Subjects Receiving Vaccine without Adjuvant | EXPERIMENTAL | Each subject received two doses of vaccine without adjuvant (Begrivac®), the first on Study Day 1, and the second on Study Day 22 |
| Chronic Disease Subjects Receiving Vaccine with Adjuvant | EXPERIMENTAL | Each subject received two doses of vaccine with adjuvant (Focetria® or Fluad®), the first on Study Day 1, and the second on Study Day 22. |
| Chronic Disease Subjects Receiving Vaccine without Adjuvant | EXPERIMENTAL | Each subject received two doses of vaccine without adjuvant (Begrivac®), the first on Study Day 1, and the second on Study Day 22. |
| Name | Type | Description |
|---|---|---|
| Focetria® | BIOLOGICAL | 7.5 ug of HA antigen; adjuvanted; monovalent |
| Begrivac® | BIOLOGICAL | 15 ug of HA antigen; non-adjuvanted; trivalent |
| Fluad® | BIOLOGICAL | 15 ug of HA antigen; adjuvanted; trivalent |
Inclusion Criteria: For HIV-1 Infected Subjects: * Adults between 18-60 years old (inclusive) * Any sex or ethnicity * Confirmed Diagnosis of HIV-1 infection * CD4+ cells count \>200 per mm3 within 3 months prior to inclusion in the study * HIV-1 viral load below 200 copies/mL within 90 days prior...
Focetria is an influenza vaccine studied for protection against H1N1 Influenza Virus. Its clinical trials enrolled adults with HIV-1 infection, chronic pulmonary disease, chronic heart disease, or diabetes mellitus, groups at higher risk from influenza. It is identified as an MF59-adjuvanted influenza vaccine.
Focetria is associated with Fortrea Holdings Inc. Common Stock, which trades under the ticker FTRE. The company is listed as the developer of this H1N1 influenza vaccine candidate.
Focetria has been studied in Phase 3 clinical development. Two Phase 3 trials have been completed, and no trials are currently active. The program enrolled a total of 496 participants across those completed studies.
Focetria was evaluated in two completed Phase 3 trials. NCT01032408 tested immunogenicity, safety, and tolerability of MF59-adjuvanted versus non-adjuvanted influenza vaccines in patients with HIV-1 infection in Brazil. NCT01032395 ran the same comparison in patients with chronic pulmonary disease, chronic heart disease, or diabetes mellitus, also in Brazil.
Yes, Focetria and Focetria® refer to the same product. Focetria® is the registered trademark form of the name, while Focetria is the plain-text version used in scientific and clinical references.