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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 investigational vaccine being studied for the prevention of H1N1 influenza virus infection. It is being evaluated in patients with underlying conditions such as chronic pulmonary disease, chronic heart disease, diabetes mellitus, and HIV-1 infection. The vaccine is administered to adults aged 18 years and older.
Focetria is being developed by Fortrea Holdings Inc., which trades under the ticker symbol FTRE. The company is conducting clinical trials to evaluate the vaccine's immunogenicity, safety, and tolerability in various patient populations.
Focetria is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, with a total of 496 participants enrolled across studies in Brazil.
Focetria has been studied in two completed Phase 3 trials. NCT01032395 evaluated the vaccine in patients with chronic pulmonary disease, chronic heart disease, or diabetes mellitus, enrolling 342 participants. NCT01032408 evaluated it in patients with HIV-1 infection, enrolling 154 participants. Both trials were conducted in Brazil.
Focetria is a monoclonal antibody-based vaccine designed to target the H1N1 influenza virus. It is formulated with an MF59 adjuvant to enhance the immune response. The vaccine is intended to stimulate the body's immune system to produce antibodies against the H1N1 virus, providing protection against infection.
Focetria is a specific vaccine formulation that includes an MF59 adjuvant, which is designed to boost the immune response. It is being compared to non-adjuvanted influenza vaccines in clinical trials to assess its immunogenicity and safety profile. The vaccine is being studied for use in high-risk patient populations.