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H7N9c low dose with adjuvant · 1 trial · 1 indication
Immunogenicity was measured by Hemagglutination Inhibition (HI) assay and summarized through the geometric mean titers (GMTs) at baseline (day 1) and three weeks after the second (day 43) vaccination
Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after second (day 43) vaccination.
Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after second (day 43) vaccination. Seroconversion is defined as postvaccination HI titer\> 40 for subjects with baseline (day 1); HI titer \<1:10 or a minimum 4-fold increase in titer for subjects with baseline titer \>1:10.
Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after second (Day 43) vaccination.
Safety was assessed as the number of subjects who reported any AEs, and at least possibly related AEs are collected from day 1 to day 43 following vaccination with adjuvanted and unadjuvanted formulations of H7N9c vaccine.
The number of subjects reporting unsolicited adverse events after receiving adjuvanted and unadjuvanted formulations of H7N9c vaccine was reported. Safety was assessed as the number of subjects who reported SAEs, at least possibly related SAEs, new onset of chronic diseases (NOCDs), medically attended AEs, AEs of Special Interest (AESIs), AEs leading to withdrawal from the study were collected from day 1 to day 366 following vaccination with adjuvanted and unadjuvanted formulations of H7N9 vaccine.
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 to day 7 of vaccination of adjuvanted and unadjuvanted formulations of H7N9c vaccine.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | H7N9c low dose with adjuvant |
| Group B | EXPERIMENTAL | H7N9c medium dose with adjuvant |
| Group C | EXPERIMENTAL | H7N9c high dose with adjuvant |
| Group D | EXPERIMENTAL | H7N9c high dose without adjuvant |
| Name | Type | Description |
|---|---|---|
| H7N9c low dose with adjuvant | BIOLOGICAL | - |
| H7N9c medium dose with adjuvant | BIOLOGICAL | - |
| H7N9c high dose with adjuvant | BIOLOGICAL | - |
| H7N9c high dose without adjuvant | BIOLOGICAL | - |
Inclusion Criteria: 1. Healthy adult subject ages 18-64 years. 2. Individuals willing to provide written informed consent 3. Individuals in good health. 4. Individuals who can comply with study procedures and follow-up. Exclusion Criteria: 1. Individuals with history of cognitive or behavioral im...
H7N9c low dose with adjuvant is an investigational H7N9 influenza vaccine being studied for the prevention of H7N9 influenza. It is a low-dose formulation administered with an adjuvant to enhance the immune response. The vaccine is currently in Phase 1 clinical development.
H7N9c low dose with adjuvant is being developed by Novartis AG, a global healthcare company. Novartis is listed on the stock exchange under the ticker symbol NVS. The vaccine is currently in Phase 1 clinical development for H7N9 influenza.
H7N9c low dose with adjuvant is in Phase 1 clinical development. It is an investigational vaccine for H7N9 influenza and has not yet been approved by regulatory authorities. The Phase 1 trial has been completed.
H7N9c low dose with adjuvant was studied in a Phase 1 clinical trial with the identifier NCT01928472. This was a dose-finding study of four dosage levels of an H7N9 influenza vaccine in adults between the ages of 18 and 65 years. The trial was conducted in the United States and has been completed.
Yes, H7N9c low dose with adjuvant is a formulation of an H7N9 influenza vaccine. It is designed to protect against H7N9 influenza, a subtype of influenza A virus. The vaccine is currently in Phase 1 clinical development and is being studied for its safety and immunogenicity.