Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Swine Influenza · 1 trial · 1 indication
Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (3 to \<9 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.
Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (9 to \<18 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.
Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (18 to \< 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.
Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (≥ 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.
The number of subjects reporting any unsolicited adverse events (AEs) from day 1 through day 21 after last vaccination within each vaccine group are reported. The number of subjects reporting any serious adverse events (SAEs), AEs leading to withdrawal from the study, medically attended AEs, AE of special interest (AESI), new onset chronic disease (NOCDs) from day 1 through day 366, after receiving with H3N2 monovalent vaccine are reported.
The percentages of subjects (3 to ≥ 65 years of age) achieving seroconversion or significant increase in HI antibody titers against H3N2 homologous strain, three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported. Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer \<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43.
The percentages of subjects (3 to ≥ 65 years of age) achieving HI titers ≥1:40 against H3N2 homologous strain at baseline (Day 1) and three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | 3.75 µg H3N2c HA + 0.125 mL MF59 |
| Group B | EXPERIMENTAL | 7.5 µg H3N2c HÁ + 0.250 mL MF59 |
| Group C | EXPERIMENTAL | 15 µg H3N2c unadjuvanted |
| Name | Type | Description |
|---|---|---|
| Swine Influenza | BIOLOGICAL | Comparison of different dosages of vaccines |
Inclusion Criteria: 1. Males and females 3 years of age and older 2. Individuals or, (for children and adolescents) parents or legal guardians, who have given written consent after the nature of the study has been explained according to local regulatory requirements. Assent is required depending on...
Swine Influenza is an investigational monoclonal antibody being developed for the prophylaxis of A/H3N2v Influenza, a variant of the swine-origin influenza virus. It is intended to prevent infection in individuals at risk of exposure to this specific influenza strain.
Swine Influenza is being developed by Novartis AG, a multinational pharmaceutical company headquartered in Switzerland. Novartis trades on the New York Stock Exchange under the ticker symbol NVS.
Swine Influenza is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical evaluation.
Swine Influenza has one completed clinical trial, registered as NCT01855945. This Phase 1 study evaluated the safety and immunogenicity of three dosage levels of the vaccine in children, adolescents, adults, and elderly participants in the United States. The trial enrolled 627 healthy volunteers.
Swine Influenza is described as a monoclonal antibody, not a traditional vaccine. However, the completed clinical trial NCT01855945 is titled as a vaccine study, suggesting the investigational product may be evaluated in a vaccine-like format for prophylaxis against A/H3N2v influenza.