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Multi-dose Quadrivalent Influenza Vaccine · 1 trial · 1 indication
Anti-hemagglutinin (HA) antibody titers against the 4 influenza strains are assessed by a hemagglutination inhibition (HAI) assay
Anti-HA antibody titers against the 4 influenza strains are assessed by an HAI assay. GMT ratio is assessed as the individual ratio of post-/pre-vaccination titers
Anti-HA antibody titers against the 4 influenza strains are assessed by an HAI assay. Seroconversion is defined as either post-vaccination titer ≥ 40 (1/dil), or pre-vaccination titer ≥ 10 (1/dil) and ≥ 4-fold increase in post-vaccination titer
| Arm | Type | Description |
|---|---|---|
| Multi-dose Quadrivalent Influenza Vaccine | EXPERIMENTAL | Quadrivalent influenza vaccine (split-virion, inactivated, 2017-2018 formulation, thiomersal containing) in multi-dose presentation. Participants aged 9 to 17 years will receive 1 dose and subjects aged 6 months to 8 years will receive 2 doses 28 days apart |
| Single-dose Quadrivalent Influenza Vaccine | ACTIVE_COMPARATOR | Quadrivalent influenza vaccine (split-virion, inactivated, 2017-2018 formulation, thiomersal free) in single-dose syringe presentation. Participants aged 9 to 17 years will receive 1 dose and subjects aged 6 months to 8 years will receive 2 doses 28 days apart |
| Name | Type | Description |
|---|---|---|
| Multi-dose Quadrivalent Influenza Vaccine | BIOLOGICAL | 0.5 mL, intramuscular |
| Single-dose Quadrivalent Influenza Vaccine | BIOLOGICAL | 0.5 mL, intramuscular |
Inclusion Criteria: * Aged 6 months to 17 years on the day of inclusion * Assent form has been signed and dated by the subject aged 7 to 17 years, and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and by an independent witness, if requ...
Multi-dose Quadrivalent Influenza Vaccine is an investigational vaccine being developed for the prevention of influenza. It is designed to provide immunity against four influenza virus strains. The vaccine is currently in Phase 3 clinical development and is intended for use in individuals as young as 6 months of age.
Multi-dose Quadrivalent Influenza Vaccine is being developed by Sanofi, a global biopharmaceutical company. Sanofi is listed on the stock exchange under the ticker symbol SNY. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity for influenza prevention.
Multi-dose Quadrivalent Influenza Vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. A Phase 3 clinical trial has been completed to assess its immunogenicity and safety in preventing influenza.
Multi-dose Quadrivalent Influenza Vaccine has been studied in one completed Phase 3 clinical trial, identified as NCT03391193. This trial, titled 'Immunogenicity and Safety of a Multi-Dose Quadrivalent Influenza Vaccine,' enrolled 301 participants in Mexico. The study evaluated the vaccine's safety and immune response in healthy volunteers aged 6 months and older.
No, Multi-dose Quadrivalent Influenza Vaccine is not a monoclonal antibody. Although its modality is listed as a monoclonal antibody in some databases, it is actually a vaccine designed to stimulate the immune system to produce antibodies against influenza. The vaccine is being developed for active immunization against influenza.