Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Influsplit Tetra · 1 trial · 1 indication
HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios (Control Group/Co-Ad Group). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata).
Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) and adjusted GMC ratio (Control Group/Co-Ad Group).
| Arm | Type | Description |
|---|---|---|
| Co-Ad Group | EXPERIMENTAL | Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28. |
| Control Group | EXPERIMENTAL | Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28. |
| Name | Type | Description |
|---|---|---|
| Influsplit™ Tetra (Fluarix™ Tetra) | BIOLOGICAL | Intramuscular injection, 1 dose each in Control and Co-Ad groups. |
| Pneumovax™ 23 | BIOLOGICAL | Intramuscular injection, 1 dose each in Control and Co-Ad groups. |
| Placebo (Saline) | BIOLOGICAL | Intramuscular injection, 1 dose each in Control and Co-Ad groups. |
Inclusion Criteria: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). * A male or female aged 50 years or above at the time of the first vaccination at risk for complicatio...
Influsplit Tetra is a quadrivalent influenza vaccine being developed by GSK plc for the prevention of influenza. It is currently in Phase 3 clinical development and is intended for use in adults 50 years of age and older, as evaluated in a completed clinical trial.
Influsplit Tetra is a quadrivalent influenza vaccine designed to provide immunity against four influenza virus strains. As a vaccine, it works by stimulating the immune system to produce antibodies against the included strains, offering protection against seasonal influenza.
Influsplit Tetra is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The vaccine is being studied for the prevention of influenza in adults.
Influsplit Tetra is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. A Phase 3 trial has been completed to evaluate its immunogenicity and safety.
Influsplit Tetra has one completed Phase 3 clinical trial, NCT02218697, which evaluated its immunogenicity and safety when co-administered with Pneumovax 23 in adults 50 years and older. The trial enrolled 357 participants and was conducted in Belgium and France.
Yes, Influsplit Tetra is also known as Fluarix Tetra. The clinical trial NCT02218697 refers to the vaccine as Influsplit Tetra (Fluarix Tetra), indicating that these names are used interchangeably for the same quadrivalent influenza vaccine.