Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fluarix VB · 1 trial · 1 indication
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.
| Arm | Type | Description |
|---|---|---|
| GSK2282512A 1 Group | EXPERIMENTAL | Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Victoria strain Fluarix Group | ACTIVE_COMPARATOR | Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Yamagata strain Fluarix Group | ACTIVE_COMPARATOR | Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| GSK2282512A 2 Group | EXPERIMENTAL | Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants \<12 months of age. |
| Name | Type | Description |
|---|---|---|
| Quadrivalent seasonal influenza vaccine GSK2282512A | BIOLOGICAL | For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 17 years of age, single intramuscular dose. |
| Fluarix™ VB | BIOLOGICAL | For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose. |
| Fluarix™ YB | BIOLOGICAL | For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose |
Inclusion Criteria: * Subjects who the investigator believes that they and/or their parent(s) or legally acceptable representative(s) can and will comply with the requirements of the protocol. * A male or female child aged between 6 months and 17 years inclusive at the time of the first vaccination...
Fluarix VB is a seasonal influenza vaccine being developed for the prevention of influenza. It is intended for use in children as young as 6 months of age. The vaccine is designed to generate an immune response against influenza viruses, helping to protect against seasonal flu infection.
Fluarix VB is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical development of this seasonal influenza vaccine candidate for use in children.
Fluarix VB 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 safety and immunogenicity in children.
Fluarix VB has one completed Phase 3 clinical trial, registered as NCT01198756. This study evaluated the safety and immunogenicity of GSK Biologicals' seasonal influenza vaccine in children. The trial enrolled 3,109 participants across the United States, Canada, Mexico, Spain, and Taiwan.
Fluarix VB is a seasonal influenza vaccine that works by stimulating the immune system to produce antibodies against influenza viruses. It is designed to be administered to children to help protect them against seasonal flu. The vaccine's mechanism involves presenting influenza antigens to the immune system to generate a protective response.