Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fluarix Tetra · 1 trial · 1 indication
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cutoff value of 1:10. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination HI titer less than (\<) 1:10 and a post-vaccination HI titer ≥1:40 or pre-vaccination HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination HI titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
SPP was defined as the number of vaccinated subjects with a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
MGI also known as the seroconversion factor \[SCF\] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
| Arm | Type | Description |
|---|---|---|
| Fluarix Tetra (Southern Hemisphere) Adult Group | EXPERIMENTAL | Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. |
| Fluarix Tetra (Southern Hemisphere) Elderly Group | EXPERIMENTAL | Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. |
| Name | Type | Description |
|---|---|---|
| Fluarix Tetra | BIOLOGICAL | One dose of the Fluarix™ Tetra vaccine was administered to all subjects on Day 0 (Visit 1) intramuscularly into the deltoid of the non-dominant arm. |
Inclusion Criteria: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject prior to performing any study specific procedure. * A male or female aged 18 years or above at the time of vaccinat...
Fluarix Tetra is a quadrivalent split virion influenza vaccine used for the prevention of influenza in adults 18 years of age and above. It is designed to provide protection against four influenza virus strains, including two A subtypes and two B lineages, as indicated in its clinical development program.
Fluarix Tetra is developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The vaccine is being investigated for its immunogenicity and reactogenicity in adults, as part of GSK's infectious disease portfolio.
Fluarix Tetra is in Phase 3 clinical development. It is an investigational vaccine, not yet approved by regulatory authorities. A Phase 3 trial has been completed to evaluate its immunogenicity and reactogenicity in adults aged 18 years and above.
Fluarix Tetra has one completed Phase 3 clinical trial, identified as NCT02369341. This study, titled 'Immunogenicity and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra (2015 Season Southern Hemisphere) in Adults 18 Years of Age and Above,' was conducted in Brazil with 121 participants.
Fluarix Tetra is a quadrivalent formulation of the influenza vaccine, containing four virus strains, whereas Fluarix is typically a trivalent vaccine containing three strains. The 'Tetra' designation indicates the quadrivalent composition, distinguishing it from the trivalent version.