Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fluarix Quadrivalent · 1 trial · 1 indication
Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer ≥ 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Mean geometric increase was defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Seroprotection rate was defined as the number of vaccinees with a serum HI titer greater than or equal to(≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
| Arm | Type | Description |
|---|---|---|
| Fluarix Quadrivalent Primed Group | EXPERIMENTAL | Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm. |
| Fluarix Quadrivalent Unprimed Group | EXPERIMENTAL | Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm. |
| Name | Type | Description |
|---|---|---|
| Fluarix Quadrivalent | BIOLOGICAL | 1 or 2 doses administered intramuscularly (IM) in deltoid region depending on the priming status |
Inclusion Criteria: * Subjects who the investigator believes that parent(s)/LAR(s) can and will comply with the requirements of the protocol. * Children, male or female who received a 2-dose vaccination in the study 115345 (NCT01439360). * Written informed consent obtained from the parent(s)/LAR(s)...
Fluarix Quadrivalent is an investigational vaccine being studied for the prevention of influenza. It is a quadrivalent influenza vaccine developed by GSK plc. The drug is currently in Phase 3 clinical development and has been evaluated in a completed clinical trial involving children.
Fluarix Quadrivalent is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's immunogenicity and safety for influenza prevention.
Fluarix Quadrivalent is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the vaccine remains under clinical investigation for influenza.
Fluarix Quadrivalent has one completed Phase 3 clinical trial with the identifier NCT01702454. This study evaluated the immunogenicity and safety of the vaccine in children who previously participated in a prior study. The trial enrolled 470 participants across Czechia, Poland, Spain, and the United Kingdom.
Fluarix Quadrivalent is a quadrivalent formulation of the influenza vaccine, designed to protect against four influenza virus strains. It is distinct from the trivalent Fluarix vaccine, which targets three strains. Both are developed by GSK plc, but they differ in the number of strains they cover.