Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fluviral · 7 trials · 3 indications
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
MGI 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/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
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/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine influenza strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.
A seroprotected subject was defined as a subject with serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The influenza vaccine strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.
MGI was defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0).
The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane
A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.
A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination (Day 21) compared to prevaccination (Day 0).
Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Data are displayed as GMTs for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
The cut-off value was defined as a serum HI titer \>= 1:40, which is usually accepted as indicating protection. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
A seroconverted subject is a subject who had either a prevaccination 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. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0). Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
The cut-off value was a titer of 1:40. Data are displayed for each of the three influenza virus vaccine strains: A/Brisbane(H1N1); A/Uruguay(H3N2); B/Brisbane.
Titers, given as geometric mean titers (GMTs), are presented for all three vaccine influenza virus strains.
Seroprotection, defined as a serum HI antibody titer ≥ 1:40, is presented for all three vaccine influenza virus strains.
The fold increase in serum HI antibody titer post-vaccination (Day 21) compared to pre-vaccination (Day 0) was calculated by dividing the geometric mean antibody titers of Day 21 by those of Day 0. Data are presented for all three vaccine influenza virus strains.
| Arm | Type | Description |
|---|---|---|
| Fluviral 18-60 Years Group | EXPERIMENTAL | Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
| Fluviral >60 Years Group | EXPERIMENTAL | Subjects aged \> 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm |
| Fluviral Adults Group | EXPERIMENTAL | Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0. |
| Fluviral Elderly Group | EXPERIMENTAL | Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0. |
| Fluviral A Group | EXPERIMENTAL | Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm. |
| Fluviral B Group | EXPERIMENTAL | Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm. |
| Fluviral Adult Group | EXPERIMENTAL | Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm |
| Fluviral Group | EXPERIMENTAL | - |
| Fluzone Group | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Fluviral™ | BIOLOGICAL | 1 dose administered intramuscularly in deltoid region of non-dominant arm. |
| Fluviral® | BIOLOGICAL | 1 dose administered intramuscularly in deltoid region of non-dominant arm at Day 0 |
| Fluzone® | BIOLOGICAL | Intramuscular, single dose |
Inclusion Criteria: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female 18 years of age and older at the time of the first vaccination. * Written informed consent obtained from the subject. * Healthy subjects or subjects ...
Fluviral is an investigational seasonal influenza vaccine being developed for the prevention of influenza in adults. It is designed to generate an immune response against circulating influenza virus strains. Clinical studies have evaluated its immunogenicity and safety in healthy adults aged 18 years and older, including those over 60 years.
Fluviral is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. GSK has conducted multiple clinical trials to assess the vaccine's safety and immunogenicity across different influenza seasons.
Fluviral is in Phase 3 clinical development. It has completed five Phase 3 trials, with no active trials currently ongoing. The vaccine remains investigational and has not been approved by regulatory authorities. All completed trials focused on evaluating its safety and immunogenicity in adult populations.
Fluviral has been studied in five completed Phase 3 trials, including NCT00718120, NCT00929331, NCT01153685, and NCT01389479. These trials enrolled a total of 1,464 healthy adults aged 18 years and older, primarily in Canada, to evaluate the vaccine's immunogenicity and safety across multiple influenza seasons from 2008 to 2011.
Fluviral is a seasonal influenza vaccine, similar in purpose to standard flu shots, but it is specifically formulated for each influenza season. It is designed to protect against circulating strains and has been tested in healthy adults. However, it remains investigational and is not yet a licensed commercial flu vaccine.