Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GSK Biologicals' influenza vaccine GSK1557482A
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 ...
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Fluviral is a trivalent split virion influenza vaccine developed by GSK plc for the prevention of influenza in adults. It is studied in adults aged 18 years and older, including adults over 60 years, and is given as a seasonal vaccine formulation that changes with each influenza season.
Fluviral is used for immunization against influenza in adults. Clinical studies have evaluated it in adults aged 18 years and older, including people over 60 years, and it is designed to protect against seasonal influenza. It is studied as a trivalent split virion influenza vaccine.
Fluviral is made by GSK plc, which trades under the ticker GSK. GSK Biologicals develops and studies the vaccine, and the clinical trials of Fluviral were run under the GlaxoSmithKline Biologicals name.
Fluviral has been studied in Phase 3 clinical trials. Five trials of Fluviral are listed, all of them completed, with no active trials currently listed. The studies enrolled a total of 1,464 participants and used randomized, double-blind, controlled designs.
Fluviral has been evaluated in completed Phase 3 trials including NCT01878825, NCT01626820, NCT01389479, and NCT01153685. These studies assessed immunogenicity and safety in adults, with the largest trial, NCT01389479, enrolling 1,000 healthy adults. Several trials were conducted in Canada.
Yes. Fluviral, Fluviral®, and Fluviral™ all refer to the same GSK influenza vaccine. The registered and trademark symbols are simply stylized forms of the same product name, so searches for any of these terms point to the same trivalent split virion influenza vaccine.