Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01878825 | Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Trivalent Split Virion Influenza Vaccine Fluviral™ (2013-2014 Season) in Adults Aged 18 Years and Older | PHASE3 | COMPLETED | 121 | — | — | Jul 18, 2013 | Aug 9, 2013 | Sep 7, 2018 | 1 | Canada |
| NCT01626820 | Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Fluviral® (2012/2013 Season) in Adults | PHASE3 | COMPLETED | 113 | — | — | Jul 19, 2012 | Aug 10, 2012 | Sep 7, 2018 | 1 | Canada |
| NCT01153685 | Immunogenicity & Safety Study of Fluviral® (2010 - 2011 Season) in Adults Aged 18 to 60 Years and Over 60 Years | PHASE3 | COMPLETED | 120 | — | — | Jul 9, 2010 | Jul 31, 2010 | Jun 8, 2018 | 1 | Canada |
| NCT00505453 | A Phase III, Open-Label, Single-Dose Study to Evaluate the Safety and Immunogenicity of Fluviral® Vaccine | PHASE3 | COMPLETED | 110 | — | — | Jul 1, 2007 | Aug 1, 2007 | Nov 4, 2016 | 2 | Canada |
| NCT01389479 | Study to Evaluate the Safety, Tolerance and Immunogenicity of Fluviral™ in Healthy Adults | PHASE3 | COMPLETED | 1,000 | — | — | Jan 1, 2005 | May 1, 2005 | Jun 8, 2017 | - | — |
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).
| 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 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 ...