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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02242643 | Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age | PHASE3 | COMPLETED | 2,432 | — | — | Oct 1, 2014 | Jun 23, 2015 | Sep 7, 2018 | 66 | United States, Mexico |
| NCT01440387 | A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older | PHASE3 | COMPLETED | 112 | — | — | Sep 30, 2011 | Oct 22, 2011 | Sep 7, 2018 | 1 | Canada |
| NCT01218308 | A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children | PHASE3 | COMPLETED | 5,220 | — | — | Dec 9, 2010 | Jan 9, 2012 | Aug 1, 2018 | 12 | Bangladesh, Dominican Republic +6 |
| NCT01974895 | Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age | PHASE2 | COMPLETED | 316 | — | — | Oct 23, 2013 | Jul 3, 2014 | Sep 7, 2018 | 12 | United States |
Antibody titers were expressed as Seroconversion rate (SCR) and SCR difference. SCR was defined as the proportion of vaccinees who had either a pre-vaccination 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. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).
HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).
Antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu B/Florida/4/06 (Yamagata), FluB/Bri/60/08 (Victoria), Flu A/CAL/7/09 (H1N1) and Flu A/Victoria/210/09 (H3N2) antigens.
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.
A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (\<) 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 assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.
SCFs were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.
To confirm influenza A and/or B disease, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.
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), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the FluLaval Quadrivalent Group. Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010. Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010.
| Arm | Type | Description |
|---|---|---|
| FluLaval™ Quadrivalent Group | EXPERIMENTAL | Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age). |
| Fluzone® Quadrivalent Group | ACTIVE_COMPARATOR | Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age). |
| FLULAVAL QUADRIVALENT Adult Group | EXPERIMENTAL | Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. |
| FLULAVAL QUADRIVALENT Elderly Group | EXPERIMENTAL | Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm. |
| FluLaval® Quadrivalent Group | EXPERIMENTAL | Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. |
| Havrix Group | ACTIVE_COMPARATOR | Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. |
| FluLaval Quadrivalent Group | EXPERIMENTAL | Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status. |
| Fluzone Group | ACTIVE_COMPARATOR | Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status. |
| Name | Type | Description |
|---|---|---|
| FluLaval™ Quadrivalent | BIOLOGICAL | 1 or 2 doses administered intramusculary (IM) in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects \<12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively |
| Fluzone® Quadrivalent | BIOLOGICAL | 1 or 2 doses administered IM in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects \<12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively |
| FLULAVAL® QUADRIVALENT | BIOLOGICAL | Intramuscular injection, 1 dose each in FLULAVAL QUADRIVALENT Adults and FLULAVAL QUADRIVALENT Elderly Groups |
| Havrix™ | BIOLOGICAL | Two intramuscular doses for primed subjects. Three intramuscular doses for unprimed subjects. |
| Fluzone® | BIOLOGICAL | 1 or 2 doses administered IM in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects \<12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively. |
Inclusion Criteria: * Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female between, and including, 6 and 35 months of age at the time of the first vaccination. * Wri...