Trial Outcomes & Findings for Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine, Fluarix/Influsplit Tetra® (2013/2014 Season), in Adults 18 Years of Age and Older (NCT NCT01878812)

Last Updated: 2018-09-07

Results Overview

The strains assessed were: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) ,Flu B/Brisbane/60/2008 Victoria HI. Titers are presented as geometric mean titers (GMTs).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

117 participants

Primary outcome timeframe

At Days 0 and 21

Results posted on

2018-09-07

Participant Flow

Participant milestones

Participant milestones
Measure	Fluarix/Influsplit Tetra® Adult Group Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix/Influsplit Tetra® Elderly Group Subjects \>60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Study STARTED	60	57
Overall Study COMPLETED	60	57
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine, Fluarix/Influsplit Tetra® (2013/2014 Season), in Adults 18 Years of Age and Older

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluarix/Influsplit Tetra® Adult Group n=60 Participants Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix/Influsplit Tetra® Elderly Group n=57 Participants Subjects \>60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.	Total n=117 Participants Total of all reporting groups
Age, Continuous	38.7 Years STANDARD_DEVIATION 12.24 • n=5 Participants	70.6 Years STANDARD_DEVIATION 6.81 • n=7 Participants	54.24 Years STANDARD_DEVIATION 18.84 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	26 Participants n=7 Participants	54 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Days 0 and 21

Population: The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit Tetra® Adult Group n=60 Participants Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix/Influsplit Tetra® Elderly Group n=56 Participants Subjects \>60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Anti-HI Antibody Titers Against 4 Strains of Influenza Disease Flu A/Christchurch/16/2010 H1N1, Day 0 [N=60,56]	29.8 Titers Interval 20.7 to 42.8	14.9 Titers Interval 10.9 to 20.4
Anti-HI Antibody Titers Against 4 Strains of Influenza Disease Flu A/Texas/50/2012 H3N2, Day 0 [N=60,56]	13.1 Titers Interval 10.1 to 17.0	13.5 Titers Interval 10.1 to 18.1
Anti-HI Antibody Titers Against 4 Strains of Influenza Disease Flu B/Mass/2/2012 Yamagata, Day 0 [N=60,56]	151.0 Titers Interval 111.3 to 204.7	110.4 Titers Interval 88.5 to 137.6
Anti-HI Antibody Titers Against 4 Strains of Influenza Disease Flu B/Brisbane/60/2008 Victoria, Day 0 [N=60,56]	58.5 Titers Interval 44.4 to 77.1	56.6 Titers Interval 44.6 to 71.7
Anti-HI Antibody Titers Against 4 Strains of Influenza Disease Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56]	94.0 Titers Interval 74.1 to 119.3	77.9 Titers Interval 58.5 to 103.9
Anti-HI Antibody Titers Against 4 Strains of Influenza Disease Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56]	346.9 Titers Interval 288.0 to 417.9	239.2 Titers Interval 193.3 to 296.0
Anti-HI Antibody Titers Against 4 Strains of Influenza Disease Flu A/Christchurch/16/2010 H1N1, Day 21 [N=60,56]	505.0 Titers Interval 400.1 to 637.4	230.3 Titers Interval 160.7 to 330.2
Anti-HI Antibody Titers Against 4 Strains of Influenza Disease Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56]	792.6 Titers Interval 661.6 to 949.5	535.0 Titers Interval 442.2 to 647.2

PRIMARY outcome

Timeframe: At Day 21

Population: The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.

The strains are: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI,(referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroprotected subject is defined as a subject with serum HI titre ≥ 1:40.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit Tetra® Adult Group n=60 Participants Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix/Influsplit Tetra® Elderly Group n=56 Participants Subjects \>60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56]	54 Subjects	40 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease Flu B/Mass/2/2012 Yamagata, Day 0 [N=60,56]	56 Subjects	52 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56]	60 Subjects	56 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease Flu B/Brisbane/60/2008 Victoria, Day 0 [N=60,56]	43 Subjects	40 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease Flu A/Christchurch/16/2010 H1N1, Day 0 [N=60,56]	29 Subjects	12 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease Flu A/Christchurch/16/2010 H1N1, Day 21 [N=60,56]	60 Subjects	49 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease Flu A/Texas/50/2012 H3N2, Day 0 [N=60,56]	12 Subjects	15 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56]	60 Subjects	55 Subjects

PRIMARY outcome

Timeframe: At Day 21

Population: The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.

The strains are: Flu A/Christchurch/16/2010 H1N1 HI,(referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroconverted subject is defined as a subject with either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit Tetra® Adult Group n=60 Participants Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix/Influsplit Tetra® Elderly Group n=56 Participants Subjects \>60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease Flu A/Christch/16/2010 H1N1, Day 21 [N=60,56]	48 Subjects	43 Subjects
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56]	41 Subjects	27 Subjects
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56]	35 Subjects	32 Subjects
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56]	37 Subjects	24 Subjects

PRIMARY outcome

Timeframe: At Day 21

Population: The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit Tetra® Adult Group n=60 Participants Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix/Influsplit Tetra® Elderly Group n=56 Participants Subjects \>60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease Flu A/Christch/16/2010 H1N1, Day 21 [N=60,56]	17.0 Fold increase Interval 11.6 to 24.8	15.4 Fold increase Interval 10.5 to 22.6
Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56]	7.2 Fold increase Interval 5.5 to 9.3	5.8 Fold increase Interval 4.3 to 7.8
Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56]	5.3 Fold increase Interval 3.8 to 7.2	4.8 Fold increase Interval 3.9 to 6.1
Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56]	5.9 Fold increase Interval 4.4 to 7.9	4.2 Fold increase Interval 3.2 to 5.7

PRIMARY outcome

Timeframe: During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)

Population: The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit Tetra® Adult Group n=48 Participants Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix/Influsplit Tetra® Elderly Group n=44 Participants Subjects \>60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease Flu A/Christch/16/2010 H1N1, Day 21 [N=31,44]	100 Percentage of subjects	84.1 Percentage of subjects
Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease Flu A/Texas/50/2012 H3N2, Day 21 [N=48,41]	87.5 Percentage of subjects	61.0 Percentage of subjects
Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease Flu B/Mass/2/2012 Yamagata, Day 21 [N=17, 16]	100 Percentage of subjects	93.8 Percentage of subjects
Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease Flu B/Brisbane/60/2008 Victoria, Day 21 [N=4,4]	100 Percentage of subjects	100 Percentage of subjects

SECONDARY outcome

Timeframe: During a 21-day follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)

Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit Tetra® Adult Group n=60 Participants Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix/Influsplit Tetra® Elderly Group n=57 Participants Subjects \>60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Solicited Local Symptoms Any Ecchymosis	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Ecchymosis	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any Induration	6 Subjects	5 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Induration	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any Pain	37 Subjects	19 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Pain	1 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any Redness	3 Subjects	6 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Redness	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any Swelling	3 Subjects	2 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 Swelling	0 Subjects	0 Subjects

SECONDARY outcome

Timeframe: During the entire study period (Days 0 to 21)

Population: The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered with the respective symptoms reported.

Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. The number of days is expressed as a mean value.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit Tetra® Adult Group n=37 Participants Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix/Influsplit Tetra® Elderly Group n=19 Participants Subjects \>60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Days of Solicited Local Symptoms Induration [N=6;5]	1.8 Days Interval 1.0 to 2.0	2.2 Days Interval 2.0 to 3.0
Number of Days of Solicited Local Symptoms Pain [N=37;19]	2.2 Days Interval 2.0 to 3.0	1.9 Days Interval 1.0 to 2.0
Number of Days of Solicited Local Symptoms Redness [N=3;6]	2.0 Days Interval 1.0 to 3.0	1.5 Days Interval 1.0 to 2.0
Number of Days of Solicited Local Symptoms Swelling [N=3;2]	2.7 Days Interval 2.0 to 3.0	2.0 Days Interval 2.0 to 2.0

SECONDARY outcome

Timeframe: During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)

Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and temperature \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\],. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit Tetra® Adult Group n=60 Participants Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix/Influsplit Tetra® Elderly Group n=57 Participants Subjects \>60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Solicited General Symptoms Any Arthralgia	3 Subjects	6 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Arthralgia	1 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Arthralgia	1 Subjects	4 Subjects
Number of Subjects With Solicited General Symptoms Any Fatigue	10 Subjects	4 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Fatigue	1 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Fatigue	8 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Any Gastrointestinal symptoms	3 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Gastrointestinal symptoms	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Gastrointestinal symptoms	0 Subjects	1 Subjects
Number of Subjects With Solicited General Symptoms Any Headache	9 Subjects	5 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Headache	1 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Headache	4 Subjects	4 Subjects
Number of Subjects With Solicited General Symptoms Any Myalgia	14 Subjects	7 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Myalgia	1 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Sweating	2 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Sweating	1 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Sweating	1 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Any Shivering	3 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Shivering	1 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Shivering	3 Subjects	2 Subjects
Number of Subjects With Solicited General Symptoms Any Temperature	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Grade 3 Temperature	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Temperature	0 Subjects	0 Subjects
Number of Subjects With Solicited General Symptoms Related Myalgia	12 Subjects	5 Subjects

SECONDARY outcome

Timeframe: During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)

Population: The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered with the respective symptoms reported.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit Tetra® Adult Group n=14 Participants Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix/Influsplit Tetra® Elderly Group n=7 Participants Subjects \>60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Days of Solicited General Symptoms Arthralgia [N=3;6]	2.7 Days Interval 2.0 to 3.0	1.8 Days Interval 1.0 to 2.0
Number of Days of Solicited General Symptoms Fatigue [N=10;4]	1.6 Days Interval 1.0 to 2.0	2.8 Days Interval 2.0 to 3.5
Number of Days of Solicited General Symptoms Headache [N=9;5]	1.9 Days Interval 1.0 to 2.0	1.4 Days Interval 1.0 to 2.0
Number of Days of Solicited General Symptoms Myalgia [N=14;7]	1.8 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0
Number of Days of Solicited General Symptoms Sweating [N=3;2]	1.7 Days Interval 1.0 to 3.0	2.0 Days Interval 2.0 to 2.0
Number of Days of Solicited General Symptoms Gastrointestinal symptoms [N=3;2]	2.0 Days Interval 1.0 to 3.0	2.5 Days Interval 1.0 to 4.0
Number of Days of Solicited General Symptoms Shivering [N=2;0]	2.0 Days Interval 1.0 to 3.0	NA Days Duration of this symptom was not assessed or confirmation was missing because the symptom was not reported in this group.

SECONDARY outcome

Timeframe: During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit Tetra® Adult Group n=60 Participants Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix/Influsplit Tetra® Elderly Group n=57 Participants Subjects \>60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Subjects with any AE(s)	6 Subjects	9 Subjects
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Subjects with grade 3 AE(s)	1 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Subjects with related AE(s)	0 Subjects	0 Subjects

SECONDARY outcome

Timeframe: At Days 0 and 21

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit Tetra® Adult Group n=60 Participants Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix/Influsplit Tetra® Elderly Group n=57 Participants Subjects \>60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs). Subjects with any SAE(s)	0 Subjects	0 Subjects
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs). Subjects with related SAE(s)	0 Subjects	0 Subjects

SECONDARY outcome

Timeframe: At Days 0 and 21

Population: The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.

The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. Titers are presented as geometric mean titers (GMTs). Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit Tetra® Adult Group n=60 Participants Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix/Influsplit Tetra® Elderly Group n=56 Participants Subjects \>60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status Flu A/Christch/16/2010 H1N1, Day 0,Y [N=12,24]	65.4 Titers Interval 31.9 to 134.1	16.1 Titers Interval 10.5 to 24.7
Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status Flu B/Mass/2/2012 Yamagata, Day 0,Y [N=12,24]	174.4 Titers Interval 88.4 to 343.8	111.6 Titers Interval 83.7 to 148.7
Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status Flu B/Mass/2/2012 Yamagata, Day 0,N [N=48,32]	145.6 Titers Interval 102.4 to 207.1	109.5 Titers Interval 78.4 to 152.8
Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status Flu B/Brisbane/60/2008 Victoria, Day 0,Y [N=12,24]	113.2 Titers Interval 67.2 to 190.8	62.7 Titers Interval 44.5 to 88.2
Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status Flu B/Brisbane/60/2008 Victoria, Day 0,N [N=48,32]	49.6 Titers Interval 36.4 to 67.6	52.4 Titers Interval 37.2 to 73.6
Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status Flu A/Christch/16/2010 H1N1, Day 21,Y [N=12,24]	570.2 Titers Interval 362.2 to 897.4	198.6 Titers Interval 111.2 to 355.0
Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status Flu A/Christch/16/2010 H1N1, Day 21,N [N=48,32]	489.9 Titers Interval 372.2 to 644.9	257.4 Titers Interval 159.1 to 416.2
Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status Flu A/Texas/50/2012 H3N2, Day 21,Y [N=12,24]	119.9 Titers Interval 67.8 to 211.9	68.2 Titers Interval 44.9 to 103.7
Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status Flu A/Texas/50/2012 H3N2, Day 21,N [N=48,32]	88.5 Titers Interval 67.6 to 115.8	86.1 Titers Interval 57.3 to 129.6
Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status Flu B/Mass/2/2012 Yamagata, Day 21,Y [N=12,24]	522.9 Titers Interval 316.8 to 863.0	415.2 Titers Interval 305.8 to 563.6
Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status Flu B/Mass/2/2012 Yamagata, Day 21,N [N=48,32]	879.5 Titers Interval 729.8 to 1059.9	647.0 Titers Interval 511.9 to 817.8
Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status Flu B/Brisbane/60/2008 Victoria,Day 21,Y [N=12,24]	269.0 Titers Interval 188.1 to 384.8	162.2 Titers Interval 117.9 to 223.2
Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status Flu B/Brisbane/60/2008 Victoria,Day 21,N [N=48,32]	369.7 Titers Interval 297.6 to 459.1	320.0 Titers Interval 248.3 to 412.5
Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status Flu A/Christch/16/2010 H1N1, Day 0,N [N=48,32]	24.5 Titers Interval 16.2 to 36.8	14.1 Titers Interval 8.9 to 22.4
Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status Flu A/Texas/50/2012 H3N2, Day 0, Y [N=12.24]	21.8 Titers Interval 9.5 to 50.0	15.0 Titers Interval 9.4 to 23.8
Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status Flu A/Texas/50/2012 H3N2, Day 0, N [N=48,32]	11.5 Titers Interval 8.9 to 15.0	12.6 Titers Interval 8.5 to 18.6

SECONDARY outcome

Timeframe: At Day 21

Population: The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.

The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroprotected subject is defined as a subject with serum HI titre ≥ 1:40. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit Tetra® Adult Group n=60 Participants Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix/Influsplit Tetra® Elderly Group n=56 Participants Subjects \>60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu A/Christch/16/2010 H1N1, Day 0,Y [N=12,24]	9 Subjects	5 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu A/Christch/16/2010 H1N1, Day 0,N [N=48,32]	20 Subjects	7 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu A/Texas/50/2012 H3N2, Day 0, Y [N=12.24]	4 Subjects	7 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu A/Texas/50/2012 H3N2, Day 0, N [N=48,32]	8 Subjects	8 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu B/Mass/2/2012 Yamagata, Day 0,Y [N=12,24]	11 Subjects	23 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu B/Mass/2/2012 Yamagata, Day 0,N [N=48,32]	45 Subjects	29 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu B/Brisbane/60/2008 Victoria, Day 0,Y [N=12,24]	11 Subjects	20 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu B/Brisbane/60/2008 Victoria, Day 0,N [N=48,32]	32 Subjects	20 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu A/Christch/16/2010 H1N1, Day 21,Y [N=12,24]	12 Subjects	21 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu A/Christch/16/2010 H1N1, Day 21,N [N=48,32]	48 Subjects	28 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu A/Texas/50/2012 H3N2, Day 21,Y [N=12,24]	11 Subjects	18 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu A/Texas/50/2012 H3N2, Day 21,N [N=48,32]	43 Subjects	22 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu B/Mass/2/2012 Yamagata, Day 21,Y [N=12,24]	12 Subjects	24 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu B/Mass/2/2012 Yamagata, Day 21,N [N=48,32]	48 Subjects	32 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu B/Brisbane/60/2008 Victoria,Day 21,Y [N=12,24]	12 Subjects	23 Subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu B/Brisbane/60/2008 Victoria,Day 21,N [N=48,32]	48 Subjects	32 Subjects

SECONDARY outcome

Timeframe: At Day 21

Population: The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.

The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroconverted subject is defined as a subject with either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit Tetra® Adult Group n=60 Participants Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix/Influsplit Tetra® Elderly Group n=56 Participants Subjects \>60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu A/Christch/16/2010 H1N1, Day 21,Y [N=12,24]	8 Subjects	18 Subjects
Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu A/Christch/16/2010 H1N1, Day 21,N [N=48,32]	40 Subjects	25 Subjects
Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu A/Texas/50/2012 H3N2, Day 21,Y [N=12,24]	7 Subjects	10 Subjects
Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu A/Texas/50/2012 H3N2, Day 21,N [N=48,32]	34 Subjects	17 Subjects
Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu B/Mass/2/2012 Yamagata, Day 21,N [N=48,32]	32 Subjects	22 Subjects
Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu B/Brisbane/60/2008 Victoria,Day 21,Y [N=12,24]	2 Subjects	4 Subjects
Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu B/Brisbane/60/2008 Victoria,Day 21,N [N=48,32]	35 Subjects	20 Subjects
Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status Flu B/Mass/2/2012 Yamagata, Day 21,Y [N=12,24]	3 Subjects	10 Subjects

SECONDARY outcome

Timeframe: At Day 21

Population: The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.

The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. MGI was defined as the fold increase in serum HI geometric mean titers post-vaccination compared to Day 0. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit Tetra® Adult Group n=60 Participants Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix/Influsplit Tetra® Elderly Group n=56 Participants Subjects \>60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status Flu A/Christch/16/2010 H1N1, Day 21,Y [N=12,24]	8.7 Titers Interval 3.3 to 23.2	12.4 Titers Interval 7.1 to 21.6
Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status Flu A/Christch/16/2010 H1N1, Day 21,N [N=48,32]	20.0 Titers Interval 13.2 to 30.3	18.2 Titers Interval 10.6 to 31.4
Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status Flu A/Texas/50/2012 H3N2, Day 21,Y [N=12,24]	5.5 Titers Interval 2.5 to 12.0	4.6 Titers Interval 2.9 to 7.2
Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status Flu A/Texas/50/2012 H3N2, Day 21,N [N=48,32]	7.7 Titers Interval 5.8 to 10.1	6.9 Titers Interval 4.5 to 10.4
Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status Flu B/Mass/2/2012 Yamagata, Day 21,Y [N=12,24]	3.0 Titers Interval 1.6 to 5.7	3.7 Titers Interval 2.7 to 5.2
Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status Flu B/Mass/2/2012 Yamagata, Day 21,N [N=48,32]	6.0 Titers Interval 4.2 to 8.6	5.9 Titers Interval 4.4 to 7.9
Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status Flu B/Brisbane/60/2008 Victoria,Day 21,Y [N=12,24]	2.4 Titers Interval 1.6 to 3.6	2.6 Titers Interval 1.7 to 3.9
Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status Flu B/Brisbane/60/2008 Victoria,Day 21,N [N=48,32]	7.4 Titers Interval 5.4 to 10.3	6.1 Titers Interval 4.2 to 8.9

Adverse Events

Fluarix/Influsplit Tetra® Adult Group

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Fluarix/Influsplit Tetra® Elderly Group

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fluarix/Influsplit Tetra® Adult Group n=60 participants at risk Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix/Influsplit Tetra® Elderly Group n=57 participants at risk Subjects \>60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
General disorders Induration	10.0% 6/60 • Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).	8.8% 5/57 • Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).
General disorders Pain	61.7% 37/60 • Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).	33.3% 19/57 • Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).
General disorders Redness	5.0% 3/60 • Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).	10.5% 6/57 • Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).
General disorders Swelling	5.0% 3/60 • Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).	3.5% 2/57 • Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).
General disorders Arthralgia	5.0% 3/60 • Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).	10.5% 6/57 • Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).
General disorders Fatigue	16.7% 10/60 • Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).	7.0% 4/57 • Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).
General disorders Gastrointestinal symptoms	5.0% 3/60 • Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).	3.5% 2/57 • Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).
General disorders Headache	15.0% 9/60 • Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).	8.8% 5/57 • Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).
General disorders Myalgia	23.3% 14/60 • Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).	12.3% 7/57 • Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).
General disorders Sweating	5.0% 3/60 • Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).	3.5% 2/57 • Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER