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Trial record 85 of 150 for:    tetracycline

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01878812
Recruitment Status : Completed
First Posted : June 17, 2013
Results First Posted : January 12, 2015
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Fluarix/Influsplit Tetra® (2013-2014 season)
Enrollment 117
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fluarix/Influsplit Tetra® Adult Group Fluarix/Influsplit Tetra® Elderly Group
Hide Arm/Group Description Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm. Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Period Title: Overall Study
Started 60 57
Completed 60 57
Not Completed 0 0
Arm/Group Title Fluarix/Influsplit Tetra® Adult Group Fluarix/Influsplit Tetra® Elderly Group Total
Hide Arm/Group Description Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm. Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm. Total of all reporting groups
Overall Number of Baseline Participants 60 57 117
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 57 participants 117 participants
38.7  (12.24) 70.6  (6.81) 54.24  (18.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 57 participants 117 participants
Female
32
  53.3%
31
  54.4%
63
  53.8%
Male
28
  46.7%
26
  45.6%
54
  46.2%
1.Primary Outcome
Title Anti-HI Antibody Titers Against 4 Strains of Influenza Disease
Hide Description 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).
Time Frame At Days 0 and 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluarix/Influsplit Tetra® Adult Group Fluarix/Influsplit Tetra® Elderly Group
Hide Arm/Group Description:
Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 60 56
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/Christchurch/16/2010 H1N1, Day 0 [N=60,56]
29.8
(20.7 to 42.8)
14.9
(10.9 to 20.4)
Flu A/Texas/50/2012 H3N2, Day 0 [N=60,56]
13.1
(10.1 to 17.0)
13.5
(10.1 to 18.1)
Flu B/Mass/2/2012 Yamagata, Day 0 [N=60,56]
151.0
(111.3 to 204.7)
110.4
(88.5 to 137.6)
Flu B/Brisbane/60/2008 Victoria, Day 0 [N=60,56]
58.5
(44.4 to 77.1)
56.6
(44.6 to 71.7)
Flu A/Christchurch/16/2010 H1N1, Day 21 [N=60,56]
505.0
(400.1 to 637.4)
230.3
(160.7 to 330.2)
Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56]
94.0
(74.1 to 119.3)
77.9
(58.5 to 103.9)
Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56]
792.6
(661.6 to 949.5)
535.0
(442.2 to 647.2)
Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56]
346.9
(288.0 to 417.9)
239.2
(193.3 to 296.0)
2.Primary Outcome
Title Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
Hide Description 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.
Time Frame At Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluarix/Influsplit Tetra® Adult Group Fluarix/Influsplit Tetra® Elderly Group
Hide Arm/Group Description:
Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 60 56
Measure Type: Number
Unit of Measure: Subjects
Flu A/Christchurch/16/2010 H1N1, Day 0 [N=60,56] 29 12
Flu A/Christchurch/16/2010 H1N1, Day 21 [N=60,56] 60 49
Flu A/Texas/50/2012 H3N2, Day 0 [N=60,56] 12 15
Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56] 54 40
Flu B/Mass/2/2012 Yamagata, Day 0 [N=60,56] 56 52
Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56] 60 56
Flu B/Brisbane/60/2008 Victoria, Day 0 [N=60,56] 43 40
Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56] 60 55
3.Primary Outcome
Title Number of Seroconverted Subjects Against 4 Strains of Influenza Disease
Hide Description 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.
Time Frame At Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluarix/Influsplit Tetra® Adult Group Fluarix/Influsplit Tetra® Elderly Group
Hide Arm/Group Description:
Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 60 56
Measure Type: Number
Unit of Measure: Subjects
Flu A/Christch/16/2010 H1N1, Day 21 [N=60,56] 48 43
Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56] 41 27
Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56] 35 32
Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56] 37 24
4.Primary Outcome
Title Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease
Hide Description 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.
Time Frame At Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluarix/Influsplit Tetra® Adult Group Fluarix/Influsplit Tetra® Elderly Group
Hide Arm/Group Description:
Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 60 56
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold increase
Flu A/Christch/16/2010 H1N1, Day 21 [N=60,56]
17.0
(11.6 to 24.8)
15.4
(10.5 to 22.6)
Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56]
7.2
(5.5 to 9.3)
5.8
(4.3 to 7.8)
Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56]
5.3
(3.8 to 7.2)
4.8
(3.9 to 6.1)
Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56]
5.9
(4.4 to 7.9)
4.2
(3.2 to 5.7)
5.Primary Outcome
Title Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease
Hide Description 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. SPP is defined as the percentage of subjects who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40.
Time Frame During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluarix/Influsplit Tetra® Adult Group Fluarix/Influsplit Tetra® Elderly Group
Hide Arm/Group Description:
Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 48 44
Measure Type: Number
Unit of Measure: Percentage of subjects
Flu A/Christch/16/2010 H1N1, Day 21 [N=31,44] 100 84.1
Flu A/Texas/50/2012 H3N2, Day 21 [N=48,41] 87.5 61.0
Flu B/Mass/2/2012 Yamagata, Day 21 [N=17, 16] 100 93.8
Flu B/Brisbane/60/2008 Victoria, Day 21 [N=4,4] 100 100
6.Secondary Outcome
Title Number of Subjects With Solicited Local Symptoms
Hide Description 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.
Time Frame During a 21-day follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluarix/Influsplit Tetra® Adult Group Fluarix/Influsplit Tetra® Elderly Group
Hide Arm/Group Description:
Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 60 57
Measure Type: Number
Unit of Measure: Subjects
Any Ecchymosis 0 0
Grade 3 Ecchymosis 0 0
Any Induration 6 5
Grade 3 Induration 0 0
Any Pain 37 19
Grade 3 Pain 1 0
Any Redness 3 6
Grade 3 Redness 0 0
Any Swelling 3 2
Grade 3 Swelling 0 0
7.Secondary Outcome
Title Number of Days of Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. The number of days is expressed as a mean value.
Time Frame During the entire study period (Days 0 to 21)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered with the respective symptoms reported.
Arm/Group Title Fluarix/Influsplit Tetra® Adult Group Fluarix/Influsplit Tetra® Elderly Group
Hide Arm/Group Description:
Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 37 19
Mean (Inter-Quartile Range)
Unit of Measure: Days
Induration [N=6;5]
1.8
(1.0 to 2.0)
2.2
(2.0 to 3.0)
Pain [N=37;19]
2.2
(2.0 to 3.0)
1.9
(1.0 to 2.0)
Redness [N=3;6]
2.0
(1.0 to 3.0)
1.5
(1.0 to 2.0)
Swelling [N=3;2]
2.7
(2.0 to 3.0)
2.0
(2.0 to 2.0)
8.Secondary Outcome
Title Number of Subjects With Solicited General Symptoms
Hide Description 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.
Time Frame During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluarix/Influsplit Tetra® Adult Group Fluarix/Influsplit Tetra® Elderly Group
Hide Arm/Group Description:
Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 60 57
Measure Type: Number
Unit of Measure: Subjects
Any Arthralgia 3 6
Grade 3 Arthralgia 1 0
Related Arthralgia 1 4
Any Fatigue 10 4
Grade 3 Fatigue 1 0
Related Fatigue 8 2
Any Gastrointestinal symptoms 3 2
Grade 3 Gastrointestinal symptoms 0 0
Related Gastrointestinal symptoms 0 1
Any Headache 9 5
Grade 3 Headache 1 0
Related Headache 4 4
Any Myalgia 14 7
Grade 3 Myalgia 1 0
Related Myalgia 12 5
Any Sweating 2 0
Grade 3 Sweating 1 0
Related Sweating 1 0
Any Shivering 3 2
Grade 3 Shivering 1 0
Related Shivering 3 2
Any Temperature 0 0
Grade 3 Temperature 0 0
Related Temperature 0 0
9.Secondary Outcome
Title Number of Days of Solicited General Symptoms
Hide Description 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. The number of days is expressed as a mean value.
Time Frame During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered with the respective symptoms reported.
Arm/Group Title Fluarix/Influsplit Tetra® Adult Group Fluarix/Influsplit Tetra® Elderly Group
Hide Arm/Group Description:
Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 14 7
Mean (Inter-Quartile Range)
Unit of Measure: Days
Arthralgia [N=3;6]
2.7
(2.0 to 3.0)
1.8
(1.0 to 2.0)
Fatigue [N=10;4]
1.6
(1.0 to 2.0)
2.8
(2.0 to 3.5)
Gastrointestinal symptoms [N=3;2]
2.0
(1.0 to 3.0)
2.5
(1.0 to 4.0)
Headache [N=9;5]
1.9
(1.0 to 2.0)
1.4
(1.0 to 2.0)
Myalgia [N=14;7]
1.8
(1.0 to 2.0)
2.0
(1.0 to 2.0)
Sweating [N=3;2]
1.7
(1.0 to 3.0)
2.0
(2.0 to 2.0)
Shivering [N=2;0]
2.0
(1.0 to 3.0)
NA [1] 
(NA to NA)
[1]
Duration of this symptom was not assessed or confirmation was missing because the symptom was not reported in this group.
10.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Hide Description 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.
Time Frame During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluarix/Influsplit Tetra® Adult Group Fluarix/Influsplit Tetra® Elderly Group
Hide Arm/Group Description:
Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 60 57
Measure Type: Number
Unit of Measure: Subjects
Subjects with any AE(s) 6 9
Subjects with grade 3 AE(s) 1 0
Subjects with related AE(s) 0 0
11.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs).
Hide Description 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.
Time Frame At Days 0 and 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluarix/Influsplit Tetra® Adult Group Fluarix/Influsplit Tetra® Elderly Group
Hide Arm/Group Description:
Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 60 57
Measure Type: Number
Unit of Measure: Subjects
Subjects with any SAE(s) 0 0
Subjects with related SAE(s) 0 0
12.Secondary Outcome
Title Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status
Hide Description 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.
Time Frame At Days 0 and 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluarix/Influsplit Tetra® Adult Group Fluarix/Influsplit Tetra® Elderly Group
Hide Arm/Group Description:
Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 60 56
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/Christch/16/2010 H1N1, Day 0,Y [N=12,24]
65.4
(31.9 to 134.1)
16.1
(10.5 to 24.7)
Flu A/Christch/16/2010 H1N1, Day 0,N [N=48,32]
24.5
(16.2 to 36.8)
14.1
(8.9 to 22.4)
Flu A/Texas/50/2012 H3N2, Day 0, Y [N=12.24]
21.8
(9.5 to 50.0)
15.0
(9.4 to 23.8)
Flu A/Texas/50/2012 H3N2, Day 0, N [N=48,32]
11.5
(8.9 to 15.0)
12.6
(8.5 to 18.6)
Flu B/Mass/2/2012 Yamagata, Day 0,Y [N=12,24]
174.4
(88.4 to 343.8)
111.6
(83.7 to 148.7)
Flu B/Mass/2/2012 Yamagata, Day 0,N [N=48,32]
145.6
(102.4 to 207.1)
109.5
(78.4 to 152.8)
Flu B/Brisbane/60/2008 Victoria, Day 0,Y [N=12,24]
113.2
(67.2 to 190.8)
62.7
(44.5 to 88.2)
Flu B/Brisbane/60/2008 Victoria, Day 0,N [N=48,32]
49.6
(36.4 to 67.6)
52.4
(37.2 to 73.6)
Flu A/Christch/16/2010 H1N1, Day 21,Y [N=12,24]
570.2
(362.2 to 897.4)
198.6
(111.2 to 355.0)
Flu A/Christch/16/2010 H1N1, Day 21,N [N=48,32]
489.9
(372.2 to 644.9)
257.4
(159.1 to 416.2)
Flu A/Texas/50/2012 H3N2, Day 21,Y [N=12,24]
119.9
(67.8 to 211.9)
68.2
(44.9 to 103.7)
Flu A/Texas/50/2012 H3N2, Day 21,N [N=48,32]
88.5
(67.6 to 115.8)
86.1
(57.3 to 129.6)
Flu B/Mass/2/2012 Yamagata, Day 21,Y [N=12,24]
522.9
(316.8 to 863.0)
415.2
(305.8 to 563.6)
Flu B/Mass/2/2012 Yamagata, Day 21,N [N=48,32]
879.5
(729.8 to 1059.9)
647.0
(511.9 to 817.8)
Flu B/Brisbane/60/2008 Victoria,Day 21,Y [N=12,24]
269.0
(188.1 to 384.8)
162.2
(117.9 to 223.2)
Flu B/Brisbane/60/2008 Victoria,Day 21,N [N=48,32]
369.7
(297.6 to 459.1)
320.0
(248.3 to 412.5)
13.Secondary Outcome
Title Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status
Hide Description 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.
Time Frame At Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluarix/Influsplit Tetra® Adult Group Fluarix/Influsplit Tetra® Elderly Group
Hide Arm/Group Description:
Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 60 56
Measure Type: Number
Unit of Measure: Subjects
Flu A/Christch/16/2010 H1N1, Day 0,Y [N=12,24] 9 5
Flu A/Christch/16/2010 H1N1, Day 0,N [N=48,32] 20 7
Flu A/Texas/50/2012 H3N2, Day 0, Y [N=12.24] 4 7
Flu A/Texas/50/2012 H3N2, Day 0, N [N=48,32] 8 8
Flu B/Mass/2/2012 Yamagata, Day 0,Y [N=12,24] 11 23
Flu B/Mass/2/2012 Yamagata, Day 0,N [N=48,32] 45 29
Flu B/Brisbane/60/2008 Victoria, Day 0,Y [N=12,24] 11 20
Flu B/Brisbane/60/2008 Victoria, Day 0,N [N=48,32] 32 20
Flu A/Christch/16/2010 H1N1, Day 21,Y [N=12,24] 12 21
Flu A/Christch/16/2010 H1N1, Day 21,N [N=48,32] 48 28
Flu A/Texas/50/2012 H3N2, Day 21,Y [N=12,24] 11 18
Flu A/Texas/50/2012 H3N2, Day 21,N [N=48,32] 43 22
Flu B/Mass/2/2012 Yamagata, Day 21,Y [N=12,24] 12 24
Flu B/Mass/2/2012 Yamagata, Day 21,N [N=48,32] 48 32
Flu B/Brisbane/60/2008 Victoria,Day 21,Y [N=12,24] 12 23
Flu B/Brisbane/60/2008 Victoria,Day 21,N [N=48,32] 48 32
14.Secondary Outcome
Title Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status
Hide Description 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.
Time Frame At Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluarix/Influsplit Tetra® Adult Group Fluarix/Influsplit Tetra® Elderly Group
Hide Arm/Group Description:
Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 60 56
Measure Type: Number
Unit of Measure: Subjects
Flu A/Christch/16/2010 H1N1, Day 21,Y [N=12,24] 8 18
Flu A/Christch/16/2010 H1N1, Day 21,N [N=48,32] 40 25
Flu A/Texas/50/2012 H3N2, Day 21,Y [N=12,24] 7 10
Flu A/Texas/50/2012 H3N2, Day 21,N [N=48,32] 34 17
Flu B/Mass/2/2012 Yamagata, Day 21,Y [N=12,24] 3 10
Flu B/Mass/2/2012 Yamagata, Day 21,N [N=48,32] 32 22
Flu B/Brisbane/60/2008 Victoria,Day 21,Y [N=12,24] 2 4
Flu B/Brisbane/60/2008 Victoria,Day 21,N [N=48,32] 35 20
15.Secondary Outcome
Title Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status
Hide Description 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.
Time Frame At Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluarix/Influsplit Tetra® Adult Group Fluarix/Influsplit Tetra® Elderly Group
Hide Arm/Group Description:
Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 60 56
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Flu A/Christch/16/2010 H1N1, Day 21,Y [N=12,24]
8.7
(3.3 to 23.2)
12.4
(7.1 to 21.6)
Flu A/Christch/16/2010 H1N1, Day 21,N [N=48,32]
20.0
(13.2 to 30.3)
18.2
(10.6 to 31.4)
Flu A/Texas/50/2012 H3N2, Day 21,Y [N=12,24]
5.5
(2.5 to 12.0)
4.6
(2.9 to 7.2)
Flu A/Texas/50/2012 H3N2, Day 21,N [N=48,32]
7.7
(5.8 to 10.1)
6.9
(4.5 to 10.4)
Flu B/Mass/2/2012 Yamagata, Day 21,Y [N=12,24]
3.0
(1.6 to 5.7)
3.7
(2.7 to 5.2)
Flu B/Mass/2/2012 Yamagata, Day 21,N [N=48,32]
6.0
(4.2 to 8.6)
5.9
(4.4 to 7.9)
Flu B/Brisbane/60/2008 Victoria,Day 21,Y [N=12,24]
2.4
(1.6 to 3.6)
2.6
(1.7 to 3.9)
Flu B/Brisbane/60/2008 Victoria,Day 21,N [N=48,32]
7.4
(5.4 to 10.3)
6.1
(4.2 to 8.9)
Time Frame Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluarix/Influsplit Tetra® Adult Group Fluarix/Influsplit Tetra® Elderly Group
Hide Arm/Group Description Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm. Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
All-Cause Mortality
Fluarix/Influsplit Tetra® Adult Group Fluarix/Influsplit Tetra® Elderly Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fluarix/Influsplit Tetra® Adult Group Fluarix/Influsplit Tetra® Elderly Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/57 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fluarix/Influsplit Tetra® Adult Group Fluarix/Influsplit Tetra® Elderly Group
Affected / at Risk (%) Affected / at Risk (%)
Total   46/60 (76.67%)   24/57 (42.11%) 
General disorders     
Induration  1  6/60 (10.00%)  5/57 (8.77%) 
Pain  1  37/60 (61.67%)  19/57 (33.33%) 
Redness  1  3/60 (5.00%)  6/57 (10.53%) 
Swelling  1  3/60 (5.00%)  2/57 (3.51%) 
Arthralgia  1  3/60 (5.00%)  6/57 (10.53%) 
Fatigue  1  10/60 (16.67%)  4/57 (7.02%) 
Gastrointestinal symptoms  1  3/60 (5.00%)  2/57 (3.51%) 
Headache  1  9/60 (15.00%)  5/57 (8.77%) 
Myalgia  1  14/60 (23.33%)  7/57 (12.28%) 
Sweating  1  3/60 (5.00%)  2/57 (3.51%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01878812     History of Changes
Other Study ID Numbers: 200188
2013-001094-25 ( EudraCT Number )
First Submitted: June 13, 2013
First Posted: June 17, 2013
Results First Submitted: November 20, 2014
Results First Posted: January 12, 2015
Last Update Posted: September 7, 2018