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Trial record 73 of 597 for:    Fluzone® | Studies With Results

Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate

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ClinicalTrials.gov Identifier: NCT00363077
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : May 7, 2013
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: GSK1247446A Group
Biological: Fluarix™
Enrollment 150

Recruitment Details  
Pre-assignment Details  
Arm/Group Title GSK1247446A Group Fluarix Group
Hide Arm/Group Description Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Period Title: Overall Study
Started 75 75
Completed 75 75
Not Completed 0 0
Arm/Group Title GSK1247446A Group Fluarix Group Total
Hide Arm/Group Description Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. Total of all reporting groups
Overall Number of Baseline Participants 75 75 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 75 participants 150 participants
64.4  (4.22) 64.5  (4.18) 64.4  (4.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
Female
38
  50.7%
38
  50.7%
76
  50.7%
Male
37
  49.3%
37
  49.3%
74
  49.3%
1.Primary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Hide Description Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia. The seropositivity cut-off assay was 1:10.
Time Frame At Days 0 and 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.
Arm/Group Title GSK1247446A Group Fluarix Group
Hide Arm/Group Description:
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 74 74
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
A/New Caledonia, Day 0
45.3
(35.9 to 57.1)
81.1
(61.5 to 106.8)
A/New Caledonia, Day 21
116.4
(91.2 to 148.5)
170.9
(132.7 to 220.3)
A/Wisconsin, Day 0
28.8
(20.7 to 40.1)
41.3
(29.1 to 58.6)
A/Wisconsin, Day 21
251.9
(188.7 to 336.4)
228.4
(168.5 to 309.6)
B/Malaysia, Day 0
27.1
(21.8 to 33.6)
31.6
(25.1 to 39.8)
B/Malaysia, Day 21
161.6
(131.4 to 198.6)
131.4
(105.8 to 163.1)
2.Primary Outcome
Title Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
Hide Description A seroconverted subject was defined as a vaccinated subject 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 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Time Frame At Day 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.
Arm/Group Title GSK1247446A Group Fluarix Group
Hide Arm/Group Description:
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 74 74
Measure Type: Number
Unit of Measure: subjects
A/New Caledonia 21 12
A/Wisconsin 52 40
B/Malaysia 46 31
3.Primary Outcome
Title Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
Hide Description A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Time Frame At Day 0 and Day 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.
Arm/Group Title GSK1247446A Group Fluarix Group
Hide Arm/Group Description:
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 74 74
Measure Type: Number
Unit of Measure: subjects
A/New Caledonia, Day 0 40 54
A/New Caledonia, Day 21 68 73
A/Wisconsin, Day 0 35 44
A/Wisconsin, Day 21 69 71
B/Malaysia, Day 0 28 39
B/Malaysia, Day 21 72 70
4.Primary Outcome
Title Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Hide Description The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
Time Frame At Day 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.
Arm/Group Title GSK1247446A Group Fluarix Group
Hide Arm/Group Description:
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 74 74
Geometric Mean (95% Confidence Interval)
Unit of Measure: fold increase
A/New Caledonia
2.6
(2.0 to 3.3)
2.1
(1.6 to 2.8)
A/Wisconsin
8.7
(6.3 to 12.1)
5.5
(4.0 to 7.6)
B/Malaysia
6.0
(4.6 to 7.8)
4.2
(3.2 to 5.4)
5.Secondary Outcome
Title Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Hide Description The geometric mean was calculated for CD4 T-cells (per million CD4 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).
Time Frame At Days 0 and 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.
Arm/Group Title GSK1247446A Group Fluarix Group
Hide Arm/Group Description:
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 73 73
Geometric Mean (Standard Deviation)
Unit of Measure: cytokine-positive cells/million cells
All Doubles, B/Malaysia, Day 0 [N=73;71] 436.58  (348.81) 451.35  (448.35)
All Doubles, B/Malaysia, Day 21 [N=73;73] 1555.92  (1060.11) 736.15  (588.56)
All Doubles, A/New Caledonia, Day 0 [N=73;71] 322.57  (348.20) 370.36  (408.19)
All Doubles, A/New Caledonia, Day 21 [N=73;73] 872.71  (662.32) 510.86  (604.98)
All Doubles, A/Wisconsin, Day 0 [N=73;71] 37.33  (155.75) 50.79  (212.97)
All Doubles, A/Wisconsin, Day 21 [N=73;73] 113.74  (412.68) 72.43  (190.60)
CD40L, B/Malaysia, Day 0 [N=73;71] 424.07  (328.40) 433.94  (406.20)
CD40L, B/Malaysia, Day 21 [N=73;73] 1409.79  (983.81) 694.68  (550.36)
CD40L, A/New Caledonia, Day 0 [N=73;71] 317.25  (337.18) 354.60  (399.44)
CD40L, A/New Caledonia, Day 21 [N=73;73] 786.97  (598.31) 475.96  (576.45)
CD40L, A/Wisconsin, Day 0 [N=73;71] 36.53  (145.90) 52.22  (208.27)
CD40L, A/Wisconsin, Day 21 [N=73;73] 97.23  (346.59) 65.37  (168.16)
IFN-g, B/Malaysia, Day 0 [N=73;71] 265.46  (297.90) 244.30  (377.07)
IFN-g, B/Malaysia, Day 21 [N=73;73] 1081.98  (840.54) 530.64  (451.71)
IFN-g, A/New Caledonia, Day 0 [N=73;71] 225.76  (265.96) 239.78  (285.26)
IFN-g, A/New Caledonia, Day 21 [N=73;73] 527.98  (522.30) 407.10  (492.37)
IFN-g, A/Wisconsin, Day 0 [N=73;71] 24.45  (114.69) 30.49  (83.91)
IFN-g, A/Wisconsin, Day 21 [N=73;73] 83.99  (365.27) 38.46  (126.65)
IL2, B/Malaysia, Day 0 [N=73;71] 379.42  (318.77) 382.48  (378.85)
IL2, B/Malaysia, Day 21 [N=73;73] 1297.82  (880.34) 647.93  (508.83)
IL2, A/New Caledonia, Day 0 [N=73;71] 256.57  (307.83) 220.62  (301.07)
IL2, A/New Caledonia, Day 21 [N=73;73] 652.75  (539.89) 300.71  (502.30)
IL2, A/Wisconsin, Day 0 [N=73;71] 31.74  (130.05) 53.93  (127.47)
IL2, A/Wisconsin, Day 21 [N=73;73] 89.97  (301.28) 53.47  (148.09)
TNF-α, B/Malaysia, Day 0 [N=73;71] 332.83  (298.11) 331.52  (383.96)
TNF-α, B/Malaysia, Day 21 [N=73;73] 1098.28  (869.02) 532.81  (420.99)
TNF-α, A/New Caledonia, Day 0 [N=73;71] 219.03  (276.48) 261.91  (369.60)
TNF-α, A/New Caledonia, Day 21 [N=73;73] 582.62  (506.95) 317.96  (416.78)
TNF-α, A/Wisconsin, Day 0 [N=73;71] 23.29  (119.05) 36.16  (190.06)
TNF-α, A/Wisconsin, Day 21 [N=73;73] 84.99  (308.52) 44.97  (157.29)
6.Secondary Outcome
Title Geometric Mean of Influenza-specific Cluster of Differentiation (CD) 8 T-cells.
Hide Description The geometric mean was calculated for CD8 T-cells (per million CD8 T-cells) producing at least two different cytokines (All Doubles), at least CD40L, at least INF gamma (IFN-g), at least IL2 and at least TNF alpha (TNF-α).
Time Frame At Days 0 and 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine, for whom administration site of study vaccine was known, who did not receive a vaccine forbidden in the protocol and for whom immunogenicity data were available.
Arm/Group Title GSK1247446A Group Fluarix Group
Hide Arm/Group Description:
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 73 73
Geometric Mean (Standard Deviation)
Unit of Measure: cytokine-positive cells/million cells
All doubles, B/Malaysia, Day 0 [N=72;69] 7.91  (83.49) 4.17  (70.59)
All doubles, B/Malaysia, Day 21 [N=73;72] 7.82  (95.80) 3.74  (120.67)
All doubles, A/New Caledonia, Day 0 [N=71;69] 6.22  (233.32) 7.31  (112.56)
All doubles, A/New Caledonia, Day 21 [N=73;70] 7.81  (191.24) 4.40  (141.07)
All doubles, A/Wisconsin, Day 0 [N=72;69] 3.93  (82.82) 6.79  (85.90)
All doubles, A/Wisconsin, Day 21 [N=73;73] 3.35  (56.70) 2.79  (70.15)
CD40L, B/Malaysia, Day 0 [N=72;69] 2.20  (34.98) 2.11  (36.15)
CD40L, B/Malaysia, Day 21 [N=73;72] 3.66  (45.91) 1.98  (32.45)
CD40L, A/New Caledonia, Day 0 [N=71;69] 2.56  (113.11) 5.34  (65.09)
CD40L, A/New Caledonia, Day 21 [N=73;70] 4.17  (93.16) 2.11  (51.19)
CD40L, A/Wisconsin, Day 0 [N=72;69] 2.15  (53.59) 2.70  (44.68)
CD40L, A/Wisconsin, Day 21 [N=73;73] 2.18  (39.28) 2.11  (39.64)
IFN-g, B/Malaysia, Day 0 [N=72;69] 4.28  (56.03) 2.71  (56.13)
IFN-g, B/Malaysia, Day 21 [N=73;72] 6.24  (74.51) 3.53  (118.94)
IFN-g, A/New Caledonia, Day 0 [N=71;69] 5.67  (231.67) 4.34  (97.73)
IFN-g, A/New Caledonia, Day 21 [N=73;70] 5.04  (174.85) 3.98  (133.45)
IFN-g, A/Wisconsin, Day 0 [N=72;69] 2.84  (73.55) 4.40  (69.48)
IFN-g, A/Wisconsin, Day 21 [N=73;73] 2.46  (44.69) 1.98  (36.44)
IL2, B/Malaysia, Day 0 [N=72;69] 3.60  (92.44) 2.12  (44.04)
IL2, B/Malaysia, Day 21 [N=73;72] 3.45  (60.32) 2.44  (32.77)
IL2, A/New Caledonia, Day 0 [N=71;69] 2.48  (131.52) 4.43  (60.02)
IL2, A/New Caledonia, Day 21 [N=73;70] 4.63  (125.59) 2.44  (62.17)
IL2, A/Wisconsin, Day 0 [N=72;69] 1.93  (55.19) 3.23  (61.15)
IL2, A/Wisconsin, Day 21 [N=73;73] 2.76  (45.28) 2.55  (61.31)
TNF-α, B/Malaysia, Day 0 [N=72;69] 8.41  (83.63) 4.29  (78.46)
TNF-α, B/Malaysia, Day 21 [N=73;72] 6.25  (91.95) 3.90  (124.66)
TNF-α, A/New Caledonia, Day 0 [N=71;69] 6.07  (218.59) 6.05  (114.14)
TNF-α, A/New Caledonia, Day 21 [N=73;70] 8.15  (171.91) 5.50  (128.58)
TNF-α, A/Wisconsin, Day 0 [N=72;69] 3.12  (58.61) 5.55  (92.14)
TNF-α, A/Wisconsin, Day 21 [N=73;73] 2.56  (49.21) 2.33  (70.96)
7.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Hide Description Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were considered to be related to vaccination.
Time Frame During the 7-day (Days 0-6) post-vaccination period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.
Arm/Group Title GSK1247446A Group Fluarix Group
Hide Arm/Group Description:
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 75 75
Measure Type: Number
Unit of Measure: subjects
Any Ecchymosis 1 1
Ecchymosis > 50 mm 1 0
Any Pain 57 25
Grade 3 Pain 1 0
Any Redness 14 8
Redness > 50 mm 4 0
Any Swelling 18 5
Swelling > 50 mm 3 1
8.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Hide Description Assessed solicited general symptoms were arthralgia, fatigue, fever [axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.
Time Frame During the 7-day (Days 0-6) post-vaccination period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.
Arm/Group Title GSK1247446A Group Fluarix Group
Hide Arm/Group Description:
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 75 75
Measure Type: Number
Unit of Measure: subjects
Any Arthralgia 12 8
Grade 3 Arthralgia 0 0
Related Arthralgia 10 4
Any Fatigue 30 13
Grade 3 Fatigue 0 0
Related Fatigue 29 12
Fever ≥ 37.5°C 2 0
Fever > 39.0°C 0 0
Related Fever 2 0
Any Headache 28 10
Grade 3 Headache 0 0
Related Headache 24 7
Any Muscle aches 17 10
Grade 3 Muscle aches 1 0
Related Muscle aches 15 8
Any Shivering 10 3
Grade 3 Shivering 1 0
Related Shivering 9 3
9.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Hide Description Unsolicited AE covers any AE 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 = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented everyday activities. Related = unsolicited AE assessed by the investigator as related to the vaccination.
Time Frame During the 30-day (Days 0-29) post vaccination period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.
Arm/Group Title GSK1247446A Group Fluarix Group
Hide Arm/Group Description:
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 75 75
Measure Type: Number
Unit of Measure: subjects
Subjects with any AE(s) 31 22
Subjects with grade 3 AE(s) 1 0
Subjects with related AE(s) 11 7
10.Secondary Outcome
Title Number of Subjects With Any and Related Serious Adverse Events (SAEs).
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE considered by the investigator to have a causal relationship to study vaccination.
Time Frame During the entire study period (from Day 0 to Day 29)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, on all subjects with the documented dose.
Arm/Group Title GSK1247446A Group Fluarix Group
Hide Arm/Group Description:
Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 75 75
Measure Type: Number
Unit of Measure: subjects
Subjects with any SAE(s) 0 1
Subjects with related SAE(s) 0 0
Time Frame SAE(s): during the entire study (from Day 0 to Day 29); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination; Unsolicited AE(s): during the 30-day (Days 0-29) follow-up period after any vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GSK1247446A Group Fluarix Group
Hide Arm/Group Description Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
All-Cause Mortality
GSK1247446A Group Fluarix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
GSK1247446A Group Fluarix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/75 (0.00%)   1/75 (1.33%) 
Cardiac disorders     
Coronary artery disease *  0/75 (0.00%)  1/75 (1.33%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GSK1247446A Group Fluarix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   69/75 (92.00%)   45/75 (60.00%) 
General disorders     
Influenza like illness *  2/75 (2.67%)  4/75 (5.33%) 
Pain   57/75 (76.00%)  25/75 (33.33%) 
Redness   14/75 (18.67%)  8/75 (10.67%) 
Swelling   18/75 (24.00%)  5/75 (6.67%) 
Arthralgia   12/75 (16.00%)  8/75 (10.67%) 
Fatigue   30/75 (40.00%)  13/75 (17.33%) 
Headache   28/75 (37.33%)  10/75 (13.33%) 
Muscle aches   17/75 (22.67%)  10/75 (13.33%) 
Shivering   10/75 (13.33%)  3/75 (4.00%) 
Infections and infestations     
Nasopharyngitis *  7/75 (9.33%)  4/75 (5.33%) 
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal pain *  4/75 (5.33%)  1/75 (1.33%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00363077     History of Changes
Other Study ID Numbers: 107975
First Submitted: August 7, 2006
First Posted: August 15, 2006
Results First Submitted: March 21, 2013
Results First Posted: May 7, 2013
Last Update Posted: June 8, 2018