Trial Outcomes & Findings for Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults. (NCT NCT00714285)
NCT ID: NCT00714285
Last Updated: 2018-06-08
Results Overview
Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
420 participants
Primary outcome timeframe
At Day 0 and Day 21
Results posted on
2018-06-08
Participant Flow
Participant milestones
| Measure |
Quadrivalent Influenza Vaccine GSK 2115160A Group 1
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Quadrivalent Influenza Vaccine GSK 2115160A Group 2
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Trivalent Influenza Vaccine GSK 2115160A Group 1
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Trivalent Influenza Vaccine GSK 2115160A Group 2
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
105
|
105
|
105
|
105
|
|
Overall Study
COMPLETED
|
105
|
102
|
105
|
104
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
0
|
1
|
Reasons for withdrawal
| Measure |
Quadrivalent Influenza Vaccine GSK 2115160A Group 1
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Quadrivalent Influenza Vaccine GSK 2115160A Group 2
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Trivalent Influenza Vaccine GSK 2115160A Group 1
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Trivalent Influenza Vaccine GSK 2115160A Group 2
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
1
|
|
Overall Study
Migrated/moved from study area
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.
Baseline characteristics by cohort
| Measure |
Quadrivalent Influenza Vaccine GSK 2115160A Group 1
n=105 Participants
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Quadrivalent Influenza Vaccine GSK 2115160A Group 2
n=105 Participants
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Trivalent Influenza Vaccine GSK 2115160A Group 1
n=105 Participants
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Trivalent Influenza Vaccine GSK 2115160A Group 2
n=105 Participants
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Total
n=420 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.5 Years
STANDARD_DEVIATION 11.85 • n=93 Participants
|
37.6 Years
STANDARD_DEVIATION 12.30 • n=4 Participants
|
36.6 Years
STANDARD_DEVIATION 12.87 • n=27 Participants
|
37.4 Years
STANDARD_DEVIATION 12.51 • n=483 Participants
|
37.5 Years
STANDARD_DEVIATION 12.36 • n=36 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
58 Participants
n=483 Participants
|
251 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
47 Participants
n=483 Participants
|
169 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: At Day 0 and Day 21Population: Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens.
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine GSK 2115160A Group 1
n=104 Participants
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Quadrivalent Influenza Vaccine GSK 2115160A Group 2
n=104 Participants
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Trivalent Influenza Vaccine GSK 2115160A Group 1
n=104 Participants
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0.
|
Trivalent Influenza Vaccine GSK 2115160A Group 2
n=105 Participants
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
|---|---|---|---|---|
|
Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
A/Solomon Islands strain, Day 21
|
130.0 Titer
Interval 106.1 to 159.4
|
150.6 Titer
Interval 118.4 to 191.5
|
160.4 Titer
Interval 129.1 to 199.3
|
133.8 Titer
Interval 105.6 to 169.7
|
|
Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
A/Solomon Islands strain, Day 0
|
21.4 Titer
Interval 16.1 to 28.4
|
22.2 Titer
Interval 16.6 to 29.5
|
23.3 Titer
Interval 17.5 to 31.0
|
18.4 Titer
Interval 14.3 to 23.7
|
|
Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
A/Wisconsin strain, Day 0
|
29.3 Titer
Interval 23.0 to 37.3
|
25.7 Titer
Interval 19.8 to 33.3
|
30.7 Titer
Interval 23.7 to 39.8
|
29.0 Titer
Interval 22.5 to 37.4
|
|
Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
A/Wisconsin strain, Day 21
|
162.1 Titer
Interval 138.0 to 190.4
|
189.5 Titer
Interval 158.9 to 226.0
|
197.9 Titer
Interval 169.1 to 231.7
|
156.3 Titer
Interval 127.5 to 191.6
|
|
Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
B/Malaysia strain, Day 0
|
32.2 Titer
Interval 24.8 to 41.8
|
26.6 Titer
Interval 20.2 to 35.0
|
23.2 Titer
Interval 17.7 to 30.4
|
27.2 Titer
Interval 20.6 to 35.8
|
|
Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
B/Malaysia strain, Day 21
|
192.8 Titer
Interval 159.6 to 232.9
|
213.0 Titer
Interval 174.0 to 260.9
|
187.0 Titer
Interval 151.9 to 230.3
|
188.5 Titer
Interval 150.0 to 237.0
|
|
Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
B/Jiangsu strain, Day 0
|
19.6 Titer
Interval 15.6 to 24.8
|
19.5 Titer
Interval 15.4 to 24.5
|
23.4 Titer
Interval 18.3 to 29.7
|
19.2 Titer
Interval 15.2 to 24.3
|
|
Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
B/Jiangsu strain, Day 21
|
179.1 Titer
Interval 151.4 to 211.9
|
158.3 Titer
Interval 130.7 to 191.9
|
59.2 Titer
Interval 47.3 to 74.0
|
43.4 Titer
Interval 34.5 to 54.6
|
SECONDARY outcome
Timeframe: At Day 21Population: Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine influenza strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine GSK 2115160A Group 1
n=104 Participants
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Quadrivalent Influenza Vaccine GSK 2115160A Group 2
n=104 Participants
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Trivalent Influenza Vaccine GSK 2115160A Group 1
n=104 Participants
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0.
|
Trivalent Influenza Vaccine GSK 2115160A Group 2
n=105 Participants
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
|---|---|---|---|---|
|
Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.
A/Solomon Islands strain
|
59 Subjects
|
60 Subjects
|
57 Subjects
|
63 Subjects
|
|
Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.
A/Wisconsin strain
|
63 Subjects
|
69 Subjects
|
67 Subjects
|
62 Subjects
|
|
Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.
B/Malaysia strain
|
60 Subjects
|
68 Subjects
|
59 Subjects
|
62 Subjects
|
|
Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.
B/Jiangsu strain
|
79 Subjects
|
82 Subjects
|
28 Subjects
|
20 Subjects
|
SECONDARY outcome
Timeframe: Day 21Population: Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine GSK 2115160A Group 1
n=104 Participants
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Quadrivalent Influenza Vaccine GSK 2115160A Group 2
n=104 Participants
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Trivalent Influenza Vaccine GSK 2115160A Group 1
n=104 Participants
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0.
|
Trivalent Influenza Vaccine GSK 2115160A Group 2
n=105 Participants
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
|---|---|---|---|---|
|
HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains
FA/Solomon Islands strain
|
6.1 Fold increase
Interval 4.6 to 8.0
|
6.8 Fold increase
Interval 5.0 to 9.2
|
6.9 Fold increase
Interval 5.0 to 9.4
|
7.3 Fold increase
Interval 5.3 to 9.9
|
|
HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains
A/Wisconsin strain
|
5.5 Fold increase
Interval 4.4 to 6.9
|
7.4 Fold increase
Interval 5.8 to 9.4
|
6.4 Fold increase
Interval 5.0 to 8.3
|
5.4 Fold increase
Interval 4.1 to 7.0
|
|
HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains
B/Malaysia strain
|
6.0 Fold increase
Interval 4.7 to 7.7
|
8.0 Fold increase
Interval 6.1 to 10.5
|
8.1 Fold increase
Interval 5.9 to 11.0
|
6.9 Fold increase
Interval 5.2 to 9.3
|
|
HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains
B/Jiangsu strain
|
9.1 Fold increase
Interval 7.2 to 11.5
|
8.1 Fold increase
Interval 6.6 to 10.0
|
2.5 Fold increase
Interval 2.1 to 3.0
|
2.3 Fold increase
Interval 1.9 to 2.6
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
A seroprotected subject was defined as a subject with a serum HI titer ≥1:40 that usually is accepted as indicating protection. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine GSK 2115160A Group 1
n=104 Participants
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Quadrivalent Influenza Vaccine GSK 2115160A Group 2
n=104 Participants
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Trivalent Influenza Vaccine GSK 2115160A Group 1
n=104 Participants
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0.
|
Trivalent Influenza Vaccine GSK 2115160A Group 2
n=105 Participants
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
|---|---|---|---|---|
|
Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
B/Jiangsu strain, Day 21
|
102 Subjects
|
99 Subjects
|
78 Subjects
|
67 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
A/Solomon Islands strain, Day 0
|
39 Subjects
|
44 Subjects
|
42 Subjects
|
37 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
A/Solomon Islands strain, Day 21
|
96 Subjects
|
92 Subjects
|
97 Subjects
|
95 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
A/Wisconsin strain, Day 0
|
53 Subjects
|
48 Subjects
|
56 Subjects
|
58 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
A/Wisconsin strain, Day 21
|
101 Subjects
|
102 Subjects
|
104 Subjects
|
101 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
B/Malaysia strain, Day 0
|
53 Subjects
|
49 Subjects
|
44 Subjects
|
47 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
B/Malaysia strain, Day 21
|
101 Subjects
|
101 Subjects
|
100 Subjects
|
98 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
B/Jiangsu strain, Day 0
|
33 Subjects
|
40 Subjects
|
45 Subjects
|
41 Subjects
|
SECONDARY outcome
Timeframe: During a 7 day (Days 0-6) follow-up period after vaccinationPopulation: Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine GSK 2115160A Group 1
n=105 Participants
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Quadrivalent Influenza Vaccine GSK 2115160A Group 2
n=104 Participants
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Trivalent Influenza Vaccine GSK 2115160A Group 1
n=105 Participants
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0.
|
Trivalent Influenza Vaccine GSK 2115160A Group 2
n=105 Participants
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Any Pain
|
76 Subjects
|
79 Subjects
|
74 Subjects
|
52 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Grade 3 Pain
|
0 Subjects
|
2 Subjects
|
3 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Any Redness
|
3 Subjects
|
6 Subjects
|
5 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Grade 3 Redness
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Any Swelling
|
3 Subjects
|
4 Subjects
|
7 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Grade 3 Swelling
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During a 7-day follow-up period (Days 0-6) after vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed.
Solicited local symptoms assessed by the former GSK rules of grading were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine GSK 2115160A Group 1
n=105 Participants
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Quadrivalent Influenza Vaccine GSK 2115160A Group 2
n=104 Participants
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Trivalent Influenza Vaccine GSK 2115160A Group 1
n=105 Participants
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0.
|
Trivalent Influenza Vaccine GSK 2115160A Group 2
n=105 Participants
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.
Any Pain
|
76 Subjects
|
79 Subjects
|
74 Subjects
|
52 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.
Grade 3 Pain
|
0 Subjects
|
2 Subjects
|
3 Subjects
|
0 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.
Any Redness
|
3 Subjects
|
6 Subjects
|
5 Subjects
|
1 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.
Grade 3 Redness
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.
Any Swelling
|
3 Subjects
|
4 Subjects
|
7 Subjects
|
2 Subjects
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.
Grade 3 Swelling
|
1 Subjects
|
2 Subjects
|
3 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: During a 7-day follow-up period (Days 0-6) after vaccinationPopulation: Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed
Solicited general symptoms assessed were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature ≥39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine GSK 2115160A Group 1
n=105 Participants
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Quadrivalent Influenza Vaccine GSK 2115160A Group 2
n=104 Participants
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Trivalent Influenza Vaccine GSK 2115160A Group 1
n=105 Participants
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0.
|
Trivalent Influenza Vaccine GSK 2115160A Group 2
n=105 Participants
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Arthralgia
|
6 Subjects
|
25 Subjects
|
13 Subjects
|
12 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Arthralgia
|
1 Subjects
|
3 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Arthralgia
|
6 Subjects
|
25 Subjects
|
13 Subjects
|
11 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Fatigue
|
33 Subjects
|
47 Subjects
|
36 Subjects
|
34 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Fatigue
|
2 Subjects
|
4 Subjects
|
3 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Fatigue
|
32 Subjects
|
47 Subjects
|
36 Subjects
|
33 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Headache
|
25 Subjects
|
36 Subjects
|
28 Subjects
|
26 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Headache
|
3 Subjects
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Headache
|
24 Subjects
|
33 Subjects
|
26 Subjects
|
23 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Myalgia
|
17 Subjects
|
40 Subjects
|
33 Subjects
|
15 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Myalgia
|
1 Subjects
|
3 Subjects
|
3 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Myalgia
|
17 Subjects
|
40 Subjects
|
33 Subjects
|
15 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Nausea
|
8 Subjects
|
11 Subjects
|
8 Subjects
|
9 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Nausea
|
2 Subjects
|
2 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Nausea
|
8 Subjects
|
10 Subjects
|
8 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Shivering
|
4 Subjects
|
10 Subjects
|
9 Subjects
|
4 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Shivering
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Shivering
|
4 Subjects
|
10 Subjects
|
9 Subjects
|
4 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Fever
|
1 Subjects
|
3 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Fever
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Fever
|
1 Subjects
|
3 Subjects
|
2 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: During a 7-day follow-up period (Days 0-6) after vaccinationPopulation: Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed
Solicited general symptoms assessed by the former GSK rules of grading were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 °C. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature above 39.0°C. . Related = symptoms considered by the investigator to have a causal relationship to vaccination.
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine GSK 2115160A Group 1
n=105 Participants
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Quadrivalent Influenza Vaccine GSK 2115160A Group 2
n=104 Participants
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Trivalent Influenza Vaccine GSK 2115160A Group 1
n=105 Participants
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0.
|
Trivalent Influenza Vaccine GSK 2115160A Group 2
n=105 Participants
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
|---|---|---|---|---|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Any Arthralgia
|
6 Subjects
|
25 Subjects
|
13 Subjects
|
12 Subjects
|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Grade 3 Arthralgia
|
1 Subjects
|
3 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Related Arthralgia
|
6 Subjects
|
25 Subjects
|
13 Subjects
|
11 Subjects
|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Any Fatigue
|
33 Subjects
|
47 Subjects
|
36 Subjects
|
34 Subjects
|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Grade 3 Fatigue
|
2 Subjects
|
4 Subjects
|
3 Subjects
|
1 Subjects
|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Related Fatigue
|
32 Subjects
|
47 Subjects
|
36 Subjects
|
33 Subjects
|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Any Headache
|
25 Subjects
|
36 Subjects
|
28 Subjects
|
26 Subjects
|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Grade 3 Headache
|
3 Subjects
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Related Headache
|
24 Subjects
|
33 Subjects
|
26 Subjects
|
23 Subjects
|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Any Myalgia
|
17 Subjects
|
40 Subjects
|
33 Subjects
|
15 Subjects
|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Grade 3 Myalgia
|
1 Subjects
|
3 Subjects
|
3 Subjects
|
1 Subjects
|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Related Myalgia
|
17 Subjects
|
40 Subjects
|
33 Subjects
|
15 Subjects
|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Any Nausea
|
8 Subjects
|
11 Subjects
|
8 Subjects
|
9 Subjects
|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Grade 3 Nausea
|
2 Subjects
|
2 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Related Nausea
|
8 Subjects
|
10 Subjects
|
8 Subjects
|
8 Subjects
|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Any Shivering
|
4 Subjects
|
10 Subjects
|
9 Subjects
|
4 Subjects
|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Grade 3 Shivering
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Related Shivering
|
4 Subjects
|
10 Subjects
|
9 Subjects
|
4 Subjects
|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Any Fever
|
1 Subjects
|
2 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Grade 3 Fever
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Related Fever
|
1 Subjects
|
2 Subjects
|
2 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Days 0-180)Population: Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.
MSCs were defined as those adverse events (AEs) prompting emergency room visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. AIDs include a large group of diseases characterized by abnormal functioning of the immune system that causes immune system to produce antibodies against own tissues.
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine GSK 2115160A Group 1
n=105 Participants
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Quadrivalent Influenza Vaccine GSK 2115160A Group 2
n=105 Participants
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Trivalent Influenza Vaccine GSK 2115160A Group 1
n=105 Participants
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0.
|
Trivalent Influenza Vaccine GSK 2115160A Group 2
n=105 Participants
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs).
MAE(s)
|
1 Subjects
|
4 Subjects
|
5 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs).
AID
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During a 21 day (Days 0-20) follow-up period after vaccination-Population: Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.
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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine GSK 2115160A Group 1
n=105 Participants
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Quadrivalent Influenza Vaccine GSK 2115160A Group 2
n=105 Participants
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Trivalent Influenza Vaccine GSK 2115160A Group 1
n=105 Participants
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0.
|
Trivalent Influenza Vaccine GSK 2115160A Group 2
n=105 Participants
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).
Related unsolicited AE(s)
|
3 Subjects
|
3 Subjects
|
7 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).
Any unsolicited AE(s)
|
7 Subjects
|
7 Subjects
|
16 Subjects
|
11 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).
Grade 3 unsolicited AE(s)
|
0 Subjects
|
1 Subjects
|
3 Subjects
|
2 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Days 0-180)Population: Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.
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. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine GSK 2115160A Group 1
n=105 Participants
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Quadrivalent Influenza Vaccine GSK 2115160A Group 2
n=105 Participants
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Trivalent Influenza Vaccine GSK 2115160A Group 1
n=105 Participants
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0.
|
Trivalent Influenza Vaccine GSK 2115160A Group 2
n=105 Participants
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Any SAE(s)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1.0 Subjects
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Related SAE(s)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
Adverse Events
Quadrivalent Influenza Vaccine GSK 2115160A Group 1
Serious events: 0 serious events
Other events: 84 other events
Deaths: 0 deaths
Quadrivalent Influenza Vaccine GSK 2115160A Group 2
Serious events: 0 serious events
Other events: 90 other events
Deaths: 0 deaths
Trivalent Influenza Vaccine GSK 2115160A Group 1
Serious events: 0 serious events
Other events: 81 other events
Deaths: 0 deaths
Trivalent Influenza Vaccine GSK 2115160A Group 2
Serious events: 1 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Quadrivalent Influenza Vaccine GSK 2115160A Group 1
n=105 participants at risk
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Quadrivalent Influenza Vaccine GSK 2115160A Group 2
n=105 participants at risk
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Trivalent Influenza Vaccine GSK 2115160A Group 1
n=105 participants at risk
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Trivalent Influenza Vaccine GSK 2115160A Group 2
n=105 participants at risk
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
|---|---|---|---|---|
|
Vascular disorders
Haemorrhage
|
0.00%
0/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.95%
1/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
Other adverse events
| Measure |
Quadrivalent Influenza Vaccine GSK 2115160A Group 1
n=105 participants at risk
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Quadrivalent Influenza Vaccine GSK 2115160A Group 2
n=105 participants at risk
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Trivalent Influenza Vaccine GSK 2115160A Group 1
n=105 participants at risk
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
Trivalent Influenza Vaccine GSK 2115160A Group 2
n=105 participants at risk
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
|
|---|---|---|---|---|
|
General disorders
Pain
|
72.4%
76/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
75.2%
79/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
70.5%
74/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
49.5%
52/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Redness
|
2.9%
3/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
5.7%
6/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
4.8%
5/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.95%
1/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Swellling
|
2.9%
3/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
3.8%
4/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
6.7%
7/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
1.9%
2/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Arthralgia
|
5.7%
6/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
23.8%
25/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
12.4%
13/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
11.4%
12/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Fatigue
|
31.4%
33/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
44.8%
47/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
34.3%
36/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
32.4%
34/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Headache
|
23.8%
25/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
34.3%
36/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
26.7%
28/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
24.8%
26/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Myalgia
|
16.2%
17/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
38.1%
40/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
31.4%
33/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
14.3%
15/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Nausea
|
7.6%
8/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
10.5%
11/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
7.6%
8/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
8.6%
9/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Shivering
|
3.8%
4/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
9.5%
10/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
8.6%
9/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
3.8%
4/105 • Serious adverse events (SAEs): During the entire study period i.e. Day 0 to Day 180 ; Solicited local and general symptoms: During Day 0- Day 6 post vaccination period.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
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