Trial Outcomes & Findings for Evaluation of Safety and Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults (NCT NCT00538213)
NCT ID: NCT00538213
Last Updated: 2018-06-08
Results Overview
Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter i.e. \>100 mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
133 participants
Primary outcome timeframe
Day 0-6
Results posted on
2018-06-08
Participant Flow
Participant milestones
| Measure |
Adjuvanted Influenza Vaccine GSK576389A Group
Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
|
Fluarix Elderly Group
Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
Fluarix Young Group
Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
|---|---|---|---|
|
Overall Study
STARTED
|
55
|
40
|
38
|
|
Overall Study
COMPLETED
|
55
|
40
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Safety and Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults
Baseline characteristics by cohort
| Measure |
Adjuvanted Influenza Vaccine GSK576389A Group
n=55 Participants
Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
|
Fluarix Elderly Group
n=40 Participants
Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
Fluarix Young Group
n=38 Participants
Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.2 Years
STANDARD_DEVIATION 3.07 • n=99 Participants
|
71.2 Years
STANDARD_DEVIATION 3.47 • n=107 Participants
|
27.4 Years
STANDARD_DEVIATION 6.08 • n=206 Participants
|
58.69 Years
STANDARD_DEVIATION 20.30 • n=7 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
55 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
78 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Day 0-6Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter i.e. \>100 mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine GSK576389A Group
n=55 Participants
Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A in this study.
|
Fluarix Elderly Group
n=40 Participants
Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
Fluarix Young Group
n=38 Participants
Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
|---|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Any ecchymosis
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 ecchymosis
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Any pain
|
40 subjects
|
12 subjects
|
34 subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 pain
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Any redness
|
13 subjects
|
6 subjects
|
1 subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 redness
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Any swelling
|
6 subjects
|
4 subjects
|
0 subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 swelling
|
0 subjects
|
0 subjects
|
0 subjects
|
PRIMARY outcome
Timeframe: Day 0-6Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.
Duration was defined as number of days with any grade of local symptoms.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine GSK576389A Group
n=40 Participants
Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A in this study.
|
Fluarix Elderly Group
n=12 Participants
Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
Fluarix Young Group
n=34 Participants
Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
|---|---|---|---|
|
Duration of Solicited Local AEs
Pain (N=40; 12; 34)
|
2.0 Days
Interval 1.0 to 5.0
|
1.5 Days
Interval 1.0 to 4.0
|
2.0 Days
Interval 1.0 to 4.0
|
|
Duration of Solicited Local AEs
Redness (N=13; 6; 1)
|
3.0 Days
Interval 1.0 to 4.0
|
1.0 Days
Interval 1.0 to 3.0
|
1.0 Days
Interval 1.0 to 1.0
|
|
Duration of Solicited Local AEs
Swelling (N=6; 4; 0)
|
3.0 Days
Interval 2.0 to 5.0
|
1.0 Days
Interval 1.0 to 3.0
|
NA Days
No subjects from this group reported any swelling
|
PRIMARY outcome
Timeframe: Day 0-6Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
Any temperature was defined as axillary temperature ≥38.0 degree centigrade (°C), grade 3 temperature was axillary temperature ≥39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as general symptom that prevented normal activity. Related was general symptom assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine GSK576389A Group
n=55 Participants
Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A in this study.
|
Fluarix Elderly Group
n=40 Participants
Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
Fluarix Young Group
n=38 Participants
Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any arthralgia
|
6 subjects
|
6 subjects
|
2 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 arthralgia
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related arthralgia
|
4 subjects
|
3 subjects
|
2 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any fatigue
|
19 subjects
|
6 subjects
|
9 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 fatigue
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related fatigue
|
19 subjects
|
3 subjects
|
8 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any headache
|
13 subjects
|
5 subjects
|
8 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 headache
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related headache
|
11 subjects
|
2 subjects
|
7 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any myalgia
|
10 subjects
|
3 subjects
|
10 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 myalgia
|
0 subjects
|
0 subjects
|
1 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related myalgia
|
10 subjects
|
1 subjects
|
10 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any nausea
|
4 subjects
|
0 subjects
|
3 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 nausea
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related nausea
|
4 subjects
|
0 subjects
|
1 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any shivering
|
10 subjects
|
0 subjects
|
2 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 shivering
|
0 subjects
|
0 subjects
|
1 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related shivering
|
9 subjects
|
0 subjects
|
2 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any temperature
|
4 subjects
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 temperature
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related temperature
|
4 subjects
|
0 subjects
|
0 subjects
|
PRIMARY outcome
Timeframe: Day 0-6Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.
Duration was defined as number of days with any grade of general symptoms.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine GSK576389A Group
n=19 Participants
Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A in this study.
|
Fluarix Elderly Group
n=6 Participants
Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
Fluarix Young Group
n=10 Participants
Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
|---|---|---|---|
|
Duration of Solicited General AEs
Arthralgia (N=6; 6; 2)
|
2.5 Days
Interval 1.0 to 6.0
|
2.0 Days
Interval 1.0 to 7.0
|
1.5 Days
Interval 1.0 to 2.0
|
|
Duration of Solicited General AEs
Fatigue (N=19; 6; 9)
|
2.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 2.0
|
2.0 Days
Interval 1.0 to 3.0
|
|
Duration of Solicited General AEs
Headache (N=13; 5; 8)
|
1.0 Days
Interval 1.0 to 5.0
|
1.0 Days
Interval 1.0 to 2.0
|
2.0 Days
Interval 1.0 to 4.0
|
|
Duration of Solicited General AEs
Myalgia (N=10; 3; 10)
|
2.0 Days
Interval 1.0 to 5.0
|
2.0 Days
Interval 2.0 to 3.0
|
2.0 Days
Interval 1.0 to 3.0
|
|
Duration of Solicited General AEs
Nausea (N=4; 0; 3)
|
1.0 Days
Interval 1.0 to 2.0
|
NA Days
No subjects from this group reported any nausea
|
1.0 Days
Interval 1.0 to 2.0
|
|
Duration of Solicited General AEs
Shivering (N=10; 0; 2)
|
1.0 Days
Interval 1.0 to 3.0
|
NA Days
No subjects from this group reported any shivering
|
3.5 Days
Interval 1.0 to 6.0
|
|
Duration of Solicited General AEs
Temperature (N=4; 0; 0)
|
1.0 Days
Interval 1.0 to 1.0
|
NA Days
No subjects from this group reported any temperature
|
NA Days
No subjects from this group reported any temperature
|
PRIMARY outcome
Timeframe: Day 0-20Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
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 event that prevented normal activities and related was defined as unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine GSK576389A Group
n=55 Participants
Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A in this study.
|
Fluarix Elderly Group
n=40 Participants
Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
Fluarix Young Group
n=38 Participants
Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Any AE(s)
|
18 subjects
|
9 subjects
|
19 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Grade 3 AE(s)
|
1 subjects
|
1 subjects
|
1 subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Related AE(s)
|
6 subjects
|
2 subjects
|
3 subjects
|
PRIMARY outcome
Timeframe: Day 0-20Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
MSCs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. At least one MSC was defined as at least one MSC experienced. Grade 3 was MSC that prevented normal activities and Related was defined as MSC assessed by the investigator to be causally related to the study vaccination.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine GSK576389A Group
n=55 Participants
Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A in this study.
|
Fluarix Elderly Group
n=40 Participants
Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
Fluarix Young Group
n=38 Participants
Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
|---|---|---|---|
|
Number of Subjects Reporting at Least One, Grade 3 and Related Medically Significant Conditions (MSCs)
At least one MSC
|
5 subjects
|
1 subjects
|
2 subjects
|
|
Number of Subjects Reporting at Least One, Grade 3 and Related Medically Significant Conditions (MSCs)
Grade 3 MSC
|
0 subjects
|
0 subjects
|
1 subjects
|
|
Number of Subjects Reporting at Least One, Grade 3 and Related Medically Significant Conditions (MSCs)
Related MSC
|
0 subjects
|
0 subjects
|
0 subjects
|
PRIMARY outcome
Timeframe: Day 0-20Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
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 and related was event assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine GSK576389A Group
n=55 Participants
Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A in this study.
|
Fluarix Elderly Group
n=40 Participants
Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
Fluarix Young Group
n=38 Participants
Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
|---|---|---|---|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Any SAE(s)
|
0 subjects
|
0 subjects
|
0 subjects
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Related SAE(s)
|
0 subjects
|
0 subjects
|
0 subjects
|
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 were available at day 21.
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine GSK576389A Group
n=52 Participants
Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A in this study.
|
Fluarix Elderly Group
n=39 Participants
Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
Fluarix Young Group
n=38 Participants
Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
|---|---|---|---|
|
Haemagglutination Inhibition (HI) Antibody Titers
A/Solomon Islands strain at Day 0 (N=52; 39; 38)
|
8.5 titer
Interval 6.7 to 10.8
|
6.9 titer
Interval 5.7 to 8.5
|
56.0 titer
Interval 35.2 to 89.1
|
|
Haemagglutination Inhibition (HI) Antibody Titers
A/Solomon Islands strain at Day 21 (N=51; 39; 38)
|
91.6 titer
Interval 64.1 to 131.0
|
30.3 titer
Interval 18.7 to 49.2
|
110.0 titer
Interval 76.5 to 158.3
|
|
Haemagglutination Inhibition (HI) Antibody Titers
A/Wisconsin strain at Day 0 (N=52; 39; 38)
|
141.9 titer
Interval 103.1 to 195.3
|
70.6 titer
Interval 47.4 to 105.2
|
115.1 titer
Interval 77.5 to 171.1
|
|
Haemagglutination Inhibition (HI) Antibody Titers
A/Wisconsin strain at Day 21 (N=51; 39; 38)
|
384.5 titer
Interval 301.7 to 489.8
|
147.6 titer
Interval 105.9 to 205.6
|
190.1 titer
Interval 144.0 to 251.0
|
|
Haemagglutination Inhibition (HI) Antibody Titers
B/Malaysia strain at Day 0 (N=52; 39; 38)
|
82.6 titer
Interval 64.7 to 105.6
|
59.6 titer
Interval 42.3 to 83.8
|
139.4 titer
Interval 98.5 to 197.2
|
|
Haemagglutination Inhibition (HI) Antibody Titers
B/Malaysia strain at Day 21 (N=51; 39; 38)
|
163.2 titer
Interval 129.6 to 205.7
|
93.8 titer
Interval 68.4 to 128.8
|
210.3 titer
Interval 158.6 to 278.7
|
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 were available at day 21.
Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e. ≥ 1:10. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine GSK576389A Group
n=52 Participants
Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A in this study.
|
Fluarix Elderly Group
n=39 Participants
Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
Fluarix Young Group
n=38 Participants
Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
|---|---|---|---|
|
The Number of Subjects Seropositive to HI Antibodies
A/Solomon Islands strain at Day 0 (N=52; 39; 38)
|
19 subjects
|
12 subjects
|
33 subjects
|
|
The Number of Subjects Seropositive to HI Antibodies
A/Solomon Islands strain at Day 21 (N=51; 39; 38)
|
48 subjects
|
28 subjects
|
37 subjects
|
|
The Number of Subjects Seropositive to HI Antibodies
A/Wisconsin strain at Day 0 (N=52; 39; 38)
|
50 subjects
|
37 subjects
|
37 subjects
|
|
The Number of Subjects Seropositive to HI Antibodies
A/Wisconsin strain at Day 21 (N=51; 39; 38)
|
51 subjects
|
39 subjects
|
38 subjects
|
|
The Number of Subjects Seropositive to HI Antibodies
B/Malaysia strain at Day 0 (N=52; 39; 38)
|
52 subjects
|
38 subjects
|
37 subjects
|
|
The Number of Subjects Seropositive to HI Antibodies
B/Malaysia strain at Day 21 (N=51; 39; 38)
|
51 subjects
|
38 subjects
|
38 subjects
|
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 were available at day 21.
Seroconversion was defined as 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 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine GSK576389A Group
n=51 Participants
Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A in this study.
|
Fluarix Elderly Group
n=39 Participants
Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
Fluarix Young Group
n=38 Participants
Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
|---|---|---|---|
|
The Number of Subjects Seroconverted to HI Antibodies
A/Solomon Islands strain
|
39 subjects
|
19 subjects
|
6 subjects
|
|
The Number of Subjects Seroconverted to HI Antibodies
A/Wisconsin strain
|
18 subjects
|
6 subjects
|
4 subjects
|
|
The Number of Subjects Seroconverted to HI Antibodies
B/Malaysia strain
|
10 subjects
|
4 subjects
|
2 subjects
|
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 were available at day 21.
SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine GSK576389A Group
n=51 Participants
Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A in this study.
|
Fluarix Elderly Group
n=39 Participants
Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
Fluarix Young Group
n=38 Participants
Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
|---|---|---|---|
|
HI Antibody Seroconversion Factors (SCF)
A/Solomon Islands strain
|
10.6 fold increase
Interval 7.4 to 15.2
|
4.4 fold increase
Interval 2.8 to 6.8
|
2.0 fold increase
Interval 1.5 to 2.5
|
|
HI Antibody Seroconversion Factors (SCF)
A/Wisconsin strain
|
2.7 fold increase
Interval 2.2 to 3.3
|
2.1 fold increase
Interval 1.7 to 2.5
|
1.7 fold increase
Interval 1.4 to 2.0
|
|
HI Antibody Seroconversion Factors (SCF)
B/Malaysia strain
|
2.0 fold increase
Interval 1.7 to 2.3
|
1.6 fold increase
Interval 1.3 to 1.9
|
1.5 fold increase
Interval 1.3 to 1.8
|
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 were available at day 21.
Seroprotection was defined as serum HI titer ≥1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine GSK576389A Group
n=52 Participants
Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A in this study.
|
Fluarix Elderly Group
n=39 Participants
Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
Fluarix Young Group
n=38 Participants
Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
|---|---|---|---|
|
The Number of Subjects Seroprotected to HI Antibodies
A/Solomon Islands strain at Day 0 (52; 39; 38)
|
6 subjects
|
1 subjects
|
25 subjects
|
|
The Number of Subjects Seroprotected to HI Antibodies
A/Solomon Islands strain at Day 21 (51; 39; 38)
|
42 subjects
|
21 subjects
|
32 subjects
|
|
The Number of Subjects Seroprotected to HI Antibodies
A/Wisconsin strain at Day 0 (N= 52; 39; 38)
|
49 subjects
|
31 subjects
|
33 subjects
|
|
The Number of Subjects Seroprotected to HI Antibodies
A/Wisconsin strain at Day 21 (N= 51; 39; 38)
|
50 subjects
|
35 subjects
|
37 subjects
|
|
The Number of Subjects Seroprotected to HI Antibodies
B/Malaysia strain at Day 0 (N=52; 39; 38)
|
47 subjects
|
31 subjects
|
35 subjects
|
|
The Number of Subjects Seroprotected to HI Antibodies
B/Malaysia strain at Day 21 (N=51; 39; 38)
|
51 subjects
|
37 subjects
|
37 subjects
|
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 were available at day 21.
The vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and Pool FLU antigens and the markers assessed were Cluster of Differentiation 4-All doubles i.e. CD4-All doubles, CD40 Ligand (CD40L), interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α).
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine GSK576389A Group
n=44 Participants
Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A in this study.
|
Fluarix Elderly Group
n=36 Participants
Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
Fluarix Young Group
n=36 Participants
Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
|---|---|---|---|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Solomon Islands[CD4-All doubles] D0(N=44;36;36)
|
289.37 CD4 cells/10^6 CD4+ cells
Standard Deviation 316.11
|
180.39 CD4 cells/10^6 CD4+ cells
Standard Deviation 228.07
|
331.14 CD4 cells/10^6 CD4+ cells
Standard Deviation 494.08
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Solomon Islands[CD4-All doubles] D21(N=44;36;35)
|
700.62 CD4 cells/10^6 CD4+ cells
Standard Deviation 634.14
|
337.23 CD4 cells/10^6 CD4+ cells
Standard Deviation 500.65
|
258.27 CD4 cells/10^6 CD4+ cells
Standard Deviation 637.94
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Wisconsin[CD4-All doubles] D0 (N=44;36;36)
|
603.80 CD4 cells/10^6 CD4+ cells
Standard Deviation 540.62
|
489.94 CD4 cells/10^6 CD4+ cells
Standard Deviation 426.96
|
905.24 CD4 cells/10^6 CD4+ cells
Standard Deviation 750.96
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Wisconsin[CD4-All doubles] D21 (N=44;36;35)
|
1020.35 CD4 cells/10^6 CD4+ cells
Standard Deviation 830.08
|
776.74 CD4 cells/10^6 CD4+ cells
Standard Deviation 654.62
|
868.45 CD4 cells/10^6 CD4+ cells
Standard Deviation 946.28
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
B/Malaysia[CD4-All doubles] D0 (N=44;35;36)
|
448.88 CD4 cells/10^6 CD4+ cells
Standard Deviation 497.51
|
381.99 CD4 cells/10^6 CD4+ cells
Standard Deviation 341.08
|
566.22 CD4 cells/10^6 CD4+ cells
Standard Deviation 581.71
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
B/Malaysia[CD4-All doubles] D21 (N=44;36;35)
|
925.46 CD4 cells/10^6 CD4+ cells
Standard Deviation 607.25
|
681.59 CD4 cells/10^6 CD4+ cells
Standard Deviation 593.45
|
786.37 CD4 cells/10^6 CD4+ cells
Standard Deviation 723.64
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Pool FLU[CD4-All doubles] D0 (N=44;36;36)
|
1054.11 CD4 cells/10^6 CD4+ cells
Standard Deviation 945.41
|
983.41 CD4 cells/10^6 CD4+ cells
Standard Deviation 598.15
|
1693.14 CD4 cells/10^6 CD4+ cells
Standard Deviation 1045.17
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Pool FLU[CD4-All doubles] D21 (N=44;36;35)
|
2115.03 CD4 cells/10^6 CD4+ cells
Standard Deviation 1368.50
|
1509.46 CD4 cells/10^6 CD4+ cells
Standard Deviation 1159.17
|
1998.24 CD4 cells/10^6 CD4+ cells
Standard Deviation 1287.85
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Solomon Islands[CD4-CD40L] D0 (N=44;36;36)
|
270.70 CD4 cells/10^6 CD4+ cells
Standard Deviation 307.98
|
165.45 CD4 cells/10^6 CD4+ cells
Standard Deviation 211.89
|
309.92 CD4 cells/10^6 CD4+ cells
Standard Deviation 437.51
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Solomon Islands[CD4-CD40L] D21(N=44;36;35)
|
642.40 CD4 cells/10^6 CD4+ cells
Standard Deviation 596.29
|
302.95 CD4 cells/10^6 CD4+ cells
Standard Deviation 473.99
|
236.63 CD4 cells/10^6 CD4+ cells
Standard Deviation 553.12
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Wisconsin[CD4-CD40L] D0 (N=44;36;36)
|
549.05 CD4 cells/10^6 CD4+ cells
Standard Deviation 509.04
|
447.08 CD4 cells/10^6 CD4+ cells
Standard Deviation 404.96
|
851.31 CD4 cells/10^6 CD4+ cells
Standard Deviation 663.11
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Wisconsin[CD4-CD40L] D21 (N=44;36;35)
|
930.92 CD4 cells/10^6 CD4+ cells
Standard Deviation 790.99
|
709.71 CD4 cells/10^6 CD4+ cells
Standard Deviation 622.14
|
726.97 CD4 cells/10^6 CD4+ cells
Standard Deviation 809.91
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
B/Malaysia[CD4-CD40L] D0 (N=44;35;36)
|
429.49 CD4 cells/10^6 CD4+ cells
Standard Deviation 476.96
|
332.83 CD4 cells/10^6 CD4+ cells
Standard Deviation 337.05
|
595.14 CD4 cells/10^6 CD4+ cells
Standard Deviation 562.39
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
B/Malaysia[CD4-CD40L] D21 (N=44;36;35)
|
858.29 CD4 cells/10^6 CD4+ cells
Standard Deviation 562.66
|
648.87 CD4 cells/10^6 CD4+ cells
Standard Deviation 571.71
|
748.64 CD4 cells/10^6 CD4+ cells
Standard Deviation 673.49
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Pool FLU[CD4-CD40L] D0 (N=44;36;36)
|
987.45 CD4 cells/10^6 CD4+ cells
Standard Deviation 890.57
|
923.21 CD4 cells/10^6 CD4+ cells
Standard Deviation 555.48
|
1625.21 CD4 cells/10^6 CD4+ cells
Standard Deviation 968.97
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Pool FLU[CD4-CD40L] D0 (N=44;36;35)
|
1941.32 CD4 cells/10^6 CD4+ cells
Standard Deviation 1283.08
|
1399.44 CD4 cells/10^6 CD4+ cells
Standard Deviation 1125.57
|
1891.90 CD4 cells/10^6 CD4+ cells
Standard Deviation 1180.76
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Solomon Islands[CD4-IFNγ] D0 (N=44;36;36)
|
225.18 CD4 cells/10^6 CD4+ cells
Standard Deviation 246.92
|
178.68 CD4 cells/10^6 CD4+ cells
Standard Deviation 209.78
|
321.79 CD4 cells/10^6 CD4+ cells
Standard Deviation 394.96
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Solomon Islands[CD4-IFNγ] D21 (N=44;36;35)
|
444.36 CD4 cells/10^6 CD4+ cells
Standard Deviation 446.32
|
297.00 CD4 cells/10^6 CD4+ cells
Standard Deviation 380.68
|
276.77 CD4 cells/10^6 CD4+ cells
Standard Deviation 478.52
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Wisconsin[CD4-IFNγ] D0 (N=44;36;36)
|
327.24 CD4 cells/10^6 CD4+ cells
Standard Deviation 327.82
|
280.71 CD4 cells/10^6 CD4+ cells
Standard Deviation 243.51
|
431.80 CD4 cells/10^6 CD4+ cells
Standard Deviation 490.54
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Wisconsin[CD4-IFNγ] D21 (N=44;36;35)
|
594.70 CD4 cells/10^6 CD4+ cells
Standard Deviation 547.10
|
425.95 CD4 cells/10^6 CD4+ cells
Standard Deviation 366.97
|
374.53 CD4 cells/10^6 CD4+ cells
Standard Deviation 618.57
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
B/Malaysia[CD4-IFNγ] D0 (N=44;35;36)
|
314.05 CD4 cells/10^6 CD4+ cells
Standard Deviation 343.68
|
254.50 CD4 cells/10^6 CD4+ cells
Standard Deviation 268.96
|
471.54 CD4 cells/10^6 CD4+ cells
Standard Deviation 429.46
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
B/Malaysia[CD4-IFNγ] D21 (N=44;36;35)
|
565.96 CD4 cells/10^6 CD4+ cells
Standard Deviation 386.51
|
395.62 CD4 cells/10^6 CD4+ cells
Standard Deviation 445.62
|
612.24 CD4 cells/10^6 CD4+ cells
Standard Deviation 529.06
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Pool FLU[CD4-IFNγ] D0 (N=44;36;36)
|
702.42 CD4 cells/10^6 CD4+ cells
Standard Deviation 642.37
|
575.66 CD4 cells/10^6 CD4+ cells
Standard Deviation 442.31
|
924.86 CD4 cells/10^6 CD4+ cells
Standard Deviation 704.75
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Pool FLU[CD4-IFNγ] D21 (N=44;36;35)
|
1231.82 CD4 cells/10^6 CD4+ cells
Standard Deviation 926.67
|
892.48 CD4 cells/10^6 CD4+ cells
Standard Deviation 794.53
|
1108.49 CD4 cells/10^6 CD4+ cells
Standard Deviation 956.85
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Solomon Islands[CD4-IL2] D0 (N=44;36;36)
|
253.44 CD4 cells/10^6 CD4+ cells
Standard Deviation 281.09
|
146.65 CD4 cells/10^6 CD4+ cells
Standard Deviation 216.35
|
314.65 CD4 cells/10^6 CD4+ cells
Standard Deviation 418.81
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Solomon Islands[CD4-IL2] D21 (N=44;36;35)
|
616.24 CD4 cells/10^6 CD4+ cells
Standard Deviation 527.94
|
386.68 CD4 cells/10^6 CD4+ cells
Standard Deviation 403.33
|
278.09 CD4 cells/10^6 CD4+ cells
Standard Deviation 479.01
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Wisconsin[CD4-IL2] D0 (N=44;36;36)
|
500.73 CD4 cells/10^6 CD4+ cells
Standard Deviation 465.55
|
425.33 CD4 cells/10^6 CD4+ cells
Standard Deviation 377.19
|
735.18 CD4 cells/10^6 CD4+ cells
Standard Deviation 560.20
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Wisconsin[CD4-IL2] D21 (N=44;36;35)
|
836.51 CD4 cells/10^6 CD4+ cells
Standard Deviation 650.10
|
649.78 CD4 cells/10^6 CD4+ cells
Standard Deviation 561.75
|
507.19 CD4 cells/10^6 CD4+ cells
Standard Deviation 747.26
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
B/Malaysia[CD4- IL2] D0 (N=44;35;36)
|
423.52 CD4 cells/10^6 CD4+ cells
Standard Deviation 454.12
|
317.95 CD4 cells/10^6 CD4+ cells
Standard Deviation 314.42
|
598.54 CD4 cells/10^6 CD4+ cells
Standard Deviation 495.94
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
B/Malaysia[CD4- IL2] D21 (N=44;36;35)
|
837.64 CD4 cells/10^6 CD4+ cells
Standard Deviation 530.27
|
609.36 CD4 cells/10^6 CD4+ cells
Standard Deviation 501.15
|
797.20 CD4 cells/10^6 CD4+ cells
Standard Deviation 619.24
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Pool FLU[CD4-IL2] D0 (N=44;36;36)
|
861.71 CD4 cells/10^6 CD4+ cells
Standard Deviation 826.31
|
852.92 CD4 cells/10^6 CD4+ cells
Standard Deviation 562.42
|
1398.63 CD4 cells/10^6 CD4+ cells
Standard Deviation 889.24
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Pool FLU[CD4-IL2] D21 (N=44;36;35)
|
1711.92 CD4 cells/10^6 CD4+ cells
Standard Deviation 1141.42
|
1253.42 CD4 cells/10^6 CD4+ cells
Standard Deviation 962.58
|
1643.55 CD4 cells/10^6 CD4+ cells
Standard Deviation 1047.94
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Solomon Islands[CD4-TFNα] D0 (N=44;36;36)
|
213.84 CD4 cells/10^6 CD4+ cells
Standard Deviation 261.37
|
157.07 CD4 cells/10^6 CD4+ cells
Standard Deviation 191.42
|
257.79 CD4 cells/10^6 CD4+ cells
Standard Deviation 414.20
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Solomon Islands[CD4-TFNα] D21 (N=44;36;35)
|
438.22 CD4 cells/10^6 CD4+ cells
Standard Deviation 458.26
|
200.94 CD4 cells/10^6 CD4+ cells
Standard Deviation 422.70
|
234.56 CD4 cells/10^6 CD4+ cells
Standard Deviation 509.44
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Wisconsin[CD4-TFNα] D0 (N=44;36;36)
|
505.57 CD4 cells/10^6 CD4+ cells
Standard Deviation 480.19
|
398.34 CD4 cells/10^6 CD4+ cells
Standard Deviation 330.78
|
626.76 CD4 cells/10^6 CD4+ cells
Standard Deviation 667.79
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Wisconsin[CD4-TFNα] D21 (N=44;36;35)
|
765.11 CD4 cells/10^6 CD4+ cells
Standard Deviation 686.36
|
567.86 CD4 cells/10^6 CD4+ cells
Standard Deviation 528.70
|
787.77 CD4 cells/10^6 CD4+ cells
Standard Deviation 804.78
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
B/Malaysia[CD4- TFNα] D0 (N=44;35;36)
|
257.07 CD4 cells/10^6 CD4+ cells
Standard Deviation 342.41
|
180.31 CD4 cells/10^6 CD4+ cells
Standard Deviation 263.66
|
381.85 CD4 cells/10^6 CD4+ cells
Standard Deviation 435.63
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
B/Malaysia[CD4- TFNα] D21 (N=44;36;35)
|
495.31 CD4 cells/10^6 CD4+ cells
Standard Deviation 410.07
|
304.21 CD4 cells/10^6 CD4+ cells
Standard Deviation 460.57
|
494.64 CD4 cells/10^6 CD4+ cells
Standard Deviation 550.12
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Pool FLU[CD4-TFNα] D0 (N=44;36;36)
|
700.87 CD4 cells/10^6 CD4+ cells
Standard Deviation 778.74
|
687.37 CD4 cells/10^6 CD4+ cells
Standard Deviation 473.04
|
1236.53 CD4 cells/10^6 CD4+ cells
Standard Deviation 885.31
|
|
The Geometric Mean (GM) Number of CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Pool FLU[CD4-TFNα] D21 (N=44;36;35)
|
1368.75 CD4 cells/10^6 CD4+ cells
Standard Deviation 1094.14
|
1016.67 CD4 cells/10^6 CD4+ cells
Standard Deviation 899.04
|
1356.89 CD4 cells/10^6 CD4+ cells
Standard Deviation 1093.09
|
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 were available at day 21.
The vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and Pool FLU antigens and the markers assessed were CD8-All doubles, CD40L, IFN-γ, IL-2 and TNF-α.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine GSK576389A Group
n=44 Participants
Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A in this study.
|
Fluarix Elderly Group
n=36 Participants
Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
Fluarix Young Group
n=36 Participants
Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
|---|---|---|---|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Solomon Islands[CD8-All doubles] D0 (N=44;36;36)
|
2.26 CD8 cells/10^6 CD8+ cells
Standard Deviation 136.77
|
3.28 CD8 cells/10^6 CD8+ cells
Standard Deviation 101.08
|
4.14 CD8 cells/10^6 CD8+ cells
Standard Deviation 186.27
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Solomon Islands[CD8-All doubles] D21 (N=44;36;35
|
1.84 CD8 cells/10^6 CD8+ cells
Standard Deviation 88.15
|
1.92 CD8 cells/10^6 CD8+ cells
Standard Deviation 55.86
|
3.60 CD8 cells/10^6 CD8+ cells
Standard Deviation 138.60
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Wisconsin[CD8-All doubles] D0 (N=43;36;36)
|
2.75 CD8 cells/10^6 CD8+ cells
Standard Deviation 60.50
|
5.30 CD8 cells/10^6 CD8+ cells
Standard Deviation 264.71
|
2.44 CD8 cells/10^6 CD8+ cells
Standard Deviation 39.72
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Wisconsin[CD8-All doubles] D21 (N=44;36;35)
|
2.04 CD8 cells/10^6 CD8+ cells
Standard Deviation 65.79
|
2.55 CD8 cells/10^6 CD8+ cells
Standard Deviation 54.17
|
3.69 CD8 cells/10^6 CD8+ cells
Standard Deviation 62.67
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
B/Malaysia[CD8-All doubles] D0 (N=44;35;36)
|
3.28 CD8 cells/10^6 CD8+ cells
Standard Deviation 159.00
|
4.12 CD8 cells/10^6 CD8+ cells
Standard Deviation 154.66
|
2.39 CD8 cells/10^6 CD8+ cells
Standard Deviation 72.34
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
B/Malaysia[CD8-All doubles] D21 (N=44;36;35)
|
3.03 CD8 cells/10^6 CD8+ cells
Standard Deviation 89.02
|
2.69 CD8 cells/10^6 CD8+ cells
Standard Deviation 83.37
|
2.28 CD8 cells/10^6 CD8+ cells
Standard Deviation 44.43
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Pool FLU[CD8-All doubles] D0 (N=44;36;36)
|
8.91 CD8 cells/10^6 CD8+ cells
Standard Deviation 213.18
|
10.47 CD8 cells/10^6 CD8+ cells
Standard Deviation 89.43
|
9.43 CD8 cells/10^6 CD8+ cells
Standard Deviation 153.80
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Pool FLU[CD8-All doubles] D21 (N=44;36;35)
|
9.98 CD8 cells/10^6 CD8+ cells
Standard Deviation 149.19
|
8.02 CD8 cells/10^6 CD8+ cells
Standard Deviation 158.53
|
6.50 CD8 cells/10^6 CD8+ cells
Standard Deviation 95.79
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Solomon Islands[CD8-CD40L] D0 (N=44;36;36)
|
2.17 CD8 cells/10^6 CD8+ cells
Standard Deviation 124.96
|
1.97 CD8 cells/10^6 CD8+ cells
Standard Deviation 88.18
|
1.61 CD8 cells/10^6 CD8+ cells
Standard Deviation 22.41
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Solomon Islands[CD8-CD40L] D21 (N=44;36;35)
|
1.43 CD8 cells/10^6 CD8+ cells
Standard Deviation 40.80
|
1.64 CD8 cells/10^6 CD8+ cells
Standard Deviation 30.98
|
1.94 CD8 cells/10^6 CD8+ cells
Standard Deviation 47.82
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Wisconsin[CD8-CD40L] D0 (N=43;36;36)
|
2.14 CD8 cells/10^6 CD8+ cells
Standard Deviation 32.90
|
2.67 CD8 cells/10^6 CD8+ cells
Standard Deviation 222.75
|
1.70 CD8 cells/10^6 CD8+ cells
Standard Deviation 35.64
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Wisconsin[CD8-CD40L] D21 (N=44;36;35)
|
1.52 CD8 cells/10^6 CD8+ cells
Standard Deviation 45.12
|
1.68 CD8 cells/10^6 CD8+ cells
Standard Deviation 40.13
|
2.55 CD8 cells/10^6 CD8+ cells
Standard Deviation 44.60
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
B/Malaysia[CD8-CD40L] D0 (N=44;35;36)
|
3.44 CD8 cells/10^6 CD8+ cells
Standard Deviation 150.26
|
2.27 CD8 cells/10^6 CD8+ cells
Standard Deviation 96.08
|
2.49 CD8 cells/10^6 CD8+ cells
Standard Deviation 57.45
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
B/Malaysia[CD8-CD40L] D21 (N=44;36;35)
|
2.49 CD8 cells/10^6 CD8+ cells
Standard Deviation 90.52
|
1.62 CD8 cells/10^6 CD8+ cells
Standard Deviation 40.21
|
2.59 CD8 cells/10^6 CD8+ cells
Standard Deviation 45.37
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Pool FLU[CD8-CD40L] D0 (N=44;36;36)
|
7.70 CD8 cells/10^6 CD8+ cells
Standard Deviation 171.70
|
6.52 CD8 cells/10^6 CD8+ cells
Standard Deviation 67.52
|
4.42 CD8 cells/10^6 CD8+ cells
Standard Deviation 49.26
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Pool FLU[CD8-CD40L] D21 (N=44;36;35)
|
4.92 CD8 cells/10^6 CD8+ cells
Standard Deviation 129.03
|
4.64 CD8 cells/10^6 CD8+ cells
Standard Deviation 135.66
|
3.41 CD8 cells/10^6 CD8+ cells
Standard Deviation 60.34
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Solomon Islands[CD8-IFNγ] D0 (N=44;36;36)
|
2.07 CD8 cells/10^6 CD8+ cells
Standard Deviation 36.81
|
1.49 CD8 cells/10^6 CD8+ cells
Standard Deviation 49.87
|
3.15 CD8 cells/10^6 CD8+ cells
Standard Deviation 173.10
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Solomon Islands[CD8-IFNγ] D21 (N=44;36;35)
|
1.77 CD8 cells/10^6 CD8+ cells
Standard Deviation 72.15
|
2.12 CD8 cells/10^6 CD8+ cells
Standard Deviation 38.86
|
3.53 CD8 cells/10^6 CD8+ cells
Standard Deviation 113.89
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Wisconsin[CD8-IFNγ] D0 (N=43;36;36)
|
1.71 CD8 cells/10^6 CD8+ cells
Standard Deviation 31.52
|
2.76 CD8 cells/10^6 CD8+ cells
Standard Deviation 45.51
|
1.27 CD8 cells/10^6 CD8+ cells
Standard Deviation 16.73
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Wisconsin[CD8-IFNγ] D21 (N=44;36;35)
|
1.80 CD8 cells/10^6 CD8+ cells
Standard Deviation 26.18
|
2.73 CD8 cells/10^6 CD8+ cells
Standard Deviation 55.42
|
1.88 CD8 cells/10^6 CD8+ cells
Standard Deviation 33.19
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
B/Malaysia[CD8-IFNγ] D0 (N=44;35;36)
|
1.93 CD8 cells/10^6 CD8+ cells
Standard Deviation 47.54
|
2.75 CD8 cells/10^6 CD8+ cells
Standard Deviation 135.21
|
2.43 CD8 cells/10^6 CD8+ cells
Standard Deviation 53.85
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
B/Malaysia[CD8-IFNγ] D21 (N=44;36;35)
|
2.15 CD8 cells/10^6 CD8+ cells
Standard Deviation 35.22
|
2.24 CD8 cells/10^6 CD8+ cells
Standard Deviation 59.72
|
1.47 CD8 cells/10^6 CD8+ cells
Standard Deviation 19.69
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Pool FLU[CD8-IFNγ] D0 (N=44;36;36)
|
2.86 CD8 cells/10^6 CD8+ cells
Standard Deviation 46.18
|
2.48 CD8 cells/10^6 CD8+ cells
Standard Deviation 50.62
|
3.88 CD8 cells/10^6 CD8+ cells
Standard Deviation 117.16
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Pool FLU[CD8-IFNγ] D21 (N=44;36;35)
|
2.55 CD8 cells/10^6 CD8+ cells
Standard Deviation 47.59
|
4.17 CD8 cells/10^6 CD8+ cells
Standard Deviation 75.18
|
2.57 CD8 cells/10^6 CD8+ cells
Standard Deviation 50.74
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Solomon Islands[CD8-IL2] D0 (N=44;36;36)
|
2.17 CD8 cells/10^6 CD8+ cells
Standard Deviation 135.16
|
3.16 CD8 cells/10^6 CD8+ cells
Standard Deviation 92.06
|
2.49 CD8 cells/10^6 CD8+ cells
Standard Deviation 125.60
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Solomon Islands[CD8-IL2] D21 (N=44;36;35)
|
1.54 CD8 cells/10^6 CD8+ cells
Standard Deviation 76.05
|
1.46 CD8 cells/10^6 CD8+ cells
Standard Deviation 28.82
|
4.26 CD8 cells/10^6 CD8+ cells
Standard Deviation 129.70
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Wisconsin[CD8-IL2] D0 (N=43;36;36)
|
2.55 CD8 cells/10^6 CD8+ cells
Standard Deviation 65.54
|
4.58 CD8 cells/10^6 CD8+ cells
Standard Deviation 263.11
|
1.69 CD8 cells/10^6 CD8+ cells
Standard Deviation 30.56
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Wisconsin[CD8-IL2] D21 (N=44;36;35)
|
2.30 CD8 cells/10^6 CD8+ cells
Standard Deviation 65.28
|
1.87 CD8 cells/10^6 CD8+ cells
Standard Deviation 46.74
|
2.95 CD8 cells/10^6 CD8+ cells
Standard Deviation 74.62
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
B/Malaysia[CD8-IL2] D0 (N=44;35;36)
|
2.35 CD8 cells/10^6 CD8+ cells
Standard Deviation 136.20
|
3.18 CD8 cells/10^6 CD8+ cells
Standard Deviation 142.54
|
1.90 CD8 cells/10^6 CD8+ cells
Standard Deviation 32.04
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
B/Malaysia[CD8-IL2] D21 (N=44;36;35)
|
3.12 CD8 cells/10^6 CD8+ cells
Standard Deviation 97.43
|
2.36 CD8 cells/10^6 CD8+ cells
Standard Deviation 73.10
|
3.69 CD8 cells/10^6 CD8+ cells
Standard Deviation 50.07
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Pool FLU[CD8-IL2] D0 (N=44;36;36)
|
7.71 CD8 cells/10^6 CD8+ cells
Standard Deviation 210.95
|
8.20 CD8 cells/10^6 CD8+ cells
Standard Deviation 96.31
|
6.61 CD8 cells/10^6 CD8+ cells
Standard Deviation 63.15
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Pool FLU[CD8-IL2] D21 (N=44;36;35)
|
9.19 CD8 cells/10^6 CD8+ cells
Standard Deviation 155.66
|
8.89 CD8 cells/10^6 CD8+ cells
Standard Deviation 149.48
|
5.36 CD8 cells/10^6 CD8+ cells
Standard Deviation 73.11
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Solomon Islands[CD8-TFNα] D0 (N=44;36;36)
|
2.42 CD8 cells/10^6 CD8+ cells
Standard Deviation 49.99
|
1.99 CD8 cells/10^6 CD8+ cells
Standard Deviation 70.11
|
3.75 CD8 cells/10^6 CD8+ cells
Standard Deviation 175.10
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Solomon Islands[CD8-TFNα] D21 (N=44;36;35)
|
1.97 CD8 cells/10^6 CD8+ cells
Standard Deviation 68.53
|
2.40 CD8 cells/10^6 CD8+ cells
Standard Deviation 41.63
|
2.99 CD8 cells/10^6 CD8+ cells
Standard Deviation 132.56
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Wisconsin[CD8-TFNα] D0 (N=43;36;36)
|
3.54 CD8 cells/10^6 CD8+ cells
Standard Deviation 76.40
|
5.58 CD8 cells/10^6 CD8+ cells
Standard Deviation 70.98
|
2.44 CD8 cells/10^6 CD8+ cells
Standard Deviation 44.31
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
A/Wisconsin[CD8-TFNα] D21 (N=44;36;35)
|
2.84 CD8 cells/10^6 CD8+ cells
Standard Deviation 42.13
|
2.76 CD8 cells/10^6 CD8+ cells
Standard Deviation 65.68
|
2.19 CD8 cells/10^6 CD8+ cells
Standard Deviation 48.45
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
B/Malaysia[CD8-TFNα] D0 (N=44;35;36)
|
2.73 CD8 cells/10^6 CD8+ cells
Standard Deviation 80.16
|
8.42 CD8 cells/10^6 CD8+ cells
Standard Deviation 104.25
|
2.38 CD8 cells/10^6 CD8+ cells
Standard Deviation 72.34
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
B/Malaysia[CD8-TFNα] D21 (N=44;36;35)
|
2.76 CD8 cells/10^6 CD8+ cells
Standard Deviation 52.39
|
3.42 CD8 cells/10^6 CD8+ cells
Standard Deviation 64.32
|
1.66 CD8 cells/10^6 CD8+ cells
Standard Deviation 30.79
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Pool FLU[CD8-TFNα] D0 (N=44;36;36)
|
6.74 CD8 cells/10^6 CD8+ cells
Standard Deviation 92.88
|
8.70 CD8 cells/10^6 CD8+ cells
Standard Deviation 72.98
|
3.32 CD8 cells/10^6 CD8+ cells
Standard Deviation 142.50
|
|
The GM Number of CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain and for Pooled Vaccine Strains Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker
Pool FLU[CD8-TFNα] D21 (N=44;36;35)
|
5.86 CD8 cells/10^6 CD8+ cells
Standard Deviation 58.58
|
5.55 CD8 cells/10^6 CD8+ cells
Standard Deviation 104.44
|
4.56 CD8 cells/10^6 CD8+ cells
Standard Deviation 70.82
|
Adverse Events
Adjuvanted Influenza Vaccine GSK576389A Group
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Fluarix Elderly Group
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Fluarix Young Group
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adjuvanted Influenza Vaccine GSK576389A Group
n=55 participants at risk
Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
|
Fluarix Elderly Group
n=40 participants at risk
Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
Fluarix Young Group
n=38 participants at risk
Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
|
|---|---|---|---|
|
General disorders
Pain
|
72.7%
40/55 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
30.0%
12/40 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
89.5%
34/38 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Redness
|
23.6%
13/55 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
15.0%
6/40 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
2.6%
1/38 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Swelling
|
10.9%
6/55 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
10.0%
4/40 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/38 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Arthralgia
|
10.9%
6/55 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
15.0%
6/40 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
5.3%
2/38 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Fatigue
|
34.5%
19/55 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
15.0%
6/40 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
23.7%
9/38 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Headache
|
23.6%
13/55 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
12.5%
5/40 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
21.1%
8/38 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Myalgia
|
18.2%
10/55 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
7.5%
3/40 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
26.3%
10/38 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Nausea
|
7.3%
4/55 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/40 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
7.9%
3/38 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Shivering
|
18.2%
10/55 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/40 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
5.3%
2/38 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Temperature
|
7.3%
4/55 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/40 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/38 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
5/55 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
7.5%
3/40 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
2.6%
1/38 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/55 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
5.0%
2/40 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
10.5%
4/38 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Infections and infestations
Rhinitis
|
3.6%
2/55 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
2.5%
1/40 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
5.3%
2/38 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/55 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
2.5%
1/40 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
5.3%
2/38 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
Nervous system disorders
Headache
|
0.00%
0/55 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/40 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
7.9%
3/38 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Influenza like illness
|
0.00%
0/55 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/40 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
7.9%
3/38 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
|
General disorders
Injection site pruritus
|
1.8%
1/55 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
5.0%
2/40 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
|
0.00%
0/38 • Serious adverse events were assessed up to day 21. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively.
For the frequent 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