Trial Outcomes & Findings for Evaluate Safety and Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults (NCT NCT00538473)
NCT ID: NCT00538473
Last Updated: 2018-06-08
Results Overview
Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
During a 7-day follow-up period after vaccination
Results posted on
2018-06-08
Participant Flow
Participant milestones
| Measure |
FluAS25 (GSK576389A) Group
Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
|
Fluarix Group
Subjects received 1 dose of Fluarix™.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
35
|
|
Overall Study
COMPLETED
|
32
|
35
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
FluAS25 (GSK576389A) Group
Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
|
Fluarix Group
Subjects received 1 dose of Fluarix™.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Evaluate Safety and Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults
Baseline characteristics by cohort
| Measure |
FluAS25 (GSK576389A) Group
n=33 Participants
Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
|
Fluarix Group
n=35 Participants
Subjects received 1 dose of Fluarix™.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.1 Years
STANDARD_DEVIATION 4.53 • n=39 Participants
|
73.2 Years
STANDARD_DEVIATION 5.34 • n=41 Participants
|
73.15 Years
STANDARD_DEVIATION 4.93 • n=35 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: During a 7-day follow-up period after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.
Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
Outcome measures
| Measure |
Fluarix Group
n=35 Participants
Subjects received 1 dose of Fluarix™.
|
FluAS25 (GSK576389A) Group
n=33 Participants
Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
|
|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any ecchymosis
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 ecchymosis
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any pain
|
7 Subjects
|
17 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 pain
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any redness
|
4 Subjects
|
10 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 redness
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any swelling
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 swelling
|
0 Subjects
|
0 Subjects
|
PRIMARY outcome
Timeframe: During a 7-day follow-up period after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.
Duration was expressed as median number of days any symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: occurrence of any local symptom regardless of their intensity grade.
Outcome measures
| Measure |
Fluarix Group
n=7 Participants
Subjects received 1 dose of Fluarix™.
|
FluAS25 (GSK576389A) Group
n=17 Participants
Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
|
|---|---|---|
|
Duration of Solicited Local Symptoms
Ecchymosis (N= 0; 1)
|
5.0 Days
Interval 5.0 to 5.0
|
NA Days
No subjects experienced this symptom
|
|
Duration of Solicited Local Symptoms
Pain (N= 17; 7)
|
2.0 Days
Interval 1.0 to 4.0
|
2.0 Days
Interval 1.0 to 4.0
|
|
Duration of Solicited Local Symptoms
Redness (N= 10; 4)
|
2.0 Days
Interval 1.0 to 2.0
|
2.5 Days
Interval 1.0 to 6.0
|
|
Duration of Solicited Local Symptoms
Swelling (N= 2; 2)
|
2.5 Days
Interval 2.0 to 3.0
|
1.5 Days
Interval 1.0 to 2.0
|
PRIMARY outcome
Timeframe: During a 7-day follow-up period after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Fluarix Group
n=35 Participants
Subjects received 1 dose of Fluarix™.
|
FluAS25 (GSK576389A) Group
n=33 Participants
Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any arthralgia
|
5 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 arthralgia
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related arthralgia
|
1 Subjects
|
7 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any fatigue
|
3 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 fatigue
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related fatigue
|
2 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any headache
|
3 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 headache
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related headache
|
2 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any myalgia
|
1 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 myalgia
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related myalgia
|
0 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any nausea
|
1 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 nausea
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related nausea
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any shivering
|
3 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 shivering
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related shivering
|
2 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any fever
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 fever
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related fever
|
0 Subjects
|
1 Subjects
|
PRIMARY outcome
Timeframe: During a 7-day follow-up period after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort on those subjects who reported the specific symptom.
Duration was expressed as median number of days any symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: occurrence of any general symptom regardless of their intensity grade or relationship to vaccination.
Outcome measures
| Measure |
Fluarix Group
n=5 Participants
Subjects received 1 dose of Fluarix™.
|
FluAS25 (GSK576389A) Group
n=8 Participants
Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
|
|---|---|---|
|
Duration of Solicited General Symptoms
Arthralgia (N= 8; 5)
|
3.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 5.0
|
|
Duration of Solicited General Symptoms
Fatigue (N= 8; 3)
|
1.0 Days
Interval 1.0 to 2.0
|
2.5 Days
Interval 1.0 to 6.0
|
|
Duration of Solicited General Symptoms
Headache (N= 8; 3)
|
1.0 Days
Interval 1.0 to 2.0
|
1.5 Days
Interval 1.0 to 3.0
|
|
Duration of Solicited General Symptoms
Myalgia (N= 8; 1)
|
1.0 Days
Interval 1.0 to 1.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited General Symptoms
Nausea (N= 3; 1)
|
2.0 Days
Interval 2.0 to 2.0
|
4.0 Days
Interval 2.0 to 4.0
|
|
Duration of Solicited General Symptoms
Shivering (N= 6; 3)
|
1.0 Days
Interval 1.0 to 2.0
|
1.0 Days
Interval 1.0 to 2.0
|
|
Duration of Solicited General Symptoms
Fever (N= 1; 0)
|
NA Days
None of the subjects in this group reported fever.
|
NA Days
Information on duration of fever was missing from this subject's symptom sheet.
|
PRIMARY outcome
Timeframe: During a 21-day follow-up period after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.
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: occurrence of any unsolicited AE regardless of their intensity grade or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activities. Related: unsolicited AE assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Fluarix Group
n=35 Participants
Subjects received 1 dose of Fluarix™.
|
FluAS25 (GSK576389A) Group
n=33 Participants
Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any AEs
|
7 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 AEs
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related AEs
|
2 Subjects
|
1 Subjects
|
PRIMARY outcome
Timeframe: During a 21-day follow-up period after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.
Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit. Any: occurrence of any MSC regardless of their intensity grade or relationship to vaccination. Grade 3: MSC that prevented normal everyday activities. Related: MSC assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Fluarix Group
n=35 Participants
Subjects received 1 dose of Fluarix™.
|
FluAS25 (GSK576389A) Group
n=33 Participants
Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Grade 3 MSCs
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Any MSCs
|
4 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Related MSCs
|
0 Subjects
|
0 Subjects
|
PRIMARY outcome
Timeframe: Throughout the entire study (up to Day 21)Population: The analysis was performed on the Total Vaccinated Cohort including all subjects with the study vaccine administered.
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: occurrence of any SAE regardless of their relationship to vaccination. Related: SAE assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Fluarix Group
n=35 Participants
Subjects received 1 dose of Fluarix™.
|
FluAS25 (GSK576389A) Group
n=33 Participants
Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
|
|---|---|---|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Any SAEs
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Related SAEs
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Titers were expressed as Geometric Mean Titers. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Outcome measures
| Measure |
Fluarix Group
n=35 Participants
Subjects received 1 dose of Fluarix™.
|
FluAS25 (GSK576389A) Group
n=32 Participants
Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
|
|---|---|---|
|
Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains
A/Solomon Islands [Day 0]
|
9.0 Titer
Interval 6.4 to 12.5
|
12.7 Titer
Interval 8.8 to 18.2
|
|
Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains
A/Solomon Islands [Day 21]
|
42.4 Titer
Interval 28.3 to 63.5
|
63.0 Titer
Interval 41.5 to 95.7
|
|
Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains
A/Wisconsin [Day 0]
|
83.1 Titer
Interval 63.1 to 109.5
|
100.3 Titer
Interval 67.2 to 149.7
|
|
Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains
A/Wisconsin [Day 21]
|
158.4 Titer
Interval 114.1 to 219.7
|
252.2 Titer
Interval 195.8 to 324.7
|
|
Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains
B/Malaysia [Day 0]
|
61.2 Titer
Interval 44.2 to 84.6
|
55.8 Titer
Interval 37.4 to 83.3
|
|
Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Strains
B/Malaysia [Day 21]
|
99.4 Titer
Interval 74.2 to 133.3
|
126.1 Titer
Interval 90.2 to 176.3
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Outcome measures
| Measure |
Fluarix Group
n=35 Participants
Subjects received 1 dose of Fluarix™.
|
FluAS25 (GSK576389A) Group
n=32 Participants
Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
|
|---|---|---|
|
Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains
A/Wisconsin [Day 0]
|
35 Subjects
|
30 Subjects
|
|
Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains
A/Solomon Islands [Day 0]
|
15 Subjects
|
18 Subjects
|
|
Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains
A/Solomon Islands [Day 21]
|
32 Subjects
|
29 Subjects
|
|
Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains
A/Wisconsin [Day 21]
|
35 Subjects
|
32 Subjects
|
|
Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains
B/Malaysia [Day 0]
|
34 Subjects
|
31 Subjects
|
|
Number of Subjects Seropositive for HI Antibodies Against Each of the Three Vaccine Strains
B/Malaysia [Day 21]
|
35 Subjects
|
32 Subjects
|
SECONDARY outcome
Timeframe: At Day 21Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects 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 below1:10 and a post-vaccination titer greater than or equal to1:40 or a pre-vaccination titer greater than or equal to1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Outcome measures
| Measure |
Fluarix Group
n=35 Participants
Subjects received 1 dose of Fluarix™.
|
FluAS25 (GSK576389A) Group
n=32 Participants
Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
|
|---|---|---|
|
Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains
A/Solomon Islands
|
17 Subjects
|
20 Subjects
|
|
Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains
A/Wisconsin
|
7 Subjects
|
9 Subjects
|
|
Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains
B/Malaysia
|
3 Subjects
|
8 Subjects
|
SECONDARY outcome
Timeframe: At Day 21Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Outcome measures
| Measure |
Fluarix Group
n=35 Participants
Subjects received 1 dose of Fluarix™.
|
FluAS25 (GSK576389A) Group
n=32 Participants
Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
|
|---|---|---|
|
Seroconversion Factors (SCFs) for HI Antibodies Against Each of the Three Vaccine Strains
A/Solomon Islands
|
4.7 fold increase
Interval 3.2 to 7.0
|
5.0 fold increase
Interval 3.3 to 7.5
|
|
Seroconversion Factors (SCFs) for HI Antibodies Against Each of the Three Vaccine Strains
A/Wisconsin
|
1.9 fold increase
Interval 1.6 to 2.3
|
2.5 fold increase
Interval 2.0 to 3.1
|
|
Seroconversion Factors (SCFs) for HI Antibodies Against Each of the Three Vaccine Strains
B/Malaysia
|
1.6 fold increase
Interval 1.4 to 1.9
|
2.3 fold increase
Interval 1.8 to 2.9
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects 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 greater than or equal to 1:40 that usually is accepted as indicating protection.
Outcome measures
| Measure |
Fluarix Group
n=35 Participants
Subjects received 1 dose of Fluarix™.
|
FluAS25 (GSK576389A) Group
n=32 Participants
Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
|
|---|---|---|
|
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains
A/Solomon Islands [Day 0]
|
3 Subjects
|
9 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains
A/Solomon Islands [Day 21]
|
22 Subjects
|
27 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains
A/Wisconsin [Day 0]
|
31 Subjects
|
29 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains
A/Wisconsin [Day 21]
|
35 Subjects
|
32 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains
B/Malaysia [Day 0]
|
29 Subjects
|
20 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains
B/Malaysia [Day 21]
|
34 Subjects
|
31 Subjects
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Results are presented as geometric mean number of specific influenza CD4 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD4 T lymphocytes expressing at least 2 different cytokines \[Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-α), Interferon gamma (IFN-γ)\]) and for CD4 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-α, or IFN-γ) and least one other.
Outcome measures
| Measure |
Fluarix Group
n=32 Participants
Subjects received 1 dose of Fluarix™.
|
FluAS25 (GSK576389A) Group
n=30 Participants
Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
|
|---|---|---|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
All Doubles A/Solomon Islands [Day 0] (N= 30; 32)
|
353.41 Cells per million
Standard Deviation 289.83
|
611.15 Cells per million
Standard Deviation 487.68
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
All Doubles A/Solomon Islands [Day 21] (N= 25; 31)
|
285.45 Cells per million
Standard Deviation 288.42
|
761.22 Cells per million
Standard Deviation 783.59
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
All Doubles A/Wisconsin [Day 0] (N= 30; 32)
|
476.38 Cells per million
Standard Deviation 438.45
|
877.26 Cells per million
Standard Deviation 529.44
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
All Doubles A/Wisconsin [Day 21] (N= 25; 31)
|
357.12 Cells per million
Standard Deviation 376.31
|
830.38 Cells per million
Standard Deviation 652.85
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
All Doubles B/Malaysia [Day 0] (N= 30; 32)
|
391.89 Cells per million
Standard Deviation 285.28
|
643.26 Cells per million
Standard Deviation 382.49
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
All Doubles B/Malaysia [Day 21] (N= 25; 31)
|
200.13 Cells per million
Standard Deviation 370.22
|
657.31 Cells per million
Standard Deviation 542.67
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
All Doubles Pooled Strains [Day 0] (N= 30; 32)
|
767.10 Cells per million
Standard Deviation 490.04
|
1401.41 Cells per million
Standard Deviation 671.68
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
All Doubles Pooled Strains [Day 21] (N= 25; 31)
|
545.68 Cells per million
Standard Deviation 480.37
|
1227.87 Cells per million
Standard Deviation 1013.31
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
CD40L A/Solomon Islands [Day 0] (N= 30; 32)
|
341.61 Cells per million
Standard Deviation 291.23
|
606.58 Cells per million
Standard Deviation 484.99
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
CD40L A/Solomon Islands [Day 21] (N= 25; 31)
|
279.59 Cells per million
Standard Deviation 284.97
|
758.40 Cells per million
Standard Deviation 773.73
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
CD40L A/Wisconsin [Day 0] (N= 30; 32)
|
472.33 Cells per million
Standard Deviation 427.69
|
871.43 Cells per million
Standard Deviation 512.44
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
CD40L A/Wisconsin [Day 21] (N= 25; 31)
|
353.78 Cells per million
Standard Deviation 377.73
|
829.38 Cells per million
Standard Deviation 648.50
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
CD40L B/Malaysia [Day 0] (N= 30; 32)
|
387.23 Cells per million
Standard Deviation 280.03
|
640.49 Cells per million
Standard Deviation 370.62
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
CD40L B/Malaysia [Day 21] (N= 25; 31)
|
188.93 Cells per million
Standard Deviation 361.66
|
648.93 Cells per million
Standard Deviation 535.97
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
CD40L Pooled Strains [Day 0] (N= 30; 32)
|
757.53 Cells per million
Standard Deviation 489.79
|
1388.14 Cells per million
Standard Deviation 661.04
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
CD40L Pooled Strains [Day 21] (N= 25; 31)
|
539.55 Cells per million
Standard Deviation 476.23
|
1209.75 Cells per million
Standard Deviation 996.45
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IFN-γ A/Solomon Islands [Day 0] (N= 30; 32)
|
180.69 Cells per million
Standard Deviation 182.12
|
393.40 Cells per million
Standard Deviation 328.18
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IFN-γ A/Solomon Islands [Day 21] (N= 25; 31)
|
150.29 Cells per million
Standard Deviation 185.78
|
411.23 Cells per million
Standard Deviation 509.98
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IFN-γ A/Wisconsin [Day 0] (N= 30; 32)
|
232.70 Cells per million
Standard Deviation 278.10
|
477.81 Cells per million
Standard Deviation 299.82
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IFN-γ A/Wisconsin [Day 21] (N= 25; 31)
|
212.25 Cells per million
Standard Deviation 191.16
|
357.56 Cells per million
Standard Deviation 423.90
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IFN-γ B/Malaysia [Day 0] (N= 30; 32)
|
175.13 Cells per million
Standard Deviation 210.56
|
405.44 Cells per million
Standard Deviation 279.02
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IFN-γ B/Malaysia [Day 21] (N= 25; 31)
|
174.94 Cells per million
Standard Deviation 229.30
|
442.51 Cells per million
Standard Deviation 384.08
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IFN-γ Pooled Strains [Day 0] (N= 30; 32)
|
436.69 Cells per million
Standard Deviation 307.38
|
824.34 Cells per million
Standard Deviation 491.16
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IFN-γ Pooled Strains [Day 21] (N= 25; 31)
|
343.86 Cells per million
Standard Deviation 315.56
|
840.65 Cells per million
Standard Deviation 671.16
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IL-2 A/Solomon Islands [Day 0] (N= 30; 32)
|
321.49 Cells per million
Standard Deviation 258.81
|
550.06 Cells per million
Standard Deviation 433.42
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IL-2 A/Solomon Islands [Day 21] (N= 25; 31)
|
241.86 Cells per million
Standard Deviation 225.01
|
635.35 Cells per million
Standard Deviation 631.73
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IL-2 A/Wisconsin [Day 0] (N= 30; 32)
|
407.21 Cells per million
Standard Deviation 381.85
|
738.42 Cells per million
Standard Deviation 509.02
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IL-2 A/Wisconsin [Day 21] (N= 25; 31)
|
259.27 Cells per million
Standard Deviation 313.49
|
682.25 Cells per million
Standard Deviation 547.67
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IL-2 B/Malaysia [Day 0] (N= 30; 32)
|
377.10 Cells per million
Standard Deviation 257.06
|
562.01 Cells per million
Standard Deviation 340.18
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IL-2 B/Malaysia [Day 21] (N= 25; 31)
|
194.20 Cells per million
Standard Deviation 319.95
|
577.43 Cells per million
Standard Deviation 470.86
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IL-2 Pooled Strains [Day 0] (N= 30; 32)
|
720.90 Cells per million
Standard Deviation 421.55
|
1192.89 Cells per million
Standard Deviation 595.71
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IL-2 Pooled Strains [Day 21] (N= 25; 31)
|
463.25 Cells per million
Standard Deviation 390.68
|
977.48 Cells per million
Standard Deviation 819.44
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
TNF-α A/Solomon Islands [Day 0] (N= 30; 32)
|
194.00 Cells per million
Standard Deviation 169.53
|
270.39 Cells per million
Standard Deviation 328.20
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
TNF-α A/Solomon Islands [Day 21] (N= 25; 31)
|
129.21 Cells per million
Standard Deviation 163.10
|
371.92 Cells per million
Standard Deviation 409.87
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
TNF-α A/Wisconsin [Day 0] (N= 30; 32)
|
334.97 Cells per million
Standard Deviation 281.45
|
584.58 Cells per million
Standard Deviation 352.86
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
TNF-α A/Wisconsin [Day 21] (N= 25; 31)
|
271.33 Cells per million
Standard Deviation 204.03
|
432.47 Cells per million
Standard Deviation 428.19
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
TNF-α B/Malaysia [Day 0] (N= 30; 32)
|
140.68 Cells per million
Standard Deviation 165.67
|
278.06 Cells per million
Standard Deviation 239.29
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
TNF-α B/Malaysia [Day 21] (N= 25; 31)
|
102.33 Cells per million
Standard Deviation 205.58
|
299.35 Cells per million
Standard Deviation 322.28
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
TNF-α Pooled Strains [Day 0] (N= 30; 32)
|
496.30 Cells per million
Standard Deviation 298.79
|
794.15 Cells per million
Standard Deviation 504.33
|
|
Number of Cytokine-positive Cluster of Differentiation 4 (CD4) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
TNF-α Pooled Strains [Day 21] (N= 25; 31)
|
251.59 Cells per million
Standard Deviation 290.29
|
674.35 Cells per million
Standard Deviation 584.50
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Results are presented as geometric mean number of specific influenza CD8 T lymphocytes per million T lymphocytes. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia. Results are given for All doubles (i.e. CD8 T lymphocytes expressing at least 2 different cytokines \[Cluster of Differentiation 40L (CD40L), Interleukin-2 (IL-2), Tumor Necrosis Factor alpha (TNF-α), Interferon gamma (IFN-γ)\]) and for CD8 T lymphocytes expressing one particular cytokine (CD40L, IL-2, TNF-α, or IFN-γ) and least one other.
Outcome measures
| Measure |
Fluarix Group
n=32 Participants
Subjects received 1 dose of Fluarix™.
|
FluAS25 (GSK576389A) Group
n=30 Participants
Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
|
|---|---|---|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
All Doubles A/Solomon Islands [Day 0] (N= 30; 32)
|
3.01 Cells per million
Standard Deviation 124.67
|
2.50 Cells per million
Standard Deviation 54.81
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
All Doubles A/Solomon Islands [Day 21] (N= 25; 31)
|
3.81 Cells per million
Standard Deviation 52.84
|
6.18 Cells per million
Standard Deviation 80.49
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
All Doubles A/Wisconsin [Day 0] (N= 29; 32)
|
1.55 Cells per million
Standard Deviation 40.24
|
5.48 Cells per million
Standard Deviation 87.38
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
All Doubles A/Wisconsin [Day 21] (N= 25; 31)
|
2.49 Cells per million
Standard Deviation 55.29
|
3.11 Cells per million
Standard Deviation 95.32
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
All Doubles B/Malaysia [Day 0] (N= 29; 32)
|
2.51 Cells per million
Standard Deviation 63.21
|
6.20 Cells per million
Standard Deviation 90.23
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
All Doubles B/Malaysia [Day 21] (N= 25; 31)
|
4.59 Cells per million
Standard Deviation 70.75
|
3.26 Cells per million
Standard Deviation 186.70
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
All Doubles Pooled Strains [Day 0] (N= 29; 32)
|
4.43 Cells per million
Standard Deviation 75.73
|
8.67 Cells per million
Standard Deviation 123.74
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
All Doubles Pooled Strains [Day 21] (N= 24; 31)
|
4.16 Cells per million
Standard Deviation 98.01
|
10.96 Cells per million
Standard Deviation 135.32
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
CD40L A/Solomon Islands [Day 0] (N= 30; 32)
|
2.38 Cells per million
Standard Deviation 57.63
|
2.05 Cells per million
Standard Deviation 27.92
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
CD40L A/Solomon Islands [Day 21] (N= 25; 31)
|
3.17 Cells per million
Standard Deviation 44.66
|
5.00 Cells per million
Standard Deviation 52.91
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
CD40L A/Wisconsin [Day 0] (N= 29; 32)
|
1.55 Cells per million
Standard Deviation 40.24
|
4.28 Cells per million
Standard Deviation 60.42
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
CD40L A/Wisconsin [Day 21] (N= 25; 31)
|
1.83 Cells per million
Standard Deviation 41.14
|
2.14 Cells per million
Standard Deviation 51.75
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
CD40L B/Malaysia [Day 0] (N= 29; 32)
|
2.03 Cells per million
Standard Deviation 45.49
|
6.59 Cells per million
Standard Deviation 77.30
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
CD40L B/Malaysia [Day 21] (N= 25; 31)
|
3.67 Cells per million
Standard Deviation 64.11
|
3.08 Cells per million
Standard Deviation 75.58
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
CD40L Pooled Strains [Day 0] (N= 29; 32)
|
3.65 Cells per million
Standard Deviation 58.75
|
6.61 Cells per million
Standard Deviation 69.93
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
CD40L Pooled Strains [Day 21] (N= 24; 31)
|
2.91 Cells per million
Standard Deviation 87.43
|
6.37 Cells per million
Standard Deviation 88.95
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IFN-γ A/Solomon Islands [Day 0] (N= 30; 32)
|
1.60 Cells per million
Standard Deviation 123.31
|
1.77 Cells per million
Standard Deviation 25.17
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IFN-γ A/Solomon Islands [Day 21] (N= 25; 31)
|
1.73 Cells per million
Standard Deviation 23.95
|
1.40 Cells per million
Standard Deviation 18.00
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IFN-γ A/Wisconsin [Day 0] (N= 29; 32)
|
1.52 Cells per million
Standard Deviation 26.15
|
1.96 Cells per million
Standard Deviation 58.89
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IFN-γ A/Wisconsin [Day 21] (N= 25; 31)
|
1.78 Cells per million
Standard Deviation 33.55
|
1.41 Cells per million
Standard Deviation 19.53
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IFN-γ B/Malaysia [Day 0] (N= 29; 32)
|
2.34 Cells per million
Standard Deviation 63.80
|
3.18 Cells per million
Standard Deviation 60.84
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IFN-γ B/Malaysia [Day 21] (N= 25; 31)
|
1.52 Cells per million
Standard Deviation 22.73
|
1.92 Cells per million
Standard Deviation 127.13
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IFN-γ Pooled Strains [Day 0] (N= 29; 32)
|
1.53 Cells per million
Standard Deviation 30.78
|
2.39 Cells per million
Standard Deviation 93.19
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IFN-γ Pooled Strains [Day 21] (N= 24; 31)
|
1.84 Cells per million
Standard Deviation 39.83
|
3.24 Cells per million
Standard Deviation 61.69
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IL-2 A/Solomon Islands [Day 0] (N= 30; 32)
|
2.46 Cells per million
Standard Deviation 66.32
|
2.49 Cells per million
Standard Deviation 54.69
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IL-2 A/Solomon Islands [Day 21] (N= 25; 31)
|
3.38 Cells per million
Standard Deviation 48.89
|
4.39 Cells per million
Standard Deviation 76.84
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IL-2 A/Wisconsin [Day 0] (N= 29; 32)
|
1.76 Cells per million
Standard Deviation 41.38
|
5.27 Cells per million
Standard Deviation 69.84
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IL-2 A/Wisconsin [Day 21] (N= 25; 31)
|
1.82 Cells per million
Standard Deviation 38.90
|
2.63 Cells per million
Standard Deviation 95.37
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IL-2 B/Malaysia [Day 0] (N= 29; 32)
|
1.78 Cells per million
Standard Deviation 44.85
|
4.86 Cells per million
Standard Deviation 77.20
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IL-2 B/Malaysia [Day 21] (N= 25; 31)
|
3.72 Cells per million
Standard Deviation 63.72
|
2.60 Cells per million
Standard Deviation 75.43
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IL-2 Pooled Strains [Day 0] (N= 29; 32)
|
6.54 Cells per million
Standard Deviation 69.82
|
7.44 Cells per million
Standard Deviation 95.70
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
IL-2 Pooled Strains [Day 21] (N= 24; 31)
|
3.39 Cells per million
Standard Deviation 91.57
|
6.63 Cells per million
Standard Deviation 107.41
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
TNF-α A/Solomon Islands [Day 0] (N= 30; 32)
|
2.77 Cells per million
Standard Deviation 101.63
|
1.58 Cells per million
Standard Deviation 23.46
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
TNF-α A/Solomon Islands [Day 21] (N= 25; 31)
|
2.67 Cells per million
Standard Deviation 36.03
|
2.47 Cells per million
Standard Deviation 55.20
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
TNF-α A/Wisconsin [Day 0] (N= 29; 32)
|
1.31 Cells per million
Standard Deviation 18.78
|
2.36 Cells per million
Standard Deviation 69.91
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
TNF-α A/Wisconsin [Day 21] (N= 25; 31)
|
2.03 Cells per million
Standard Deviation 32.51
|
2.08 Cells per million
Standard Deviation 53.64
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
TNF-α B/Malaysia [Day 0] (N= 29; 32)
|
3.29 Cells per million
Standard Deviation 77.18
|
3.09 Cells per million
Standard Deviation 61.50
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
TNF-α B/Malaysia [Day 21] (N= 25; 31)
|
1.83 Cells per million
Standard Deviation 34.42
|
1.92 Cells per million
Standard Deviation 127.13
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
TNF-α Pooled Strains [Day 0] (N= 29; 32)
|
1.59 Cells per million
Standard Deviation 50.66
|
2.37 Cells per million
Standard Deviation 82.35
|
|
Number of Cytokine-positive Cluster of Differentiation 8 (CD8) T Lymphocytes Per Million T Lymphocytes for Each of the Three Vaccine Strains
TNF-α Pooled Strains [Day 21] (N= 24; 31)
|
2.38 Cells per million
Standard Deviation 37.12
|
4.12 Cells per million
Standard Deviation 88.07
|
Adverse Events
FluAS25 (GSK576389A) Group
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Fluarix Group
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FluAS25 (GSK576389A) Group
n=33 participants at risk
Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals' AS25 adjuvanted influenza vaccine (GSK576389A).
|
Fluarix Group
n=35 participants at risk
Subjects received 1 dose of Fluarix™.
|
|---|---|---|
|
General disorders
Pain
|
51.5%
17/33 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
20.0%
7/35 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
General disorders
Swelling
|
6.1%
2/33 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
5.7%
2/35 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
General disorders
Redness
|
30.3%
10/33 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
11.4%
4/35 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
General disorders
Arthralgia
|
24.2%
8/33 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
14.3%
5/35 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
General disorders
Fatigue
|
24.2%
8/33 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
8.6%
3/35 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
General disorders
Headache
|
24.2%
8/33 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
8.6%
3/35 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
General disorders
Myalgia
|
24.2%
8/33 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
2.9%
1/35 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
General disorders
Nausea
|
9.1%
3/33 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
2.9%
1/35 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
General disorders
Shivering
|
18.2%
6/33 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
8.6%
3/35 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
2/33 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
2.9%
1/35 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/33 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
5.7%
2/35 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/33 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
5.7%
2/35 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
|
General disorders
Injection site pruritus
|
0.00%
0/33 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
5.7%
2/35 • Events collected by systematic assessment: 7-day follow-up period after vaccination. Events collected by non-systematic assessment: 21-day follow-up period after vaccination.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER