Trial Outcomes & Findings for Revaccination With Influenza Vaccine GSK1247446A (NCT NCT00545025)
NCT ID: NCT00545025
Last Updated: 2019-06-26
Results Overview
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms assessed were considered by the investigator as related to study vaccination.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
243 participants
Primary outcome timeframe
During a 7-day (Days 0-6) follow-up period after re-vaccination
Results posted on
2019-06-26
Participant Flow
Subjects enrolled and vaccinated in this NCT00545025 follow-up previously participated in the NCT00374842 study, wherein they were vaccinated with either the GSK1247446A or Fluarix™ vaccines.
Subjects were allocated to study groups based on their vaccination course in the NCT00374842 primary study, so as to receive a re-vaccination dose of the vaccine previously administered.
Participant milestones
| Measure |
GSK1247446A Group
Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
|
Fluarix Group
Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
|
|---|---|---|
|
Overall Study
STARTED
|
160
|
83
|
|
Overall Study
COMPLETED
|
160
|
83
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Revaccination With Influenza Vaccine GSK1247446A
Baseline characteristics by cohort
| Measure |
GSK1247446A Group
n=160 Participants
Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
|
Fluarix Group
n=83 Participants
Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.4 Years
STANDARD_DEVIATION 13.66 • n=5 Participants
|
40.9 Years
STANDARD_DEVIATION 13.66 • n=7 Participants
|
39.9 Years
STANDARD_DEVIATION 13.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During a 7-day (Days 0-6) follow-up period after re-vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms assessed were considered by the investigator as related to study vaccination.
Outcome measures
| Measure |
GSK1247446A Group
n=160 Participants
Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
|
Fluarix Group
n=83 Participants
Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any Ecchymosis
|
8 Subjects
|
5 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Ecchymosis > 50mm
|
1 Subjects
|
2 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any Pain
|
143 Subjects
|
57 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Grade 3 Pain
|
9 Subjects
|
2 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any Redness
|
24 Subjects
|
10 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Redness > 50mm
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Any Swelling
|
29 Subjects
|
13 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Swelling > 50mm
|
4 Subjects
|
2 Subjects
|
PRIMARY outcome
Timeframe: During a 7-day (Days 0-6) follow-up after re-vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Assessed solicited general symptoms were arthralgia, fatigue, fever \[oral temperature equal to or above ≥ 37.5 degrees Celsius (°C)\], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.
Outcome measures
| Measure |
GSK1247446A Group
n=160 Participants
Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
|
Fluarix Group
n=83 Participants
Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Arthralgia
|
28 Subjects
|
5 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Arthralgia
|
3 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Arthralgia
|
26 Subjects
|
5 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Fatigue
|
72 Subjects
|
12 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Fatigue
|
7 Subjects
|
2 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Fatigue
|
71 Subjects
|
10 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Fever ≥37.5°C
|
27 Subjects
|
2 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Fever >39.0°C
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Fever
|
27 Subjects
|
2 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Headache
|
65 Subjects
|
18 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Headache
|
6 Subjects
|
1 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Headache
|
61 Subjects
|
16 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Myalgia
|
56 Subjects
|
8 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Myalgia
|
4 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Myalgia
|
52 Subjects
|
8 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Nausea
|
23 Subjects
|
4 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Nausea
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Nausea
|
21 Subjects
|
3 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Shivering
|
39 Subjects
|
3 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Shivering
|
4 Subjects
|
0 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Shivering
|
39 Subjects
|
2 Subjects
|
PRIMARY outcome
Timeframe: During a 30-day (Days 0-29) follow-up period after re-vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
GSK1247446A Group
n=160 Participants
Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
|
Fluarix Group
n=83 Participants
Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any AEs
|
69 Subjects
|
31 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 AEs
|
16 Subjects
|
10 Subjects
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related AEs
|
35 Subjects
|
8 Subjects
|
PRIMARY outcome
Timeframe: During the entire study period (Days 0-30)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
GSK1247446A Group
n=160 Participants
Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
|
Fluarix Group
n=83 Participants
Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
|
|---|---|---|
|
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Any SAEs
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Related SAEs
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). The seropositivity cut-off assay was 1:10.
Outcome measures
| Measure |
GSK1247446A Group
n=159 Participants
Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
|
Fluarix Group
n=82 Participants
Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
|
|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
A/SOL, Day 0 [N=158, 82]
|
41.0 Titer
Interval 32.2 to 52.3
|
43.0 Titer
Interval 29.7 to 62.1
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
A/SOL, Day 21 [N=159, 82]
|
162.4 Titer
Interval 140.0 to 188.4
|
127.2 Titer
Interval 97.2 to 166.5
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
A/WIS, Day 0 [N=158, 82]
|
83.2 Titer
Interval 71.3 to 97.1
|
78.9 Titer
Interval 61.2 to 101.8
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
A/WIS, Day 21 [N=159, 82]
|
191.7 Titer
Interval 171.7 to 214.0
|
147.0 Titer
Interval 121.6 to 177.6
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
B/MAL, Day 0 [N=158, 82]
|
107.3 Titer
Interval 89.3 to 128.8
|
75.7 Titer
Interval 57.6 to 99.4
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
B/MAL, Day 21 [N=159, 82]
|
334.2 Titer
Interval 296.0 to 377.4
|
199.3 Titer
Interval 164.5 to 241.5
|
SECONDARY outcome
Timeframe: At Day 21Population: The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).
Outcome measures
| Measure |
GSK1247446A Group
n=159 Participants
Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
|
Fluarix Group
n=82 Participants
Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
|
|---|---|---|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
A/SOL
|
73 Subjects
|
30 Subjects
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
A/WIS
|
40 Subjects
|
13 Subjects
|
|
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
B/MAL
|
61 Subjects
|
23 Subjects
|
SECONDARY outcome
Timeframe: At Day 0 and 21Population: The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).
Outcome measures
| Measure |
GSK1247446A Group
n=159 Participants
Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
|
Fluarix Group
n=82 Participants
Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
|
|---|---|---|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
A/WIS, Day 0 [N=158, 82]
|
139 Subjects
|
69 Subjects
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
A/SOL, Day 0 [N=158, 82]
|
87 Subjects
|
45 Subjects
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
A/SOL, Day 21 [159, 82]
|
155 Subjects
|
75 Subjects
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
A/WIS, Day 21 [N=159, 82]
|
159 Subjects
|
80 Subjects
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
B/MAL, Day 0 [N=158, 82]
|
133 Subjects
|
67 Subjects
|
|
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
B/MAL, Day 21 [N=159, 82]
|
159 Subjects
|
82 Subjects
|
SECONDARY outcome
Timeframe: At Day 21Population: The analysis was based on the according-to-protocol (ATP) Cohort for immunogenicity, which included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after revaccination.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).
Outcome measures
| Measure |
GSK1247446A Group
n=158 Participants
Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
|
Fluarix Group
n=82 Participants
Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
|
|---|---|---|
|
Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease.
A/SOL
|
3.9 Fold increase
Interval 3.3 to 4.8
|
3.0 Fold increase
Interval 2.3 to 3.8
|
|
Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease.
A/WIS
|
2.3 Fold increase
Interval 2.1 to 2.6
|
1.9 Fold increase
Interval 1.6 to 2.2
|
|
Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease.
B/MAL
|
3.1 Fold increase
Interval 2.7 to 3.6
|
2.6 Fold increase
Interval 2.2 to 3.2
|
Adverse Events
GSK1247446A Group
Serious events: 0 serious events
Other events: 143 other events
Deaths: 0 deaths
Fluarix Group
Serious events: 1 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK1247446A Group
n=160 participants at risk
Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine adjuvanted with a full dose of AS03-adjuvant in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03- adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
|
Fluarix Group
n=83 participants at risk
Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
|
|---|---|---|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/160 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
1.2%
1/83 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
Other adverse events
| Measure |
GSK1247446A Group
n=160 participants at risk
Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine adjuvanted with a full dose of AS03-adjuvant in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03- adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
|
Fluarix Group
n=83 participants at risk
Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
9.4%
15/160 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
14.5%
12/83 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Nervous system disorders
Headache
|
5.0%
8/160 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
3.6%
3/83 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
9/160 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
1.2%
1/83 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Arthralgia
|
17.5%
28/160 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
6.0%
5/83 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Fatigue
|
45.0%
72/160 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
14.5%
12/83 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Fever
|
16.9%
27/160 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
2.4%
2/83 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Headache
|
40.6%
65/160 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
21.7%
18/83 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Myalgia
|
35.0%
56/160 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
9.6%
8/83 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Nausea
|
14.4%
23/160 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
4.8%
4/83 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Shivering
|
24.4%
39/160 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
3.6%
3/83 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Ecchymosis
|
5.0%
8/160 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
6.0%
5/83 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Pain
|
89.4%
143/160 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
68.7%
57/83 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Redness
|
15.0%
24/160 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
12.0%
10/83 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Swelling
|
18.1%
29/160 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
15.7%
13/83 • Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
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