Revaccination With Influenza Vaccine GSK1247446A
Study Details
Study Description
Brief Summary
The protocol is designed to demonstrate the safety of influenza vaccine GSK1247446A after revaccination.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Biological: Influenza Vaccine GSK1247446A
Single dose, Intramuscular injection
|
| Active Comparator: 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 deltiod region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862. |
Biological: Fluarix™
Single dose, Intramuscular injection
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms [During a 7-day (Days 0-6) follow-up period after re-vaccination]
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.
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. [During a 7-day (Days 0-6) follow-up after re-vaccination]
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.
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [During a 30-day (Days 0-29) follow-up period after re-vaccination]
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.
- Number of Subjects With Any and Related Serious Adverse Events (SAEs) [During the entire study period (Days 0-30)]
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.
Secondary Outcome Measures
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. [At Days 0 and 21]
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.
- Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. [At Day 21]
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).
- Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. [At Day 0 and 21]
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).
- Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease. [At Day 21]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
A male or female aged 18-60 years old at the time of vaccination, who previously participated in 108656 clinical trial.
-
Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
-
Written informed consent obtained from the subject.
-
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
-
If the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
Exclusion Criteria:
-
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the administration of the study vaccine, or planned use during the study period.
-
Planned administration of an influenza vaccine other than the study vaccines during the entire study period
-
Previous vaccination against influenza since January 2007.
-
Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
-
Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
-
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
-
Administration of immunoglobulins and/or any blood products within three months preceding the dose of study vaccine or planned administration during the study period.
-
History of hypersensitivity to a previous dose of influenza vaccine.
-
History of confirmed influenza infection within the last 12 months.
-
Pregnancy.
-
History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
-
Acute disease at the time of enrolment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Wilrijk | Belgium | 2610 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 110674
- 2007-002783-10
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | GSK1247446A Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 160 | 83 |
| COMPLETED | 160 | 83 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | GSK1247446A Group | Fluarix Group | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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 of all reporting groups |
| Overall Participants | 160 | 83 | 243 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
39.4
(13.66)
|
40.9
(13.66)
|
39.9
(13.66)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
98
61.3%
|
44
53%
|
142
58.4%
|
| Male |
62
38.8%
|
39
47%
|
101
41.6%
|
Outcome Measures
| Title | Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms |
|---|---|
| Description | Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal 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. |
| Time Frame | During a 7-day (Days 0-6) follow-up period after re-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. |
| Arm/Group Title | GSK1247446A Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 160 | 83 |
| Any Ecchymosis |
8
|
5
|
| Ecchymosis > 50mm |
1
|
2
|
| Any Pain |
143
|
57
|
| Grade 3 Pain |
9
|
2
|
| Any Redness |
24
|
10
|
| Redness > 50mm |
2
|
1
|
| Any Swelling |
29
|
13
|
| Swelling > 50mm |
4
|
2
|
| Title | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. |
|---|---|
| Description | 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. |
| Time Frame | During a 7-day (Days 0-6) follow-up after re-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. |
| Arm/Group Title | GSK1247446A Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 160 | 83 |
| Any Arthralgia |
28
|
5
|
| Grade 3 Arthralgia |
3
|
0
|
| Related Arthralgia |
26
|
5
|
| Any Fatigue |
72
|
12
|
| Grade 3 Fatigue |
7
|
2
|
| Related Fatigue |
71
|
10
|
| Fever ≥37.5°C |
27
|
2
|
| Fever >39.0°C |
0
|
0
|
| Related Fever |
27
|
2
|
| Any Headache |
65
|
18
|
| Grade 3 Headache |
6
|
1
|
| Related Headache |
61
|
16
|
| Any Myalgia |
56
|
8
|
| Grade 3 Myalgia |
4
|
0
|
| Related Myalgia |
52
|
8
|
| Any Nausea |
23
|
4
|
| Grade 3 Nausea |
0
|
0
|
| Related Nausea |
21
|
3
|
| Any Shivering |
39
|
3
|
| Grade 3 Shivering |
4
|
0
|
| Related Shivering |
39
|
2
|
| Title | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
|---|---|
| Description | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination. |
| Time Frame | During a 30-day (Days 0-29) follow-up period after re-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. |
| Arm/Group Title | GSK1247446A Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 160 | 83 |
| Any AEs |
69
|
31
|
| Grade 3 AEs |
16
|
10
|
| Related AEs |
35
|
8
|
| Title | Number of Subjects With Any and Related Serious Adverse Events (SAEs) |
|---|---|
| Description | 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. |
| Time Frame | During the entire study period (Days 0-30) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. |
| Arm/Group Title | GSK1247446A Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 160 | 83 |
| Any SAEs |
0
|
1
|
| Related SAEs |
0
|
0
|
| Title | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. |
|---|---|
| Description | 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. |
| Time Frame | At Days 0 and 21 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | GSK1247446A Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 159 | 82 |
| A/SOL, Day 0 [N=158, 82] |
41.0
|
43.0
|
| A/SOL, Day 21 [N=159, 82] |
162.4
|
127.2
|
| A/WIS, Day 0 [N=158, 82] |
83.2
|
78.9
|
| A/WIS, Day 21 [N=159, 82] |
191.7
|
147.0
|
| B/MAL, Day 0 [N=158, 82] |
107.3
|
75.7
|
| B/MAL, Day 21 [N=159, 82] |
334.2
|
199.3
|
| Title | Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. |
|---|---|
| Description | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). |
| Time Frame | At Day 21 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | GSK1247446A Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 159 | 82 |
| A/SOL |
73
|
30
|
| A/WIS |
40
|
13
|
| B/MAL |
61
|
23
|
| Title | Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. |
|---|---|
| Description | A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). |
| Time Frame | At Day 0 and 21 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | GSK1247446A Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 159 | 82 |
| A/SOL, Day 0 [N=158, 82] |
87
|
45
|
| A/SOL, Day 21 [159, 82] |
155
|
75
|
| A/WIS, Day 0 [N=158, 82] |
139
|
69
|
| A/WIS, Day 21 [N=159, 82] |
159
|
80
|
| B/MAL, Day 0 [N=158, 82] |
133
|
67
|
| B/MAL, Day 21 [N=159, 82] |
159
|
82
|
| Title | Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease. |
|---|---|
| Description | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). |
| Time Frame | At Day 21 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | GSK1247446A Group | Fluarix Group |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 158 | 82 |
| A/SOL |
3.9
|
3.0
|
| A/WIS |
2.3
|
1.9
|
| B/MAL |
3.1
|
2.6
|
Adverse Events
| Time Frame | 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). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||
| Arm/Group Title | GSK1247446A Group | Fluarix Group | ||
| Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
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| GSK1247446A Group | Fluarix Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/160 (0%) | 0/83 (0%) | ||
Serious Adverse Events |
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| GSK1247446A Group | Fluarix Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/160 (0%) | 1/83 (1.2%) | ||
| Nervous system disorders | ||||
| Cerebrovascular accident | 0/160 (0%) | 1/83 (1.2%) | ||
Other (Not Including Serious) Adverse Events |
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| GSK1247446A Group | Fluarix Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 143/160 (89.4%) | 57/83 (68.7%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 9/160 (5.6%) | 1/83 (1.2%) | ||
| General disorders | ||||
| Arthralgia | 28/160 (17.5%) | 5/83 (6%) | ||
| Fatigue | 72/160 (45%) | 12/83 (14.5%) | ||
| Fever | 27/160 (16.9%) | 2/83 (2.4%) | ||
| Headache | 65/160 (40.6%) | 18/83 (21.7%) | ||
| Myalgia | 56/160 (35%) | 8/83 (9.6%) | ||
| Nausea | 23/160 (14.4%) | 4/83 (4.8%) | ||
| Shivering | 39/160 (24.4%) | 3/83 (3.6%) | ||
| Ecchymosis | 8/160 (5%) | 5/83 (6%) | ||
| Pain | 143/160 (89.4%) | 57/83 (68.7%) | ||
| Redness | 24/160 (15%) | 10/83 (12%) | ||
| Swelling | 29/160 (18.1%) | 13/83 (15.7%) | ||
| Infections and infestations | ||||
| Nasopharyngitis | 15/160 (9.4%) | 12/83 (14.5%) | ||
| Nervous system disorders | ||||
| Headache | 8/160 (5%) | 3/83 (3.6%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
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