Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT01204671
Collaborator
(none)
4,659
42
5
8
110.9
13.8
Study Details
Study Description
Brief Summary
This study is designed to assess the safety and immunogenicity of a GSK Biologicals' investigational vaccine GSK2321138A in adults 18 years old and older. This study is also designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be double blind for all groups except for the GSK2604409A Group which will be open.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
4659 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Partially-blind Immunogenicity and Safety Study of GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults.
Study Start Date
:
Oct 4, 2010
Actual Primary Completion Date
:
Jun 6, 2011
Actual Study Completion Date
:
Jun 6, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GSK2321138A Lot 1 Group Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
Biological: Influenza vaccine GSK2321138A
One intramuscular injection
|
| Experimental: GSK2321138A Lot 2 Group Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
Biological: Influenza vaccine GSK2321138A
One intramuscular injection
|
| Experimental: GSK2321138A Lot 3 Group Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
Biological: Influenza vaccine GSK2321138A
One intramuscular injection
|
| Active Comparator: Fluarix Group Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
Biological: FluarixTM
One intramuscular injection
|
| Active Comparator: GSK2604409A Group Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
Biological: Influenza vaccine GSK2604409A
One intramuscular injection
|
Outcome Measures
Primary Outcome Measures
- Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease [At Day 0 (D 0), and at Day 21 (D 21)]
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. HI antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
- Number of Seroconverted Subjects Against 4 Strains of Influenza Disease [At Day 21 (D 21)]
A seroconverted subject was a vaccinated subject who had either a pre-vaccination hemagglutination inhibition (HI) antibody titer < 1:10 and a post-vaccination titer above or equal (>=) 1:40, or a pre-vaccination HI antibody titer >= 1:10 and at least a 4-fold increase in post-vaccination HI antibody titer. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
Secondary Outcome Measures
- Number of Seropositive Subjects Against 4 Strains of Influenza Disease [At Day 0 (D 0), and at Day 21 (D 21)]
A seropositive subject was a vaccinated subject with hemagglutination inhibition (HI) antibody titer above or equal (>=) the reference cut-off value of 1:10. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
- Number of Seroprotected Subjects Against 4 Strains of Influenza Disease [At Day 0 (D 0), and at Day 21 (D 21)]
A seroprotected subject was a vaccinated subject who had hemagglutination inhibition (HI) antibody titer above or equal (>=) 1:40. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
- Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease [At Day 21 (D 21)]
Increase in hemagglutination inhibition (HI) antibodies is presented in terms of mean geometric increase (MGI), defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer , expressed using "fold increase" as unit . Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms. [Within the 7-day (Days 0-6) follow-up period after vaccination]
Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
- Number of Days With Solicited Local Symptoms [Within the 7-day (Days 0-6) follow-up period after vaccination]
Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site.
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [Within the 7-day (Days 0-6) follow-up period after vaccination]
Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature [axillary temperature above or equal to (>=) 37.5 degrees Celsius (°C)]. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = symptom which prevented normal every day activities. Grade 3 temperature = axillary temperature > 39°C. Related = symptom assessed as causally related to study vaccination.
- Number of Days With Solicited General Symptoms [Within the 7-day (Days 0-6) follow-up period after vaccination]
Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature [defined as axillary temperature above or equal to (≥) 37.5 degrees Celsius (°C)].
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [Within the 21-day (Days 0-20) follow-up period after vaccination]
Unsolicited AEs cover 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 unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 unsolicited AE = unsolicited AE that prevented normal everyday activity Related unsolicited AE = unsolicited AE assessed by the investigator as related to the vaccination.
- Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs) [From the beginning of the study (Day 0) to study end (Day 180)]
Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a MAE was leading to hospitalisation (or met any other serious adverse event criterion), it was reported as serious adverse event. Related MAE = MAE assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
- Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) [From the beginning of the study (Day 0) to study end (Day 180)]
Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure.
- Number of Subjects With Any and Related Serious Adverse Events (SAEs) [From the beginning of the study (Day 0) to study end (Day 180)]
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. Any SAE = any SAE regardless of intensity or relationship to vaccination. Related SAE = SAE assessed by the investigator as related to the vaccination.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
A male or female 18 years of age or older at the time of the first vaccination
-
Subjects who the investigator believes can and will comply with the requirements of the protocol.
-
Written informed consent obtained from the subject.
-
Healthy subjects or those with chronic well-controlled disease as established by physical examination before entering into the study.
-
Female subjects of non-childbearing potential may be enrolled in the study.
-
Female subjects of childbearing potential may be enrolled in the study, if the subject:
-
- has practiced adequate contraception for 30 days prior to vaccination,
-
- and has a negative urine pregnancy test on the day of vaccination,
-
and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series
Exclusion Criteria:
-
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of the study vaccine or planned use during the study period.
-
Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
-
Administration of an influenza vaccine during the 6 months preceding entry into the study.
-
Planned administration / administration of a vaccine not foreseen by the study protocol within 30 days before vaccination and up to Day 21.
-
Any contra-indication to intramuscular administration of the influenza vaccines.
-
History of hypersensitivity/anaphylaxis to a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
-
Any administration of a long-acting immune-modifying drug within 3 months before study start, or planned administration during the study period.
-
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
-
Acute disease and/or fever at the time of enrolment.
-
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
-
History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
-
Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
-
History of chronic alcohol consumption and/or drug abuse.
-
Any condition which, in the opinion of the investigator, prevents the subject from participating in the study
-
Pregnant or lactating female.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Chandler | Arizona | United States | 85224 |
| 2 | GSK Investigational Site | Miami | Florida | United States | 33143 |
| 3 | GSK Investigational Site | Newton | Kansas | United States | 67114 |
| 4 | GSK Investigational Site | Lexington | Kentucky | United States | 40509 |
| 5 | GSK Investigational Site | Columbia | Maryland | United States | 21045 |
| 6 | GSK Investigational Site | Milford | Massachusetts | United States | 01757 |
| 7 | GSK Investigational Site | Las Vegas | Nevada | United States | 89119 |
| 8 | GSK Investigational Site | Salisbury | North Carolina | United States | 28144 |
| 9 | GSK Investigational Site | Erie | Pennsylvania | United States | 16506 |
| 10 | GSK Investigational Site | Nashville | Tennessee | United States | 37203 |
| 11 | GSK Investigational Site | Tuebingen | Baden-Wuerttemberg | Germany | 72074 |
| 12 | GSK Investigational Site | Augsburg | Bayern | Germany | 86150 |
| 13 | GSK Investigational Site | Haag | Bayern | Germany | 83527 |
| 14 | GSK Investigational Site | Finsterwalde | Brandenburg | Germany | 03238 |
| 15 | GSK Investigational Site | Frankfurt am Main | Hessen | Germany | 60596 |
| 16 | GSK Investigational Site | Mainz | Rheinland-Pfalz | Germany | 55131 |
| 17 | GSK Investigational Site | Dresden | Sachsen | Germany | 01277 |
| 18 | GSK Investigational Site | Dresden | Sachsen | Germany | 01307 |
| 19 | GSK Investigational Site | Dresden | Sachsen | Germany | 01309 |
| 20 | GSK Investigational Site | Freiberg | Sachsen | Germany | 09599 |
| 21 | GSK Investigational Site | Berlin | Germany | 10367 | |
| 22 | GSK Investigational Site | Berlin | Germany | 13086 | |
| 23 | GSK Investigational Site | Guro Gu | Korea, Republic of | 152703 | |
| 24 | GSK Investigational Site | Gyeonggi | Korea, Republic of | 442-723 | |
| 25 | GSK Investigational Site | Incheon | Korea, Republic of | 400-711 | |
| 26 | GSK Investigational Site | Seoul | Korea, Republic of | 150-719 | |
| 27 | GSK Investigational Site | Braila | Romania | 810384 | |
| 28 | GSK Investigational Site | Brasov | Romania | 500260 | |
| 29 | GSK Investigational Site | Bucharest | Romania | 020142 | |
| 30 | GSK Investigational Site | Bucharest | Romania | 062289 | |
| 31 | GSK Investigational Site | Bucharest | Romania | 077190 | |
| 32 | GSK Investigational Site | Galati | Romania | 800494 | |
| 33 | GSK Investigational Site | Galati | Romania | 800578 | |
| 34 | GSK Investigational Site | Pantelimon | Romania | 77145 | |
| 35 | GSK Investigational Site | Ploiesti | Romania | 100172 | |
| 36 | GSK Investigational Site | Balenyà (Barcelona) | Spain | 08550 | |
| 37 | GSK Investigational Site | Barcelona | Spain | 08035 | |
| 38 | GSK Investigational Site | Centelles | Spain | ||
| 39 | GSK Investigational Site | La Roca Del Valles (Barcelona) | Spain | 08430 | |
| 40 | GSK Investigational Site | Vic/ Barcelona | Spain | 08500 | |
| 41 | GSK Investigational Site | Taichung | Taiwan | 404 | |
| 42 | GSK Investigational Site | Taipei | Taiwan |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01204671
Other Study ID Numbers:
- 114269
First Posted:
Sep 17, 2010
Last Update Posted:
Sep 24, 2018
Last Verified:
Feb 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | A total of 4659 subjects (all aged 18 years and older at the time of their first vaccination as part of this study) were enrolled in this study, of which 4656 were vaccinated. The study vaccine dose was not administrated but subject number was allocated for the other 3 subjects. |
|---|---|
| Pre-assignment Detail | Subjects receiving the GSK2321138A and Fluarix™ vaccines were followed in a double-blinded manner throughout the entire study period, from Day 0 to Day 180. Subjects receiving the GSK2604409A vaccine were followed in an open manner until Day 21 only. |
| Arm/Group Title | GSK2321138A Lot 1 Group | GSK2321138A Lot 2 Group | GSK2321138A Lot 3 Group | Fluarix Group | GSK2604409A Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| Period Title: Overall Study | |||||
| STARTED | 1012 | 1013 | 1011 | 1010 | 610 |
| COMPLETED | 998 | 998 | 998 | 997 | 606 |
| NOT COMPLETED | 14 | 15 | 13 | 13 | 4 |
Baseline Characteristics
| Arm/Group Title | GSK2321138A Lot 1 Group | GSK2321138A Lot 2 Group | GSK2321138A Lot 3 Group | Fluarix Group | GSK2604409A Group | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Total of all reporting groups |
| Overall Participants | 1012 | 1013 | 1011 | 1010 | 610 | 4656 |
| Age (Years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [Years] |
57.7
(17.90)
|
58.0
(17.41)
|
57.9
(17.80)
|
58.1
(17.83)
|
58.1
(17.92)
|
58.0
(17.75)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
598
59.1%
|
578
57.1%
|
569
56.3%
|
548
54.3%
|
343
56.2%
|
2636
56.6%
|
| Male |
414
40.9%
|
435
42.9%
|
442
43.7%
|
462
45.7%
|
267
43.8%
|
2020
43.4%
|
Outcome Measures
| Title | Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease |
|---|---|
| Description | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. HI antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. |
| Time Frame | At Day 0 (D 0), and at Day 21 (D 21) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. |
| Arm/Group Title | GSK2321138A Group | Fluarix Group | GSK2604409A Group |
|---|---|---|---|
| Arm/Group Description | Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| Measure Participants | 1809 | 608 | 534 |
| H1N1 Strain - D 0 |
14.7
|
15.6
|
14.4
|
| H1N1 Strain - D 21 |
201.1
|
218.4
|
213.0
|
| H3N2 Strain - D 0 |
34.0
|
38.1
|
35.7
|
| H3N2 Strain - D 21 |
314.7
|
298.2
|
340.4
|
| Victoria Strain - D 0 |
73.8
|
73.6
|
71.7
|
| Victoria Strain - D 21 |
404.6
|
393.8
|
258.5
|
| Yamagata Strain - D 0 |
101.4
|
100.9
|
99.8
|
| Yamagata Strain - D 21 |
601.8
|
386.6
|
582.5
|
| Title | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease |
|---|---|
| Description | A seroconverted subject was a vaccinated subject who had either a pre-vaccination hemagglutination inhibition (HI) antibody titer < 1:10 and a post-vaccination titer above or equal (>=) 1:40, or a pre-vaccination HI antibody titer >= 1:10 and at least a 4-fold increase in post-vaccination HI antibody titer. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. |
| Time Frame | At Day 21 (D 21) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. |
| Arm/Group Title | GSK2321138A Group | Fluarix Group | GSK2604409A Group |
|---|---|---|---|
| Arm/Group Description | Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| Measure Participants | 1801 | 605 | 530 |
| H1N1 Strain - D 21 |
1396
137.9%
|
467
46.1%
|
425
42%
|
| H3N2 Strain - D 21 |
1287
127.2%
|
398
39.3%
|
371
36.7%
|
| Victoria Strain - D 21 |
1046
103.4%
|
335
33.1%
|
252
24.9%
|
| Yamagata Strain - D 21 |
1112
109.9%
|
276
27.2%
|
313
31%
|
| Title | Number of Seropositive Subjects Against 4 Strains of Influenza Disease |
|---|---|
| Description | A seropositive subject was a vaccinated subject with hemagglutination inhibition (HI) antibody titer above or equal (>=) the reference cut-off value of 1:10. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. |
| Time Frame | At Day 0 (D 0), and at Day 21 (D 21) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. |
| Arm/Group Title | GSK2321138A Group | Fluarix Group | GSK2604409A Group |
|---|---|---|---|
| Arm/Group Description | Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| Measure Participants | 1809 | 608 | 534 |
| H1N1 Strain - D 0 |
967
95.6%
|
352
34.7%
|
291
28.8%
|
| H1N1 Strain - D 21 |
1738
171.7%
|
586
57.8%
|
514
50.8%
|
| H3N2 Strain - D 0 |
1416
139.9%
|
488
48.2%
|
425
42%
|
| H3N2 Strain - D 21 |
1783
176.2%
|
594
58.6%
|
528
52.2%
|
| Victoria Strain - D 0 |
1541
152.3%
|
511
50.4%
|
452
44.7%
|
| Victoria Strain - D 21 |
1795
177.4%
|
601
59.3%
|
518
51.2%
|
| Yamagata Strain - D 0 |
1554
153.6%
|
525
51.8%
|
457
45.2%
|
| Yamagata Strain - D 21 |
1794
177.3%
|
597
58.9%
|
532
52.6%
|
| Title | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease |
|---|---|
| Description | A seroprotected subject was a vaccinated subject who had hemagglutination inhibition (HI) antibody titer above or equal (>=) 1:40. Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. |
| Time Frame | At Day 0 (D 0), and at Day 21 (D 21) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. |
| Arm/Group Title | GSK2321138A Group | Fluarix Group | GSK2604409A Group |
|---|---|---|---|
| Arm/Group Description | Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| Measure Participants | 1809 | 608 | 534 |
| H1N1 Strain - D 0 |
514
50.8%
|
167
16.5%
|
139
13.7%
|
| H1N1 Strain - D 21 |
1651
163.1%
|
558
55.1%
|
495
49%
|
| H3N2 Strain - D 0 |
965
95.4%
|
353
34.8%
|
285
28.2%
|
| H3N2 Strain - D 21 |
1751
173%
|
583
57.6%
|
517
51.1%
|
| Victoria Strain - D 0 |
1423
140.6%
|
477
47.1%
|
412
40.8%
|
| Victoria Strain - D 21 |
1788
176.7%
|
599
59.1%
|
513
50.7%
|
| Yamagata Strain - D 0 |
1494
147.6%
|
497
49.1%
|
441
43.6%
|
| Yamagata Strain - D 21 |
1792
177.1%
|
595
58.7%
|
532
52.6%
|
| Title | Increase in Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease |
|---|---|
| Description | Increase in hemagglutination inhibition (HI) antibodies is presented in terms of mean geometric increase (MGI), defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer , expressed using "fold increase" as unit . Antibodies assessed were HI antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria), and B/Brisbane/3/2007 (Yamagata) flu strains. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. |
| Time Frame | At Day 21 (D 21) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available, and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. |
| Arm/Group Title | GSK2321138A Group | Fluarix Group | GSK2604409A Group |
|---|---|---|---|
| Arm/Group Description | Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| Measure Participants | 1801 | 605 | 530 |
| H1N1 Strain - D 21 |
13.69
|
13.92
|
14.88
|
| H3N2 Strain - D 21 |
9.28
|
7.84
|
9.52
|
| Victoria Strain - D 21 |
5.48
|
5.37
|
3.60
|
| Yamagata Strain - D 21 |
5.93
|
3.84
|
5.84
|
| Title | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. |
|---|---|
| Description | Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. |
| Time Frame | Within the 7-day (Days 0-6) follow-up period after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results. |
| Arm/Group Title | GSK2321138A Lot 1 Group | GSK2321138A Lot 2 Group | GSK2321138A Lot 3 Group | Fluarix Group | GSK2604409A Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| Measure Participants | 1008 | 1003 | 1004 | 1003 | 607 |
| Any Pain |
377
37.3%
|
362
35.7%
|
357
35.3%
|
369
36.5%
|
190
31.1%
|
| Grade 3 Pain |
13
1.3%
|
6
0.6%
|
5
0.5%
|
12
1.2%
|
3
0.5%
|
| Any Redness |
24
2.4%
|
12
1.2%
|
22
2.2%
|
17
1.7%
|
12
2%
|
| Grade 3 Redness (≥ 100 mm) |
0
0%
|
1
0.1%
|
0
0%
|
0
0%
|
0
0%
|
| Any Swelling |
26
2.6%
|
20
2%
|
16
1.6%
|
21
2.1%
|
8
1.3%
|
| Grade 3 Swelling (≥ 100 mm) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Days With Solicited Local Symptoms |
|---|---|
| Description | Assessed solicited local symptoms post vaccination were pain, redness and swelling at the injection site. |
| Time Frame | Within the 7-day (Days 0-6) follow-up period after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results. |
| Arm/Group Title | GSK2321138A Lot 1 Group | GSK2321138A Lot 2 Group | GSK2321138A Lot 3 Group | Fluarix Group | GSK2604409A Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| Measure Participants | 377 | 362 | 357 | 369 | 190 |
| Pain |
2.0
|
2.0
|
2.0
|
2.0
|
2.0
|
| Redness |
2.0
|
2.5
|
2.0
|
1.0
|
1.0
|
| Swelling |
2.0
|
2.0
|
2.0
|
2.0
|
2.5
|
| Title | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
|---|---|
| Description | Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature [axillary temperature above or equal to (>=) 37.5 degrees Celsius (°C)]. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = symptom which prevented normal every day activities. Grade 3 temperature = axillary temperature > 39°C. Related = symptom assessed as causally related to study vaccination. |
| Time Frame | Within the 7-day (Days 0-6) follow-up period after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results. |
| Arm/Group Title | GSK2321138A Lot 1 Group | GSK2321138A Lot 2 Group | GSK2321138A Lot 3 Group | Fluarix Group | GSK2604409A Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| Measure Participants | 1008 | 1001 | 1002 | 1003 | 607 |
| Any Fatigue |
152
15%
|
154
15.2%
|
171
16.9%
|
185
18.3%
|
90
14.8%
|
| Grade 3 Fatigue |
9
0.9%
|
4
0.4%
|
8
0.8%
|
6
0.6%
|
3
0.5%
|
| Related Fatigue |
109
10.8%
|
107
10.6%
|
118
11.7%
|
132
13.1%
|
64
10.5%
|
| Any Gastr. |
64
6.3%
|
63
6.2%
|
70
6.9%
|
65
6.4%
|
36
5.9%
|
| Grade 3 Gastr. |
5
0.5%
|
3
0.3%
|
3
0.3%
|
2
0.2%
|
2
0.3%
|
| Related Gastr. |
37
3.7%
|
34
3.4%
|
38
3.8%
|
35
3.5%
|
19
3.1%
|
| Any Headache |
163
16.1%
|
162
16%
|
155
15.3%
|
164
16.2%
|
80
13.1%
|
| Grade 3 Headache |
10
1%
|
8
0.8%
|
8
0.8%
|
8
0.8%
|
4
0.7%
|
| Related Headache |
87
8.6%
|
92
9.1%
|
98
9.7%
|
97
9.6%
|
48
7.9%
|
| Any Joint Pain |
96
9.5%
|
84
8.3%
|
74
7.3%
|
104
10.3%
|
57
9.3%
|
| Grade 3 Joint Pain |
6
0.6%
|
5
0.5%
|
3
0.3%
|
7
0.7%
|
2
0.3%
|
| Related Joint Pain |
67
6.6%
|
54
5.3%
|
51
5%
|
61
6%
|
29
4.8%
|
| Any Muscle Aches |
165
16.3%
|
172
17%
|
156
15.4%
|
195
19.3%
|
98
16.1%
|
| Grade 3 Muscle Aches |
5
0.5%
|
2
0.2%
|
7
0.7%
|
8
0.8%
|
3
0.5%
|
| Related Muscle Aches |
117
11.6%
|
130
12.8%
|
109
10.8%
|
137
13.6%
|
61
10%
|
| Any Shivering |
45
4.4%
|
32
3.2%
|
48
4.7%
|
50
5%
|
26
4.3%
|
| Grade 3 Shivering |
3
0.3%
|
2
0.2%
|
6
0.6%
|
3
0.3%
|
1
0.2%
|
| Related Shivering |
31
3.1%
|
19
1.9%
|
32
3.2%
|
30
3%
|
19
3.1%
|
| Any Temperature (≥ 37.5°C) |
19
1.9%
|
21
2.1%
|
8
0.8%
|
12
1.2%
|
9
1.5%
|
| Grade 3 Temperature (> 39.0°C) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Related Temperature |
11
1.1%
|
16
1.6%
|
3
0.3%
|
5
0.5%
|
6
1%
|
| Title | Number of Days With Solicited General Symptoms |
|---|---|
| Description | Assessed solicited general symptoms post vaccination were fatigue, gastrointestinal symptoms (Gastr.), headache, joint pain at other location (Joint Pain), muscle aches, shivering, and temperature [defined as axillary temperature above or equal to (≥) 37.5 degrees Celsius (°C)]. |
| Time Frame | Within the 7-day (Days 0-6) follow-up period after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects, solely on subjects with available results. |
| Arm/Group Title | GSK2321138A Lot 1 Group | GSK2321138A Lot 2 Group | GSK2321138A Lot 3 Group | Fluarix Group | GSK2604409A Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| Measure Participants | 165 | 172 | 171 | 195 | 98 |
| Fatigue |
2.0
|
2.0
|
2.0
|
2.0
|
2.0
|
| Gastr. |
2.0
|
2.0
|
2.0
|
2.0
|
2.0
|
| Headache |
1.0
|
2.0
|
2.0
|
2.0
|
1.0
|
| Joint Pain |
2.0
|
2.0
|
2.0
|
2.0
|
2.0
|
| Muscle Aches |
2.0
|
2.0
|
2.0
|
2.0
|
2.0
|
| Shivering |
2.0
|
2.0
|
2.0
|
1.0
|
1.5
|
| Temperature |
1.0
|
1.0
|
1.0
|
1.0
|
2.0
|
| Title | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
|---|---|
| Description | Unsolicited AEs cover 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 unsolicited AE = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 unsolicited AE = unsolicited AE that prevented normal everyday activity Related unsolicited AE = unsolicited AE assessed by the investigator as related to the vaccination. |
| Time Frame | Within the 21-day (Days 0-20) follow-up period after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. |
| Arm/Group Title | GSK2321138A Lot 1 Group | GSK2321138A Lot 2 Group | GSK2321138A Lot 3 Group | Fluarix Group | GSK2604409A Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| Measure Participants | 1012 | 1013 | 1011 | 1010 | 610 |
| Any Unsolicited AE(s) |
125
12.4%
|
120
11.8%
|
134
13.3%
|
138
13.7%
|
92
15.1%
|
| Grade 3 Unsolicited AE(s) |
11
1.1%
|
12
1.2%
|
16
1.6%
|
7
0.7%
|
2
0.3%
|
| Related Unsolicited AE(s) |
17
1.7%
|
20
2%
|
27
2.7%
|
26
2.6%
|
14
2.3%
|
| Title | Number of Subjects With Any and Related Adverse Events With Medically-attended Events (MAEs) |
|---|---|
| Description | Medically-attended events (MAEs) refer to non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a MAE was leading to hospitalisation (or met any other serious adverse event criterion), it was reported as serious adverse event. Related MAE = MAE assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. |
| Time Frame | From the beginning of the study (Day 0) to study end (Day 180) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. |
| Arm/Group Title | GSK2321138A Group | Fluarix Group | GSK2604409A Group |
|---|---|---|---|
| Arm/Group Description | Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| Measure Participants | 3036 | 1010 | 610 |
| Any MAE(s) |
688
68%
|
216
21.3%
|
52
5.1%
|
| Related MAE(s) |
11
1.1%
|
4
0.4%
|
5
0.5%
|
| Title | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) |
|---|---|
| Description | Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related pIMD = pIMD assessed by the investigator as related to the vaccination. Subjects receiving the GSK2321138A vaccine were pooled for this outcome measure. |
| Time Frame | From the beginning of the study (Day 0) to study end (Day 180) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. |
| Arm/Group Title | GSK2321138A Group | Fluarix Group | GSK2604409A Group |
|---|---|---|---|
| Arm/Group Description | Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| Measure Participants | 3036 | 1010 | 610 |
| Any pIMD(s) |
1
0.1%
|
1
0.1%
|
0
0%
|
| Related pIMD(s) |
0
0%
|
0
0%
|
0
0%
|
| 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. Any SAE = any SAE regardless of intensity or relationship to vaccination. Related SAE = SAE assessed by the investigator as related to the vaccination. |
| Time Frame | From the beginning of the study (Day 0) to study end (Day 180) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. |
| Arm/Group Title | GSK2321138A Lot 1 Group | GSK2321138A Lot 2 Group | GSK2321138A Lot 3 Group | Fluarix Group | GSK2604409A Group |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. |
| Measure Participants | 1012 | 1013 | 1011 | 1010 | 610 |
| Any SAE(s) |
28
2.8%
|
20
2%
|
22
2.2%
|
26
2.6%
|
1
0.2%
|
| Related SAE(s) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | Solicited symptoms: Within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 21-day (Days 0-20) follow-up period after vaccination. Serious adverse events: Throughout the study period (Days 0 to 180) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Analysis for unsolicited AEs and SAEs was performed on all vaccinated subjects, and analysis for solicited symptoms was performed solely on vaccinated subjects for whom results were available. | |||||||||
| Arm/Group Title | GSK2321138A Lot 1 Group | GSK2321138A Lot 2 Group | GSK2321138A Lot 3 Group | Fluarix Group | GSK2604409A Group | |||||
| Arm/Group Description | Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the 1 dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm. | |||||
All Cause Mortality |
||||||||||
| GSK2321138A Lot 1 Group | GSK2321138A Lot 2 Group | GSK2321138A Lot 3 Group | Fluarix Group | GSK2604409A Group | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| GSK2321138A Lot 1 Group | GSK2321138A Lot 2 Group | GSK2321138A Lot 3 Group | Fluarix Group | GSK2604409A Group | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 28/1012 (2.8%) | 20/1013 (2%) | 22/1011 (2.2%) | 26/1010 (2.6%) | 1/610 (0.2%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Cardiac disorders | ||||||||||
| Acute myocardial infarction | 0/1012 (0%) | 0/1013 (0%) | 1/1011 (0.1%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Arteriosclerosis coronary artery | 0/1012 (0%) | 0/1013 (0%) | 1/1011 (0.1%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Atrial fibrillation | 0/1012 (0%) | 0/1013 (0%) | 0/1011 (0%) | 1/1010 (0.1%) | 0/610 (0%) | |||||
| Cardiac arrest | 0/1012 (0%) | 0/1013 (0%) | 0/1011 (0%) | 1/1010 (0.1%) | 0/610 (0%) | |||||
| Cardiac disorder | 0/1012 (0%) | 0/1013 (0%) | 0/1011 (0%) | 1/1010 (0.1%) | 0/610 (0%) | |||||
| Cardiac failure | 2/1012 (0.2%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Cardiac failure congestive | 1/1012 (0.1%) | 1/1013 (0.1%) | 1/1011 (0.1%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Cardio-respiratory arrest | 0/1012 (0%) | 0/1013 (0%) | 0/1011 (0%) | 1/1010 (0.1%) | 0/610 (0%) | |||||
| Cardiopulmonary failure | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Coronary artery disease | 0/1012 (0%) | 0/1013 (0%) | 0/1011 (0%) | 1/1010 (0.1%) | 0/610 (0%) | |||||
| Myocardial infarction | 1/1012 (0.1%) | 2/1013 (0.2%) | 2/1011 (0.2%) | 1/1010 (0.1%) | 0/610 (0%) | |||||
| Myocardial ischaemia | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Ear and labyrinth disorders | ||||||||||
| Vertigo | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 1/1010 (0.1%) | 0/610 (0%) | |||||
| Vestibular disorder | 0/1012 (0%) | 0/1013 (0%) | 1/1011 (0.1%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Eye disorders | ||||||||||
| Diplopia | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal hernia | 0/1012 (0%) | 0/1013 (0%) | 0/1011 (0%) | 1/1010 (0.1%) | 0/610 (0%) | |||||
| Acute abdomen | 0/1012 (0%) | 0/1013 (0%) | 0/1011 (0%) | 1/1010 (0.1%) | 0/610 (0%) | |||||
| Gastric ulcer | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Gastric ulcer haemorrhage | 1/1012 (0.1%) | 0/1013 (0%) | 1/1011 (0.1%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Inguinal hernia | 0/1012 (0%) | 0/1013 (0%) | 1/1011 (0.1%) | 1/1010 (0.1%) | 0/610 (0%) | |||||
| Intestinal infarction | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Oesophagitis | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Upper gastrointestinal haemorrhage | 0/1012 (0%) | 0/1013 (0%) | 0/1011 (0%) | 1/1010 (0.1%) | 0/610 (0%) | |||||
| General disorders | ||||||||||
| Death | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Non-cardiac chest pain | 0/1012 (0%) | 0/1013 (0%) | 1/1011 (0.1%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Sudden death | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Hepatobiliary disorders | ||||||||||
| Cholelithiasis | 1/1012 (0.1%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Jaundice | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Infections and infestations | ||||||||||
| Bronchiolitis | 0/1012 (0%) | 0/1013 (0%) | 1/1011 (0.1%) | 1/1010 (0.1%) | 0/610 (0%) | |||||
| Central nervous system infection | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Device related infection | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Erysipelas | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Gastroenteritis | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 1/1010 (0.1%) | 0/610 (0%) | |||||
| Groin abscess | 0/1012 (0%) | 0/1013 (0%) | 0/1011 (0%) | 1/1010 (0.1%) | 0/610 (0%) | |||||
| Osteomyelitis | 0/1012 (0%) | 0/1013 (0%) | 0/1011 (0%) | 1/1010 (0.1%) | 0/610 (0%) | |||||
| Pneumonia | 0/1012 (0%) | 0/1013 (0%) | 3/1011 (0.3%) | 2/1010 (0.2%) | 0/610 (0%) | |||||
| Pyelonephritis acute | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Respiratory tract infection | 0/1012 (0%) | 1/1013 (0.1%) | 1/1011 (0.1%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Tooth abscess | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Urinary tract infection | 2/1012 (0.2%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Foot fracture | 0/1012 (0%) | 0/1013 (0%) | 0/1011 (0%) | 1/1010 (0.1%) | 0/610 (0%) | |||||
| Head injury | 0/1012 (0%) | 0/1013 (0%) | 0/1011 (0%) | 1/1010 (0.1%) | 0/610 (0%) | |||||
| Hip fracture | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Joint dislocation | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Ligament rupture | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Lumbar vertebral fracture | 0/1012 (0%) | 0/1013 (0%) | 1/1011 (0.1%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Pelvic fracture | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Radius fracture | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Tendon rupture | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Investigations | ||||||||||
| Ammonia increased | 0/1012 (0%) | 0/1013 (0%) | 1/1011 (0.1%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Dehydration | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Diabetes mellitus | 0/1012 (0%) | 0/1013 (0%) | 0/1011 (0%) | 1/1010 (0.1%) | 0/610 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthralgia | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Intervertebral disc disorder | 0/1012 (0%) | 0/1013 (0%) | 1/1011 (0.1%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Intervertebral disc protrusion | 0/1012 (0%) | 0/1013 (0%) | 2/1011 (0.2%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Muscular weakness | 0/1012 (0%) | 0/1013 (0%) | 1/1011 (0.1%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Rotator cuff syndrome | 0/1012 (0%) | 0/1013 (0%) | 0/1011 (0%) | 1/1010 (0.1%) | 0/610 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Breast cancer | 1/1012 (0.1%) | 0/1013 (0%) | 1/1011 (0.1%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Colon cancer | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Gastric adenoma | 2/1012 (0.2%) | 0/1013 (0%) | 1/1011 (0.1%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Gastric cancer | 0/1012 (0%) | 0/1013 (0%) | 0/1011 (0%) | 1/1010 (0.1%) | 0/610 (0%) | |||||
| Hepatic neoplasm malignant | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Rectal cancer ( | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Renal cell carcinoma | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Small cell lung cancer stage unspecified | 0/1012 (0%) | 0/1013 (0%) | 1/1011 (0.1%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Thyroid cancer | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Nervous system disorders | ||||||||||
| Carotid artery stenosis | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Cerebrovascular accident | 3/1012 (0.3%) | 0/1013 (0%) | 2/1011 (0.2%) | 2/1010 (0.2%) | 0/610 (0%) | |||||
| Coma hepatic | 0/1012 (0%) | 0/1013 (0%) | 1/1011 (0.1%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Depressed level of consciousness | 0/1012 (0%) | 0/1013 (0%) | 1/1011 (0.1%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Dizziness | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Headache | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Intracranial aneurysm | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Ischaemic stroke | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Subarachnoid haemorrhage | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Transient ischaemic attack | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Confusional state | 0/1012 (0%) | 0/1013 (0%) | 1/1011 (0.1%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Nephrolithiasis | 0/1012 (0%) | 0/1013 (0%) | 0/1011 (0%) | 2/1010 (0.2%) | 0/610 (0%) | |||||
| Ureteric stenosis | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Urinary incontinence | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Reproductive system and breast disorders | ||||||||||
| Benign prostatic hyperplasia | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Acute respiratory failure | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Asthma | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 1/1010 (0.1%) | 0/610 (0%) | |||||
| Atelectasis | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Bronchospasm | 0/1012 (0%) | 0/1013 (0%) | 1/1011 (0.1%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Pleurisy | 0/1012 (0%) | 0/1013 (0%) | 1/1011 (0.1%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Pneumonia aspiration | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Pulmonary hypertension | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Respiratory failure | 0/1012 (0%) | 0/1013 (0%) | 1/1011 (0.1%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Pruritus | 1/1012 (0.1%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Vascular disorders | ||||||||||
| Aortic aneurysm | 0/1012 (0%) | 1/1013 (0.1%) | 0/1011 (0%) | 0/1010 (0%) | 0/610 (0%) | |||||
| Arteriosclerosis | 0/1012 (0%) | 0/1013 (0%) | 0/1011 (0%) | 0/1010 (0%) | 1/610 (0.2%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| GSK2321138A Lot 1 Group | GSK2321138A Lot 2 Group | GSK2321138A Lot 3 Group | Fluarix Group | GSK2604409A Group | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 485/1008 (48.1%) | 472/1003 (47.1%) | 482/1004 (48%) | 500/1003 (49.9%) | 275/607 (45.3%) | |||||
| General disorders | ||||||||||
| Pain | 377/1008 (37.4%) | 362/1003 (36.1%) | 357/1004 (35.6%) | 369/1003 (36.8%) | 190/607 (31.3%) | |||||
| Fatigue | 152/1008 (15.1%) | 154/1003 (15.4%) | 171/1004 (17%) | 185/1003 (18.4%) | 90/607 (14.8%) | |||||
| Gastrointestinal symptoms | 64/1008 (6.3%) | 63/1003 (6.3%) | 70/1004 (7%) | 65/1003 (6.5%) | 36/607 (5.9%) | |||||
| Headache | 163/1008 (16.2%) | 162/1003 (16.2%) | 155/1004 (15.4%) | 164/1003 (16.4%) | 80/607 (13.2%) | |||||
| Joint pain | 96/1008 (9.5%) | 84/1003 (8.4%) | 74/1004 (7.4%) | 104/1003 (10.4%) | 57/607 (9.4%) | |||||
| Muscle aches | 165/1008 (16.4%) | 172/1003 (17.1%) | 156/1004 (15.5%) | 195/1003 (19.4%) | 98/607 (16.1%) | |||||
Limitations/Caveats
Concerns arose about data integrity for a Romanian site (102 subjects) after completion of analysis. These data were not excluded from this reporting as they did not reveal irregularities and GSK does not plan to use them towards regulatory filing.
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 |
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01204671
Other Study ID Numbers:
- 114269
First Posted:
Sep 17, 2010
Last Update Posted:
Sep 24, 2018
Last Verified:
Feb 1, 2017