Clinical Study of the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in People Aged 65 Years or Older
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00765076
Collaborator
(none)
192
4
3
13.6
48
3.5
Study Details
Study Description
Brief Summary
This clinical trial aims to study the immunogenicity of GSK Biologicals' influenza vaccine GSK2186877A in people aged 65 years or older.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The amendment to the protocol posting: minor change in one inclusion criterion and in one secondary outcome measure.
Study Design
Study Type:
Interventional
Actual Enrollment
:
192 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Observer-blind Immunogenicity Study of GSK Biologicals' Influenza Vaccine GSK2186877A in Elderly Subjects
Study Start Date
:
Oct 16, 2008
Actual Primary Completion Date
:
Dec 4, 2009
Actual Study Completion Date
:
Dec 4, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: New generation influenza vaccine GSK2186877A Group Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 |
Biological: GSK Biologicals' influenza vaccine GSK2186877A
One intramuscular injection at Day 0
|
| Active Comparator: Fluarix elderly Group Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 |
Biological: GSK Biologicals' Fluarix
One intramuscular injection at Day 0
|
| Active Comparator: Fluarix young Group Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
Biological: GSK Biologicals' Fluarix
One intramuscular injection at Day 0
|
Outcome Measures
Primary Outcome Measures
- The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers [Day 21]
The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α), interferon-gamma (IFN-γ)
Secondary Outcome Measures
- The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers [At Day 0, 21, 42 and 180]
The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.
- The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker [At Day 0, 21, 42 and 180]
The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens.
- Haemagglutinin Inhibition (HI) Antibody Titers [At Day 0, 21, 42 and 180]
Antibody titers were expressed as Geometric mean titers (GMTs) calculated after invitro stimulation with separate vaccine strains.
- The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains. [At Day 0, 21, 42 and 180]
Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10
- The Number of Subjects Seroconverted to HI Antibodies [At Day 21, 42 and 180]
Seroconversion was defined as the number of vaccinees who had either a prevaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
- HI Antibody Seroconversion Factors [At Day 21, 42 and 180]
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
- The Number of Subjects Seroprotected to HI Antibodies [At Day 0, 21, 42 and 180]
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
- Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) [Day 0 -6]
Grade 3 ecchymosis, redness and swelling was >100mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activity.
- Duration of Solicited Local AEs [Day 0 -6]
Duration was defined as the number of days with any grade of local symptoms.
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs [Day 0 -6]
Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was defined as oral temperature ≥ 39.0°C. For other symptoms grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.
- Duration of Solicited General AEs [Day 0 -6]
Duration was defined as number of days with any grade of general symptoms.
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs [Day 0-20]
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom, regardless of intensity or relation to vaccination, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.
- Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) [Day 0-179]
For each solicited and unsolicited AE the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination.
- Number of Subjects Reporting Any AEs of Specific Interest (AESI) [Day 0-364]
AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination.
- Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) [Day 0-364]
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination and related was event assessed by investigator as causally related to the study vaccination.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
All subjects must satisfy the following criteria at study entry:
-
Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected or known drug or alcohol abuse.
-
Written informed consent obtained from the subject.
-
Free of an acute aggravation of the health status as established by medical history and clinical examination before entering into the study.
Elderly adults:
• A man or woman 65 year of age or older at the time of the first vaccination.
Young adults:
-
Man or woman between the ages of 18 and 40 years, inclusive.
-
If the subject is female, she must be of non-childbearing potential or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after vaccination.
Exclusion Criteria:
-
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
-
Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to Visit 4 after vaccination and of an influenza vaccine other than the study vaccines up to Visit 4.
-
Vaccination against influenza since February 2008 with a seasonal influenza vaccine.
-
Previous vaccination in the last three years with an investigational adjuvanted vaccine candidate seasonal or pandemic influenza vaccine.
-
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
-
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
-
History of hypersensivity to a previous dose of influenza vaccine.
-
History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg or chicken protein.
-
Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation or pre-existing laboratory screening tests.
-
Acute disease at the time of enrolment.
-
Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.
-
Any medical conditions in which intramuscular injections are contraindicated.
-
Pregnant or lactating female.
-
Female of childbearing age planning to become pregnant or planning to discontinue contraceptive precautions.
-
Any medical condition that in the opinion of the investigator precludes the collection of blood volumes as required by the protocol.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Houston | Texas | United States | 77030 |
| 2 | GSK Investigational Site | Barcelona | Spain | 08035 | |
| 3 | GSK Investigational Site | Madrid | Spain | 28046 | |
| 4 | GSK Investigational Site | Marid | Spain | 28040 |
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:
NCT00765076
Other Study ID Numbers:
- 112147
First Posted:
Oct 2, 2008
Last Update Posted:
Jul 31, 2018
Last Verified:
Oct 1, 2016
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 | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group |
|---|---|---|---|
| Arm/Group Description | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
| Period Title: Overall Study | |||
| STARTED | 69 | 73 | 50 |
| COMPLETED | 68 | 73 | 49 |
| NOT COMPLETED | 1 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group | Total |
|---|---|---|---|---|
| Arm/Group Description | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 | Total of all reporting groups |
| Overall Participants | 69 | 73 | 50 | 192 |
| Age (Years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Years] |
71.5
(5.44)
|
71.5
(5.32)
|
26.0
(4.91)
|
59.7
(20.69)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
36
52.2%
|
29
39.7%
|
27
54%
|
92
47.9%
|
| Male |
33
47.8%
|
44
60.3%
|
23
46%
|
100
52.1%
|
Outcome Measures
| Title | The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains Which Are Producing at Least Two Different Markers |
|---|---|
| Description | The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α), interferon-gamma (IFN-γ) |
| Time Frame | Day 21 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available. Analysis was only performed for New generation influenza vaccine GSK2186877A Group and Fluarix elderly Group. |
| Arm/Group Title | New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group |
|---|---|---|---|
| Arm/Group Description | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
| Measure Participants | 62 | 61 | 0 |
| Geometric Mean (Standard Deviation) [cells per million CD4+ Tcells] |
3371.11
(3602.15)
|
2108.10
(1728.38)
|
| Title | The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Which Were Producing at Least Two Different Markers |
|---|---|
| Description | The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens. |
| Time Frame | At Day 0, 21, 42 and 180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available. |
| Arm/Group Title | New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group |
|---|---|---|---|
| Arm/Group Description | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
| Measure Participants | 62 | 64 | 44 |
| pooled vaccine strain Day 0 |
1269.34
(1032.60)
|
1309.30
(2098.97)
|
2026.14
(1004.93)
|
| pooled vaccine strain Day 21 |
3371.11
(3602.15)
|
2108.10
(1728.38)
|
3228.91
(1714.91)
|
| pooled vaccine strain Day 42 |
2657.07
(1903.38)
|
1540.08
(1138.94)
|
2669.41
(1391.70)
|
| pooled vaccine strain Day 180 |
2105.66
(1232.80)
|
1484.11
(1024.53)
|
2746.76
(1232.90)
|
| A/Brisbane vaccine strain Day 0 |
402.28
(421.64)
|
340.57
(352.55)
|
793.58
(452.84)
|
| A/Brisbane vaccine strain Day 21 |
1062.79
(1049.87)
|
462.34
(712.32)
|
982.18
(727.70)
|
| A/Brisbane vaccine strain Day 42 |
822.07
(667.91)
|
392.04
(498.81)
|
874.34
(544.91)
|
| A/Brisbane vaccine strain Day 180 |
669.67
(579.75)
|
463.94
(458.04)
|
973.29
(555.34)
|
| A/Uruguay vaccine strain Day 0 |
342.58
(340.83)
|
274.47
(282.29)
|
437.07
(410.66)
|
| A/Uruguay vaccine strain Day 21 |
930.98
(1262.81)
|
497.49
(479.98)
|
667.38
(465.08)
|
| A/Uruguay vaccine strain Day 42 |
678.88
(669.99)
|
331.62
(365.40)
|
473.17
(500.92)
|
| A/Uruguay vaccine strain Day 180 |
640.97
(567.70)
|
331.02
(324.69)
|
654.30
(503.69)
|
| B/Brisbane vaccine strain Day 0 |
672.58
(615.67)
|
504.36
(588.82)
|
1183.48
(582.67)
|
| B/Brisbane vaccine strain Day 21 |
1755.55
(1961.87)
|
1149.98
(1032.36)
|
1861.66
(884.81)
|
| B/Brisbane vaccine strain Day 42 |
1325.35
(1094.01)
|
807.46
(639.01)
|
1572.47
(719.96)
|
| B/Brisbane vaccine strain Day 180 |
1034.78
(725.84)
|
778.13
(630.32)
|
1640.71
(897.14)
|
| Title | The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells Identified After in Vitro Stimulation With Pooled Vaccine Strains and With Each Vaccine Strain Separately Producing Each of the Immune Markers Plus Another Immune Marker |
|---|---|
| Description | The markers assessed were CD40L, IL-2, TNF-α, IFN-γ. The separate vaccine strains tested included A/Brisbane, A/Uruguay, B/Brisbane antigens. |
| Time Frame | At Day 0, 21, 42 and 180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was based on According-to-Protocol (ATP) Immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available. |
| Arm/Group Title | New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group |
|---|---|---|---|
| Arm/Group Description | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
| Measure Participants | 62 | 64 | 44 |
| pooled strain[CD4-CD40L] D 0 |
1104.24
(987.15)
|
1211.72
(1086.88)
|
1879.85
(963.74)
|
| pooled strain[CD4-CD40L] D 21 |
2817.50
(3166.07)
|
1935.66
(1597.56)
|
2929.86
(1644.61)
|
| pooled strain[CD4-CD40L] D 42 |
2447.37
(1766.85)
|
1425.02
(1082.35)
|
2436.43
(1365.81)
|
| pooled strain[CD4-CD40L] D 180 |
2036.70
(1170.14)
|
1416.78
(973.63)
|
2619.74
(1167.44)
|
| pooled strain[CD4- IFN-γ] D 0 |
832.47
(798.10)
|
835.22
(1598.81)
|
1403.57
(777.81)
|
| pooled strain[CD4- IFN-γ] D 21 |
2305.58
(2712.79)
|
1341.17
(1195.01)
|
2258.27
(1307.01)
|
| pooled strain[CD4- IFN-γ] D 42 |
1775.61
(1464.84)
|
997.25
(818.08)
|
1849.44
(1124.86)
|
| pooled strain[CD4- IFN-γ] D 180 |
1495.36
(1031.14)
|
1019.64
(790.42)
|
2102.93
(1074.53)
|
| pooled strain[CD4-IL-2] D 0 |
1085.32
(930.22)
|
1119.34
(1002.46)
|
1717.41
(852.57)
|
| pooled strain[CD4-IL-2] D 21 |
2534.86
(3188.65)
|
1779.41
(1595.66)
|
2690.36
(1583.12)
|
| pooled strain[CD4-IL-2] D42 |
2205.91
(1754.74)
|
1310.05
(1062.08)
|
2199.18
(1251.48)
|
| pooled strain[CD4-IL-2] D 180 |
1837.60
(1093.26)
|
1285.14
(955.76)
|
2302.51
(1042.85)
|
| pooled strain[CD4-TNF-α] D 0 |
874.43
(812.98)
|
928.86
(1924.68)
|
1425.50
(768.88)
|
| pooled strain[CD4-TNF-α] D 21 |
2114.47
(2448.22)
|
1284.20
(1080.26)
|
1999.07
(1010.68)
|
| pooled strain[CD4-TNF-α] D 42 |
1741.65
(1350.73)
|
1012.42
(805.86)
|
1752.99
(933.90)
|
| pooled strain[CD4-TNF-α] D 180 |
1413.29
(865.27)
|
1015.29
(830.38)
|
1821.04
(880.59)
|
| A/Brisbane strain[CD4-CD40L] D 0 |
387.76
(400.63)
|
320.29
(338.91)
|
750.57
(435.67)
|
| A/Brisbane strain[CD4-CD40L] D 21 |
980.10
(937.63)
|
462.64
(676.17)
|
919.30
(679.26)
|
| A/Brisbane strain[CD4-CD40L] D 42 |
771.49
(616.20)
|
365.94
(474.72)
|
818.54
(522.72)
|
| A/Brisbane strain[CD4-CD40L] D 180 |
653.13
(547.36)
|
466.55
(429.28)
|
922.06
(511.19)
|
| A/Uruguay strain[CD4-CD40L] D 0 |
308.73
(316.94)
|
227.76
(266.35)
|
384.02
(397.54)
|
| A/Uruguay strain[CD4-CD40L] D 21 |
805.56
(1066.84)
|
451.52
(459.24)
|
602.51
(431.82)
|
| A/Uruguay strain[CD4-CD40L] D 42 |
592.88
(579.07)
|
286.06
(333.05)
|
417.15
(468.52)
|
| A/Uruguay strain[CD4-CD40L] D 180 |
609.34
(524.50)
|
298.70
(295.58)
|
584.68
(446.49)
|
| B/Brisbane strain[CD4-CD40L] D 0 |
647.94
(581.98)
|
515.89
(566.11)
|
1129.44
(573.40)
|
| B/Brisbane strain[CD4-CD40L] D 21 |
1607.98
(1806.43)
|
1077.12
(990.77)
|
1737.45
(842.62)
|
| B/Brisbane strain[CD4-CD40L] D 42 |
1246.10
(1033.85)
|
763.04
(606.04)
|
1472.48
(725.44)
|
| B/Brisbane strain[CD4-CD40L] D 180 |
1011.39
(682.07)
|
757.17
(611.01)
|
1570.98
(843.76)
|
| A/Brisbane strain[CD4- IFN-γ] D 0 |
279.24
(337.13)
|
258.94
(258.55)
|
563.26
(323.39)
|
| A/Brisbane strain[CD4- IFN-γ] D 21 |
725.55
(752.84)
|
344.39
(447.19)
|
680.40
(543.42)
|
| A/Brisbane strain[CD4- IFN-γ] D 42 |
572.87
(520.31)
|
326.66
(322.73)
|
623.21
(409.74)
|
| A/Brisbane strain[CD4- IFN-γ] D 180 |
586.26
(474.54)
|
363.03
(361.43)
|
773.40
(486.08)
|
| A/Uruguay strain[CD4- IFN-γ] D 0 |
214.92
(245.84)
|
164.78
(199.00)
|
283.81
(267.71)
|
| A/Uruguay strain[CD4- IFN-γ] D 21 |
641.94
(944.37)
|
314.63
(311.72)
|
403.00
(355.57)
|
| A/Uruguay strain[CD4- IFN-γ] D 42 |
458.72
(501.32)
|
246.18
(227.80)
|
331.47
(356.93)
|
| A/Uruguay strain[CD4- IFN-γ] D 180 |
426.59
(418.38)
|
228.06
(215.33)
|
451.90
(400.61)
|
| B/Brisbane strain[CD4- IFN-γ] D 0 |
342.59
(532.27)
|
319.38
(507.10)
|
824.76
(496.44)
|
| B/Brisbane strain[CD4- IFN-γ] D 21 |
1219.72
(1581.26)
|
721.43
(849.49)
|
1361.31
(712.84)
|
| B/Brisbane strain[CD4- IFN-γ] D 42 |
903.71
(918.49)
|
517.83
(501.51)
|
1095.12
(676.34)
|
| B/Brisbane strain[CD4- IFN-γ] D 180 |
697.03
(635.80)
|
510.37
(539.79)
|
1253.33
(862.51)
|
| A/Brisbane strain[CD4-IL2] D 0 |
346.00
(369.76)
|
319.16
(331.16)
|
677.11
(397.23)
|
| A/Brisbane strain[CD4-IL2] D 21 |
872.32
(897.70)
|
427.26
(664.07)
|
816.95
(655.93)
|
| A/Brisbane strain[CD4-IL2] D 42 |
696.36
(598.29)
|
393.67
(460.81)
|
720.28
(468.43)
|
| A/Brisbane strain[CD4-IL2] D 180 |
570.30
(503.83)
|
387.63
(429.61)
|
817.80
(470.25)
|
| A/Uruguay strain[CD4-IL2] D 0 |
278.66
(306.46)
|
240.26
(261.18)
|
369.77
(322.49)
|
| A/Uruguay strain[CD4-IL2] D 21 |
680.16
(1060.47)
|
391.84
(425.96)
|
510.88
(385.11)
|
| A/Uruguay strain[CD4-IL2] D 42 |
534.07
(579.96)
|
295.90
(322.75)
|
438.09
(401.87)
|
| A/Uruguay strain[CD4-IL2] D 180 |
526.12
(483.57)
|
299.67
(274.20)
|
514.55
(404.73)
|
| B/Brisbane strain[CD4-IL2] D 0 |
587.16
(566.46)
|
451.89
(549.60)
|
1019.08
(512.69)
|
| B/Brisbane strain[CD4-IL2] D 21 |
1496.41
(1826.01)
|
1004.17
(966.20)
|
1592.61
(810.35)
|
| B/Brisbane strain[CD4-IL2] D 42 |
1144.72
(1021.68)
|
724.10
(593.13)
|
1322.64
(664.52)
|
| B/Brisbane strain[CD4-IL2] D 180 |
933.06
(660.87)
|
704.18
(602.50)
|
1439.92
(753.90)
|
| A/Brisbane strain[CD4-TNF-α] D 0 |
262.44
(349.53)
|
247.22
(274.83)
|
536.34
(369.21)
|
| A/Brisbane strain[CD4-TNF-α] D 21 |
621.35
(746.04)
|
289.38
(376.07)
|
497.77
(499.72)
|
| A/Brisbane strain[CD4-TNF-α] D 42 |
500.13
(518.12)
|
238.28
(329.62)
|
564.91
(395.51)
|
| A/Brisbane strain[CD4-TNF-α] D 180 |
462.60
(402.23)
|
308.96
(347.12)
|
616.75
(383.70)
|
| A/Uruguay strain[CD4-TNF-α] D 0 |
223.83
(292.61)
|
191.52
(234.42)
|
284.69
(317.94)
|
| A/Uruguay strain[CD4-TNF-α] D 21 |
600.99
(932.13)
|
320.59
(308.63)
|
411.24
(333.50)
|
| A/Uruguay strain[CD4-TNF-α] D 42 |
452.35
(515.50)
|
211.12
(267.39)
|
333.52
(375.97)
|
| A/Uruguay strain[CD4-TNF-α] D 180 |
370.86
(415.54)
|
230.70
(241.03)
|
477.18
(355.92)
|
| B/Brisbane strain[CD4-TNF-α] D 0 |
414.10
(472.20)
|
305.51
(516.15)
|
773.44
(420.89)
|
| B/Brisbane strain[CD4-TNF-α] D 21 |
967.79
(1226.62)
|
639.74
(663.66)
|
1057.83
(507.15)
|
| B/Brisbane strain[CD4-TNF-α] D 42 |
775.92
(756.63)
|
413.38
(490.41)
|
953.30
(491.50)
|
| B/Brisbane strain[CD4-TNF-α] D 180 |
642.05
(520.83)
|
475.44
(511.57)
|
1051.51
(664.61)
|
| Title | Haemagglutinin Inhibition (HI) Antibody Titers |
|---|---|
| Description | Antibody titers were expressed as Geometric mean titers (GMTs) calculated after invitro stimulation with separate vaccine strains. |
| Time Frame | At Day 0, 21, 42 and 180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis of immunogenicity was performed on According-to-Protocol (ATP) Immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available. |
| Arm/Group Title | New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group |
|---|---|---|---|
| Arm/Group Description | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
| Measure Participants | 62 | 66 | 44 |
| A/Brisbane strain at Day 0 |
16.5
|
14.3
|
20.5
|
| A/Brisbane strain at Day 21 |
105.1
|
67.2
|
220.8
|
| A/Brisbane strain at Day 42 |
82.3
|
56.8
|
181.4
|
| A/Brisbane strain at Day 180 |
38.4
|
32.1
|
90.3
|
| A/Uruguay strain at Day 0 |
21.4
|
17.5
|
16.4
|
| A/Uruguay strain at Day 21 |
330.9
|
164.2
|
179.0
|
| A/Uruguay strain at Day 42 |
254.8
|
110.1
|
130.3
|
| A/Uruguay strain at Day 180 |
117.0
|
59.9
|
74.4
|
| B/Brisbane strain at Day 0 |
92.0
|
97.0
|
169.0
|
| B/Brisbane strain at Day 21 |
699.9
|
502.6
|
1229.4
|
| B/Brisbane strain at Day 42 |
487.2
|
393.9
|
971.6
|
| B/Brisbane strain at Day 180 |
254.5
|
238.4
|
677.2
|
| Title | The Number of Subjects Seropositive to HI Antibodies Calculated After in Vitro Stimulation With Separate Vaccine Strains. |
|---|---|
| Description | Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10 |
| Time Frame | At Day 0, 21, 42 and 180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available. |
| Arm/Group Title | New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group |
|---|---|---|---|
| Arm/Group Description | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
| Measure Participants | 62 | 66 | 44 |
| A/Brisbane strain at Day 0 |
43
62.3%
|
40
54.8%
|
25
50%
|
| A/Brisbane strain at Day 21 |
61
88.4%
|
62
84.9%
|
43
86%
|
| A/Brisbane strain at Day 42 |
60
87%
|
62
84.9%
|
44
88%
|
| A/Brisbane strain at Day 180 |
57
82.6%
|
57
78.1%
|
40
80%
|
| A/Uruguay strain at Day 0 |
41
59.4%
|
45
61.6%
|
24
48%
|
| A/Uruguay strain at Day 21 |
62
89.9%
|
63
86.3%
|
41
82%
|
| A/Uruguay strain at Day 42 |
60
87%
|
62
84.9%
|
42
84%
|
| A/Uruguay strain at Day 180 |
61
88.4%
|
59
80.8%
|
39
78%
|
| B/Brisbane strain at Day 0 |
59
85.5%
|
65
89%
|
42
84%
|
| B/Brisbane strain at Day 21 |
62
89.9%
|
66
90.4%
|
43
86%
|
| B/Brisbane strain at Day 42 |
61
88.4%
|
65
89%
|
44
88%
|
| B/Brisbane strain at Day 180 |
62
89.9%
|
66
90.4%
|
43
86%
|
| Title | The Number of Subjects Seroconverted to HI Antibodies |
|---|---|
| Description | Seroconversion was defined as the number of vaccinees who had either a prevaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. |
| Time Frame | At Day 21, 42 and 180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available. |
| Arm/Group Title | New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group |
|---|---|---|---|
| Arm/Group Description | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
| Measure Participants | 62 | 66 | 44 |
| A/Brisbane strain at Day 21 |
36
52.2%
|
32
43.8%
|
29
58%
|
| A/Brisbane strain at Day 42 |
33
47.8%
|
25
34.2%
|
29
58%
|
| A/Brisbane strain at Day 180 |
16
23.2%
|
16
21.9%
|
23
46%
|
| A/Uruguay strain at Day 21 |
52
75.4%
|
50
68.5%
|
33
66%
|
| A/Uruguay strain at Day 42 |
48
69.6%
|
44
60.3%
|
30
60%
|
| A/Uruguay strain at Day 180 |
36
52.2%
|
28
38.4%
|
20
40%
|
| B/Brisbane strain at Day 21 |
44
63.8%
|
38
52.1%
|
29
58%
|
| B/Brisbane strain at Day 42 |
38
55.1%
|
35
47.9%
|
25
50%
|
| B/Brisbane strain at Day 180 |
22
31.9%
|
22
30.1%
|
20
40%
|
| Title | HI Antibody Seroconversion Factors |
|---|---|
| Description | Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. |
| Time Frame | At Day 21, 42 and 180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available. |
| Arm/Group Title | New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group |
|---|---|---|---|
| Arm/Group Description | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
| Measure Participants | 62 | 66 | 44 |
| A/Brisbane strain at Day 21 |
6.4
|
4.7
|
10.6
|
| A/Brisbane strain at Day 42 |
5.1
|
3.9
|
8.9
|
| A/Brisbane strain at Day 180 |
2.3
|
2.2
|
4.6
|
| A/Uruguay strain at Day 21 |
15.5
|
9.4
|
11.3
|
| A/Uruguay strain at Day 42 |
12.2
|
6.4
|
7.9
|
| A/Uruguay strain at Day 180 |
5.5
|
3.4
|
4.5
|
| B/Brisbane strain at Day 21 |
7.6
|
5.2
|
7.4
|
| B/Brisbane strain at Day 42 |
5.4
|
4.1
|
5.8
|
| B/Brisbane strain at Day 180 |
2.8
|
2.5
|
4.0
|
| Title | The Number of Subjects Seroprotected to HI Antibodies |
|---|---|
| Description | A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. |
| Time Frame | At Day 0, 21, 42 and 180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on According-to-Protocol (ATP) immunogenicity cohort which included all evaluable subjects for whom data concerning immunogenicity data were available. |
| Arm/Group Title | New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group |
|---|---|---|---|
| Arm/Group Description | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
| Measure Participants | 62 | 66 | 44 |
| A/Brisbane strain at Day 0 |
20
29%
|
16
21.9%
|
18
36%
|
| A/Brisbane strain at Day 21 |
57
82.6%
|
53
72.6%
|
42
84%
|
| A/Brisbane strain at Day 42 |
56
81.2%
|
47
64.4%
|
42
84%
|
| A/Brisbane strain at Day 180 |
39
56.5%
|
34
46.6%
|
36
72%
|
| A/Uruguay strain at Day 0 |
26
37.7%
|
24
32.9%
|
16
32%
|
| A/Uruguay strain at Day 21 |
61
88.4%
|
57
78.1%
|
39
78%
|
| A/Uruguay strain at Day 42 |
59
85.5%
|
53
72.6%
|
39
78%
|
| A/Uruguay strain at Day 180 |
53
76.8%
|
48
65.8%
|
33
66%
|
| B/Brisbane strain at Day 0 |
51
73.9%
|
57
78.1%
|
39
78%
|
| B/Brisbane strain at Day 21 |
62
89.9%
|
65
89%
|
43
86%
|
| B/Brisbane strain at Day 42 |
61
88.4%
|
64
87.7%
|
44
88%
|
| B/Brisbane strain at Day 180 |
60
87%
|
65
89%
|
42
84%
|
| Title | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) |
|---|---|
| Description | Grade 3 ecchymosis, redness and swelling was >100mm and grade 3 pain was considerable pain at rest, that prevented normal everyday activity. |
| Time Frame | Day 0 -6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. |
| Arm/Group Title | New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group |
|---|---|---|---|
| Arm/Group Description | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
| Measure Participants | 69 | 73 | 50 |
| Any ecchymosis |
2
2.9%
|
1
1.4%
|
0
0%
|
| Grade 3 ecchymosis |
0
0%
|
0
0%
|
0
0%
|
| Any pain |
43
62.3%
|
15
20.5%
|
35
70%
|
| Grade 3 pain |
0
0%
|
0
0%
|
0
0%
|
| Any redness |
5
7.2%
|
0
0%
|
0
0%
|
| Grade 3 redness |
0
0%
|
0
0%
|
0
0%
|
| Any swelling |
8
11.6%
|
1
1.4%
|
0
0%
|
| Grade 3 swelling |
0
0%
|
0
0%
|
0
0%
|
| Title | Duration of Solicited Local AEs |
|---|---|
| Description | Duration was defined as the number of days with any grade of local symptoms. |
| Time Frame | Day 0 -6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom. |
| Arm/Group Title | New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group |
|---|---|---|---|
| Arm/Group Description | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
| Measure Participants | 43 | 15 | 35 |
| Ecchymosis |
3.5
|
5.0
|
|
| Pain |
2.0
|
1.0
|
2.0
|
| Redness |
2.0
|
||
| Swelling |
4.0
|
5.0
|
| Title | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs |
|---|---|
| Description | Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was defined as oral temperature ≥ 39.0°C. For other symptoms grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination. |
| Time Frame | Day 0 -6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. |
| Arm/Group Title | New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group |
|---|---|---|---|
| Arm/Group Description | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
| Measure Participants | 69 | 73 | 50 |
| Any arthralgia |
14
20.3%
|
3
4.1%
|
4
8%
|
| Grade 3 arthralgia |
0
0%
|
0
0%
|
0
0%
|
| Related arthralgia |
12
17.4%
|
1
1.4%
|
3
6%
|
| Any fatigue |
22
31.9%
|
12
16.4%
|
21
42%
|
| Grade 3 fatigue |
0
0%
|
0
0%
|
0
0%
|
| Related fatigue |
21
30.4%
|
8
11%
|
11
22%
|
| Any gastrointestinal symptoms |
6
8.7%
|
4
5.5%
|
6
12%
|
| Grade 3 gastrointestinal symptoms |
0
0%
|
0
0%
|
0
0%
|
| Related gastrointestinal symptoms |
5
7.2%
|
1
1.4%
|
4
8%
|
| Any headache |
22
31.9%
|
7
9.6%
|
14
28%
|
| Grade 3 headache |
0
0%
|
0
0%
|
0
0%
|
| Related headache |
17
24.6%
|
2
2.7%
|
7
14%
|
| Any myalgia |
17
24.6%
|
8
11%
|
11
22%
|
| Grade 3 myalgia |
0
0%
|
0
0%
|
0
0%
|
| Related myalgia |
16
23.2%
|
7
9.6%
|
9
18%
|
| Any shivering |
11
15.9%
|
0
0%
|
2
4%
|
| Grade 3 shivering |
0
0%
|
0
0%
|
1
2%
|
| Related shivering |
8
11.6%
|
0
0%
|
1
2%
|
| Any fever |
2
2.9%
|
0
0%
|
0
0%
|
| Grade 3 fever |
1
1.4%
|
0
0%
|
0
0%
|
| Related fever |
2
2.9%
|
0
0%
|
0
0%
|
| Title | Duration of Solicited General AEs |
|---|---|
| Description | Duration was defined as number of days with any grade of general symptoms. |
| Time Frame | Day 0 -6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented on subjects who experienced the symptom. |
| Arm/Group Title | New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group |
|---|---|---|---|
| Arm/Group Description | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
| Measure Participants | 22 | 12 | 21 |
| Arthralgia |
2.0
|
2.0
|
1.5
|
| Fatigue |
2.0
|
2.5
|
2.0
|
| Gastrointestinal symptoms |
1.0
|
2.0
|
1.0
|
| Headache |
1.0
|
2.0
|
1.5
|
| Myalgia |
2.0
|
1.5
|
1.0
|
| Shivering |
1.0
|
2.5
|
|
| Fever |
2.0
|
| Title | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited 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 was defined as occurrence of any unsolicited symptom, regardless of intensity or relation to vaccination, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination. |
| Time Frame | Day 0-20 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. |
| Arm/Group Title | New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group |
|---|---|---|---|
| Arm/Group Description | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
| Measure Participants | 69 | 73 | 50 |
| Any AE(s) |
13
18.8%
|
21
28.8%
|
15
30%
|
| Grade 3 AE(s) |
2
2.9%
|
2
2.7%
|
1
2%
|
| Related AE(s) |
3
4.3%
|
2
2.7%
|
1
2%
|
| Title | Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) |
|---|---|
| Description | For each solicited and unsolicited AE the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was event assessed by investigator as causally related to the study vaccination. |
| Time Frame | Day 0-179 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. |
| Arm/Group Title | New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group |
|---|---|---|---|
| Arm/Group Description | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
| Measure Participants | 69 | 73 | 50 |
| Any MAE(s) |
24
34.8%
|
21
28.8%
|
13
26%
|
| Grade 3 MAE(s) |
4
5.8%
|
9
12.3%
|
3
6%
|
| Related MAE(s) |
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Subjects Reporting Any AEs of Specific Interest (AESI) |
|---|---|
| Description | AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination. |
| Time Frame | Day 0-364 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. |
| Arm/Group Title | New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group |
|---|---|---|---|
| Arm/Group Description | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
| Measure Participants | 69 | 73 | 50 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) |
|---|---|
| Description | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom, regardless of intensity or relation to vaccination and related was event assessed by investigator as causally related to the study vaccination. |
| Time Frame | Day 0-364 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented. |
| Arm/Group Title | New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group |
|---|---|---|---|
| Arm/Group Description | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
| Measure Participants | 69 | 73 | 50 |
| Count of Participants [Participants] |
5
7.2%
|
11
15.1%
|
1
2%
|
Adverse Events
| Time Frame | Serious adverse events were assessed up to day 364. Systematically assessed frequent adverse events (AEs) were assessed during 7 day post vaccination period. Non systematically assessed frequent AEs were assessed during 21 day post vaccination period. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group | |||
| Arm/Group Description | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 | Subjects aged >= 65 years receiving 1 dose of Fluarix vaccine at Day 0 | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 | |||
All Cause Mortality |
||||||
| New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/69 (7.2%) | 11/73 (15.1%) | 1/50 (2%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 1/69 (1.4%) | 0/73 (0%) | 0/50 (0%) | |||
| Cardiac disorders | ||||||
| Arrhythmia | 0/69 (0%) | 1/73 (1.4%) | 0/50 (0%) | |||
| Atrial flutter | 1/69 (1.4%) | 0/73 (0%) | 0/50 (0%) | |||
| Myocardial infarction | 1/69 (1.4%) | 0/73 (0%) | 0/50 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Vertigo | 1/69 (1.4%) | 0/73 (0%) | 0/50 (0%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal hernia | 1/69 (1.4%) | 0/73 (0%) | 0/50 (0%) | |||
| Rectal haemorrhage | 1/69 (1.4%) | 0/73 (0%) | 0/50 (0%) | |||
| General disorders | ||||||
| Non-cardiac chest pain | 0/69 (0%) | 1/73 (1.4%) | 0/50 (0%) | |||
| Hepatobiliary disorders | ||||||
| Cholecystitis acute | 0/69 (0%) | 1/73 (1.4%) | 0/50 (0%) | |||
| Immune system disorders | ||||||
| Hypersensitivity | 0/69 (0%) | 0/73 (0%) | 1/50 (2%) | |||
| Injury, poisoning and procedural complications | ||||||
| Ligament rupture | 0/69 (0%) | 1/73 (1.4%) | 0/50 (0%) | |||
| Rib fracture | 0/69 (0%) | 1/73 (1.4%) | 0/50 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Brain neoplasm | 0/69 (0%) | 1/73 (1.4%) | 0/50 (0%) | |||
| Lymphoma | 0/69 (0%) | 1/73 (1.4%) | 0/50 (0%) | |||
| Meningioma | 1/69 (1.4%) | 0/73 (0%) | 0/50 (0%) | |||
| Metastases to lung | 0/69 (0%) | 1/73 (1.4%) | 0/50 (0%) | |||
| Urinary tract neoplasm | 0/69 (0%) | 1/73 (1.4%) | 0/50 (0%) | |||
| Uterine cancer | 0/69 (0%) | 1/73 (1.4%) | 0/50 (0%) | |||
| Nervous system disorders | ||||||
| Amnesia | 0/69 (0%) | 1/73 (1.4%) | 0/50 (0%) | |||
| Syncope | 0/69 (0%) | 1/73 (1.4%) | 0/50 (0%) | |||
| Renal and urinary disorders | ||||||
| Nephritis | 0/69 (0%) | 1/73 (1.4%) | 0/50 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| New Generation Influenza Vaccine GSK2186877A Group | Fluarix Elderly Group | Fluarix Young Group | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 53/69 (76.8%) | 27/73 (37%) | 43/50 (86%) | |||
| General disorders | ||||||
| Pain | 43/69 (62.3%) | 15/73 (20.5%) | 35/50 (70%) | |||
| Redness | 5/69 (7.2%) | 0/73 (0%) | 0/50 (0%) | |||
| Swelling | 8/69 (11.6%) | 1/73 (1.4%) | 0/50 (0%) | |||
| Arthralgia | 14/69 (20.3%) | 3/73 (4.1%) | 4/50 (8%) | |||
| Fatigue | 22/69 (31.9%) | 12/73 (16.4%) | 21/50 (42%) | |||
| Gastrointestinal symptoms | 6/69 (8.7%) | 4/73 (5.5%) | 6/50 (12%) | |||
| Headache | 22/69 (31.9%) | 7/73 (9.6%) | 14/50 (28%) | |||
| Myalgia | 17/69 (24.6%) | 8/73 (11%) | 11/50 (22%) | |||
| Shivering | 11/69 (15.9%) | 0/73 (0%) | 2/50 (4%) | |||
| Infections and infestations | ||||||
| Nasopharyngitis | 2/69 (2.9%) | 2/73 (2.7%) | 4/50 (8%) | |||
Limitations/Caveats
[Not Specified]
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:
NCT00765076
Other Study ID Numbers:
- 112147
First Posted:
Oct 2, 2008
Last Update Posted:
Jul 31, 2018
Last Verified:
Oct 1, 2016