Trial Outcomes & Findings for Evaluation of the Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly (NCT NCT00772889)

Last Updated: 2018-07-31

Results Overview

Grade 3 ecchymosis, redness and swelling were ≥ 100 millimeters (mm) and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was \>20 mm for ecchymosis, redness and swelling.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

971 participants

Primary outcome timeframe

Day 0-6

Results posted on

2018-07-31

Participant Flow

Participant milestones

Participant milestones
Measure	New Generation Influenza Vaccine GSK2186877A Group Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.	Fluarix Elderly Group Subjects aged ≥66 years received one dose of Fluarix vaccine.	Fluarix Young Group Subjects aged 19-43 years received one dose of Fluarix vaccine.
Overall Study STARTED	375	393	203
Overall Study Completed at Day 21	374	390	203
Overall Study COMPLETED	353	375	187
Overall Study NOT COMPLETED	22	18	16

Reasons for withdrawal

Reasons for withdrawal
Measure	New Generation Influenza Vaccine GSK2186877A Group Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.	Fluarix Elderly Group Subjects aged ≥66 years received one dose of Fluarix vaccine.	Fluarix Young Group Subjects aged 19-43 years received one dose of Fluarix vaccine.
Overall Study Adverse Event	7	4	0
Overall Study Withdrawal by Subject	9	8	9
Overall Study Lost to Follow-up	6	6	7

Baseline Characteristics

Evaluation of the Safety and Immunogenicity of the Influenza Vaccine GSK2186877A in the Elderly

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	New Generation Influenza Vaccine GSK2186877A Group n=375 Participants Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.	Fluarix Elderly Group n=393 Participants Subjects aged ≥66 years received one dose of Fluarix vaccine.	Fluarix Young Group n=203 Participants Subjects aged 19-43 years received one dose of Fluarix vaccine.	Total n=971 Participants Total of all reporting groups
Age, Continuous	74.4 Years STANDARD_DEVIATION 5.23 • n=5 Participants	74.7 Years STANDARD_DEVIATION 5.74 • n=7 Participants	32.4 Years STANDARD_DEVIATION 6.78 • n=5 Participants	65.7 Years STANDARD_DEVIATION 18.10 • n=4 Participants
Sex: Female, Male Female	190 Participants n=5 Participants	203 Participants n=7 Participants	118 Participants n=5 Participants	511 Participants n=4 Participants
Sex: Female, Male Male	185 Participants n=5 Participants	190 Participants n=7 Participants	85 Participants n=5 Participants	460 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 0-6

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=375 Participants Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.	Fluarix Elderly Group n=392 Participants Subjects aged ≥66 years received one dose of Fluarix vaccine.	Fluarix Young Group n=203 Participants Subjects aged 19-43 years received one dose of Fluarix vaccine.
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any ecchymosis	2 Participants	3 Participants	1 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 ecchymosis	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any pain	159 Participants	49 Participants	122 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 pain	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any redness	57 Participants	10 Participants	9 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 redness	3 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Any swelling	23 Participants	6 Participants	7 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Grade 3 swelling	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 0-6

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.

Duration was defined as number of days with any grade of local symptoms.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=159 Participants Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.	Fluarix Elderly Group n=49 Participants Subjects aged ≥66 years received one dose of Fluarix vaccine.	Fluarix Young Group n=122 Participants Subjects aged 19-43 years received one dose of Fluarix vaccine.
Duration of Solicited Local AEs Ecchymosis	6.5 Days Interval 6.0 to 7.0	5.0 Days Interval 3.0 to 5.0	2.0 Days Interval 2.0 to 2.0
Duration of Solicited Local AEs Pain	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 5.0
Duration of Solicited Local AEs Redness	3.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0	1.0 Days Interval 1.0 to 6.0
Duration of Solicited Local AEs Swelling	2.0 Days Interval 1.0 to 7.0	1.5 Days Interval 1.0 to 5.0	1.0 Days Interval 1.0 to 3.0

PRIMARY outcome

Timeframe: Day 0-6

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.

Any fever was defined as oral temperature ≥38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relationship to the study vaccination, grade 3 was defined as a general symptom that prevented normal activity. Related arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever were defined as general symptoms assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=375 Participants Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.	Fluarix Elderly Group n=392 Participants Subjects aged ≥66 years received one dose of Fluarix vaccine.	Fluarix Young Group n=203 Participants Subjects aged 19-43 years received one dose of Fluarix vaccine.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any arthralgia	44 Participants	20 Participants	11 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 arthralgia	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related arthralgia	25 Participants	8 Participants	9 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any fatigue	72 Participants	37 Participants	39 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 fatigue	1 Participants	2 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related fatigue	40 Participants	17 Participants	28 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any gastrointestinal symptoms	26 Participants	18 Participants	9 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 gastrointestinal symptoms	1 Participants	1 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related gastrointestinal symptoms	11 Participants	10 Participants	7 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any headache	54 Participants	38 Participants	31 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 headache	2 Participants	2 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related headache	33 Participants	18 Participants	21 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any myalgia	68 Participants	33 Participants	36 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 myalgia	0 Participants	1 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related myalgia	44 Participants	16 Participants	26 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any shivering	32 Participants	16 Participants	10 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 shivering	1 Participants	2 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related shivering	21 Participants	8 Participants	10 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Any fever	3 Participants	1 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Grade 3 fever	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Related fever	3 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: Day 0-6

Duration was defined as number of days with any grade of general symptoms.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=72 Participants Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.	Fluarix Elderly Group n=38 Participants Subjects aged ≥66 years received one dose of Fluarix vaccine.	Fluarix Young Group n=39 Participants Subjects aged 19-43 years received one dose of Fluarix vaccine.
Duration of Solicited General AEs Arthralgia	2.0 Days Interval 1.0 to 7.0	3.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0
Duration of Solicited General AEs Fatigue	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0
Duration of Solicited General AEs Gastrointestinal symptoms	2.0 Days Interval 1.0 to 5.0	2.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0
Duration of Solicited General AEs Headache	1.0 Days Interval 1.0 to 6.0	2.0 Days Interval 1.0 to 7.0	1.0 Days Interval 1.0 to 5.0
Duration of Solicited General AEs Myalgia	2.0 Days Interval 1.0 to 7.0	3.0 Days Interval 1.0 to 7.0	2.0 Days Interval 1.0 to 7.0
Duration of Solicited General AEs Shivering	1.0 Days Interval 1.0 to 7.0	1.5 Days Interval 1.0 to 5.0	2.0 Days Interval 1.0 to 5.0
Duration of Solicited General AEs Fever	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0	3.0 Days Interval 3.0 to 3.0

PRIMARY outcome

Timeframe: Day 0-20

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

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 grade. Grade 3 was defined as an unsolicited symptom that prevented normal activity. Related was an event assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=375 Participants Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.	Fluarix Elderly Group n=393 Participants Subjects aged ≥66 years received one dose of Fluarix vaccine.	Fluarix Young Group n=203 Participants Subjects aged 19-43 years received one dose of Fluarix vaccine.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs Any AE(s)	45 Participants	47 Participants	38 Participants
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs Grade 3 AE(s)	3 Participants	8 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs Related AE(s)	8 Participants	5 Participants	3 Participants

PRIMARY outcome

Timeframe: Day 0-20

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

For each solicited and unsolicited AE the subject experienced, the subject was asked if they had 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 grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=375 Participants Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.	Fluarix Elderly Group n=393 Participants Subjects aged ≥66 years received one dose of Fluarix vaccine.	Fluarix Young Group n=203 Participants Subjects aged 19-43 years received one dose of Fluarix vaccine.
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20 Any MAE(s)	17 Participants	22 Participants	9 Participants
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20 Grade 3 MAE(s)	3 Participants	6 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) During Day 0 to Day 20 Related MAE(s)	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 0-20

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=375 Participants Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.	Fluarix Elderly Group n=393 Participants Subjects aged ≥66 years received one dose of Fluarix vaccine.	Fluarix Young Group n=203 Participants Subjects aged 19-43 years received one dose of Fluarix vaccine.
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases From Day 0 to Day 20	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 0-20

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

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 grade and related was an event assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=375 Participants Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.	Fluarix Elderly Group n=393 Participants Subjects aged ≥66 years received one dose of Fluarix vaccine.	Fluarix Young Group n=203 Participants Subjects aged 19-43 years received one dose of Fluarix vaccine.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20 Any SAEs	3 Participants	4 Participants	0 Participants
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 0 to Day 20 Related SAEs	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 21-179

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=375 Participants Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.	Fluarix Elderly Group n=393 Participants Subjects aged ≥66 years received one dose of Fluarix vaccine.	Fluarix Young Group n=203 Participants Subjects aged 19-43 years received one dose of Fluarix vaccine.
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179 Any MAE(s)	89 Participants	111 Participants	55 Participants
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179 Grade 3 MAE(s)	22 Participants	26 Participants	14 Participants
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit (MAEs) Between Day 21 and Day 179 Related MAE(s)	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 21-364.

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

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 grade, grade 3 was defined as a symptom that prevented normal activity and related was a general symptom assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=375 Participants Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.	Fluarix Elderly Group n=393 Participants Subjects aged ≥66 years received one dose of Fluarix vaccine.	Fluarix Young Group n=203 Participants Subjects aged 19-43 years received one dose of Fluarix vaccine.
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364 Any AESI	2 Participants	0 Participants	0 Participants
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364 Grade 3 AESI	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Diseases Between Day 21 and Day 364 Related AESI	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 0-21

Population: Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.

Antibody titers were expressed as Geometric mean titres (GMTs) per separate vaccine strain. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=368 Participants Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.	Fluarix Elderly Group n=375 Participants Subjects aged ≥66 years received one dose of Fluarix vaccine.	Fluarix Young Group n=194 Participants Subjects aged 19-43 years received one dose of Fluarix vaccine.
Haemagglutination Inhibition (HI) Antibody Titers A/Brisbane strain at Day 0	28.5 titer Interval 25.7 to 31.5	22.9 titer Interval 20.7 to 25.3	52.8 titer Interval 44.6 to 62.5
Haemagglutination Inhibition (HI) Antibody Titers A/Brisbane strain at Day 21	70.8 titer Interval 64.7 to 77.4	51.9 titer Interval 47.0 to 57.2	112.5 titer Interval 98.4 to 128.5
Haemagglutination Inhibition (HI) Antibody Titers A/Uruguay strain at Day 0	48.9 titer Interval 43.5 to 54.8	29.2 titer Interval 25.7 to 33.1	29.2 titer Interval 25.1 to 34.0
Haemagglutination Inhibition (HI) Antibody Titers A/Uruguay strain at Day 21	331.3 titer Interval 296.7 to 370.0	149.2 titer Interval 131.1 to 169.9	161.7 titer Interval 137.8 to 189.8
Haemagglutination Inhibition (HI) Antibody Titers B/Brisbane strain at Day 0	169.1 titer Interval 153.2 to 186.7	157.4 titer Interval 143.2 to 173.1	196.4 titer Interval 167.3 to 230.5
Haemagglutination Inhibition (HI) Antibody Titers B/Brisbane strain at Day 21	576.5 titer Interval 526.5 to 631.1	463.5 titer Interval 422.0 to 509.1	765.2 titer Interval 682.3 to 858.1

SECONDARY outcome

Timeframe: Day 0-21

Population: Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.

A seropositive subject was defined as a subject with antibody titer greater than or equal to the cut-off value i.e ≥ 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=368 Participants Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.	Fluarix Elderly Group n=375 Participants Subjects aged ≥66 years received one dose of Fluarix vaccine.	Fluarix Young Group n=194 Participants Subjects aged 19-43 years received one dose of Fluarix vaccine.
The Number of Subjects Seropositive to HI Antibodies A/Brisbane strain at Day 21	364 Participants	366 Participants	193 Participants
The Number of Subjects Seropositive to HI Antibodies A/Uruguay strain at Day 0	344 Participants	320 Participants	167 Participants
The Number of Subjects Seropositive to HI Antibodies A/Uruguay strain at Day 21	368 Participants	368 Participants	191 Participants
The Number of Subjects Seropositive to HI Antibodies B/Brisbane strain at Day 0	366 Participants	374 Participants	192 Participants
The Number of Subjects Seropositive to HI Antibodies B/Brisbane strain at Day 21	368 Participants	375 Participants	194 Participants
The Number of Subjects Seropositive to HI Antibodies A/Brisbane strain at Day 0	336 Participants	315 Participants	186 Participants

SECONDARY outcome

Timeframe: Day 0-21

Population: Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.

A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=368 Participants Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.	Fluarix Elderly Group n=375 Participants Subjects aged ≥66 years received one dose of Fluarix vaccine.	Fluarix Young Group n=194 Participants Subjects aged 19-43 years received one dose of Fluarix vaccine.
The Number of Subjects Seroprotected by HI Antibodies A/Brisbane strain at Day 0	171 Participants	142 Participants	137 Participants
The Number of Subjects Seroprotected by HI Antibodies A/Brisbane strain at Day 21	314 Participants	276 Participants	179 Participants
The Number of Subjects Seroprotected by HI Antibodies A/Uruguay strain at Day 0	247 Participants	178 Participants	102 Participants
The Number of Subjects Seroprotected by HI Antibodies A/Uruguay strain at Day 21	361 Participants	341 Participants	181 Participants
The Number of Subjects Seroprotected by HI Antibodies B/Brisbane strain at Day 0	359 Participants	363 Participants	186 Participants
The Number of Subjects Seroprotected by HI Antibodies B/Brisbane strain at Day 21	368 Participants	375 Participants	194 Participants

SECONDARY outcome

Timeframe: At Day 21

Population: Analysis was performed on According-to-Protocol (ATP) Immunogenicity cohort. This cohort included all evaluable subjects for whom data concerning immunogenicity were available.

A seroconverted subject was defined as a subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=366 Participants Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.	Fluarix Elderly Group n=374 Participants Subjects aged ≥66 years received one dose of Fluarix vaccine.	Fluarix Young Group n=194 Participants Subjects aged 19-43 years received one dose of Fluarix vaccine.
The Number of Subjects Seroconverted to HI Antibodies A/Brisbane strain	107 Participants	94 Participants	54 Participants
The Number of Subjects Seroconverted to HI Antibodies A/Uruguay strain	285 Participants	228 Participants	124 Participants
The Number of Subjects Seroconverted to HI Antibodies B/Brisbane strain	168 Participants	140 Participants	104 Participants

SECONDARY outcome

Timeframe: At Day 21

Population: Analysis was performed on According-to-Protocol (ATP) immunogenicity cohort . The cohort included all evaluable subjects for whom data concerning immunogenicity at were available.

SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=366 Participants Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.	Fluarix Elderly Group n=374 Participants Subjects aged ≥66 years received one dose of Fluarix vaccine.	Fluarix Young Group n=194 Participants Subjects aged 19-43 years received one dose of Fluarix vaccine.
HI Antibody Seroconversion Factors (SCF) A/Brisbane strain	2.5 fold increase Interval 2.3 to 2.7	2.3 fold increase Interval 2.1 to 2.5	2.1 fold increase Interval 1.9 to 2.4
HI Antibody Seroconversion Factors (SCF) A/Uruguay strain	6.8 fold increase Interval 6.1 to 7.5	5.1 fold increase Interval 4.6 to 5.7	5.5 fold increase Interval 4.7 to 6.5
HI Antibody Seroconversion Factors (SCF) B/Brisbane strain	3.4 fold increase Interval 3.1 to 3.7	2.9 fold increase Interval 2.7 to 3.2	3.9 fold increase Interval 3.3 to 4.5

SECONDARY outcome

Timeframe: Day 21-364

Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.

Outcome measures

Outcome measures
Measure	New Generation Influenza Vaccine GSK2186877A Group n=375 Participants Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.	Fluarix Elderly Group n=393 Participants Subjects aged ≥66 years received one dose of Fluarix vaccine.	Fluarix Young Group n=203 Participants Subjects aged 19-43 years received one dose of Fluarix vaccine.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364 Any SAE(s)	40 Participants	43 Participants	4 Participants
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 21 to Day 364 Related SAE(s)	0 Participants	0 Participants	0 Participants

Adverse Events

New Generation Influenza Vaccine GSK2186877A Group

Serious events: 40 serious events

Other events: 218 other events

Deaths: 0 deaths

Fluarix Elderly Group

Serious events: 43 serious events

Other events: 109 other events

Deaths: 0 deaths

Fluarix Young Group

Serious events: 4 serious events

Other events: 133 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	New Generation Influenza Vaccine GSK2186877A Group n=375 participants at risk Subjects aged ≥66 years received one dose of New generation influenza vaccine GSK2186877A.	Fluarix Elderly Group n=393 participants at risk Subjects aged ≥66 years received one dose of Fluarix vaccine.	Fluarix Young Group n=203 participants at risk Subjects aged 19-43 years received one dose of Fluarix vaccine.
General disorders Pain	42.4% 159/375 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	12.5% 49/393 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	60.1% 122/203 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Redness	15.2% 57/375 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	2.5% 10/393 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	4.4% 9/203 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Swelling	6.1% 23/375 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	1.5% 6/393 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	3.4% 7/203 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Arthralgia	11.7% 44/375 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	5.1% 20/393 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	5.4% 11/203 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Fatigue	19.2% 72/375 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	9.4% 37/393 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	19.2% 39/203 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Gastrointestinal symptoms	6.9% 26/375 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	4.6% 18/393 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	4.4% 9/203 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Headache	14.4% 54/375 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	9.7% 38/393 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	15.3% 31/203 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Myalgia	18.1% 68/375 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	8.4% 33/393 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	17.7% 36/203 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Shivering	8.5% 32/375 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	4.1% 16/393 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	4.9% 10/203 • Serious adverse events were assessed from Day 0 to 20 and from Day 21 to 364. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post-vaccination period respectively. For the frequent adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER