Trial Outcomes & Findings for Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine for the Elderly (NCT NCT00938392)
NCT ID: NCT00938392
Last Updated: 2018-08-20
Results Overview
Titers are presented as Geometric Mean Titers. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
726 participants
Primary outcome timeframe
At Days 0 and 21
Results posted on
2018-08-20
Participant Flow
Two subjects enrolled in the study did not receive any vaccination, and as such are not accounted for as started.
Participant milestones
| Measure |
FluNG Aged Group
Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
|
FluNG Fresh Group
Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
|
|---|---|---|
|
Overall Study
STARTED
|
362
|
362
|
|
Overall Study
COMPLETED
|
360
|
358
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
FluNG Aged Group
Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
|
FluNG Fresh Group
Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine for the Elderly
Baseline characteristics by cohort
| Measure |
FluNG Aged Group
n=362 Participants
Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
|
FluNG Fresh Group
n=362 Participants
Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
|
Total
n=724 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.3 Years
STANDARD_DEVIATION 6.09 • n=5 Participants
|
73.5 Years
STANDARD_DEVIATION 6.36 • n=7 Participants
|
73.4 Years
STANDARD_DEVIATION 6.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
239 Participants
n=5 Participants
|
243 Participants
n=7 Participants
|
482 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Days 0 and 21Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.
Titers are presented as Geometric Mean Titers. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.
Outcome measures
| Measure |
FluNG Aged Group
n=357 Participants
Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
|
FluNG Fresh Group
n=355 Participants
Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
|
|---|---|---|
|
Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains
A/Brisbane [Day 21]
|
108.4 Titer
Interval 95.8 to 122.6
|
108.7 Titer
Interval 95.1 to 124.1
|
|
Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains
A/Uruguay [Day 0]
|
18.5 Titer
Interval 16.1 to 21.3
|
19.1 Titer
Interval 16.7 to 21.8
|
|
Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains
A/Uruguay [Day 21]
|
291.5 Titer
Interval 251.9 to 337.4
|
282.7 Titer
Interval 244.6 to 326.8
|
|
Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains
B/Brisbane [Day 0]
|
68.2 Titer
Interval 59.3 to 78.4
|
62.3 Titer
Interval 54.8 to 70.7
|
|
Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains
B/Brisbane [Day 21]
|
537.9 Titer
Interval 483.6 to 598.3
|
534.2 Titer
Interval 483.5 to 590.3
|
|
Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains
A/Brisbane [Day 0]
|
14.1 Titer
Interval 12.7 to 15.8
|
13.4 Titer
Interval 12.1 to 14.9
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.
A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.
Outcome measures
| Measure |
FluNG Aged Group
n=357 Participants
Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
|
FluNG Fresh Group
n=355 Participants
Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
|
|---|---|---|
|
Number of Subjects Seropositive Against the 3 Vaccine Strains
A/Uruguay [Day 0]
|
231 Participants
|
236 Participants
|
|
Number of Subjects Seropositive Against the 3 Vaccine Strains
A/Uruguay [Day 21]
|
353 Participants
|
353 Participants
|
|
Number of Subjects Seropositive Against the 3 Vaccine Strains
B/Brisbane [Day 0]
|
326 Participants
|
335 Participants
|
|
Number of Subjects Seropositive Against the 3 Vaccine Strains
A/Brisbane [Day 0]
|
224 Participants
|
220 Participants
|
|
Number of Subjects Seropositive Against the 3 Vaccine Strains
A/Brisbane [Day 21]
|
353 Participants
|
349 Participants
|
|
Number of Subjects Seropositive Against the 3 Vaccine Strains
B/Brisbane [Day 21]
|
357 Participants
|
355 Participants
|
SECONDARY outcome
Timeframe: At Day 21Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time points.
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane.
Outcome measures
| Measure |
FluNG Aged Group
n=356 Participants
Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
|
FluNG Fresh Group
n=355 Participants
Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
|
|---|---|---|
|
Number of Subjects Seroconverted for the 3 Vaccine Strains
A/Uruguay
|
292 Participants
|
292 Participants
|
|
Number of Subjects Seroconverted for the 3 Vaccine Strains
B/Brisbane
|
224 Participants
|
247 Participants
|
|
Number of Subjects Seroconverted for the 3 Vaccine Strains
A/Brisbane
|
228 Participants
|
227 Participants
|
SECONDARY outcome
Timeframe: At Day 21Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time points.
Seroconversion factor 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.
Outcome measures
| Measure |
FluNG Aged Group
n=356 Participants
Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
|
FluNG Fresh Group
n=355 Participants
Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
|
|---|---|---|
|
Seroconversion Factor for the 3 Vaccine Strains
A/Uruguay
|
15.8 Fold Increase
Interval 13.4 to 18.6
|
14.8 Fold Increase
Interval 12.7 to 17.3
|
|
Seroconversion Factor for the 3 Vaccine Strains
B/Brisbane
|
7.9 Fold Increase
Interval 6.8 to 9.3
|
8.6 Fold Increase
Interval 7.4 to 9.9
|
|
Seroconversion Factor for the 3 Vaccine Strains
A/Brisbane
|
7.7 Fold Increase
Interval 6.6 to 8.9
|
8.1 Fold Increase
Interval 6.9 to 9.5
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity including all evaluable subjects for whom data concerning immunogenicity outcome variable measures were available for the specific time point.
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.
Outcome measures
| Measure |
FluNG Aged Group
n=357 Participants
Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
|
FluNG Fresh Group
n=355 Participants
Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
|
|---|---|---|
|
Number of Subjects Seroprotected for the 3 Vaccine Strains
A/Brisbane [Day 0]
|
87 Participants
|
85 Participants
|
|
Number of Subjects Seroprotected for the 3 Vaccine Strains
A/Brisbane [Day 21]
|
318 Participants
|
308 Participants
|
|
Number of Subjects Seroprotected for the 3 Vaccine Strains
A/Uruguay [Day 0]
|
120 Participants
|
131 Participants
|
|
Number of Subjects Seroprotected for the 3 Vaccine Strains
A/Uruguay [Day 21]
|
338 Participants
|
337 Participants
|
|
Number of Subjects Seroprotected for the 3 Vaccine Strains
B/Brisbane [Day 0]
|
261 Participants
|
260 Participants
|
|
Number of Subjects Seroprotected for the 3 Vaccine Strains
B/Brisbane [Day 21]
|
357 Participants
|
355 Participants
|
SECONDARY outcome
Timeframe: During the 7-day post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects with their symptom sheet completed.
Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever \[oral temperature greater than or equal to 38 degrees Celsius (°C)\]. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter. Grade 3 fever: oral temperature greater than or equal to 39°C. Related: general symptom assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
FluNG Aged Group
n=360 Participants
Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
|
FluNG Fresh Group
n=360 Participants
Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
|
|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Swelling
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia
|
49 Participants
|
63 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Any Ecchymosis
|
9 Participants
|
11 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Any Pain
|
180 Participants
|
190 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Pain
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Any Redness
|
99 Participants
|
106 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Any Swelling
|
45 Participants
|
69 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Ecchymosis
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Redness
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia
|
28 Participants
|
44 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue
|
86 Participants
|
98 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue
|
68 Participants
|
80 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal symptoms
|
29 Participants
|
29 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal symptoms
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal symptoms
|
17 Participants
|
15 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Any Headache
|
66 Participants
|
82 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Related Headache
|
47 Participants
|
62 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Any Muscle aches
|
60 Participants
|
62 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Muscle aches
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Related Muscle aches
|
47 Participants
|
49 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Any Shivering
|
28 Participants
|
26 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Related Shivering
|
20 Participants
|
23 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Any Fever
|
6 Participants
|
9 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms
Related Fever
|
4 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: During the 7-day post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, on those subjects reporting the specific symptom only.
Local symptoms assessed include ecchymosis, pain, redness and swelling. General symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, muscle aches, shivering and fever. Duration is expressed as median number of days the specific symptom was experienced.
Outcome measures
| Measure |
FluNG Aged Group
n=180 Participants
Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
|
FluNG Fresh Group
n=190 Participants
Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
|
|---|---|---|
|
Duration of Solicited Local and General Symptoms
Ecchymosis
|
4.0 Days
Interval 1.0 to 6.0
|
4.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General Symptoms
Gastrointestinal symptoms
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General Symptoms
Headache
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General Symptoms
Muscle aches
|
3.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General Symptoms
Shivering
|
1.0 Days
Interval 1.0 to 4.0
|
1.5 Days
Interval 1.0 to 5.0
|
|
Duration of Solicited Local and General Symptoms
Fever
|
1.0 Days
Interval 1.0 to 1.0
|
1.0 Days
Interval 1.0 to 2.0
|
|
Duration of Solicited Local and General Symptoms
Pain
|
2.0 Days
Interval 1.0 to 7.0
|
3.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General Symptoms
Redness
|
3.0 Days
Interval 1.0 to 7.0
|
3.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General Symptoms
Swelling
|
3.0 Days
Interval 1.0 to 6.0
|
3.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General Symptoms
Arthralgia
|
4.0 Days
Interval 1.0 to 7.0
|
3.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicited Local and General Symptoms
Fatigue
|
2.5 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: During the 21-day post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects.
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Outcome measures
| Measure |
FluNG Aged Group
n=362 Participants
Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
|
FluNG Fresh Group
n=362 Participants
Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any AEs
|
13 Participants
|
24 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 AEs
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related AEs
|
5 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: During the 21-day post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects.
AESIs for safety monitoring included autoimmune diseases and other immune mediated inflammatory disorders.
Outcome measures
| Measure |
FluNG Aged Group
n=362 Participants
Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
|
FluNG Fresh Group
n=362 Participants
Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
|
|---|---|---|
|
Number of Subjects Reporting Adverse Events of Specific Interest (AESI)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (up to Day 21)Population: The analysis was performed on the Total Vaccinated Cohort including all vaccinated subjects.
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.
Outcome measures
| Measure |
FluNG Aged Group
n=362 Participants
Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
|
FluNG Fresh Group
n=362 Participants
Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
Any SAEs
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
Related SAEs
|
0 Participants
|
0 Participants
|
Adverse Events
FluNG Aged Group
Serious events: 1 serious events
Other events: 242 other events
Deaths: 0 deaths
FluNG Fresh Group
Serious events: 1 serious events
Other events: 252 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FluNG Aged Group
n=362 participants at risk
Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
|
FluNG Fresh Group
n=362 participants at risk
Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.28%
1/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
0.00%
0/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.28%
1/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
0.00%
0/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
0.28%
1/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
Other adverse events
| Measure |
FluNG Aged Group
n=362 participants at risk
Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
|
FluNG Fresh Group
n=362 participants at risk
Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
|
|---|---|---|
|
General disorders
Pain at the injection site
|
49.7%
180/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
52.5%
190/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
|
General disorders
Redness at the injection site
|
27.3%
99/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
29.3%
106/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
|
General disorders
Swelling at the injection site
|
12.4%
45/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
19.1%
69/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
|
General disorders
Arthralgia
|
13.5%
49/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
17.4%
63/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
|
General disorders
Fatigue
|
23.8%
86/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
27.1%
98/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
|
General disorders
Gastrointestinal symptoms
|
8.0%
29/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
8.0%
29/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
|
General disorders
Headache
|
18.2%
66/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
22.7%
82/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
|
General disorders
Muscle aches
|
16.6%
60/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
17.1%
62/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
|
General disorders
Shivering
|
7.7%
28/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
7.2%
26/362 • Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
|
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