Trial Outcomes & Findings for Safety & Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A (NCT NCT00920218)
NCT ID: NCT00920218
Last Updated: 2017-12-12
Results Overview
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
During the 7-days (Days 0-6) post-vaccination period following each dose and across doses
Results posted on
2017-12-12
Participant Flow
Serological evidence of prior Varicella-Zoster Virus infection for those born in 1980 or later and for those born outside the US before 1980 in a tropical or sub-tropical region was required. All subjects were to have undergone autologous hematopoietic stem cell transplantation (HCT) within the past 50-70 days; and had no additional HCTs planned.
Out of the 121 subjects enrolled into this study, 1 subject was eliminated due to not receiving study vaccination and hence only 120 subjects started.
Participant milestones
| Measure |
GSK 1437173A F1 Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
Placebo-GSK 1437173A F1 Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
Placebo Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
31
|
30
|
|
Overall Study
COMPLETED
|
28
|
24
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
8
|
7
|
Reasons for withdrawal
| Measure |
GSK 1437173A F1 Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
Placebo-GSK 1437173A F1 Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
Placebo Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|
|
Overall Study
Serious Adverse Event
|
2
|
0
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
2
|
0
|
|
Overall Study
Migrated/moved from study area
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
3
|
|
Overall Study
Transplant failed/malignancy recurrence
|
0
|
1
|
2
|
3
|
|
Overall Study
Other
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety & Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A
Baseline characteristics by cohort
| Measure |
GSK 1437173A F1 Group
n=30 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=29 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
Placebo-GSK 1437173A F1 Group
n=31 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
Placebo Group
n=30 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.1 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
56.0 Years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
57.8 Years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
57.3 Years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
56.1 Years
STANDARD_DEVIATION 10.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African Heritage/African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian-Central/South Asian Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian-East Asian Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian-Japanese Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White-Arabic/North African Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White-Caucasian/European Heritage
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: During the 7-days (Days 0-6) post-vaccination period following each dose and across dosesPopulation: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=30 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=29 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=28 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=30 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
n=30 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1
|
25 Participants
|
19 Participants
|
22 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 1
|
2 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1
|
1 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2
|
24 Participants
|
19 Participants
|
22 Participants
|
—
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 2
|
2 Participants
|
2 Participants
|
7 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 3
|
1 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 3
|
6 Participants
|
4 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 3
|
4 Participants
|
1 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Across Doses
|
27 Participants
|
22 Participants
|
24 Participants
|
4 Participants
|
7 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Across Doses
|
3 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Across Doses
|
6 Participants
|
7 Participants
|
7 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Across Doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Across Doses
|
6 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Across Doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 3
|
24 Participants
|
15 Participants
|
—
|
—
|
4 Participants
|
PRIMARY outcome
Timeframe: During the 7-days (Days 0-6) post-vaccination period following each dose and across dosesPopulation: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms \[including nausea, vomiting, diarrhoea and abdominal pain\], temperature \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache and myalgia. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=30 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=29 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=28 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=30 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
n=30 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 1
|
13 Participants
|
11 Participants
|
12 Participants
|
15 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 1
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 1
|
5 Participants
|
7 Participants
|
8 Participants
|
6 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastr. sympt., Dose 1
|
6 Participants
|
4 Participants
|
1 Participants
|
9 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastr. sympt., Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastr. sympt., Dose 1
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 1
|
4 Participants
|
1 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 1
|
3 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 1
|
14 Participants
|
12 Participants
|
13 Participants
|
9 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 1
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 1
|
12 Participants
|
9 Participants
|
10 Participants
|
6 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 1
|
3 Participants
|
3 Participants
|
5 Participants
|
7 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 1
|
3 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 2
|
10 Participants
|
8 Participants
|
16 Participants
|
—
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 2
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 2
|
7 Participants
|
3 Participants
|
10 Participants
|
—
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastr. sympt., Dose 2
|
2 Participants
|
2 Participants
|
6 Participants
|
—
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastr. sympt., Dose 2
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastr. sympt., Dose 2
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 2
|
7 Participants
|
1 Participants
|
6 Participants
|
—
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 2
|
4 Participants
|
0 Participants
|
4 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 2
|
13 Participants
|
13 Participants
|
19 Participants
|
—
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 2
|
12 Participants
|
11 Participants
|
12 Participants
|
—
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 2
|
10 Participants
|
4 Participants
|
4 Participants
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 2
|
8 Participants
|
3 Participants
|
4 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 3
|
15 Participants
|
10 Participants
|
—
|
—
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 3
|
3 Participants
|
0 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 3
|
9 Participants
|
8 Participants
|
—
|
—
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastr. sympt., Dose 3
|
4 Participants
|
3 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 3
|
2 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 3
|
9 Participants
|
1 Participants
|
—
|
—
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 3
|
18 Participants
|
7 Participants
|
—
|
—
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 3
|
4 Participants
|
0 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 3
|
14 Participants
|
7 Participants
|
—
|
—
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 3
|
6 Participants
|
3 Participants
|
—
|
—
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 3
|
1 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 3
|
6 Participants
|
3 Participants
|
—
|
—
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Across Doses
|
18 Participants
|
18 Participants
|
20 Participants
|
15 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Across Doses
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Across Doses
|
11 Participants
|
11 Participants
|
14 Participants
|
6 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastr. sympt., Across Doses
|
10 Participants
|
7 Participants
|
6 Participants
|
9 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastr. sympt., Across Doses
|
7 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Across Doses
|
13 Participants
|
3 Participants
|
9 Participants
|
7 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Across Doses
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Across Doses
|
19 Participants
|
15 Participants
|
16 Participants
|
6 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Across Doses
|
12 Participants
|
8 Participants
|
8 Participants
|
7 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Across Doses
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Across Doses
|
10 Participants
|
7 Participants
|
7 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 2
|
4 Participants
|
2 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastr. sympt., Dose 3
|
9 Participants
|
5 Participants
|
—
|
—
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastr. sympt., Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 3
|
12 Participants
|
1 Participants
|
—
|
—
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastr. sympt., Across Doses
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 2
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Across Doses
|
9 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Across Doses
|
21 Participants
|
18 Participants
|
22 Participants
|
9 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Across Doses
|
8 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: During the 30-day (Days 0-29) post-vaccination periodPopulation: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities.
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=30 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=29 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=29 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=31 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
n=30 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs)
Any AEs
|
25 Participants
|
23 Participants
|
22 Participants
|
16 Participants
|
21 Participants
|
|
Number of Subjects With Any and Grade 3 Unsolicited Adverse Events (AEs)
Grade 3 AEs
|
5 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Any time during the study up to Day 29 after the last vaccinationPopulation: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=30 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=29 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=29 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=31 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
n=30 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
3 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: During the entire study period (from Day 0 up to Month 15)Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=30 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=29 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=31 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=30 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
6 Participants
|
9 Participants
|
10 Participants
|
8 Participants
|
—
|
PRIMARY outcome
Timeframe: Within the 30-day (Days 0-29) post last vaccination periodPopulation: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Any new onset of autoimmune diseases and immune mediated inflammatory disorders were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=30 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=29 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=31 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=30 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: During the entire study period (from Day 0 to Month 15)Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Any new onset of autoimmune diseases and immune mediated inflammatory disorders were to be reported throughout the entire study period, whether or not they were considered to be possibly related to the treatment administration. These included neurological/demyelinating events, rheumatic and connective diseases, autoimmune endocrine diseases, inflammatory bowel diseases, autoimmune blood disorders, inflammatory skin disorders, other autoimmune/inflammatory events, autoimmune bullous skin diseases, vasculitis and liver autoimmune diseases.
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=30 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=29 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=31 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=30 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs) and Other Immune Mediated Inflammatory Disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: At Month 0Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=30 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=29 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=31 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=30 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
ALT · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
ALT · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
ALT · Normal
|
28 Participants
|
29 Participants
|
31 Participants
|
29 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CAL · Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CAL · Below
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CAL · Normal
|
30 Participants
|
27 Participants
|
29 Participants
|
26 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CAL · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CREA · Below
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CREA · Normal
|
28 Participants
|
25 Participants
|
27 Participants
|
27 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
EOS · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
EOS · Below
|
5 Participants
|
1 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
EOS · Above
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
FIBR · Normal
|
25 Participants
|
22 Participants
|
21 Participants
|
24 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HGB · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HGB · Below
|
22 Participants
|
22 Participants
|
27 Participants
|
23 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HGB · Normal
|
8 Participants
|
7 Participants
|
4 Participants
|
6 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HCT · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HCT · Below
|
23 Participants
|
21 Participants
|
27 Participants
|
25 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HCT · Normal
|
7 Participants
|
7 Participants
|
4 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LDH · Normal
|
28 Participants
|
28 Participants
|
29 Participants
|
27 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LDH · Above
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LYM · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LYM · Normal
|
19 Participants
|
15 Participants
|
23 Participants
|
19 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
MON · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
NEU · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
NEU · Below
|
4 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
NEU · Normal
|
26 Participants
|
25 Participants
|
23 Participants
|
26 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
NEU · Above
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PLAT · Below
|
2 Participants
|
6 Participants
|
6 Participants
|
10 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PLAT · Normal
|
28 Participants
|
23 Participants
|
25 Participants
|
19 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PT · Normal
|
27 Participants
|
28 Participants
|
30 Participants
|
25 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PTT · Unknown
|
2 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PTT · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PTT · Normal
|
27 Participants
|
24 Participants
|
27 Participants
|
22 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PTT · Above
|
1 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
RBC · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
TP · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
TP · Below
|
5 Participants
|
3 Participants
|
8 Participants
|
7 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
WBC · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
WBC · Below
|
9 Participants
|
8 Participants
|
9 Participants
|
6 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
WBC · Normal
|
21 Participants
|
20 Participants
|
20 Participants
|
22 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
WBC · Above
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
ALT · Above
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
AST · Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
AST · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
AST · Normal
|
29 Participants
|
29 Participants
|
29 Participants
|
28 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
AST · Above
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
BAS · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
BAS · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
BAS · Normal
|
30 Participants
|
29 Participants
|
31 Participants
|
29 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
BAS · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CREA · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CREA · Above
|
1 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
EOS · Normal
|
24 Participants
|
28 Participants
|
23 Participants
|
21 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
FIBR · Unknown
|
2 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
FIBR · Below
|
3 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
FIBR · Above
|
0 Participants
|
7 Participants
|
4 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HGB · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HCT · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LDH · Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LDH · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LYM · Below
|
11 Participants
|
14 Participants
|
6 Participants
|
9 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LYM · Above
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
MON · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
MON · Below
|
3 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
MON · Normal
|
27 Participants
|
25 Participants
|
30 Participants
|
27 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PLAT · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PLAT · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PT · Unknown
|
2 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PT · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PT · Above
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
RBC · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
RBC · Below
|
24 Participants
|
25 Participants
|
29 Participants
|
26 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
RBC · Normal
|
6 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
TP · Normal
|
25 Participants
|
26 Participants
|
23 Participants
|
23 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
TP · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: At Month 1Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=30 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=29 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=30 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=30 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
EOS · Below
|
7 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
EOS · Normal
|
23 Participants
|
22 Participants
|
19 Participants
|
22 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
ALT · Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
ALT · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
ALT · Normal
|
26 Participants
|
28 Participants
|
29 Participants
|
27 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
ALT · Above
|
4 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
AST · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
AST · Normal
|
25 Participants
|
29 Participants
|
29 Participants
|
27 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
AST · Above
|
5 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
BAS · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
BAS · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
BAS · Normal
|
30 Participants
|
28 Participants
|
29 Participants
|
30 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
BAS · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CAL · Below
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CAL · Normal
|
29 Participants
|
26 Participants
|
29 Participants
|
28 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CAL · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CREA · Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CREA · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CREA · Normal
|
29 Participants
|
27 Participants
|
26 Participants
|
27 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CREA · Above
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
EOS · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
EOS · Above
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
FIBR · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
FIBR · Below
|
3 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
FIBR · Normal
|
24 Participants
|
20 Participants
|
26 Participants
|
22 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
FIBR · Above
|
3 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HGB · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HGB · Below
|
19 Participants
|
18 Participants
|
23 Participants
|
25 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HGB · Normal
|
11 Participants
|
10 Participants
|
6 Participants
|
5 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HGB · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HCT · Below
|
22 Participants
|
19 Participants
|
24 Participants
|
25 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HCT · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LDH · Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LDH · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LDH · Normal
|
30 Participants
|
28 Participants
|
29 Participants
|
27 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LYM · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LYM · Normal
|
19 Participants
|
15 Participants
|
21 Participants
|
21 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
MON · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
MON · Below
|
8 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
MON · Normal
|
22 Participants
|
22 Participants
|
27 Participants
|
25 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
NEU · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PLAT · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PLAT · Below
|
5 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PLAT · Normal
|
25 Participants
|
24 Participants
|
24 Participants
|
22 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PLAT · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PT · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PT · Normal
|
28 Participants
|
25 Participants
|
29 Participants
|
28 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PTT · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PTT · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PTT · Normal
|
26 Participants
|
23 Participants
|
26 Participants
|
26 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
RBC · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
RBC · Below
|
24 Participants
|
24 Participants
|
25 Participants
|
29 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
RBC · Normal
|
6 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
RBC · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
TP · Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
TP · Normal
|
27 Participants
|
27 Participants
|
23 Participants
|
24 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
TP · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
WBC · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
WBC · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
AST · Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CAL · Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HCT · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HCT · Normal
|
8 Participants
|
9 Participants
|
5 Participants
|
5 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LDH · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LYM · Below
|
11 Participants
|
13 Participants
|
8 Participants
|
9 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LYM · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
MON · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
NEU · Unknown
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
NEU · Below
|
6 Participants
|
9 Participants
|
5 Participants
|
6 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
NEU · Normal
|
24 Participants
|
19 Participants
|
24 Participants
|
23 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PT · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PT · Above
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PTT · Above
|
4 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
TP · Below
|
3 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
WBC · Below
|
13 Participants
|
10 Participants
|
8 Participants
|
13 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
WBC · Normal
|
17 Participants
|
17 Participants
|
21 Participants
|
16 Participants
|
—
|
PRIMARY outcome
Timeframe: At Month 2Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=30 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=28 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=29 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=28 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
MON · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
ALT · Unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
ALT · Normal
|
26 Participants
|
26 Participants
|
29 Participants
|
24 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
ALT · Above
|
3 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
AST · Unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
AST · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
AST · Above
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
BAS · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
BAS · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
BAS · Normal
|
29 Participants
|
28 Participants
|
29 Participants
|
27 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
BAS · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CAL · Unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CAL · Normal
|
27 Participants
|
26 Participants
|
28 Participants
|
27 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CREA · Unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CREA · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CREA · Normal
|
28 Participants
|
25 Participants
|
26 Participants
|
25 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CREA · Above
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
EOS · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
EOS · Below
|
7 Participants
|
7 Participants
|
5 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
EOS · Normal
|
21 Participants
|
21 Participants
|
22 Participants
|
25 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
EOS · Above
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
FIBR · Normal
|
23 Participants
|
24 Participants
|
23 Participants
|
21 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
FIBR · Above
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HGB · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HGB · Below
|
17 Participants
|
15 Participants
|
20 Participants
|
19 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HGB · Normal
|
12 Participants
|
13 Participants
|
9 Participants
|
8 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HGB · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HCT · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HCT · Normal
|
9 Participants
|
10 Participants
|
8 Participants
|
6 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HCT · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LDH · Unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LDH · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LDH · Normal
|
28 Participants
|
24 Participants
|
29 Participants
|
26 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LYM · Below
|
10 Participants
|
14 Participants
|
4 Participants
|
5 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LYM · Normal
|
19 Participants
|
14 Participants
|
25 Participants
|
22 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LYM · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
MON · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
MON · Below
|
4 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
MON · Normal
|
24 Participants
|
23 Participants
|
27 Participants
|
22 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
NEU · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
NEU · Below
|
6 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
NEU · Normal
|
23 Participants
|
23 Participants
|
23 Participants
|
24 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PLAT · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PLAT · Below
|
3 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PLAT · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PT · Unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PTT · Unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PTT · Below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PTT · Normal
|
23 Participants
|
22 Participants
|
24 Participants
|
25 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
RBC · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
RBC · Below
|
22 Participants
|
19 Participants
|
24 Participants
|
22 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
RBC · Normal
|
7 Participants
|
9 Participants
|
5 Participants
|
5 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
RBC · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
TP · Unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
TP · Normal
|
27 Participants
|
26 Participants
|
25 Participants
|
25 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
TP · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
WBC · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
WBC · Below
|
9 Participants
|
9 Participants
|
7 Participants
|
6 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
WBC · Normal
|
20 Participants
|
18 Participants
|
22 Participants
|
21 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
WBC · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
ALT · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
AST · Normal
|
28 Participants
|
26 Participants
|
29 Participants
|
26 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CAL · Below
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CAL · Above
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
FIBR · Unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
FIBR · Below
|
4 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HCT · Below
|
20 Participants
|
18 Participants
|
21 Participants
|
21 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LDH · Above
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LYM · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
NEU · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PLAT · Normal
|
26 Participants
|
24 Participants
|
24 Participants
|
20 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PT · Below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PT · Normal
|
27 Participants
|
25 Participants
|
28 Participants
|
26 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PT · Above
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PTT · Above
|
6 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
TP · Below
|
2 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: At Month 3Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=28 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=27 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=28 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=29 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HGB · Normal
|
14 Participants
|
13 Participants
|
14 Participants
|
10 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HGB · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PTT · Normal
|
20 Participants
|
23 Participants
|
22 Participants
|
25 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
RBC · Below
|
15 Participants
|
17 Participants
|
22 Participants
|
24 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
RBC · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
WBC · Unknown
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
WBC · Below
|
8 Participants
|
9 Participants
|
7 Participants
|
7 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
WBC · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
ALT · Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
ALT · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
ALT · Above
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
AST · Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
AST · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
AST · Normal
|
27 Participants
|
26 Participants
|
27 Participants
|
28 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
AST · Above
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
BAS · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CAL · Below
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CAL · Normal
|
27 Participants
|
27 Participants
|
26 Participants
|
26 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CAL · Above
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CREA · Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CREA · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CREA · Normal
|
28 Participants
|
25 Participants
|
24 Participants
|
26 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CREA · Above
|
0 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
EOS · Unknown
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
EOS · Below
|
4 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
EOS · Normal
|
20 Participants
|
21 Participants
|
22 Participants
|
20 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
FIBR · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HGB · Unknown
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HCT · Unknown
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HCT · Below
|
13 Participants
|
15 Participants
|
20 Participants
|
18 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HCT · Normal
|
12 Participants
|
11 Participants
|
8 Participants
|
10 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HCT · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LDH · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LDH · Normal
|
28 Participants
|
27 Participants
|
27 Participants
|
27 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LYM · Unknown
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LYM · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LYM · Below
|
9 Participants
|
13 Participants
|
7 Participants
|
10 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LYM · Normal
|
16 Participants
|
13 Participants
|
21 Participants
|
18 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
MON · Unknown
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
MON · Below
|
2 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
MON · Normal
|
23 Participants
|
20 Participants
|
26 Participants
|
23 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
NEU · Unknown
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
NEU · Below
|
3 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
NEU · Above
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PLAT · Unknown
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PLAT · Below
|
2 Participants
|
3 Participants
|
5 Participants
|
8 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PLAT · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
TP · Normal
|
26 Participants
|
24 Participants
|
24 Participants
|
24 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PT · Below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PTT · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PTT · Below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PTT · Above
|
7 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
TP · Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
TP · Below
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
RBC · Unknown
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
RBC · Normal
|
10 Participants
|
9 Participants
|
6 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
TP · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
WBC · Normal
|
16 Participants
|
17 Participants
|
21 Participants
|
21 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
EOS · Above
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
FIBR · Below
|
1 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
FIBR · Normal
|
20 Participants
|
21 Participants
|
21 Participants
|
24 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
FIBR · Above
|
6 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HGB · Below
|
11 Participants
|
13 Participants
|
14 Participants
|
18 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
ALT · Normal
|
25 Participants
|
26 Participants
|
27 Participants
|
27 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
BAS · Unknown
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
BAS · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
BAS · Normal
|
25 Participants
|
26 Participants
|
28 Participants
|
27 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CAL · Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LDH · Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LDH · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
MON · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
NEU · Normal
|
21 Participants
|
21 Participants
|
22 Participants
|
23 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PLAT · Normal
|
23 Participants
|
22 Participants
|
23 Participants
|
20 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PT · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PT · Normal
|
25 Participants
|
25 Participants
|
27 Participants
|
27 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PT · Above
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: At Month 4Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Hematological and biochemical parameters assessed were Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Calcium (CAL), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hemoglobin (HGB), Hematocrit (HCT), Lactate Dehydrogenase (LDH), Lymphocytes (LYM), Monocytes (MON), Neutrophils (NEU), Platelets (PLAT), Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Red Blood Cells (RBC), Total Protein (TP) and White Blood Cells (WBC).
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=29 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=26 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=27 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=26 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
ALT · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
ALT · Normal
|
26 Participants
|
26 Participants
|
27 Participants
|
25 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
AST · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
BAS · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
BAS · Normal
|
28 Participants
|
26 Participants
|
27 Participants
|
26 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CAL · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CAL · Below
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CREA · Above
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
NEU · Below
|
4 Participants
|
2 Participants
|
7 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PLAT · Normal
|
25 Participants
|
21 Participants
|
21 Participants
|
17 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PLAT · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PT · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
ALT · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
ALT · Above
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
AST · Unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
AST · Normal
|
28 Participants
|
25 Participants
|
27 Participants
|
24 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
AST · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
BAS · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
BAS · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CAL · Normal
|
25 Participants
|
26 Participants
|
27 Participants
|
25 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CAL · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CREA · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CREA · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
CREA · Normal
|
27 Participants
|
23 Participants
|
25 Participants
|
25 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
EOS · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
EOS · Below
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
EOS · Normal
|
24 Participants
|
21 Participants
|
23 Participants
|
22 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
EOS · Above
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
FIBR · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
FIBR · Below
|
4 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
FIBR · Normal
|
16 Participants
|
19 Participants
|
22 Participants
|
22 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
FIBR · Above
|
9 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HGB · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HGB · Below
|
17 Participants
|
11 Participants
|
14 Participants
|
20 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HGB · Normal
|
12 Participants
|
15 Participants
|
13 Participants
|
6 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HGB · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HCT · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HCT · Below
|
18 Participants
|
14 Participants
|
17 Participants
|
20 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HCT · Normal
|
11 Participants
|
12 Participants
|
10 Participants
|
6 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
HCT · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LDH · Unknown
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LDH · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LDH · Normal
|
26 Participants
|
24 Participants
|
26 Participants
|
25 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LDH · Above
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LYM · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LYM · Below
|
7 Participants
|
10 Participants
|
9 Participants
|
6 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LYM · Normal
|
21 Participants
|
16 Participants
|
18 Participants
|
19 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
LYM · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
MON · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
MON · Below
|
6 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
MON · Normal
|
22 Participants
|
24 Participants
|
23 Participants
|
21 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
MON · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
NEU · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
NEU · Normal
|
23 Participants
|
24 Participants
|
20 Participants
|
22 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
NEU · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PLAT · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PLAT · Below
|
4 Participants
|
5 Participants
|
6 Participants
|
9 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
RBC · Normal
|
8 Participants
|
11 Participants
|
4 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PT · Below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PT · Normal
|
27 Participants
|
23 Participants
|
26 Participants
|
23 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PT · Above
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PTT · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
RBC · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
TP · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
TP · Below
|
3 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
RBC · Below
|
21 Participants
|
15 Participants
|
23 Participants
|
23 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
TP · Normal
|
25 Participants
|
25 Participants
|
26 Participants
|
23 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
TP · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PTT · Below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PTT · Normal
|
27 Participants
|
22 Participants
|
20 Participants
|
20 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
WBC · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
PTT · Above
|
2 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
WBC · Below
|
8 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
WBC · Normal
|
19 Participants
|
19 Participants
|
19 Participants
|
16 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
RBC · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Hematological and Biochemical Parameters With Respect to Normal Laboratory Ranges
WBC · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: At Month 4Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.
The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma \[IFN-γ\], Interleukin 2 \[IL-2\], Tumour Necrosis Factor alpha \[TNF-α\] and/or CD40 Ligand \[CD40L\] as determined by in vitro intracellular cytokine staining (ICS).
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=27 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=25 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=22 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=23 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines
|
11963.56 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 11655.09
|
8114.83 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 9957.55
|
6974.97 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 10437.53
|
96.15 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 108.08
|
—
|
PRIMARY outcome
Timeframe: At Month 4Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=29 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=26 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=27 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=26 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
Anti-glycoprotein E (Anti-gE) Geometric Mean Antibody Concentrations
|
29192.9 mIU/mL
Interval 11004.7 to 77442.1
|
22503.0 mIU/mL
Interval 8432.7 to 60050.2
|
11064.6 mIU/mL
Interval 4361.2 to 28071.8
|
406.0 mIU/mL
Interval 244.2 to 674.9
|
—
|
PRIMARY outcome
Timeframe: At Month 4Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=29 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=26 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=27 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=26 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
Anti-gE Mean Antibody Concentrations
|
131471.10 mIU/mL
Standard Deviation 169644.69
|
102106.14 mIU/mL
Standard Deviation 116349.94
|
63768.06 mIU/mL
Standard Deviation 100839.95
|
840.46 mIU/mL
Standard Deviation 1119.44
|
—
|
SECONDARY outcome
Timeframe: At Months 0, 1, 2, 3, 4 and 15Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.
The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma \[IFN-γ\], Interleukin 2 \[IL-2\], Tumour Necrosis Factor alpha \[TNF-α\] and/or CD40 Ligand \[CD40L\] as determined by in vitro intracellular cytokine staining (ICS).
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=28 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=27 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=28 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=24 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
Frequency of CD4 T-cells Specific for Varicella Zoster Virus (VZV) Antigens
At Month 4
|
5359.40 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 6486.90
|
4243.82 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 6216.73
|
4481.70 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 6761.94
|
279.35 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 246.06
|
—
|
|
Frequency of CD4 T-cells Specific for Varicella Zoster Virus (VZV) Antigens
At Month 0
|
356.11 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 519.79
|
449.31 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 637.09
|
343.90 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 381.20
|
273.91 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 280.07
|
—
|
|
Frequency of CD4 T-cells Specific for Varicella Zoster Virus (VZV) Antigens
At Month 1
|
636.10 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 886.14
|
1205.59 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 2680.05
|
303.70 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 383.32
|
486.97 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 652.18
|
—
|
|
Frequency of CD4 T-cells Specific for Varicella Zoster Virus (VZV) Antigens
At Month 15
|
3104.65 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 3543.66
|
3298.68 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 4326.74
|
2669.66 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 3121.01
|
320.39 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 337.72
|
—
|
|
Frequency of CD4 T-cells Specific for Varicella Zoster Virus (VZV) Antigens
At Month 2
|
3818.03 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 3773.74
|
4466.98 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 7100.05
|
928.35 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 1773.80
|
249.91 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 243.82
|
—
|
|
Frequency of CD4 T-cells Specific for Varicella Zoster Virus (VZV) Antigens
At Month 3
|
3488.70 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 4130.59
|
3628.20 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 6682.51
|
887.86 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 1244.78
|
511.33 VZV specific CD4+ T-cells/million Tcells
Standard Deviation 909.03
|
—
|
SECONDARY outcome
Timeframe: At Months 0, 1, 2, 3 and 15Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.
The analysis focused on CD4 T-cells expressing at least 2 cytokines among Interferon gamma \[IFN-γ\], Interleukin 2 \[IL-2\], Tumour Necrosis Factor alpha \[TNF-α\] and/or CD40 Ligand \[CD40L\] as determined by in vitro intracellular cytokine staining (ICS).
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=30 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=29 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=28 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=27 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines
At Month 15
|
6865.36 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 6557.75
|
5900.24 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 7728.98
|
3859.68 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 4771.08
|
71.03 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 80.76
|
—
|
|
Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines
At Month 0
|
116.53 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 180.53
|
145.97 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 217.01
|
83.15 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 90.39
|
97.48 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 148.32
|
—
|
|
Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines
At Month 1
|
856.69 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 1551.94
|
1376.95 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 3358.49
|
91.84 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 118.22
|
133.85 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 204.90
|
—
|
|
Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines
At Month 2
|
8830.03 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 9745.11
|
9128.95 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 12539.86
|
1528.60 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 3204.39
|
124.53 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 160.24
|
—
|
|
Frequency of gE-specific Cluster of Differentiation 4 (CD4) T-cells Expressing at Least 2 Cytokines
At Month 3
|
7111.22 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 7755.09
|
8415.89 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 12235.84
|
827.83 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 1508.97
|
158.13 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 180.84
|
—
|
SECONDARY outcome
Timeframe: At Months 0, 1, 2, 3, 4 and 15Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.
Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=28 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=28 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=29 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=28 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
Varicella Zoster Virus (VZV)-Specific Geometric Mean Antibody Concentrations
At Month 0
|
570.1 mIU/mL
Interval 393.1 to 826.8
|
755.1 mIU/mL
Interval 479.2 to 1189.9
|
639.9 mIU/mL
Interval 397.5 to 1030.1
|
659.2 mIU/mL
Interval 496.9 to 874.4
|
—
|
|
Varicella Zoster Virus (VZV)-Specific Geometric Mean Antibody Concentrations
At Month 1
|
922.2 mIU/mL
Interval 575.6 to 1477.4
|
1017.3 mIU/mL
Interval 609.6 to 1697.7
|
562.4 mIU/mL
Interval 346.9 to 912.0
|
729.4 mIU/mL
Interval 512.0 to 1039.2
|
—
|
|
Varicella Zoster Virus (VZV)-Specific Geometric Mean Antibody Concentrations
At Month 2
|
4268.5 mIU/mL
Interval 2075.7 to 8777.9
|
4541.3 mIU/mL
Interval 2506.4 to 8228.2
|
702.4 mIU/mL
Interval 398.5 to 1238.0
|
523.5 mIU/mL
Interval 351.8 to 779.2
|
—
|
|
Varicella Zoster Virus (VZV)-Specific Geometric Mean Antibody Concentrations
At Month 3
|
3940.7 mIU/mL
Interval 1819.0 to 8537.5
|
4598.3 mIU/mL
Interval 2292.6 to 9222.8
|
558.2 mIU/mL
Interval 302.3 to 1030.6
|
632.7 mIU/mL
Interval 374.5 to 1068.8
|
—
|
|
Varicella Zoster Virus (VZV)-Specific Geometric Mean Antibody Concentrations
At Month 4
|
8484.1 mIU/mL
Interval 4190.6 to 17176.4
|
6223.4 mIU/mL
Interval 2893.7 to 13384.5
|
3196.6 mIU/mL
Interval 1532.2 to 6668.9
|
351.9 mIU/mL
Interval 207.9 to 595.7
|
—
|
|
Varicella Zoster Virus (VZV)-Specific Geometric Mean Antibody Concentrations
At Month 15
|
1946.5 mIU/mL
Interval 1013.4 to 3738.6
|
2598.2 mIU/mL
Interval 1327.4 to 5085.6
|
930.3 mIU/mL
Interval 390.1 to 2218.6
|
339.4 mIU/mL
Interval 159.0 to 724.1
|
—
|
SECONDARY outcome
Timeframe: At Months 0, 1, 2, 3, 4 and 15Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.
Concentrations are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=28 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=28 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=29 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=28 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
VZV-specific Mean Antibody Concentrations
At Month 4
|
23858.74 mIU/mL
Standard Deviation 31173.45
|
16752.32 mIU/mL
Standard Deviation 17738.95
|
10744.24 mIU/mL
Standard Deviation 17397.97
|
753.59 mIU/mL
Standard Deviation 1155.17
|
—
|
|
VZV-specific Mean Antibody Concentrations
At Month 0
|
968.22 mIU/mL
Standard Deviation 1466.46
|
1340.29 mIU/mL
Standard Deviation 1685.09
|
1304.22 mIU/mL
Standard Deviation 1866.32
|
843.07 mIU/mL
Standard Deviation 616.78
|
—
|
|
VZV-specific Mean Antibody Concentrations
At Month 1
|
1881.91 mIU/mL
Standard Deviation 2742.85
|
1957.16 mIU/mL
Standard Deviation 2438.00
|
1089.57 mIU/mL
Standard Deviation 1586.68
|
1158.99 mIU/mL
Standard Deviation 1407.26
|
—
|
|
VZV-specific Mean Antibody Concentrations
At Month 2
|
15155.95 mIU/mL
Standard Deviation 22198.03
|
10934.78 mIU/mL
Standard Deviation 13735.35
|
1506.49 mIU/mL
Standard Deviation 2120.19
|
911.09 mIU/mL
Standard Deviation 1211.24
|
—
|
|
VZV-specific Mean Antibody Concentrations
At Month 3
|
13342.90 mIU/mL
Standard Deviation 19278.57
|
12602.99 mIU/mL
Standard Deviation 18030.89
|
1227.40 mIU/mL
Standard Deviation 1794.62
|
2902.89 mIU/mL
Standard Deviation 10461.29
|
—
|
|
VZV-specific Mean Antibody Concentrations
At Month 15
|
4694.74 mIU/mL
Standard Deviation 5945.23
|
5482.75 mIU/mL
Standard Deviation 5769.88
|
2956.21 mIU/mL
Standard Deviation 4515.53
|
835.21 mIU/mL
Standard Deviation 947.65
|
—
|
SECONDARY outcome
Timeframe: At Months 0, 1, 2, 3 and 15Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=30 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=28 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=30 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=30 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
Anti-gE Geometric Mean Antibody Concentrations
At Month 1
|
1489.7 mIU/mL
Interval 847.3 to 2619.0
|
1288.1 mIU/mL
Interval 684.9 to 2422.5
|
376.1 mIU/mL
Interval 239.7 to 590.1
|
619.3 mIU/mL
Interval 424.2 to 904.0
|
—
|
|
Anti-gE Geometric Mean Antibody Concentrations
At Month 3
|
13412.9 mIU/mL
Interval 4967.1 to 36219.7
|
13385.4 mIU/mL
Interval 5506.5 to 32537.7
|
972.6 mIU/mL
Interval 520.6 to 1817.2
|
585.2 mIU/mL
Interval 310.0 to 1104.9
|
—
|
|
Anti-gE Geometric Mean Antibody Concentrations
At Month 0
|
531.2 mIU/mL
Interval 402.6 to 700.8
|
536.2 mIU/mL
Interval 304.0 to 945.7
|
448.0 mIU/mL
Interval 289.7 to 692.8
|
659.9 mIU/mL
Interval 470.5 to 925.4
|
—
|
|
Anti-gE Geometric Mean Antibody Concentrations
At Month 2
|
11963.0 mIU/mL
Interval 4739.4 to 30196.6
|
11628.8 mIU/mL
Interval 5196.6 to 26022.8
|
1047.8 mIU/mL
Interval 564.8 to 1943.9
|
520.2 mIU/mL
Interval 349.3 to 774.8
|
—
|
|
Anti-gE Geometric Mean Antibody Concentrations
At Month 15
|
8052.7 mIU/mL
Interval 3333.4 to 19453.7
|
9165.5 mIU/mL
Interval 3796.0 to 22130.1
|
2968.0 mIU/mL
Interval 1184.7 to 7436.1
|
362.3 mIU/mL
Interval 170.7 to 768.7
|
—
|
SECONDARY outcome
Timeframe: At Months 0, 1, 2, 3 and 15Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Only subjects with results available were included in this analysis.
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as mean concentrations, expressed in milli-international units per milliliter (mIU/mL).
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=30 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=28 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=30 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=30 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
Anti-gE Mean Antibody Concentrations
At Month 3
|
88592.39 mIU/mL
Standard Deviation 133279.24
|
62174.90 mIU/mL
Standard Deviation 94796.54
|
2739.11 mIU/mL
Standard Deviation 4458.45
|
8908.62 mIU/mL
Standard Deviation 42086.07
|
—
|
|
Anti-gE Mean Antibody Concentrations
At Month 0
|
683.78 mIU/mL
Standard Deviation 501.88
|
1366.94 mIU/mL
Standard Deviation 2510.90
|
763.58 mIU/mL
Standard Deviation 818.71
|
1025.07 mIU/mL
Standard Deviation 1177.35
|
—
|
|
Anti-gE Mean Antibody Concentrations
At Month 1
|
4435.62 mIU/mL
Standard Deviation 7776.94
|
3812.19 mIU/mL
Standard Deviation 7197.49
|
675.39 mIU/mL
Standard Deviation 776.37
|
1016.00 mIU/mL
Standard Deviation 1159.33
|
—
|
|
Anti-gE Mean Antibody Concentrations
At Month 2
|
76302.68 mIU/mL
Standard Deviation 118526.31
|
47344.49 mIU/mL
Standard Deviation 78643.10
|
2951.78 mIU/mL
Standard Deviation 4785.22
|
927.04 mIU/mL
Standard Deviation 1221.66
|
—
|
|
Anti-gE Mean Antibody Concentrations
At Month 15
|
42128.75 mIU/mL
Standard Deviation 66869.22
|
30938.91 mIU/mL
Standard Deviation 45130.79
|
16564.63 mIU/mL
Standard Deviation 30523.28
|
1091.74 mIU/mL
Standard Deviation 1585.07
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (from Day 0 to Month 15)Population: he analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
A suspected case of HZ could be confirmed by PCR and/or by clinical review of the GSK physician responsible for the study. Rash lesion samples collected from subjects clinically diagnosed as having a suspected case of HZ were tested by by polymerase chain reaction (PCR) using standardized and validated procedures for the laboratory diagnosis of HZ. If the PCR specimen was inadequate or was missing, suspected HZ cases were to be classified as 'a confirmed case of HZ' or 'not a case of HZ' based on the determination by the GSK responsible physician of the study.
Outcome measures
| Measure |
GSK 1437173A F1 Group
n=30 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=29 Participants
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A 2D Group
n=31 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following GSK 1437173A vaccine administration.
|
Placebo 1D Group
n=30 Participants
Subgroup of Placebo-GSK 1437173A F1 Group, results following placebo administration.
|
Placebo Group
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|---|
|
Number of Subjects With Confirmed Herpes Zoster (HZ) Cases
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
Adverse Events
GSK 1437173A F1 Group
Serious events: 6 serious events
Other events: 29 other events
Deaths: 3 deaths
GSK 1437173A F2 Group
Serious events: 9 serious events
Other events: 27 other events
Deaths: 1 deaths
Placebo-GSK 1437173A F1 Group
Serious events: 10 serious events
Other events: 29 other events
Deaths: 2 deaths
Placebo Group
Serious events: 8 serious events
Other events: 21 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
GSK 1437173A F1 Group
n=30 participants at risk
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=29 participants at risk
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
Placebo-GSK 1437173A F1 Group
n=31 participants at risk
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
Placebo Group
n=30 participants at risk
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.4%
1/29 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.2%
1/31 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.4%
1/29 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.2%
1/31 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
General disorders
Death
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
General disorders
Disease progression
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
General disorders
Multi-organ failure
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
General disorders
Oedema peripheral
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.2%
1/31 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
General disorders
Pyrexia
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.5%
2/31 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
General disorders
Sudden death
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.5%
2/31 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.4%
1/29 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.4%
1/29 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Infections and infestations
Device related infection
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.2%
1/31 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.4%
1/29 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.5%
2/31 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.7%
2/30 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.2%
1/31 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.2%
1/31 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.4%
1/29 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Infections and infestations
Viral infection
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.4%
1/29 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Injury, poisoning and procedural complications
Compression fracture
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.4%
1/29 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.4%
1/29 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.2%
1/31 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.2%
1/31 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.2%
1/31 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.2%
1/31 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.4%
1/29 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.5%
2/31 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peripheral t-cell lymphoma unspecified
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Nervous system disorders
Convulsion
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.2%
1/31 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.4%
1/29 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Renal and urinary disorders
Renal failure
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.4%
1/29 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.5%
2/31 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.2%
1/31 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.4%
1/29 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.4%
1/29 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.2%
1/31 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
Other adverse events
| Measure |
GSK 1437173A F1 Group
n=30 participants at risk
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
GSK 1437173A F2 Group
n=29 participants at risk
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 2 (F2) vaccine, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
Placebo-GSK 1437173A F1 Group
n=31 participants at risk
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 1 dose of the placebo followed by 2 doses of GSK 1437173A F1 vaccine. For some safety analyses, this Group was split into Placebo 1D Group (results following placebo administration) and GSK 1437173A 2D Group (results following HZV administration). All vaccines were administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
Placebo Group
n=30 participants at risk
Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of placebo, administered intramuscularly in the upper deltoid region of non-dominant arm according to a 0,1,3-months schedule.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
3/30 • Number of events 3 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.9%
2/29 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.9%
2/29 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.2%
1/31 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.5%
2/31 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
General disorders
Chills
|
6.7%
2/30 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.4%
1/29 • Number of events 3 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
12.9%
4/31 • Number of events 4 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
3/30 • Number of events 3 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
10.3%
3/29 • Number of events 3 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
9.7%
3/31 • Number of events 3 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
13.3%
4/30 • Number of events 5 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
2/30 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.4%
1/29 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.2%
1/31 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.9%
2/29 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.5%
2/31 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
20.0%
6/30 • Number of events 10 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
24.1%
7/29 • Number of events 12 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
22.6%
7/31 • Number of events 10 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
General disorders
Fatigue
|
60.0%
18/30 • Number of events 39 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
62.1%
18/29 • Number of events 30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
80.6%
25/31 • Number of events 44 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
33.3%
10/30 • Number of events 23 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
33.3%
10/30 • Number of events 17 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
24.1%
7/29 • Number of events 11 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
35.5%
11/31 • Number of events 16 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
13.3%
4/30 • Number of events 6 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Investigations
Haemoglobin decreased
|
6.7%
2/30 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.4%
1/29 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Nervous system disorders
Headache
|
43.3%
13/30 • Number of events 26 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
10.3%
3/29 • Number of events 3 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
38.7%
12/31 • Number of events 21 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
20.0%
6/30 • Number of events 8 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Vascular disorders
Hot flush
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.7%
2/30 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.7%
2/30 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.9%
2/29 • Number of events 3 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.2%
1/31 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.7%
2/30 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.9%
2/29 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.2%
1/31 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
70.0%
21/30 • Number of events 46 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
62.1%
18/29 • Number of events 32 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
74.2%
23/31 • Number of events 41 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
26.7%
8/30 • Number of events 13 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
3/30 • Number of events 4 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.4%
1/29 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.5%
2/31 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.5%
2/31 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.7%
2/30 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.4%
1/29 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.2%
1/31 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
General disorders
Oedema peripheral
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.2%
1/31 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.7%
2/30 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
5/30 • Number of events 6 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.4%
1/29 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.2%
1/31 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
10.0%
3/30 • Number of events 4 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
General disorders
Pain
|
90.0%
27/30 • Number of events 73 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
75.9%
22/29 • Number of events 53 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
77.4%
24/31 • Number of events 49 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
23.3%
7/30 • Number of events 11 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
2/30 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.9%
2/29 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.9%
2/29 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.5%
2/31 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
General disorders
Pyrexia
|
40.0%
12/30 • Number of events 19 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
31.0%
9/29 • Number of events 11 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
38.7%
12/31 • Number of events 17 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
13.3%
4/30 • Number of events 5 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
2/30 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.9%
2/29 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.5%
2/31 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Infections and infestations
Sinusitis
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
10.3%
3/29 • Number of events 3 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
General disorders
Swelling
|
20.0%
6/30 • Number of events 6 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
13.8%
4/29 • Number of events 5 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
12.9%
4/31 • Number of events 7 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.9%
2/29 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/31 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
2/30 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.4%
1/29 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
3.2%
1/31 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.7%
2/30 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/29 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
6.5%
2/31 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
0.00%
0/30 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 15).
|
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