Trial Outcomes & Findings for Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults 18 Years of Age or Older With Renal Transplant (NCT NCT02058589)
NCT ID: NCT02058589
Last Updated: 2018-08-01
Results Overview
Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination greater than or equal to (≥) 4 fold the cut-off for Anti-gE (4x97 milli-international units per milliliter \[mIU/ml\]); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. Vaccine response was determined by Enzyme-Linked ImmunoSorbent Assay (ELISA).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
265 participants
Primary outcome timeframe
At Month 2.
Results posted on
2018-08-01
Participant Flow
Out of 265 subjects originally enrolled in the study, only 264 subjects received vaccination and were hence included in the Total Vaccinated Cohort.
Participant milestones
| Measure |
GSK1437173A Group
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Control Group
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
Overall Study
STARTED
|
132
|
132
|
|
Overall Study
COMPLETED
|
130
|
130
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
GSK1437173A Group
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Control Group
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
Overall Study
Serious Adverse Event
|
1
|
1
|
|
Overall Study
Non-Serious Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults 18 Years of Age or Older With Renal Transplant
Baseline characteristics by cohort
| Measure |
GSK1437173A Group
n=132 Participants
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Control Group
n=132 Participants
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Total
n=264 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.3 Years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
52.4 Years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
52.4 Years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African Heritage / African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic / North African Heritage
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian / European Heritage
|
88 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unspecified
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Month 2.Population: The analysis was performed on the According-to-Protocol (ATP) cohort for humoral immunogenicity, which included all evaluable subjects up to Month 2, who did not meet any of the criteria for elimination from an ATP analysis, and for whom data concerning immunogenicity outcome measures were available.
Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination greater than or equal to (≥) 4 fold the cut-off for Anti-gE (4x97 milli-international units per milliliter \[mIU/ml\]); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. Vaccine response was determined by Enzyme-Linked ImmunoSorbent Assay (ELISA).
Outcome measures
| Measure |
GSK1437173A Group
n=121 Participants
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Control Group
n=119 Participants
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
Number of Subjects With a Vaccine Response for Anti-glycoprotein E (gE) Humoral Immunogenicity
|
97 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Within 7 days (Days 0-6) after each dose and across doses.Population: The analysis was performed on the subjects with symptom sheets completed from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Pain when limb was moved, which prevented everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Outcome measures
| Measure |
GSK1437173A Group
n=131 Participants
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Control Group
n=132 Participants
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
Number of Subjects With Solicited Local Symptoms
Any Redness, Dose 1
|
24 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling, Dose 1
|
10 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Pain, Across doses
|
114 Participants
|
11 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Pain, Dose 1
|
107 Participants
|
8 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
10 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Pain, Dose 2
|
93 Participants
|
6 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
9 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Redness, Dose 2
|
21 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling, Dose 2
|
11 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Pain, Across doses
|
13 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Redness, Across doses
|
33 Participants
|
2 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Redness, Across doses
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling, Across doses
|
15 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Swelling, Across doses
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 7 days (Days 0-6) after each dose and overall/dosePopulation: The analysis was performed on the subjects with solicited local symptoms from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
Assessed solicited local symptoms were pain, redness and swelling.
Outcome measures
| Measure |
GSK1437173A Group
n=114 Participants
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Control Group
n=11 Participants
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
Days With Solicited Local Symptoms
Pain, Dose 1
|
3.0 Days
Interval 2.0 to 4.0
|
1.5 Days
Interval 1.0 to 2.5
|
|
Days With Solicited Local Symptoms
Pain, Dose 2
|
3.0 Days
Interval 2.0 to 3.0
|
1.0 Days
Interval 1.0 to 2.0
|
|
Days With Solicited Local Symptoms
Redness, Dose 2
|
3.0 Days
Interval 2.0 to 7.0
|
2.0 Days
Interval 2.0 to 2.0
|
|
Days With Solicited Local Symptoms
Pain, Overall
|
3.0 Days
Interval 2.0 to 4.0
|
1.0 Days
Interval 1.0 to 2.0
|
|
Days With Solicited Local Symptoms
Redness, Dose 1
|
4.0 Days
Interval 2.5 to 6.5
|
4.0 Days
Interval 4.0 to 4.0
|
|
Days With Solicited Local Symptoms
Redness, Overall
|
4.0 Days
Interval 2.0 to 7.0
|
3.0 Days
Interval 2.0 to 4.0
|
|
Days With Solicited Local Symptoms
Swelling, Dose 1
|
4.0 Days
Interval 2.0 to 7.0
|
4.0 Days
Interval 4.0 to 4.0
|
|
Days With Solicited Local Symptoms
Swelling, Dose 2
|
4.0 Days
Interval 1.0 to 5.0
|
—
|
|
Days With Solicited Local Symptoms
Swelling, Overall
|
4.0 Days
Interval 2.0 to 6.0
|
4.0 Days
Interval 4.0 to 4.0
|
PRIMARY outcome
Timeframe: Within 7 days (Days 0-6) after each dose and across dosesPopulation: The analysis was performed on the subjects with symptom sheets completed from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\] . Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Gastrointestinal symptoms (Gastro. sympt.) included nausea, vomiting, diarrhoea and/or abdominal pain.
Outcome measures
| Measure |
GSK1437173A Group
n=131 Participants
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Control Group
n=132 Participants
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Shivering, Dose 2
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Shivering, Dose 2
|
9 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Temperature, Dose 2
|
21 Participants
|
7 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Temperature, Dose 2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Temperature, Dose 2
|
6 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Fatigue, Across doses
|
62 Participants
|
53 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Fatigue, Across doses
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Fatigue, Dose 1
|
47 Participants
|
42 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Fatigue, Dose 1
|
8 Participants
|
2 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Gastro. sympt., Dose 1
|
17 Participants
|
16 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Shivering, Dose 1
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Fatigue, Dose 2
|
49 Participants
|
36 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Shivering, Dose 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Temperature, Dose 1
|
13 Participants
|
6 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Fatigue, Across doses
|
15 Participants
|
4 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Gastro. sympt., Across doses
|
24 Participants
|
24 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Gastro. sympt., Across doses
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Gastro. sympt.,Across doses
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Headache, Across doses
|
44 Participants
|
34 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Headache, Across doses
|
2 Participants
|
5 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Headache, Across doses
|
12 Participants
|
4 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Myalgia, Dose Across doses
|
65 Participants
|
31 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Myalgia, Dose Across doses
|
9 Participants
|
3 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Myalgia, Dose Across doses
|
21 Participants
|
4 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Shivering, Dose Across doses
|
29 Participants
|
16 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Shivering, Dose Across doses
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Shivering, Dose Across doses
|
11 Participants
|
2 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Temperature, Dose Across doses
|
31 Participants
|
13 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Temperature, Dose Across doses
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Temperature, Dose Across doses
|
9 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Temperature, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Fatigue, Dose 1
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Gastro. sympt., Dose 1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Gastro. sympt., Dose 1
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Headache, Dose 1
|
32 Participants
|
25 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Headache, Dose 1
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Headache, Dose 1
|
5 Participants
|
3 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Myalgia, Dose 1
|
43 Participants
|
23 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Myalgia, Dose 1
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Myalgia, Dose 1
|
11 Participants
|
2 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Shivering, Dose 1
|
10 Participants
|
13 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Temperature, Dose 1
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Fatigue, Dose 2
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Fatigue, Dose 2
|
8 Participants
|
4 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Gastro. sympt., Dose 2
|
14 Participants
|
14 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Gastro. sympt., Dose 2
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Gastro. sympt., Dose 2
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Headache, Dose 2
|
35 Participants
|
22 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Headache, Dose 2
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Headache, Dose 2
|
9 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Myalgia, Dose 2
|
47 Participants
|
19 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Myalgia, Dose 2
|
8 Participants
|
3 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Myalgia, Dose 2
|
14 Participants
|
3 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Shivering, Dose 2
|
23 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Within 7 days (Days 0-6) after each dose and overall/dosePopulation: The analysis was performed on the subjects with solicited general symptoms from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\].
Outcome measures
| Measure |
GSK1437173A Group
n=65 Participants
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Control Group
n=53 Participants
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
Days With Solicited General Symptoms
Fatigue, Dose 1
|
3.0 Days
Interval 2.0 to 6.0
|
3.0 Days
Interval 1.0 to 7.0
|
|
Days With Solicited General Symptoms
Fatigue, Dose 2
|
3.0 Days
Interval 2.0 to 5.0
|
4.5 Days
Interval 2.0 to 7.0
|
|
Days With Solicited General Symptoms
Fatigue, Overall
|
3.0 Days
Interval 2.0 to 5.5
|
4.0 Days
Interval 2.0 to 7.0
|
|
Days With Solicited General Symptoms
Gastrointestinal symptoms, Dose 1
|
2.0 Days
Interval 1.0 to 2.0
|
3.5 Days
Interval 1.0 to 4.5
|
|
Days With Solicited General Symptoms
Gastrointestinal symptoms, Dose 2
|
2.0 Days
Interval 1.0 to 2.0
|
2.0 Days
Interval 1.0 to 3.0
|
|
Days With Solicited General Symptoms
Gastrointestinal symptoms, Overall
|
2.0 Days
Interval 1.0 to 2.0
|
2.0 Days
Interval 1.0 to 4.0
|
|
Days With Solicited General Symptoms
Headache, Dose 1
|
1.0 Days
Interval 1.0 to 2.0
|
2.0 Days
Interval 1.0 to 3.0
|
|
Days With Solicited General Symptoms
Headache, Dose 2
|
2.0 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 1.0 to 4.0
|
|
Days With Solicited General Symptoms
Headache, Overall
|
2.0 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 1.0 to 3.0
|
|
Days With Solicited General Symptoms
Myalgia, Dose 1
|
3.0 Days
Interval 2.0 to 4.0
|
3.0 Days
Interval 1.0 to 7.0
|
|
Days With Solicited General Symptoms
Myalgia, Dose 2
|
2.0 Days
Interval 1.0 to 4.0
|
7.0 Days
Interval 2.0 to 7.0
|
|
Days With Solicited General Symptoms
Myalgia, Overall
|
3.0 Days
Interval 1.0 to 4.0
|
5.0 Days
Interval 1.0 to 7.0
|
|
Days With Solicited General Symptoms
Shivering, Dose 1
|
2.0 Days
Interval 1.0 to 4.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Days With Solicited General Symptoms
Shivering, Dose 2
|
1.0 Days
Interval 1.0 to 2.0
|
3.0 Days
Interval 2.0 to 7.0
|
|
Days With Solicited General Symptoms
Shivering, Overall
|
1.0 Days
Interval 1.0 to 2.0
|
2.5 Days
Interval 1.0 to 7.0
|
|
Days With Solicited General Symptoms
Temperature, Dose 1
|
1.0 Days
Interval 1.0 to 1.0
|
1.0 Days
Interval 1.0 to 1.0
|
|
Days With Solicited General Symptoms
Temperature, Dose 2
|
1.0 Days
Interval 1.0 to 1.0
|
1.0 Days
Interval 1.0 to 1.0
|
|
Days With Solicited General Symptoms
Temperature, Overall
|
1.0 Days
Interval 1.0 to 1.0
|
1.0 Days
Interval 1.0 to 1.0
|
PRIMARY outcome
Timeframe: During the 30-day (Days 0-29) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and 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. Related = AE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK1437173A Group
n=132 Participants
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Control Group
n=132 Participants
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
Number of Subjects With Unsolicited Symptoms (AEs)
At least one symptom
|
51 Participants
|
44 Participants
|
|
Number of Subjects With Unsolicited Symptoms (AEs)
Subjects with grade 3 AEs
|
7 Participants
|
5 Participants
|
|
Number of Subjects With Unsolicited Symptoms (AEs)
Subjects with related AEs
|
7 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From first vaccination (Month 0) up to 1 month post last vaccination (Month 2).Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology
Outcome measures
| Measure |
GSK1437173A Group
n=132 Participants
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Control Group
n=132 Participants
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first vaccination (Month 0) up to 1 month post last vaccination (Month 2).Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongatoion of hospitalization, or result in disability /incapacity. Related = SAE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK1437173A Group
n=132 Participants
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Control Group
n=132 Participants
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Any SAEs
|
6 Participants
|
5 Participants
|
|
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Related SAEs
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From the first vaccination (Month 0) up to 1 month post last vaccination (Month 2).Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
Renal allograft rejection was confirmed through biopsy.
Outcome measures
| Measure |
GSK1437173A Group
n=132 Participants
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Control Group
n=132 Participants
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
Number of Subjects With Renal Allograft Rejection
Rejection confirmed
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Renal Allograft Rejection
Rejection not confirmed
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From the first vaccination (Month 0) up to 1 month post last vaccination (Month 2).Population: The analysis was performed on subjects with pre and post vaccination serum creatinine data available up to Month 2, from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
Allograft function was indicated by the increase in levels of serum creatinine (≥ 1.20, ≥ 1.50, ≥ 1.75 or ≥ 2 fold increase). The number of subjects with declining allograft function, as determined by serum creatinine measurements post-vaccination (up to 30 days post-last vaccination) compared to pre-vaccination were presented.
Outcome measures
| Measure |
GSK1437173A Group
n=113 Participants
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Control Group
n=107 Participants
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
Number of Subjects With Changes in Allograft Function
≥1.20 fold increase
|
5 Participants
|
7 Participants
|
|
Number of Subjects With Changes in Allograft Function
≥1.50 fold increase
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Changes in Allograft Function
≥1.75 fold increase
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Changes in Allograft Function
≥2 fold increase
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At Months 0, 1, 2, 7 and 13Population: The analysis was performed on the adapted ATP cohort for humoral immunogenicity, which included all evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and for whom data concerning immunogenicity outcome measures were available.
Varicella Zoster Virus (VZV) gE antibody Immunoglobulin G concentrations were determined by ELISA assay, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The reference seropositivity cut-off value was ≥ 97 mIU/mL.
Outcome measures
| Measure |
GSK1437173A Group
n=121 Participants
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Control Group
n=119 Participants
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
Anti-gE Antibody Concentrations
anti-gE, Month 0
|
1354.4 mIU/mL
Interval 1118.3 to 1640.4
|
1495.7 mIU/mL
Interval 1202.3 to 1860.8
|
|
Anti-gE Antibody Concentrations
anti-gE, Month 1
|
9530.5 mIU/mL
Interval 7111.3 to 12772.7
|
1501.9 mIU/mL
Interval 1231.3 to 1832.0
|
|
Anti-gE Antibody Concentrations
anti-gE, Month 2
|
19163.8 mIU/mL
Interval 15041.5 to 24416.0
|
1489.4 mIU/mL
Interval 1215.8 to 1824.7
|
|
Anti-gE Antibody Concentrations
anti-gE, Month 7
|
13066.7 mIU/mL
Interval 10291.5 to 16590.4
|
1533.7 mIU/mL
Interval 1249.6 to 1882.3
|
|
Anti-gE Antibody Concentrations
anti-gE, Month 13
|
8545.1 mIU/mL
Interval 6753.7 to 10811.5
|
1572.7 mIU/mL
Interval 1269.6 to 1948.1
|
SECONDARY outcome
Timeframe: At Months 1, 7 and 13Population: The analysis was performed on the adapted ATP cohort for humoral immunogenicity, which included all evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and for whom data concerning immunogenicity outcome measures were available.
Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination greater than or equal to (≥) 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. Vaccine response was determined by ELISA.
Outcome measures
| Measure |
GSK1437173A Group
n=121 Participants
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Control Group
n=119 Participants
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
Number of Subjects With a Vaccine Response for Anti-gE Humoral Immunogenicity
anti-gE, Month 1
|
77 Participants
|
3 Participants
|
|
Number of Subjects With a Vaccine Response for Anti-gE Humoral Immunogenicity
anti-gE, Month 7
|
83 Participants
|
5 Participants
|
|
Number of Subjects With a Vaccine Response for Anti-gE Humoral Immunogenicity
anti-gE, Month 13
|
74 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: At Months 0, 2 and 13Population: The analysis was performed on the adapted ATP cohort for cell-mediated immunogenicity (CMI), which included all evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and who were part of a CMI sub-cohort (Blood samples collected at Visits 1, 3 and 5 were analyzed to assess CMI response).
Descriptive statistics of gE-specific CD4+ T-cells, expressing at least two activation markers (from among interferon gamma \[IFN-γ\], interleukin-2 \[IL-2\], tumour necrosis factor alpha \[TNF-α\] and cluster of differentiation 40-ligand \[CD40L\]) were tabulated, as determined by in vitro Intracellular Cytokine Staining (ICS).
Outcome measures
| Measure |
GSK1437173A Group
n=33 Participants
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Control Group
n=31 Participants
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells
Month 13
|
1320.92 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 1823.64
|
129.41 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 197.92
|
|
Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells
Month 0
|
110.9 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 182.09
|
165.75 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 242.92
|
|
Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells
Month 2
|
2433.07 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 2102.29
|
156.98 gE-specific CD4+ T-cells/million T-cells
Standard Deviation 274.81
|
SECONDARY outcome
Timeframe: At Months 2 and 13Population: The analysis was performed on the adapted ATP cohort for cell-mediated immunogenicity (CMI), which included all evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and who were part of a CMI sub-cohort (Blood samples collected at Visits 1, 3 and 5 were analyzed to assess CMI response).
Vaccine response for gE-specific CD4+ T-cells expressing at least two activation markers (from among IFN-γ, IL-2, TNF-α and CD40L), was determined by in vitro ICS. Vaccine response was defined as: For initially subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x\<320\> Events/10 million CD4+ T-cells); For initially subjects with pre-vaccination T-cell frequencies above the threshold, at least a 2-fold increase as compared to pre-vaccination T-cell frequencies.
Outcome measures
| Measure |
GSK1437173A Group
n=30 Participants
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Control Group
n=28 Participants
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
Number of Subjects With a Vaccine Response for gE-specific CD4+ T-cells
Month 2
|
20 Participants
|
0 Participants
|
|
Number of Subjects With a Vaccine Response for gE-specific CD4+ T-cells
Month 13
|
17 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From 1 month post last vaccination (Month 2) until study end (Month 13).Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.If a subject reported a SAE exactly 1 month post-last vaccination (Month 2), it is possible that he/she might have also been taken into consideration for the Day0 up to Month2 SAEs assessment
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related = SAE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK1437173A Group
n=132 Participants
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Control Group
n=132 Participants
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
Number of Subjects With Any and Related SAEs
Any SAEs
|
21 Participants
|
29 Participants
|
|
Number of Subjects With Any and Related SAEs
Related SAEs
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From 1 month post last vaccination (Month 2) until study end (Month 13).Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
GSK1437173A Group
n=132 Participants
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Control Group
n=132 Participants
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
Number of Subjects With Any pIMDs
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From 1 month post last vaccination (Month 2) until study end (Month 13).Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
Renal allograft rejection was confirmed through biopsy.
Outcome measures
| Measure |
GSK1437173A Group
n=132 Participants
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Control Group
n=132 Participants
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
Number of Subjects With Renal Allograft Rejection
Rejection confirmed
|
4 Participants
|
7 Participants
|
|
Number of Subjects With Renal Allograft Rejection
Rejection not confirmed
|
12 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: From 1 month post last vaccination (Month 2) until study end (Month 13)Population: The analysis was performed on subjects with pre and post vaccination serum creatinine data available from Month 2 to Month 13, from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.
Allograft function was indicated by the increase in levels of serum creatinine (≥ 1.20, ≥ 1.50, ≥ 1.75 or ≥ 2 fold increase). The number of subjects with declining allograft function, as determined by serum creatinine measurements post-vaccination (from 30 days post-last vaccination up to study end) compared to pre-vaccination were presented.
Outcome measures
| Measure |
GSK1437173A Group
n=130 Participants
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Control Group
n=132 Participants
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
Number of Subjects With Changes in Allograft Function
≥1.20 fold increase
|
17 Participants
|
22 Participants
|
|
Number of Subjects With Changes in Allograft Function
≥1.50 fold increase
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Changes in Allograft Function
≥1.75 fold increase
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Changes in Allograft Function
≥2 fold increase
|
2 Participants
|
0 Participants
|
Adverse Events
GSK1437173A Group
Serious events: 26 serious events
Other events: 121 other events
Deaths: 1 deaths
Placebo Group
Serious events: 33 serious events
Other events: 78 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
GSK1437173A Group
n=132 participants at risk
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Placebo Group
n=132 participants at risk
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Gastrointestinal disorders
Gastritis
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Immune system disorders
Kidney transplant rejection
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
1.5%
2/132 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Immune system disorders
Transplant rejection
|
1.5%
2/132 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
3.0%
4/132 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Abscess limb
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Atypical pneumonia
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Clostridium colitis
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Escherichia infection
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Gastroenteritis
|
1.5%
2/132 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
3.0%
4/132 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
3.0%
4/132 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Influenza
|
2.3%
3/132 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Klebsiella sepsis
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Localised infection
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Meningitis
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Pneumonia
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Postoperative wound infection
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Pyelonephritis acute
|
3.0%
4/132 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Renal graft infection
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Respiratory tract infection
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
2/132 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
2.3%
3/132 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Urosepsis
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Infections and infestations
Viral infection
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Injury, poisoning and procedural complications
Vascular graft stenosis
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
2.3%
3/132 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign gastrointestinal neoplasm
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Renal and urinary disorders
Renal cyst
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/132 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
Other adverse events
| Measure |
GSK1437173A Group
n=132 participants at risk
Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
Placebo Group
n=132 participants at risk
Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.
|
|---|---|---|
|
General disorders
Chills
|
22.0%
29/132 • Number of events 33 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
12.1%
16/132 • Number of events 22 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
33/132 • Number of events 45 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
1.5%
2/132 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
General disorders
Fatigue
|
47.0%
62/132 • Number of events 96 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
40.9%
54/132 • Number of events 79 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
18.2%
24/132 • Number of events 31 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
18.2%
24/132 • Number of events 30 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Nervous system disorders
Headache
|
33.3%
44/132 • Number of events 68 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
26.5%
35/132 • Number of events 48 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
49.2%
65/132 • Number of events 90 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
23.5%
31/132 • Number of events 42 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
General disorders
Pain
|
86.4%
114/132 • Number of events 202 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
8.3%
11/132 • Number of events 14 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
General disorders
Pyrexia
|
24.2%
32/132 • Number of events 37 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
10.6%
14/132 • Number of events 14 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
|
General disorders
Swelling
|
11.4%
15/132 • Number of events 21 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
0.76%
1/132 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period, Unsolicited symptoms: during the 30-day (Days 0-29) post-vaccination period, Serious Adverse Events: from Month 0 up to study end at Month 13.
|
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