Trial Outcomes & Findings for Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A in Adults With a Prior Episode of Herpes Zoster (NCT NCT01827839)
NCT ID: NCT01827839
Last Updated: 2018-10-18
Results Overview
Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
96 participants
Primary outcome timeframe
At Month 3
Results posted on
2018-10-18
Participant Flow
Participant milestones
| Measure |
GSK1437173A Group
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
|
|---|---|
|
Overall Study
STARTED
|
96
|
|
Overall Study
COMPLETED
|
93
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
GSK1437173A Group
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Consent Withdrawal
|
2
|
Baseline Characteristics
Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A in Adults With a Prior Episode of Herpes Zoster
Baseline characteristics by cohort
| Measure |
GSK1437173A Group
n=96 Participants
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
|
|---|---|
|
Age, Continuous
|
64.9 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian/European
|
92 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic /North African
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Month 3Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 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.
Outcome measures
| Measure |
GSK1437173A Group
n=82 Participants
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 50-59 YOA
n=29 Participants
Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 60-69 YOA
n=28 Participants
Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group >=70 YOA
n=25 Participants
Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Vaccine Responders for Anti-gE Antibodies as Determined by ELISA
|
74 Participants
|
26 Participants
|
26 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: Within 7 days (Day 0-6) after each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and with the symptoms sheet 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 |
GSK1437173A Group
n=95 Participants
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 50-59 YOA
Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 60-69 YOA
Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group >=70 YOA
Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1
|
61 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
3 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 1
|
17 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1
|
12 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2
|
56 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
5 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 2
|
22 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2
|
13 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Across Doses
|
70 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Across Doses
|
8 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Across Doses
|
31 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Across Doses
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Across Doses
|
19 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Across Doses
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days (Day 0-6) after each vaccine dosePopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and with results available for this assessment.
The number of days with any local symptoms during the solicited post-vaccination period.
Outcome measures
| Measure |
GSK1437173A Group
n=96 Participants
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 50-59 YOA
Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 60-69 YOA
Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group >=70 YOA
Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Days With Solicited Local Symptoms
Pain post-Dose 1
|
3.0 Days
Interval 2.0 to 4.0
|
—
|
—
|
—
|
|
Number of Days With Solicited Local Symptoms
Pain post-Dose 2
|
3.0 Days
Interval 2.0 to 4.0
|
—
|
—
|
—
|
|
Number of Days With Solicited Local Symptoms
Redness post-Dose 1
|
3.0 Days
Interval 1.0 to 4.0
|
—
|
—
|
—
|
|
Number of Days With Solicited Local Symptoms
Redness post-Dose 2
|
2.5 Days
Interval 2.0 to 4.0
|
—
|
—
|
—
|
|
Number of Days With Solicited Local Symptoms
Swelling post-Dose 1
|
3.0 Days
Interval 1.5 to 4.5
|
—
|
—
|
—
|
|
Number of Days With Solicited Local Symptoms
Swelling post-Dose 2
|
2.0 Days
Interval 2.0 to 3.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days (Day 0-6) after each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and with the symptoms sheet filled in.
Assessed solicited general symptoms were fatigue, gastrointestinal (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
GSK1437173A Group
n=95 Participants
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 50-59 YOA
Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 60-69 YOA
Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group >=70 YOA
Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Across Doses
|
43 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Across Doses
|
35 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature/(Oral), Across Doses
|
19 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 1
|
37 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 1
|
29 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 1
|
5 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 1
|
14 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 1
|
6 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 1
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 1
|
22 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 1
|
15 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 1
|
1 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 1
|
25 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 1
|
21 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 1
|
5 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering, Dose 1
|
15 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering, Dose 1
|
14 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering, Dose 1
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature/(Oral), Dose 1
|
7 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature/(Oral), Dose 1
|
6 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature/(Oral), Dose 1
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 2
|
41 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 2
|
28 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 2
|
6 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 2
|
13 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 2
|
6 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 2
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 2
|
29 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 2
|
20 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 2
|
3 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 2
|
27 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 2
|
23 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 2
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering, Dose 2
|
25 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering, Dose 2
|
21 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering, Dose 2
|
5 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature/(Oral), Dose 2
|
14 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature/(Oral), Dose 2
|
11 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature/(Oral), Dose 2
|
0 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Across Doses
|
57 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Across Doses
|
10 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Across Doses
|
23 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Across Doses
|
11 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Across Doses
|
2 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Across Doses
|
37 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Across Doses
|
28 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Across Doses
|
4 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Across Doses
|
31 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Across Doses
|
6 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering, Across Doses
|
31 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering, Across Doses
|
26 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering, Across Doses
|
7 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature/(Oral), Across Doses
|
15 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature/(Oral), Across Doses
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days (Day 0-6) after each vaccine dosePopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and with results available for this assessment.
The number of days with general symptoms during the solicited post-vaccination period.
Outcome measures
| Measure |
GSK1437173A Group
n=96 Participants
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 50-59 YOA
Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 60-69 YOA
Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group >=70 YOA
Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Days With Solicited General Symptoms
Gastrointestinal symptoms post-Dose 2
|
1.0 Days
Interval 1.0 to 2.0
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Headache post-Dose 1
|
2.0 Days
Interval 1.0 to 3.0
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Headache post-Dose 2
|
2.0 Days
Interval 1.0 to 3.0
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Myalgia post-Dose 1
|
3.0 Days
Interval 2.0 to 4.0
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Myalgia post-Dose 2
|
2.0 Days
Interval 1.0 to 3.0
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Shivering post-Dose 1
|
1.0 Days
Interval 1.0 to 2.0
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Fatigue post-Dose 1
|
2.0 Days
Interval 1.0 to 4.0
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Fatigue post-Dose 2
|
2.0 Days
Interval 1.0 to 3.0
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Gastrointestinal symptoms post-Dose 1
|
1.5 Days
Interval 1.0 to 3.0
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Shivering post-Dose 2
|
1.0 Days
Interval 1.0 to 2.0
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Temperature post-Dose 1
|
1.0 Days
Interval 1.0 to 1.0
|
—
|
—
|
—
|
|
Number of Days With Solicited General Symptoms
Temperature post-Dose 2
|
1.5 Days
Interval 1.0 to 2.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 30 days (Days 0-29) after each vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.
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=96 Participants
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 50-59 YOA
Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 60-69 YOA
Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group >=70 YOA
Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 AE(s)
|
11 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any AE(s)
|
30 Participants
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related AE(s)
|
12 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first vaccination up to 30 days post last vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.
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 |
GSK1437173A Group
n=96 Participants
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 50-59 YOA
Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 60-69 YOA
Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group >=70 YOA
Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Any Serious Adverse Events (SAEs)
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first vaccination up to 30 days post last vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
Potential immune-mediated diseases (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=96 Participants
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 50-59 YOA
Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 60-69 YOA
Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group >=70 YOA
Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 0 and at Month 3Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
Anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The outcome was assessed in each of the following age ranges: 50-59 YOA, 60-69 YOA and ≥ 70 YOA, in terms of antibody concentrations.
Outcome measures
| Measure |
GSK1437173A Group
n=29 Participants
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 50-59 YOA
n=28 Participants
Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 60-69 YOA
n=25 Participants
Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group >=70 YOA
Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Anti-gE Antibody Concentrations
Anti-gE at Month 0
|
2561.4 mIU/mL
Interval 1531.4 to 4284.2
|
2083.5 mIU/mL
Interval 1357.4 to 3198.0
|
2600.6 mIU/mL
Interval 1319.4 to 5125.9
|
—
|
|
Anti-gE Antibody Concentrations
Anti-gE at Month 3
|
56413.7 mIU/mL
Interval 43783.3 to 72687.6
|
44470.8 mIU/mL
Interval 37373.2 to 52916.2
|
42642.5 mIU/mL
Interval 34698.8 to 52404.9
|
—
|
SECONDARY outcome
Timeframe: At Month 0 and at Month 3Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
The cut-off value was 97 mIU/mL.
Outcome measures
| Measure |
GSK1437173A Group
n=29 Participants
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 50-59 YOA
n=28 Participants
Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 60-69 YOA
n=25 Participants
Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group >=70 YOA
Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value
Anti-gE at Month 0
|
29 Participants
|
28 Participants
|
25 Participants
|
—
|
|
Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value
Anti-gE at Month 3
|
29 Participants
|
28 Participants
|
25 Participants
|
—
|
SECONDARY outcome
Timeframe: Starting after 30 days post last vaccination until study end (i.e. Month 14)Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
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 |
GSK1437173A Group
n=96 Participants
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 50-59 YOA
Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 60-69 YOA
Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group >=70 YOA
Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With SAEs
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Starting after 30 days post last vaccination until study end (i.e. Month 14)Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.
Potential immune-mediated diseases (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=96 Participants
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 50-59 YOA
Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group 60-69 YOA
Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
GSK1437173A Group >=70 YOA
Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
|
|---|---|---|---|---|
|
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)
|
0 Participants
|
—
|
—
|
—
|
Adverse Events
GSK1437173A Group
Serious events: 3 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK1437173A Group
n=96 participants at risk
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
|
|---|---|
|
Gastrointestinal disorders
Chronic gastritis
|
1.0%
1/96 • Number of events 1 • Serious Adverse Events were assessed throughout the study (up to Month 14). Other Adverse Events were assessed during the 30-day (Days 0-29) post-vaccination period.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
1.0%
1/96 • Number of events 1 • Serious Adverse Events were assessed throughout the study (up to Month 14). Other Adverse Events were assessed during the 30-day (Days 0-29) post-vaccination period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.0%
1/96 • Number of events 1 • Serious Adverse Events were assessed throughout the study (up to Month 14). Other Adverse Events were assessed during the 30-day (Days 0-29) post-vaccination period.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.0%
1/96 • Number of events 1 • Serious Adverse Events were assessed throughout the study (up to Month 14). Other Adverse Events were assessed during the 30-day (Days 0-29) post-vaccination period.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.0%
1/96 • Number of events 1 • Serious Adverse Events were assessed throughout the study (up to Month 14). Other Adverse Events were assessed during the 30-day (Days 0-29) post-vaccination period.
|
Other adverse events
| Measure |
GSK1437173A Group
n=96 participants at risk
Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
|
|---|---|
|
General disorders
Chills
|
32.3%
31/96 • Number of events 42 • Serious Adverse Events were assessed throughout the study (up to Month 14). Other Adverse Events were assessed during the 30-day (Days 0-29) post-vaccination period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
32.3%
31/96 • Number of events 39 • Serious Adverse Events were assessed throughout the study (up to Month 14). Other Adverse Events were assessed during the 30-day (Days 0-29) post-vaccination period.
|
|
General disorders
Fatigue
|
59.4%
57/96 • Number of events 78 • Serious Adverse Events were assessed throughout the study (up to Month 14). Other Adverse Events were assessed during the 30-day (Days 0-29) post-vaccination period.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
24.0%
23/96 • Number of events 27 • Serious Adverse Events were assessed throughout the study (up to Month 14). Other Adverse Events were assessed during the 30-day (Days 0-29) post-vaccination period.
|
|
Nervous system disorders
Headache
|
38.5%
37/96 • Number of events 51 • Serious Adverse Events were assessed throughout the study (up to Month 14). Other Adverse Events were assessed during the 30-day (Days 0-29) post-vaccination period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
36.5%
35/96 • Number of events 52 • Serious Adverse Events were assessed throughout the study (up to Month 14). Other Adverse Events were assessed during the 30-day (Days 0-29) post-vaccination period.
|
|
General disorders
Pain
|
72.9%
70/96 • Number of events 118 • Serious Adverse Events were assessed throughout the study (up to Month 14). Other Adverse Events were assessed during the 30-day (Days 0-29) post-vaccination period.
|
|
General disorders
Pyrexia
|
19.8%
19/96 • Number of events 21 • Serious Adverse Events were assessed throughout the study (up to Month 14). Other Adverse Events were assessed during the 30-day (Days 0-29) post-vaccination period.
|
|
General disorders
Swelling
|
19.8%
19/96 • Number of events 25 • Serious Adverse Events were assessed throughout the study (up to Month 14). Other Adverse Events were assessed during the 30-day (Days 0-29) post-vaccination period.
|
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