Trial Outcomes & Findings for Study to Evaluate Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A When Co-administered With Pneumovax 23™ in Adults Aged 50 Years and Older (NCT NCT02045836)
NCT ID: NCT02045836
Last Updated: 2021-05-14
Results Overview
Vaccine response rate for anti-gE antibody concentrations, as determined by enzyme-linked immunosorbent assay (ELISA), in subjects from the Co-Ad group. Vaccine response defined as : For initially seronegative subjects, antibody concentration at post-vaccination ≥ 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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
865 participants
Primary outcome timeframe
At Month 3
Results posted on
2021-05-14
Participant Flow
Participant milestones
| Measure |
Co-Ad Group
Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
Control Group
Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
|---|---|---|
|
Overall Study
STARTED
|
432
|
433
|
|
Overall Study
COMPLETED
|
423
|
419
|
|
Overall Study
NOT COMPLETED
|
9
|
14
|
Reasons for withdrawal
| Measure |
Co-Ad Group
Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
Control Group
Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
7
|
|
Overall Study
Migrated from study area
|
0
|
2
|
Baseline Characteristics
Study to Evaluate Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A When Co-administered With Pneumovax 23™ in Adults Aged 50 Years and Older
Baseline characteristics by cohort
| Measure |
Co-Ad Group
n=432 Participants
Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
Control Group
n=433 Participants
Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
Total
n=865 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.2 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
63.2 Years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
63.2 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
264 Participants
n=5 Participants
|
252 Participants
n=7 Participants
|
516 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
168 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
349 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian / European Heritage
|
408 Participants
n=5 Participants
|
406 Participants
n=7 Participants
|
814 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African Heritage / African American
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 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
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic / North African Heritage
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Origin
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Month 3Population: This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.
Vaccine response rate for anti-gE antibody concentrations, as determined by enzyme-linked immunosorbent assay (ELISA), in subjects from the Co-Ad group. Vaccine response defined as : For initially seronegative subjects, antibody concentration at post-vaccination ≥ 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
Outcome measures
| Measure |
Co-Ad Group
n=401 Participants
Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
Control Group
Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
|---|---|---|
|
Number of Subjects With a Vaccine Response for Anti-gE Antibodies
|
394 Participants
|
—
|
PRIMARY outcome
Timeframe: At one month post-dose 2 (Month 3 for the Co-Ad Group and Month 5 for the Control Group)Population: This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.
Antibody concentrations were determined by ELISA, presented as geometric mean concentrations and expressed as milli international units per milliliter (mIU/mL).
Outcome measures
| Measure |
Co-Ad Group
n=407 Participants
Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
Control Group
n=402 Participants
Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
|---|---|---|
|
Anti-glicoprotein E (gE) Antibody Concentrations
|
49918.0 mIU/mL
Interval 47143.0 to 52856.3
|
50327.9 mIU/mL
Interval 47200.4 to 53662.7
|
PRIMARY outcome
Timeframe: At one month post-dose (Month 1)Population: This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.
Anti-pneumococcal antibody titers were presented as geometric mean titers (GMTs) for the 12 following serotypes as determined by Opsonophagocytic Assay (OPA): 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.
Outcome measures
| Measure |
Co-Ad Group
n=410 Participants
Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
Control Group
n=413 Participants
Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
|---|---|---|
|
Anti-pneumococcal Antibody Titers
MOPA-1
|
65.1 Titers
Interval 54.2 to 78.1
|
68.6 Titers
Interval 56.9 to 82.7
|
|
Anti-pneumococcal Antibody Titers
MOPA-9V
|
1898.4 Titers
Interval 1618.1 to 2227.2
|
1991.3 Titers
Interval 1716.0 to 2310.8
|
|
Anti-pneumococcal Antibody Titers
MOPA-14
|
2629.4 Titers
Interval 2297.4 to 3009.3
|
2612.8 Titers
Interval 2230.7 to 3060.3
|
|
Anti-pneumococcal Antibody Titers
MOPA-3
|
106.7 Titers
Interval 92.6 to 122.9
|
107.4 Titers
Interval 92.7 to 124.4
|
|
Anti-pneumococcal Antibody Titers
MOPA-4
|
1079.4 Titers
Interval 924.0 to 1260.9
|
1328.8 Titers
Interval 1141.0 to 1547.6
|
|
Anti-pneumococcal Antibody Titers
MOPA-5
|
161.4 Titers
Interval 134.6 to 193.6
|
149.5 Titers
Interval 123.5 to 181.0
|
|
Anti-pneumococcal Antibody Titers
MOPA-6B
|
1619.0 Titers
Interval 1354.5 to 1935.0
|
1564.4 Titers
Interval 1303.5 to 1877.6
|
|
Anti-pneumococcal Antibody Titers
MOPA-19A
|
1349.6 Titers
Interval 1152.1 to 1580.8
|
1573.1 Titers
Interval 1350.7 to 1832.2
|
|
Anti-pneumococcal Antibody Titers
MOPA-19F
|
904.3 Titers
Interval 779.6 to 1049.0
|
953.0 Titers
Interval 814.8 to 1114.6
|
|
Anti-pneumococcal Antibody Titers
MOPA-23F
|
431.4 Titers
Interval 356.1 to 522.7
|
367.3 Titers
Interval 300.8 to 448.5
|
|
Anti-pneumococcal Antibody Titers
MOPA-7F
|
2352.5 Titers
Interval 2049.5 to 2700.3
|
2460.4 Titers
Interval 2128.7 to 2843.8
|
|
Anti-pneumococcal Antibody Titers
MOPA-18C
|
1077.4 Titers
Interval 921.1 to 1260.2
|
1076.0 Titers
Interval 918.2 to 1260.9
|
PRIMARY outcome
Timeframe: At 1 month after vaccinationPopulation: This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.
The Adjusted ratios of GMTs between groups (Control group and Co-Ad group) were presented for each individual pneumococcal conjugate serotype Opsonophagocytic Activity (OPA).
Outcome measures
| Measure |
Co-Ad Group
n=411 Participants
Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
Control Group
n=408 Participants
Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
|---|---|---|
|
Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups
MOPA-1
|
67.6 Titers
Interval 56.9 to 80.2
|
65.6 Titers
Interval 55.2 to 77.9
|
|
Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups
MOPA-3
|
105.0 Titers
Interval 92.2 to 119.5
|
108.9 Titers
Interval 95.7 to 124.1
|
|
Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups
MOPA-4
|
1264.1 Titers
Interval 1089.9 to 1466.2
|
1117.2 Titers
Interval 963.1 to 1296.1
|
|
Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups
MOPA-5
|
152.6 Titers
Interval 129.1 to 180.3
|
159.8 Titers
Interval 135.1 to 188.9
|
|
Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups
MOPA-6B
|
1536.8 Titers
Interval 1307.9 to 1805.7
|
1666.6 Titers
Interval 1418.0 to 1958.6
|
|
Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups
MOPA-7F
|
2491.3 Titers
Interval 2179.8 to 2847.5
|
2324.7 Titers
Interval 2033.3 to 2657.9
|
|
Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups
MOPA-9V
|
1911.8 Titers
Interval 1651.6 to 2212.9
|
1970.3 Titers
Interval 1700.9 to 2282.3
|
|
Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups
MOPA-14
|
2610.1 Titers
Interval 2281.6 to 2986.0
|
2678.1 Titers
Interval 2339.4 to 3065.8
|
|
Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups
MOPA-18C
|
1040.9 Titers
Interval 902.7 to 1200.4
|
1099.8 Titers
Interval 952.8 to 1269.6
|
|
Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups
MOPA-19A
|
1558.6 Titers
Interval 1361.8 to 1783.8
|
1350.5 Titers
Interval 1180.0 to 1545.7
|
|
Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups
MOPA-19F
|
938.2 Titers
Interval 814.6 to 1080.7
|
914.1 Titers
Interval 793.4 to 1053.3
|
|
Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups
MOPA-23F
|
372.8 Titers
Interval 316.0 to 439.8
|
419.1 Titers
Interval 354.9 to 494.9
|
PRIMARY outcome
Timeframe: At 1 month after last vaccine dosePopulation: This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.
The Adjusted ratios of GMCs between groups (Control group and Co-Ad group) was presented for anti-gE antibody ELISA concentrations
Outcome measures
| Measure |
Co-Ad Group
n=401 Participants
Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
Control Group
n=402 Participants
Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
|---|---|---|
|
Adjusted GMCs Between Groups
|
49569.0 mIU/mL
Interval 46641.4 to 52680.4
|
50474.5 mIU/mL
Interval 47497.4 to 53638.2
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0 - 6) after each vaccinationPopulation: The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine 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. The Co-Ad Group received only 2 vaccine doses.
Outcome measures
| Measure |
Co-Ad Group
n=429 Participants
Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
Control Group
n=431 Participants
Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Any Pain, Dose 1
|
344 Participants
|
169 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Grade 3 Pain, Dose 1
|
46 Participants
|
5 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Any Redness, Dose 1
|
182 Participants
|
31 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Grade 3 Redness, Dose 1
|
15 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Any Swelling, Dose 1
|
99 Participants
|
21 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Grade 3 Swelling, Dose 1
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Any Pain, Dose 2
|
298 Participants
|
290 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Any Pain, Dose 3
|
0 Participants
|
293 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Grade 3 Pain, Dose 3
|
0 Participants
|
32 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Any Redness, Dose 3
|
0 Participants
|
136 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Grade 3 Redness, Dose 3
|
0 Participants
|
8 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Any Swelling, Dose 3
|
0 Participants
|
74 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Grade 3 Swelling, Dose 3
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Any Pain, Across Doses
|
372 Participants
|
357 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Grade 3 Pain, Across Doses
|
68 Participants
|
49 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Any Redness, Across Doses
|
233 Participants
|
194 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Grade 3 Redness, Across Doses
|
27 Participants
|
12 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Any Swelling, Across Doses
|
137 Participants
|
115 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Grade 3 Pain, Dose 2
|
35 Participants
|
28 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Any Redness, Dose 2
|
146 Participants
|
129 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Grade 3 Redness, Dose 2
|
15 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Any Swelling, Dose 2
|
79 Participants
|
67 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Grade 3 Swelling, Dose 2
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose
Grade 3 Swelling, Across Doses
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0 - 6) after vaccinationPopulation: The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine 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 |
Co-Ad Group
n=429 Participants
Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
Control Group
n=431 Participants
Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
|---|---|---|
|
Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine
Any Swelling, Pneumovax 23, Across Doses
|
36 Participants
|
21 Participants
|
|
Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine
Any Pain, GSK1437173A, Across Doses
|
369 Participants
|
343 Participants
|
|
Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine
Any Pain, Pneumovax 23, Across Doses
|
223 Participants
|
169 Participants
|
|
Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine
Any Redness, GSK1437173A, Across Doses
|
223 Participants
|
186 Participants
|
|
Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine
Any Redness, Pneumovax 23, Across Doses
|
69 Participants
|
31 Participants
|
|
Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine
Any Swelling, GSK1437173A, Across Doses
|
129 Participants
|
108 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across dosesPopulation: This analysis was performed on the Total Vaccinated cohort, including subjects with at least one vaccine dose administered, only on those subjects with completed symptom sheets.
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. 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.
Outcome measures
| Measure |
Co-Ad Group
n=429 Participants
Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
Control Group
n=431 Participants
Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Myalgia, Dose 2
|
182 Participants
|
124 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Myalgia, Dose 2
|
25 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Fatigue, Dose 1
|
194 Participants
|
87 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Fatigue, Dose 1
|
27 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Fatigue, Dose 1
|
175 Participants
|
81 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Gastrointestinal symptoms, Dose 1
|
76 Participants
|
31 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Gastrointestinal symptoms, Dose 1
|
6 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Gastrointestinal symptoms, Dose 1
|
67 Participants
|
28 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Headache, Dose 1
|
156 Participants
|
72 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Headache, Dose 1
|
15 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Headache, Dose 1
|
141 Participants
|
64 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Myalgia, Dose 1
|
187 Participants
|
87 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Myalgia, Dose 1
|
29 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Myalgia, Dose 1
|
177 Participants
|
82 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Shivering, Dose 1
|
91 Participants
|
27 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Shivering, Dose 1
|
12 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Shivering, Dose 1
|
86 Participants
|
26 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Temperature, Dose 1
|
69 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Temperature, Dose 1
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Temperature, Dose 1
|
67 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Fatigue, Dose 2
|
191 Participants
|
124 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Fatigue, Dose 2
|
29 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Fatigue, Dose 2
|
174 Participants
|
109 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Gastrointestinal symptoms, Dose 2
|
61 Participants
|
38 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Gastrointestinal symptoms, Dose 2
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Gastrointestinal symptoms, Dose 2
|
52 Participants
|
29 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Headache, Dose 2
|
141 Participants
|
104 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Headache, Dose 2
|
19 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Headache, Dose 2
|
124 Participants
|
85 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Myalgia, Dose 2
|
171 Participants
|
119 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Shivering, Dose 2
|
83 Participants
|
30 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Shivering, Dose 2
|
14 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Shivering, Dose 2
|
78 Participants
|
25 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Temperature, Dose 2
|
67 Participants
|
30 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Temperature, Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Temperature, Dose 2
|
63 Participants
|
26 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Fatigue, Dose 3
|
0 Participants
|
174 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Fatigue, Dose 3
|
0 Participants
|
22 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Fatigue, Dose 3
|
0 Participants
|
166 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Gastrointestinal symptoms, Dose 3
|
0 Participants
|
47 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Gastrointestinal symptoms, Dose 3
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Gastrointestinal symptoms, Dose 3
|
0 Participants
|
46 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Headache, Dose 3
|
0 Participants
|
144 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Headache, Dose 3
|
0 Participants
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Headache, Dose 3
|
0 Participants
|
135 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Myalgia, Dose 3
|
0 Participants
|
162 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Myalgia, Dose 3
|
0 Participants
|
26 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Myalgia, Dose 3
|
0 Participants
|
157 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Shivering, Dose 3
|
0 Participants
|
72 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Shivering, Dose 3
|
0 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Shivering, Dose 3
|
0 Participants
|
69 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Fatigue, Across doses
|
236 Participants
|
216 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Gastrointestinal symptoms, Across doses
|
114 Participants
|
84 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Gastrointestinal symptoms, Across doses
|
12 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Gastrointestinal symptoms, Across doses
|
100 Participants
|
77 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Headache, Across doses
|
209 Participants
|
208 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Headache, Across doses
|
29 Participants
|
24 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Headache, Across doses
|
195 Participants
|
193 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Myalgia, Across doses
|
257 Participants
|
225 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Shivering, Across doses
|
25 Participants
|
15 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Shivering, Across doses
|
131 Participants
|
95 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Temperature, Across doses
|
112 Participants
|
96 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Temperature, Across doses
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Temperature, Across doses
|
108 Participants
|
91 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Temperature, Dose 3
|
0 Participants
|
67 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Temperature, Dose 3
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Temperature, Dose 3
|
0 Participants
|
66 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Fatigue, Across doses
|
253 Participants
|
228 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Fatigue, Across doses
|
47 Participants
|
31 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Myalgia, Across doses
|
46 Participants
|
37 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Myalgia, Across doses
|
245 Participants
|
218 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Shivering, Across doses
|
137 Participants
|
99 Participants
|
SECONDARY outcome
Timeframe: Within 7 days (Days 0 - 6) after each vaccinationPopulation: The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.
The Co-Ad Group received only 2 vaccine doses, hence the number of participants for the Dose 3 categories in this group is 0.
Outcome measures
| Measure |
Co-Ad Group
n=344 Participants
Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
Control Group
n=293 Participants
Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
|---|---|---|
|
Number of Days With Any Solicited Local and General Symptoms
Any Pain, Dose 1
|
3 days
Interval 2.0 to 4.0
|
2 days
Interval 1.0 to 3.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Pain, Dose 2
|
3 days
Interval 2.0 to 4.0
|
3 days
Interval 2.0 to 4.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Pain, Dose 3
|
—
|
3 days
Interval 2.0 to 4.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Redness, Dose 1
|
3 days
Interval 2.0 to 5.0
|
2 days
Interval 1.0 to 3.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Redness, Dose 2
|
3 days
Interval 2.0 to 4.0
|
3 days
Interval 2.0 to 5.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Redness, Dose 3
|
—
|
3 days
Interval 2.0 to 4.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Swelling, Dose 1
|
3 days
Interval 2.0 to 5.0
|
2 days
Interval 1.0 to 3.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Swelling, Dose 2
|
3 days
Interval 2.0 to 4.0
|
4 days
Interval 2.0 to 5.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Swelling, Dose 3
|
—
|
3 days
Interval 2.0 to 5.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Fatigue, Dose 1
|
2 days
Interval 1.0 to 4.0
|
2 days
Interval 1.0 to 4.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Fatigue, Dose 2
|
2 days
Interval 1.0 to 3.0
|
2 days
Interval 1.0 to 3.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Fatigue, Dose 3
|
—
|
2 days
Interval 1.0 to 3.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Gastrointestinal, Dose 1
|
2 days
Interval 1.0 to 2.5
|
2 days
Interval 1.0 to 3.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Gastrointestinal, Dose 2
|
2 days
Interval 1.0 to 3.0
|
2 days
Interval 1.0 to 3.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Gastrointestinal, Dose 3
|
—
|
2 days
Interval 1.0 to 2.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Headache, Dose 1
|
2 days
Interval 1.0 to 3.0
|
2 days
Interval 1.0 to 2.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Shivering, Dose 2
|
1 days
Interval 1.0 to 2.0
|
1 days
Interval 1.0 to 2.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Shivering, Dose 3
|
—
|
1 days
Interval 1.0 to 2.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Temperature (Oral), Dose 1
|
1 days
Interval 1.0 to 2.0
|
1 days
Interval 1.0 to 2.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Temperature (Oral), Dose 2
|
1 days
Interval 1.0 to 2.0
|
1 days
Interval 1.0 to 2.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Temperature (Oral), Dose 3
|
—
|
1 days
Interval 1.0 to 2.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Headache, Dose 2
|
2 days
Interval 1.0 to 3.0
|
2 days
Interval 1.0 to 2.5
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Headache, Dose 3
|
—
|
2 days
Interval 1.0 to 2.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Myalgia, Dose 1
|
2 days
Interval 2.0 to 4.0
|
2 days
Interval 1.0 to 3.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Myalgia, Dose 2
|
2 days
Interval 1.0 to 3.0
|
2 days
Interval 1.0 to 3.5
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Myalgia, Dose 3
|
—
|
2 days
Interval 2.0 to 3.0
|
|
Number of Days With Any Solicited Local and General Symptoms
Any Shivering, Dose 1
|
1 days
Interval 1.0 to 2.0
|
2 days
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: From the first dose up to 30 days post last vaccination periodAn 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 |
Co-Ad Group
n=432 Participants
Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
Control Group
n=433 Participants
Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Subjects with any AE(s)
|
132 Participants
|
140 Participants
|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Subjects with related AE(s)
|
34 Participants
|
28 Participants
|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Subjects with grade 3 AE(s)
|
16 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: From the first dose up to 30 days post last vaccination periodPopulation: The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.
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 |
Co-Ad Group
n=432 Participants
Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
Control Group
n=433 Participants
Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) [From the First Dose up to 30 Days Post Last Vaccination Period]
Subjects with any SAE(s)
|
7 Participants
|
9 Participants
|
|
Number of Subjects With Serious Adverse Events (SAEs) [From the First Dose up to 30 Days Post Last Vaccination Period]
Fatal SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From 30 days post last vaccination up to study endPopulation: The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.
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 |
Co-Ad Group
n=432 Participants
Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
Control Group
n=433 Participants
Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) [From 30 Days Post Last Vaccination up to Study End]
Subjects with any SAE(s)
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Serious Adverse Events (SAEs) [From 30 Days Post Last Vaccination up to Study End]
Fatal SAE(s)
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Serious Adverse Events (SAEs) [From 30 Days Post Last Vaccination up to Study End]
Related SAE(s)
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From first vaccination up to 30 days post last vaccination (Month 0 - Month 3 for the Co-Ad Group & Month 0 - Month 5 for the Control Group)Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.
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 |
Co-Ad Group
n=432 Participants
Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
Control Group
n=433 Participants
Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
|---|---|---|
|
Number of Subjects With Potential Immune Mediated Diseases (pIMDs) [From First Vaccination up to 30 Days Post Last Vaccination]
Any pIMDs
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Potential Immune Mediated Diseases (pIMDs) [From First Vaccination up to 30 Days Post Last Vaccination]
Related pIMDs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the period starting after 30 days post last vaccination up to study end (Month 3 - Month 14 for the Co-Ad Group & Month 5 - Month 16 for the Control Group)Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.
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 |
Co-Ad Group
n=432 Participants
Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
Control Group
n=433 Participants
Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
|---|---|---|
|
Number of Subjects With Potential Immune Mediated Diseases (pIMDs) [During the Period Starting After 30 Days Post Last Vaccination up to Study End]
|
1 Participants
|
0 Participants
|
Adverse Events
Co-Ad Group
Serious events: 17 serious events
Other events: 400 other events
Deaths: 2 deaths
Control Group
Serious events: 19 serious events
Other events: 393 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Co-Ad Group
n=432 participants at risk
Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
Control Group
n=433 participants at risk
Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/432
|
0.23%
1/433 • Number of events 1
|
|
Cardiac disorders
Acute myocardial infarction
|
0.69%
3/432 • Number of events 3
|
0.23%
1/433 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.46%
2/432 • Number of events 2
|
0.23%
1/433 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.23%
1/432 • Number of events 1
|
0.46%
2/433 • Number of events 2
|
|
Cardiac disorders
Tachycardia
|
0.23%
1/432 • Number of events 1
|
0.00%
0/433
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/432
|
0.23%
1/433 • Number of events 1
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/432
|
0.23%
1/433 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.23%
1/432 • Number of events 1
|
0.00%
0/433
|
|
General disorders
Asthenia
|
0.23%
1/432 • Number of events 1
|
0.00%
0/433
|
|
General disorders
Chest pain
|
0.00%
0/432
|
0.46%
2/433 • Number of events 2
|
|
Immune system disorders
Sarcoidosis
|
0.23%
1/432 • Number of events 1
|
0.00%
0/433
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/432
|
0.23%
1/433 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/432
|
0.23%
1/433 • Number of events 1
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/432
|
0.23%
1/433 • Number of events 1
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.23%
1/432 • Number of events 1
|
0.00%
0/433
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/432
|
0.23%
1/433 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.23%
1/432 • Number of events 1
|
0.69%
3/433 • Number of events 3
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.23%
1/432 • Number of events 1
|
0.00%
0/433
|
|
Metabolism and nutrition disorders
Gout
|
0.23%
1/432 • Number of events 1
|
0.00%
0/433
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/432
|
0.23%
1/433 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.23%
1/432 • Number of events 1
|
0.00%
0/433
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiomyolipoma
|
0.23%
1/432 • Number of events 1
|
0.00%
0/433
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage iv
|
0.23%
1/432 • Number of events 1
|
0.00%
0/433
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.23%
1/432 • Number of events 1
|
0.00%
0/433
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/432
|
0.23%
1/433 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/432
|
0.23%
1/433 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.23%
1/432 • Number of events 1
|
0.00%
0/433
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/432
|
0.23%
1/433 • Number of events 1
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/432
|
0.23%
1/433 • Number of events 1
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/432
|
0.46%
2/433 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
0.23%
1/432 • Number of events 1
|
0.00%
0/433
|
|
Nervous system disorders
Embolic stroke
|
0.23%
1/432 • Number of events 1
|
0.00%
0/433
|
|
Nervous system disorders
Lumbosacral radiculopathy
|
0.00%
0/432
|
0.23%
1/433 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.23%
1/432 • Number of events 1
|
0.00%
0/433
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/432
|
0.23%
1/433 • Number of events 1
|
|
Nervous system disorders
Vertebral artery dissection
|
0.00%
0/432
|
0.23%
1/433 • Number of events 1
|
|
Psychiatric disorders
Delirium
|
0.00%
0/432
|
0.23%
1/433 • Number of events 1
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/432
|
0.23%
1/433 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.23%
1/432 • Number of events 1
|
0.00%
0/433
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.23%
1/432 • Number of events 1
|
0.00%
0/433
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/432
|
0.23%
1/433 • Number of events 1
|
|
Vascular disorders
Aortic dissection
|
0.23%
1/432 • Number of events 1
|
0.00%
0/433
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/432
|
0.23%
1/433 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/432
|
0.23%
1/433 • Number of events 1
|
Other adverse events
| Measure |
Co-Ad Group
n=432 participants at risk
Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
Control Group
n=433 participants at risk
Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
26.4%
114/432 • Number of events 137
|
19.4%
84/433 • Number of events 116
|
|
Gastrointestinal disorders
Chills
|
31.7%
137/432 • Number of events 176
|
22.9%
99/433 • Number of events 130
|
|
General disorders
Fatigue
|
58.6%
253/432 • Number of events 385
|
52.7%
228/433 • Number of events 385
|
|
General disorders
Pain
|
86.1%
372/432 • Number of events 642
|
82.4%
357/433 • Number of events 754
|
|
General disorders
Pyrexia
|
25.9%
112/432 • Number of events 138
|
22.4%
97/433 • Number of events 110
|
|
General disorders
Swelling
|
31.7%
137/432 • Number of events 178
|
26.6%
115/433 • Number of events 162
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
59.5%
257/432 • Number of events 370
|
52.4%
227/433 • Number of events 376
|
|
Nervous system disorders
Headache
|
48.6%
210/432 • Number of events 306
|
48.3%
209/433 • Number of events 331
|
|
General disorders
Erythema
|
54.2%
234/432 • Number of events 330
|
44.8%
194/433 • Number of events 297
|
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