Trial Outcomes & Findings for Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™ (NCT NCT00907777)
NCT ID: NCT00907777
Last Updated: 2020-11-23
Results Overview
The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
52 participants
Primary outcome timeframe
Before (PRE) and one month after (POST) the additional dose
Results posted on
2020-11-23
Participant Flow
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participant milestones
| Measure |
Prevnar Group
Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
GSK 1024850A Group
Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
27
|
|
Overall Study
COMPLETED
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Prevnar Group
Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
GSK 1024850A Group
Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™
Baseline characteristics by cohort
| Measure |
Prevnar Group
n=25 Participants
Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
GSK 1024850A Group
n=27 Participants
Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.6 Months
STANDARD_DEVIATION 0.91 • n=5 Participants
|
46.7 Months
STANDARD_DEVIATION 0.72 • n=7 Participants
|
46.65 Months
STANDARD_DEVIATION 0.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before (PRE) and one month after (POST) the additional dosePopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.
The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Outcome measures
| Measure |
Prevnar Group
n=24 Participants
Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
GSK 1024850A Group
n=26 Participants
Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
|---|---|---|
|
Vaccine Pneumococcal Serotype Antibody Concentrations
ANTI-1 PRE
|
0.14 μg/mL
Interval 0.09 to 0.23
|
0.38 μg/mL
Interval 0.25 to 0.56
|
|
Vaccine Pneumococcal Serotype Antibody Concentrations
ANTI-1 POST
|
0.16 μg/mL
Interval 0.1 to 0.25
|
1.35 μg/mL
Interval 1.05 to 1.73
|
|
Vaccine Pneumococcal Serotype Antibody Concentrations
ANTI-4 PRE
|
0.27 μg/mL
Interval 0.15 to 0.5
|
0.12 μg/mL
Interval 0.08 to 0.19
|
|
Vaccine Pneumococcal Serotype Antibody Concentrations
ANTI-4 POST
|
4.3 μg/mL
Interval 3.38 to 5.48
|
6.76 μg/mL
Interval 4.91 to 9.3
|
|
Vaccine Pneumococcal Serotype Antibody Concentrations
ANTI-5 PRE
|
0.11 μg/mL
Interval 0.08 to 0.16
|
0.5 μg/mL
Interval 0.34 to 0.75
|
|
Vaccine Pneumococcal Serotype Antibody Concentrations
ANTI-5 POST
|
0.15 μg/mL
Interval 0.1 to 0.22
|
1.78 μg/mL
Interval 1.34 to 2.37
|
|
Vaccine Pneumococcal Serotype Antibody Concentrations
ANTI-6B PRE
|
0.65 μg/mL
Interval 0.38 to 1.12
|
0.48 μg/mL
Interval 0.26 to 0.88
|
|
Vaccine Pneumococcal Serotype Antibody Concentrations
ANTI-6B POST
|
7.46 μg/mL
Interval 4.61 to 12.08
|
1.68 μg/mL
Interval 1.1 to 2.56
|
|
Vaccine Pneumococcal Serotype Antibody Concentrations
ANTI-7F PRE
|
0.18 μg/mL
Interval 0.1 to 0.32
|
0.39 μg/mL
Interval 0.26 to 0.59
|
|
Vaccine Pneumococcal Serotype Antibody Concentrations
ANTI-7F POST
|
0.19 μg/mL
Interval 0.11 to 0.32
|
2.53 μg/mL
Interval 1.83 to 3.51
|
|
Vaccine Pneumococcal Serotype Antibody Concentrations
ANTI-9V PRE
|
0.48 μg/mL
Interval 0.27 to 0.86
|
0.44 μg/mL
Interval 0.29 to 0.65
|
|
Vaccine Pneumococcal Serotype Antibody Concentrations
ANTI-9V POST
|
6.88 μg/mL
Interval 4.98 to 9.51
|
2.13 μg/mL
Interval 1.54 to 2.94
|
|
Vaccine Pneumococcal Serotype Antibody Concentrations
ANTI-14 PRE
|
1.5 μg/mL
Interval 0.82 to 2.74
|
1.98 μg/mL
Interval 1.14 to 3.42
|
|
Vaccine Pneumococcal Serotype Antibody Concentrations
ANTI-14 POST
|
25.82 μg/mL
Interval 14.65 to 45.5
|
9.71 μg/mL
Interval 5.61 to 16.82
|
|
Vaccine Pneumococcal Serotype Antibody Concentrations
ANTI-18C PRE
|
0.34 μg/mL
Interval 0.2 to 0.58
|
0.48 μg/mL
Interval 0.26 to 0.9
|
|
Vaccine Pneumococcal Serotype Antibody Concentrations
ANTI-18C POST
|
4.23 μg/mL
Interval 2.94 to 6.08
|
6.4 μg/mL
Interval 4.61 to 8.87
|
|
Vaccine Pneumococcal Serotype Antibody Concentrations
ANTI-19F PRE
|
2.02 μg/mL
Interval 1.29 to 3.16
|
2.37 μg/mL
Interval 1.41 to 3.98
|
|
Vaccine Pneumococcal Serotype Antibody Concentrations
ANTI-19F POST
|
5.68 μg/mL
Interval 3.82 to 8.45
|
15.61 μg/mL
Interval 11.51 to 21.18
|
|
Vaccine Pneumococcal Serotype Antibody Concentrations
ANTI-23F PRE
|
0.33 μg/mL
Interval 0.2 to 0.53
|
0.23 μg/mL
Interval 0.12 to 0.43
|
|
Vaccine Pneumococcal Serotype Antibody Concentrations
ANTI-23F POST
|
5.82 μg/mL
Interval 3.77 to 8.97
|
1.27 μg/mL
Interval 0.9 to 1.8
|
SECONDARY outcome
Timeframe: Before (PRE) and one month after (POST) the additional dosePopulation: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.
The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Outcome measures
| Measure |
Prevnar Group
n=24 Participants
Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
GSK 1024850A Group
n=26 Participants
Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
|---|---|---|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
OPSONO-1 PRE
|
4 Titers
Interval 4.0 to 4.0
|
5.8 Titers
Interval 3.6 to 9.4
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
OPSONO-1 POST
|
5.5 Titers
Interval 3.4 to 9.1
|
49.3 Titers
Interval 25.5 to 95.2
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
OPSONO-4 PRE
|
20.7 Titers
Interval 6.4 to 67.5
|
12.3 Titers
Interval 4.5 to 33.9
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
OPSONO-4 POST
|
4814 Titers
Interval 3380.8 to 6854.6
|
4380.7 Titers
Interval 3020.5 to 6353.4
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
OPSONO-5 PRE
|
4.2 Titers
Interval 3.8 to 4.6
|
7.5 Titers
Interval 4.5 to 12.5
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
OPSONO-5 POST
|
4.4 Titers
Interval 3.8 to 5.1
|
50.6 Titers
Interval 30.8 to 83.0
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
OPSONO-6B PRE
|
188.2 Titers
Interval 55.5 to 638.0
|
66.3 Titers
Interval 19.7 to 222.7
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
OPSONO-6B POST
|
6734.3 Titers
Interval 3873.2 to 11708.7
|
1424.5 Titers
Interval 775.0 to 2618.4
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
OPSONO-7F PRE
|
1202.9 Titers
Interval 809.0 to 1788.8
|
1498.9 Titers
Interval 1097.8 to 2046.6
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
OPSONO-7F POST
|
1304.2 Titers
Interval 880.7 to 1931.4
|
4657.1 Titers
Interval 3321.2 to 6530.3
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
OPSONO-9V PRE
|
612.9 Titers
Interval 458.6 to 819.3
|
442 Titers
Interval 224.5 to 870.3
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
OPSONO-9V POST
|
5829.4 Titers
Interval 3909.1 to 8693.2
|
2843.5 Titers
Interval 2016.0 to 4010.6
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
OPSONO-14 PRE
|
149.7 Titers
Interval 65.2 to 343.5
|
330 Titers
Interval 186.5 to 584.0
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
OPSONO-14 POST
|
5400.8 Titers
Interval 3491.3 to 8354.8
|
2812.4 Titers
Interval 1734.3 to 4560.7
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
OPSONO-18C PRE
|
16.1 Titers
Interval 5.3 to 49.2
|
23.7 Titers
Interval 7.5 to 74.2
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
OPSONO-18C POST
|
1615.2 Titers
Interval 782.0 to 3336.1
|
2806.6 Titers
Interval 1408.8 to 5591.2
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
OPSONO-19F PRE
|
26.1 Titers
Interval 14.8 to 46.1
|
35.8 Titers
Interval 18.6 to 68.8
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
OPSONO-19F POST
|
241.6 Titers
Interval 133.6 to 436.7
|
837.3 Titers
Interval 559.5 to 1253.2
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
OPSONO-23F PRE
|
1430.2 Titers
Interval 542.5 to 3770.6
|
1383.2 Titers
Interval 630.2 to 3036.0
|
|
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
OPSONO-23F POST
|
23977.2 Titers
Interval 14185.3 to 40528.2
|
4865.1 Titers
Interval 3977.0 to 5951.4
|
SECONDARY outcome
Timeframe: Before (PRE) and one month after (POST) the additional dosePopulation: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.
The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
Outcome measures
| Measure |
Prevnar Group
n=24 Participants
Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
GSK 1024850A Group
n=26 Participants
Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
|---|---|---|
|
Cross-reactive Pneumococcal Serotype Antibody Concentrations
ANTI-6A PRE
|
0.22 μg/mL
Interval 0.13 to 0.37
|
0.19 μg/mL
Interval 0.12 to 0.32
|
|
Cross-reactive Pneumococcal Serotype Antibody Concentrations
ANTI-6A POST
|
1.78 μg/mL
Interval 0.88 to 3.59
|
0.47 μg/mL
Interval 0.29 to 0.75
|
|
Cross-reactive Pneumococcal Serotype Antibody Concentrations
ANTI-19A PRE
|
0.39 μg/mL
Interval 0.2 to 0.78
|
0.29 μg/mL
Interval 0.17 to 0.5
|
|
Cross-reactive Pneumococcal Serotype Antibody Concentrations
ANTI-19A POST
|
0.8 μg/mL
Interval 0.44 to 1.44
|
1.24 μg/mL
Interval 0.79 to 1.95
|
SECONDARY outcome
Timeframe: Before (PRE) and one month after (POST) the additional dosePopulation: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.
The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
Outcome measures
| Measure |
Prevnar Group
n=24 Participants
Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
GSK 1024850A Group
n=24 Participants
Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
|---|---|---|
|
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes
OPSONO-6A PRE
|
106.9 Titers
Interval 44.7 to 255.7
|
117.7 Titers
Interval 43.6 to 318.3
|
|
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes
OPSONO-6A POST
|
2320.4 Titers
Interval 1180.2 to 4562.5
|
966.2 Titers
Interval 634.8 to 1470.6
|
|
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes
OPSONO-19A PRE
|
10.4 Titers
Interval 4.9 to 22.1
|
19.6 Titers
Interval 6.6 to 58.8
|
|
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes
OPSONO-19A POST
|
101.3 Titers
Interval 42.7 to 240.7
|
153.9 Titers
Interval 67.7 to 349.9
|
SECONDARY outcome
Timeframe: Before (PRE) and one month after (POST) the additional dosePopulation: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.
The anti-protein D antibody cut-off value (greater than or equal to ≥100 EL.U/mL) was assessed by Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
Outcome measures
| Measure |
Prevnar Group
n=24 Participants
Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
GSK 1024850A Group
n=26 Participants
Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
|---|---|---|
|
Anti-protein D Antibody Concentrations
ANTI-PD PRE
|
104.1 EL.U/mL
Interval 76.8 to 140.9
|
173.1 EL.U/mL
Interval 113.5 to 263.9
|
|
Anti-protein D Antibody Concentrations
ANTI-PD POST
|
85.9 EL.U/mL
Interval 64.1 to 115.0
|
1135.6 EL.U/mL
Interval 709.0 to 1819.0
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7) post-additional dosePopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.
Solicited local symptoms assessed include pain, redness, and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger (\>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.
Outcome measures
| Measure |
Prevnar Group
n=25 Participants
Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
GSK 1024850A Group
n=26 Participants
Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling
|
4 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Pain
|
11 Participants
|
16 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Redness
|
13 Participants
|
14 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness
|
7 Participants
|
3 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Swelling
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: During the 8-day (Days 0-7) post-additional dosePopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.
Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (\>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal everyday activities. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.
Outcome measures
| Measure |
Prevnar Group
n=25 Participants
Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
GSK 1024850A Group
n=26 Participants
Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness
|
4 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness
|
0 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever
|
1 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever
|
0 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability
|
5 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability
|
2 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite
|
3 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite
|
1 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Within 31 days (Day 0-30) post-additional vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.
An AE is 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. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Outcome measures
| Measure |
Prevnar Group
n=25 Participants
Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
GSK 1024850A Group
n=27 Participants
Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Throughout the entire study period (approximately 1 month per subject)Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the additional vaccine administration documented.
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above.
Outcome measures
| Measure |
Prevnar Group
n=25 Participants
Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
GSK 1024850A Group
n=27 Participants
Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
Adverse Events
Prevnar Group
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
GSK 1024850A Group
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prevnar Group
n=25 participants at risk
Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
GSK 1024850A Group
n=27 participants at risk
Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 \[10PN-PD-DIT-003 (105554)\] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 \[10PN-PD-DIT-008 BST: 003 (106623)\], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
|
|---|---|---|
|
General disorders
Pain
|
44.0%
11/25 • SAEs: during the entire study period (approximately 1 month per subject); Solicited local and general symptoms: within 8 days after the additional vaccination; Unsolicited symptoms: within 31 days after the additional vaccination.
|
61.5%
16/26 • SAEs: during the entire study period (approximately 1 month per subject); Solicited local and general symptoms: within 8 days after the additional vaccination; Unsolicited symptoms: within 31 days after the additional vaccination.
|
|
General disorders
Redness
|
52.0%
13/25 • SAEs: during the entire study period (approximately 1 month per subject); Solicited local and general symptoms: within 8 days after the additional vaccination; Unsolicited symptoms: within 31 days after the additional vaccination.
|
53.8%
14/26 • SAEs: during the entire study period (approximately 1 month per subject); Solicited local and general symptoms: within 8 days after the additional vaccination; Unsolicited symptoms: within 31 days after the additional vaccination.
|
|
General disorders
Swelling
|
28.0%
7/25 • SAEs: during the entire study period (approximately 1 month per subject); Solicited local and general symptoms: within 8 days after the additional vaccination; Unsolicited symptoms: within 31 days after the additional vaccination.
|
34.6%
9/26 • SAEs: during the entire study period (approximately 1 month per subject); Solicited local and general symptoms: within 8 days after the additional vaccination; Unsolicited symptoms: within 31 days after the additional vaccination.
|
|
General disorders
Drowsiness
|
16.0%
4/25 • SAEs: during the entire study period (approximately 1 month per subject); Solicited local and general symptoms: within 8 days after the additional vaccination; Unsolicited symptoms: within 31 days after the additional vaccination.
|
46.2%
12/26 • SAEs: during the entire study period (approximately 1 month per subject); Solicited local and general symptoms: within 8 days after the additional vaccination; Unsolicited symptoms: within 31 days after the additional vaccination.
|
|
General disorders
Fever (>38.0°C)
|
4.0%
1/25 • SAEs: during the entire study period (approximately 1 month per subject); Solicited local and general symptoms: within 8 days after the additional vaccination; Unsolicited symptoms: within 31 days after the additional vaccination.
|
30.8%
8/26 • SAEs: during the entire study period (approximately 1 month per subject); Solicited local and general symptoms: within 8 days after the additional vaccination; Unsolicited symptoms: within 31 days after the additional vaccination.
|
|
General disorders
Irritability
|
20.0%
5/25 • SAEs: during the entire study period (approximately 1 month per subject); Solicited local and general symptoms: within 8 days after the additional vaccination; Unsolicited symptoms: within 31 days after the additional vaccination.
|
34.6%
9/26 • SAEs: during the entire study period (approximately 1 month per subject); Solicited local and general symptoms: within 8 days after the additional vaccination; Unsolicited symptoms: within 31 days after the additional vaccination.
|
|
General disorders
Loss of appetite
|
12.0%
3/25 • SAEs: during the entire study period (approximately 1 month per subject); Solicited local and general symptoms: within 8 days after the additional vaccination; Unsolicited symptoms: within 31 days after the additional vaccination.
|
46.2%
12/26 • SAEs: during the entire study period (approximately 1 month per subject); Solicited local and general symptoms: within 8 days after the additional vaccination; Unsolicited symptoms: within 31 days after the additional vaccination.
|
Additional Information
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