Trial Outcomes & Findings for Comparing Two Pneumococcal Vaccines in Adults With Chronic Obstructive Pulmonary Disease (NCT NCT00457977)
NCT ID: NCT00457977
Last Updated: 2015-05-12
Results Overview
Opsonophagocytosis activity (OPK) serotype specific geometric means
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
181 participants
Primary outcome timeframe
Measured at Baseline, Months 1, 12, and 24
Results posted on
2015-05-12
Participant Flow
Participant's were recruited from 10 medical centers across the US from April 9, 2007 to May 7, 2009.
Participant milestones
| Measure |
Pneumovax (PPSV23)
pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
|
Prevnar (PCV7)
diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
91
|
|
Overall Study
1-Month
|
88
|
87
|
|
Overall Study
1-Year
|
69
|
76
|
|
Overall Study
2-Year
|
62
|
66
|
|
Overall Study
COMPLETED
|
62
|
66
|
|
Overall Study
NOT COMPLETED
|
28
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Two Pneumococcal Vaccines in Adults With Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Pneumovax (PPSV23)
n=90 Participants
pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
|
Prevnar (PCV7)
n=91 Participants
diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 10 • n=5 Participants
|
63 years
STANDARD_DEVIATION 9 • n=7 Participants
|
64 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
90 participants
n=5 Participants
|
91 participants
n=7 Participants
|
181 participants
n=5 Participants
|
|
Forced expiratory volume at one second (FEV1)
|
1.27 LIters (L)
STANDARD_DEVIATION 0.50 • n=5 Participants
|
1.33 LIters (L)
STANDARD_DEVIATION 0.53 • n=7 Participants
|
1.30 LIters (L)
STANDARD_DEVIATION 0.51 • n=5 Participants
|
|
FEV1 (% Predicted)
|
44.8 percent predicted
STANDARD_DEVIATION 15.1 • n=5 Participants
|
44.9 percent predicted
STANDARD_DEVIATION 14.7 • n=7 Participants
|
44.8 percent predicted
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
forced expiratory volume at one second/forced vital capacity (FEV1/FVC)
|
45.0 percentage of FEV1/FVC
STANDARD_DEVIATION 12.5 • n=5 Participants
|
45.8 percentage of FEV1/FVC
STANDARD_DEVIATION 12.6 • n=7 Participants
|
45.4 percentage of FEV1/FVC
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Race
Caucasian
|
68 participants
n=5 Participants
|
70 participants
n=7 Participants
|
138 participants
n=5 Participants
|
|
Race
African American
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Race
Asian
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race
Native American
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race
Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race
More than one
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Oxygen use at baseline
Oxygen User
|
29 participants
n=5 Participants
|
21 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Oxygen use at baseline
Non-oxygen user
|
61 participants
n=5 Participants
|
70 participants
n=7 Participants
|
131 participants
n=5 Participants
|
|
Pack years smoking
|
54.9 pack years
STANDARD_DEVIATION 27.1 • n=5 Participants
|
52.0 pack years
STANDARD_DEVIATION 27.6 • n=7 Participants
|
53.4 pack years
STANDARD_DEVIATION 27.3 • n=5 Participants
|
|
Current Smoker
Current Smoker
|
32 participants
n=5 Participants
|
33 participants
n=7 Participants
|
65 participants
n=5 Participants
|
|
Current Smoker
Non-Current Smoker
|
58 participants
n=5 Participants
|
58 participants
n=7 Participants
|
116 participants
n=5 Participants
|
|
Vaccine Naive
Vaccine Naive
|
42 participants
n=5 Participants
|
45 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Vaccine Naive
Previously Vaccinated
|
48 participants
n=5 Participants
|
46 participants
n=7 Participants
|
94 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Baseline, Months 1, 12, and 24Population: All participants with blood samples were analyzed.
Opsonophagocytosis activity (OPK) serotype specific geometric means
Outcome measures
| Measure |
Pneumovax (PPSV23)
n=90 Participants
pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
|
Prevnar (PCV7)
n=91 Participants
diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
|
|---|---|---|
|
Serotype Opsonization Titers
Serotype 4 Baseline
|
10.85 titers
Interval 7.46 to 15.79
|
12.63 titers
Interval 8.15 to 19.58
|
|
Serotype Opsonization Titers
Serotype 4 1-Month
|
132.51 titers
Interval 79.78 to 220.09
|
908.23 titers
Interval 609.84 to 1352.63
|
|
Serotype Opsonization Titers
Serotype 4 1-Year
|
61.79 titers
Interval 35.58 to 107.34
|
268.52 titers
Interval 157.82 to 456.86
|
|
Serotype Opsonization Titers
Serotype 4 2-Year
|
69.12 titers
Interval 38.15 to 125.23
|
236.89 titers
Interval 134.53 to 417.13
|
|
Serotype Opsonization Titers
Serotype 6B Baseline
|
33.26 titers
Interval 20.7 to 53.45
|
49.76 titers
Interval 31.4 to 78.76
|
|
Serotype Opsonization Titers
Serotype 6B 1-Month
|
388.08 titers
Interval 231.39 to 650.89
|
1003.30 titers
Interval 653.4 to 1540.56
|
|
Serotype Opsonization Titers
Serotype 6B 1-Year
|
293.06 titers
Interval 129.54 to 405.8
|
476.15 titers
Interval 293.06 to 773.64
|
|
Serotype Opsonization Titers
Serotype 6B 2-Year
|
240.32 titers
Interval 126.3 to 457.28
|
322.98 titers
Interval 184.43 to 565.62
|
|
Serotype Opsonization Titers
Serotype 9V Baseline
|
37.17 titers
Interval 22.25 to 62.08
|
31.44 titers
Interval 19.72 to 50.14
|
|
Serotype Opsonization Titers
Serotype 9V 1-Month
|
267.34 titers
Interval 165.45 to 431.96
|
734.52 titers
Interval 488.94 to 1103.43
|
|
Serotype Opsonization Titers
Serotype 9V 1-Year
|
142.22 titers
Interval 81.86 to 247.1
|
443.55 titers
Interval 283.8 to 693.21
|
|
Serotype Opsonization Titers
Serotype 9V 2-Year
|
219.35 titers
Interval 122.65 to 392.28
|
432.85 titers
Interval 258.03 to 726.13
|
|
Serotype Opsonization Titers
Serotype 14 Baseline
|
138.61 titers
Interval 76.62 to 250.75
|
116.90 titers
Interval 63.07 to 216.69
|
|
Serotype Opsonization Titers
Serotype 14 1-Month
|
1895.17 titers
Interval 1207.15 to 2975.32
|
2584.06 titers
Interval 1728.32 to 3863.5
|
|
Serotype Opsonization Titers
Serotype 14 1-Year
|
839.72 titers
Interval 493.8 to 1427.96
|
1801.11 titers
Interval 1158.45 to 2800.29
|
|
Serotype Opsonization Titers
Serotype 14 2-Year
|
594.09 titers
Interval 357.99 to 985.91
|
1255.24 titers
Interval 786.0 to 2004.63
|
|
Serotype Opsonization Titers
Serotype 18C Baseline
|
42.32 titers
Interval 25.25 to 70.93
|
42.81 titers
Interval 26.18 to 70.02
|
|
Serotype Opsonization Titers
Serotype 18C 1-Month
|
544.49 titers
Interval 334.23 to 887.02
|
1815.99 titers
Interval 1217.04 to 2709.74
|
|
Serotype Opsonization Titers
Serotype 18C 1-Year
|
284.41 titers
Interval 170.67 to 473.97
|
665.09 titers
Interval 447.27 to 988.97
|
|
Serotype Opsonization Titers
Serotype 18C 2-Year
|
267.94 titers
Interval 151.74 to 473.14
|
540.01 titers
Interval 361.42 to 806.84
|
|
Serotype Opsonization Titers
Serotype 19F Baseline
|
13.71 titers
Interval 8.4 to 22.38
|
16.86 titers
Interval 10.31 to 27.57
|
|
Serotype Opsonization Titers
Serotype 19F 1-Month
|
266.49 titers
Interval 155.07 to 457.97
|
193.62 titers
Interval 110.85 to 338.22
|
|
Serotype Opsonization Titers
Serotype 19F 1-year
|
116.35 titers
Interval 65.51 to 206.66
|
85.87 titers
Interval 47.26 to 156.03
|
|
Serotype Opsonization Titers
Serotype 19F 2-Year
|
134.21 titers
Interval 77.52 to 232.36
|
116.40 titers
Interval 64.04 to 211.57
|
|
Serotype Opsonization Titers
Serotype 23F Baseline
|
11.79 titers
Interval 7.59 to 18.33
|
18.35 titers
Interval 11.34 to 29.68
|
|
Serotype Opsonization Titers
Serotype 23F 1-Month
|
114.86 titers
Interval 64.88 to 203.35
|
1170.32 titers
Interval 700.32 to 1955.75
|
|
Serotype Opsonization Titers
Serotype 23F 1-Year
|
47.75 titers
Interval 26.09 to 87.38
|
407.11 titers
Interval 238.14 to 695.95
|
|
Serotype Opsonization Titers
Serotype 23F 2-Year
|
39.97 titers
Interval 22.63 to 70.6
|
266.16 titers
Interval 140.25 to 505.09
|
SECONDARY outcome
Timeframe: Measured at Baseline, Months 1, 12, and 24Population: All participants with blood samples were analyzed.
Serotype-specific immunoglobulin G Geometric Mean IgG antibody levels (ug/ml)
Outcome measures
| Measure |
Pneumovax (PPSV23)
n=90 Participants
pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
|
Prevnar (PCV7)
n=91 Participants
diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
|
|---|---|---|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 19F Baseline
|
3.20 ug/ml
Interval 2.62 to 3.91
|
3.01 ug/ml
Interval 2.45 to 3.7
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 4 Baseline
|
0.30 ug/ml
Interval 0.23 to 0.38
|
0.28 ug/ml
Interval 0.21 to 0.37
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 4 1-Month
|
0.74 ug/ml
Interval 0.54 to 1.01
|
1.95 ug/ml
Interval 1.39 to 2.73
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 4 1-Year
|
0.43 ug/ml
Interval 0.31 to 0.6
|
0.70 ug/ml
Interval 0.5 to 0.97
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 4 2-Year
|
0.45 ug/ml
Interval 0.32 to 0.65
|
0.53 ug/ml
Interval 0.38 to 0.75
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 6B Baseline
|
0.89 ug/ml
Interval 0.73 to 1.09
|
0.90 ug/ml
Interval 0.72 to 1.13
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 6B 1-Month
|
2.26 ug/ml
Interval 1.65 to 3.09
|
3.19 ug/ml
Interval 2.35 to 4.34
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 6B 1-Year
|
1.32 ug/ml
Interval 1.02 to 1.72
|
1.77 ug/ml
Interval 1.29 to 2.42
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 6B 2-Year
|
1.27 ug/ml
Interval 0.95 to 1.69
|
1.33 ug/ml
Interval 0.95 to 1.85
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 9V Baseline
|
0.83 ug/ml
Interval 0.64 to 1.07
|
0.78 ug/ml
Interval 0.6 to 1.01
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 9V 1-Month
|
2.72 ug/ml
Interval 1.98 to 3.72
|
4.87 ug/ml
Interval 3.64 to 6.5
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 9V 1-Year
|
1.53 ug/ml
Interval 1.11 to 2.09
|
2.15 ug/ml
Interval 1.59 to 2.91
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 9V 2-Year
|
1.37 ug/ml
Interval 0.98 to 1.9
|
1.65 ug/ml
Interval 1.22 to 2.24
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 14 Baseline
|
2.59 ug/ml
Interval 1.87 to 3.57
|
2.53 ug/ml
Interval 1.77 to 3.61
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 14 1-Month
|
10.80 ug/ml
Interval 7.47 to 15.61
|
15.73 ug/ml
Interval 11.25 to 22.0
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 14 1-Year
|
5.76 ug/ml
Interval 3.97 to 8.35
|
7.47 ug/ml
Interval 5.15 to 10.84
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 14 2-Year
|
4.82 ug/ml
Interval 3.38 to 6.88
|
5.68 ug/ml
Interval 3.75 to 8.58
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 18C Baseline
|
1.16 ug/ml
Interval 0.88 to 1.53
|
1.07 ug/ml
Interval 0.78 to 1.46
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 18C 1-Month
|
4.25 ug/ml
Interval 3.11 to 5.82
|
9.65 ug/ml
Interval 7.22 to 12.89
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 18C 1-Year
|
2.25 ug/ml
Interval 1.59 to 3.19
|
3.74 ug/ml
Interval 2.78 to 5.03
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 18C 2-Year
|
1.94 ug/ml
Interval 1.38 to 2.72
|
2.77 ug/ml
Interval 2.05 to 3.74
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 19F 1-Month
|
6.79 ug/ml
Interval 5.27 to 8.76
|
7.54 ug/ml
Interval 5.76 to 9.85
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 19F 1-year
|
4.25 ug/ml
Interval 3.26 to 5.53
|
4.32 ug/ml
Interval 3.37 to 5.52
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 19F 2-Year
|
3.85 ug/ml
Interval 2.9 to 5.11
|
3.68 ug/ml
Interval 2.74 to 4.94
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 23F Baseline
|
0.58 ug/ml
Interval 0.45 to 0.75
|
0.74 ug/ml
Interval 0.56 to 0.98
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 23F 1-Month
|
1.88 ug/ml
Interval 1.29 to 2.73
|
7.76 ug/ml
Interval 5.49 to 10.97
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 23F 1-Year
|
1.12 ug/ml
Interval 0.8 to 1.55
|
2.73 ug/ml
Interval 1.94 to 3.84
|
|
Serotype-specific Immunoglobulin G (IgG) Antibody Levels
Serotype 23F 2-Year
|
1.00 ug/ml
Interval 0.72 to 1.39
|
1.99 ug/ml
Interval 1.38 to 2.86
|
Adverse Events
Pneumovax (PPSV23)
Serious events: 27 serious events
Other events: 58 other events
Deaths: 0 deaths
Prevnar (PCV7)
Serious events: 32 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pneumovax (PPSV23)
n=90 participants at risk
pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
|
Prevnar (PCV7)
n=91 participants at risk
diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
|
|---|---|---|
|
Infections and infestations
Intestinal Infectious Disease
|
0.00%
0/90 • 2 Years
|
1.1%
1/91 • Number of events 1 • 2 Years
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/90 • 2 Years
|
1.1%
1/91 • Number of events 2 • 2 Years
|
|
Infections and infestations
Viral Infection
|
1.1%
1/90 • Number of events 1 • 2 Years
|
2.2%
2/91 • Number of events 2 • 2 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral Neoplasm
|
0.00%
0/90 • 2 Years
|
1.1%
1/91 • Number of events 1 • 2 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Digestive Neoplasm
|
0.00%
0/90 • 2 Years
|
1.1%
1/91 • Number of events 1 • 2 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Respiratory Neoplasm
|
2.2%
2/90 • Number of events 2 • 2 Years
|
2.2%
2/91 • Number of events 2 • 2 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign or Uncertain Neoplasm
|
1.1%
1/90 • Number of events 1 • 2 Years
|
0.00%
0/91 • 2 Years
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/90 • 2 Years
|
1.1%
1/91 • Number of events 1 • 2 Years
|
|
Endocrine disorders
Hypercalcemia
|
0.00%
0/90 • 2 Years
|
1.1%
1/91 • Number of events 1 • 2 Years
|
|
Blood and lymphatic system disorders
Anemia
|
1.1%
1/90 • Number of events 1 • 2 Years
|
0.00%
0/91 • 2 Years
|
|
Eye disorders
Cataract
|
0.00%
0/90 • 2 Years
|
1.1%
1/91 • Number of events 1 • 2 Years
|
|
Vascular disorders
Hypertensive
|
0.00%
0/90 • 2 Years
|
1.1%
1/91 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Ischemic Heart Disease
|
1.1%
1/90 • Number of events 1 • 2 Years
|
2.2%
2/91 • Number of events 3 • 2 Years
|
|
Vascular disorders
Pulmonary Circulation
|
1.1%
1/90 • Number of events 1 • 2 Years
|
0.00%
0/91 • 2 Years
|
|
Cardiac disorders
Other Heart Disease
|
2.2%
2/90 • Number of events 2 • 2 Years
|
1.1%
1/91 • Number of events 1 • 2 Years
|
|
Vascular disorders
Atherosclerosis
|
1.1%
1/90 • Number of events 2 • 2 Years
|
0.00%
0/91 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.6%
5/90 • Number of events 7 • 2 Years
|
7.7%
7/91 • Number of events 7 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
1.1%
1/90 • Number of events 1 • 2 Years
|
0.00%
0/91 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
10.0%
9/90 • Number of events 11 • 2 Years
|
12.1%
11/91 • Number of events 14 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/90 • 2 Years
|
2.2%
2/91 • Number of events 2 • 2 Years
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/90 • 2 Years
|
1.1%
1/91 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
2.2%
2/90 • Number of events 2 • 2 Years
|
1.1%
1/91 • Number of events 2 • 2 Years
|
|
Gastrointestinal disorders
Liver Disease
|
1.1%
1/90 • Number of events 1 • 2 Years
|
1.1%
1/91 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Inflammatory diseases of prostate
|
1.1%
1/90 • Number of events 2 • 2 Years
|
0.00%
0/91 • 2 Years
|
|
Renal and urinary disorders
Cystitis
|
1.1%
1/90 • Number of events 1 • 2 Years
|
0.00%
0/91 • 2 Years
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.1%
1/90 • Number of events 1 • 2 Years
|
0.00%
0/91 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
0.00%
0/90 • 2 Years
|
1.1%
1/91 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Arthropy
|
2.2%
2/90 • Number of events 2 • 2 Years
|
1.1%
1/91 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Osteopathy
|
0.00%
0/90 • 2 Years
|
1.1%
1/91 • Number of events 1 • 2 Years
|
|
General disorders
Epistaxis
|
0.00%
0/90 • 2 Years
|
1.1%
1/91 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Other Respiratory
|
2.2%
2/90 • Number of events 2 • 2 Years
|
3.3%
3/91 • Number of events 3 • 2 Years
|
|
General disorders
Death Unkown Cause
|
2.2%
2/90 • Number of events 2 • 2 Years
|
3.3%
3/91 • Number of events 3 • 2 Years
|
|
Injury, poisoning and procedural complications
Complication from surgery
|
0.00%
0/90 • 2 Years
|
1.1%
1/91 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/90 • 2 Years
|
3.3%
3/91 • Number of events 3 • 2 Years
|
|
Injury, poisoning and procedural complications
Concussion
|
1.1%
1/90 • Number of events 1 • 2 Years
|
0.00%
0/91 • 2 Years
|
|
Injury, poisoning and procedural complications
Multiple drug intoxication
|
1.1%
1/90 • Number of events 1 • 2 Years
|
0.00%
0/91 • 2 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm
|
0.00%
0/90 • 2 Years
|
1.1%
1/91 • Number of events 1 • 2 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine Neoplasm
|
1.1%
1/90 • Number of events 1 • 2 Years
|
0.00%
0/91 • 2 Years
|
|
Nervous system disorders
Cerebrovascular Disease
|
1.1%
1/90 • Number of events 1 • 2 Years
|
0.00%
0/91 • 2 Years
|
Other adverse events
| Measure |
Pneumovax (PPSV23)
n=90 participants at risk
pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
|
Prevnar (PCV7)
n=91 participants at risk
diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign or Uncertain Neoplasms
|
1.1%
1/90 • Number of events 1 • 2 Years
|
5.5%
5/91 • Number of events 6 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Infection
|
16.7%
15/90 • Number of events 18 • 2 Years
|
16.5%
15/91 • Number of events 19 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Skin - Inflammatory
|
5.6%
5/90 • Number of events 5 • 2 Years
|
3.3%
3/91 • Number of events 3 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
5.6%
5/90 • Number of events 5 • 2 Years
|
3.3%
3/91 • Number of events 3 • 2 Years
|
|
Nervous system disorders
Pain
|
5.6%
5/90 • Number of events 7 • 2 Years
|
5.5%
5/91 • Number of events 5 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
44.4%
40/90 • Number of events 84 • 2 Years
|
39.6%
36/91 • Number of events 74 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Rheumatism
|
6.7%
6/90 • Number of events 7 • 2 Years
|
7.7%
7/91 • Number of events 11 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Other - Respiratory
|
12.2%
11/90 • Number of events 13 • 2 Years
|
12.1%
11/91 • Number of events 11 • 2 Years
|
|
Investigations
Sprains
|
6.7%
6/90 • Number of events 6 • 2 Years
|
2.2%
2/91 • Number of events 2 • 2 Years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place