A Phase 2 interventional study of ACC-001 + QS-21 and QS-21 in Alzheimer Disease, sponsored by Pfizer. Completed at 27 sites in United States. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-01-01.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in subjects with mild to moderate Alzheimer's disease.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 160 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ACC-001
Biological: ACC-001 + QS-21
QS-21
Biological: QS-21
Diluent: Phosphate Buffered Saline
Other: Diluent: Phosphate Buffered Saline
ACC-001
Biological: ACC-001
IM injection, ACC-001 (3ug, or 10ug, or 30ug) + QS-21 50ug at Day 1 and weeks 4, 12, 26, and 52
IM injection, QS-21 (50 ug) at Day 1 and weeks 4, 12, 26, and 52
IM injection, PBS Diluent at Day 1 and weeks 4, 12, 26, and 52
IM injection, ACC 001 (10 ug, 30ug) at Day 1 and weeks 4, 12, 26, and 52
Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)
An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose
Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.
Time frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.
Time frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)
IgG subtypes were not assessed
Time frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
Planned duration was approximately 110 weeks (including 6 week screening period, 52 weeks of dosing, and 52 weeks of follow-up). Participants who completed the NCT00498602 study through Week 78 had the option to exit after this time point, for continued treatment and follow-up under extension protocol extension protocol NCT00960531.
| Milestone | ACC 3 μg+QS-21 | ACC 10 μg+QS-21 | ACC 30 μg+QS-21 | ACC 10 μg | ACC 30 μg | QS-21 Alone | Phosphate Buffered Saline |
|---|---|---|---|---|---|---|---|
| Started | 36 | 61 | 40 | 35 | 12 | 44 | 17 |
| Treated | 36 | 60 | 40 | 35 | 12 | 44 | 17 |
| Completed | 26 | 51 | 32 | 30 | 8 | 31 | 15 |
| Not completed | 10 | 10 | 8 | 5 | 4 | 13 | 2 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Lack of efficacy | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 2 | 0 | 2 | 0 | 0 | 0 |
| Withdrew: Adverse event (ae) related to study drug | 1 | 0 | 3 | 2 | 0 | 1 | 0 |
| Withdrew: Ae not related to study drug | 1 | 3 | 0 | 0 | 2 | 2 | 1 |
| Withdrew: Caregiver request | 2 | 2 | 2 | 0 | 1 | 2 | 0 |
| Withdrew: Investigator request | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Subject request | 3 | 0 | 1 | 1 | 1 | 4 | 1 |
| Withdrew: Other | 2 | 3 | 1 | 0 | 0 | 3 | 0 |
An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
| percentage of participants | ACC 3 μg+QS-21 | ACC 10 μg+QS-21 | ACC 30 μg+QS-21 | ACC 10 μg | ACC 30 μg | QS-21 Alone | Phosphate Buffered Saline |
|---|---|---|---|---|---|---|---|
| Percentage of participants with AEs | 97.2 | 93.3 | 90.0 | 91.4 | 83.3 | 90.9 | 100 |
| Percentage of participants with SAEs | 16.7 | 18.3 | 17.5 | 14.3 | 41.7 | 11.4 | 17.6 |
The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.
| U/mL | ACC 3 μg+QS-21 | ACC 10 μg+QS-21 | ACC 30 μg+QS-21 | ACC 10 μg | ACC 30 μg | QS-21 Alone | Phosphate Buffered Saline |
|---|---|---|---|---|---|---|---|
| Baseline (N: 36, 59, 40, 35, 12, 44, 17) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) | 53.1 (47.1 to 59.8) | 50.0 (50.0 to 50.0) |
| Week 2 (N: 35, 60, 39, 35, 12, 43, 16) | 56.6 (49.1 to 65.3) | 69.0 (57.4 to 83.0) | 86.5 (65.7 to 113.9) | 51.7 (48.3 to 55.2) | 50.0 (50.0 to 50.0) | 52.5 (47.5 to 58.1) | 50.0 (50.0 to 50.0) |
| Week 4 (N: 35, 57, 38, 31, 12, 43, 16) | 53.2 (48.5 to 58.4) | 77.1 (61.9 to 96.0) | 82.8 (63.0 to 108.8) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) | 51.3 (48.7 to 53.9) | 50.0 (50.0 to 50.0) |
| Week 6 (N: 36, 58, 37, 33, 12, 41, 16) | 634.8 (322.7 to 1248.5) | 1089.4 (616.0 to 1837.2) | 1343.5 (716.0 to 2521.1) | 73.4 (50.6 to 106.4) | 103.7 (38.2 to 281.4) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) |
| Week 8 (N: 33, 57, 39, 33, 12, 41, 17) | 497.4 (253.5 to 976.1) | 885.2 (530.0 to 1478.7) | 1098.2 (626.9 to 1924.0) | 66.3 (48.2 to 91.1) | 99.8 (38.8 to 256.6) | 52.4 (47.6 to 57.7) | 50.0 (50.0 to 50.0) |
| Week 10 (N: 34, 59, 40, 33, 12, 43, 17) | 292.3 (156.5 to 546.0) | 762.8 (468.5 to 1242.2) | 878.5 (531.3 to 1452.6) | 77.0 (48.0 to 123.3) | 94.9 (39.8 to 226.5) | 53.0 (47.1 to 59.7) | 50.0 (50.0 to 50.0) |
| Week 14 (N: 33, 52, 39, 31, 11, 33, 14) | 907.5 (474.6 to 1735.6) | 2892.3 (1705.9 to 4903.8) | 3136.8 (1877.6 to 5240.7) | 89.6 (50.8 to 158.3) | 199.4 (73.7 to 539.8) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) |
| Week 16 (N: 33, 59, 38, 34, 12, 41, 16) | 996.1 (487.1 to 2037.1) | 3273.2 (2083.9 to 5141.4) | 3324.7 (1959.9 to 5641.3) | 91.7 (55.2 to 152.1) | 133.9 (56.1 to 319.9) | 52.6 (47.5 to 58.1) | 50.0 (50.0 to 50.0) |
| Week 24 (N: 34, 58, 37, 33, 10, 40, 16) | 547.8 (278.8 to 1076.3) | 1827.6 (1145.3 to 2916.1) | 1231.3 (712.2 to 2128.6) | 76.1 (52.1 to 111.1) | 139.1 (52.1 to 371.3) | 52.3 (47.4 to 57.4) | 50.0 (50.0 to 50.0) |
| Week 28 (N: 31, 51, 33, 29, 8, 36, 16) | 2011.2 (986.9 to 4098.8) | 4299.6 (2843.8 to 6500.8) | 5407.7 (3676.0 to 7955.3) | 108.9 (61.9 to 191.8) | 334.1 (77.1 to 1448.3) | 52.4 (47.6 to 57.6) | 50.0 (50.0 to 50.0) |
| Week 30 (N: 33, 56, 36, 32, 10, 38, 16) | 2028.9 (1035.8 to 3973.8) | 4316.8 (2900.2 to 6425.2) | 4713.0 (3076.0 to 7221.2) | 110.4 (64.1 to 190.0) | 234.5 (65.3 to 842.5) | 51.8 (48.2 to 55.7) | 50.0 (50.0 to 50.0) |
| Week 40 (N: 32, 54, 33, 33, 9, 37, 15) | 1167.3 (609.1 to 2237.1) | 2147.2 (1407.6 to 3275.3) | 2292.9 (1436.6 to 3659.8) | 97.2 (62.4 to 151.3) | 211.0 (53.6 to 830.7) | 52.1 (47.9 to 56.7) | 50.0 (50.0 to 50.0) |
| Week 50 (N: 29, 53, 33, 33, 9, 36, 16) | 937.3 (482.0 to 1822.6) | 1364.4 (911.9 to 2041.4) | 1262.3 (828.5 to 1923.2) | 80.7 (54.8 to 118.9) | 168.4 (52.4 to 541.3) | 52.8 (47.3 to 58.8) | 50.0 (50.0 to 50.0) |
| Week 54 (N: 27, 51, 30, 29, 9, 29, 14) | 2031.6 (1024.2 to 4029.7) | 5744.6 (3609.1 to 9143.7) | 6677.3 (3678.7 to 12120.1) | 160.6 (69.7 to 370.2) | 491.6 (85.9 to 2812.2) | 55.0 (45.2 to 66.9) | 50.0 (50.0 to 50.0) |
| Week 56 (N: 31, 52, 34, 32, 9, 34, 15) | 2635.7 (1355.5 to 5125.2) | 5906.1 (4058.8 to 8594.2) | 7642.5 (5057.9 to 11547.9) | 159.2 (74.2 to 341.8) | 463.7 (81.1 to 2650.5) | 53.4 (46.7 to 60.9) | 50.0 (50.0 to 50.0) |
| Week 66 (N: 31, 54, 34, 31, 9, 33, 15) | 1372.0 (717.1 to 2625.1) | 2867.4 (1835.9 to 4478.5) | 2882.2 (1793.1 to 4632.8) | 166.3 (78.8 to 350.9) | 280.0 (56.3 to 1393.9) | 63.5 (43.7 to 92.3) | 50.0 (50.0 to 50.0) |
| Week 78 (N: 31, 52, 32, 32, 8, 32, 14) | 1108.4 (585.1 to 2099.4) | 1867.5 (1197.4 to 2912.5) | 1338.1 (827.3 to 2164.4) | 142.7 (71.5 to 285.1) | 256.1 (58.2 to 1128.2) | 53.6 (46.5 to 61.6) | 50.0 (50.0 to 50.0) |
| Week 91 (N: 15, 9, 3, 8, 2, 6, 2) | 1824.6 (1063.2 to 3131.2) | 2497.0 (644.8 to 9670.1) | 543.0 (33.6 to 8767.8) | 76.8 (27.8 to 211.9) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) |
| Week 104 (N: 15, 9, 4, 7, 1, 6, 2) | 1326.1 (785.0 to 2240.2) | 2212.7 (406.4 to 12048.4) | 243.3 (28.8 to 2052.4) | 98.9 (30.7 to 318.3) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) |
The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.
| U/mL | ACC 3 μg+QS-21 | ACC 10 μg+QS-21 | ACC 30 μg+QS-21 | ACC 10 μg | ACC 30 μg | QS-21 Alone | Phosphate Buffered Saline |
|---|---|---|---|---|---|---|---|
| Baseline (N: 36, 59, 40, 35, 12, 44, 17) | 32.3 (24.6 to 42.4) | 38.2 (30.8 to 47.2) | 34.2 (27.7 to 42.2) | 32.9 (28.1 to 38.5) | 40.3 (27.1 to 59.9) | 30.8 (26.4 to 36.0) | 25.0 (25.0 to 25.0) |
| Week 2 (N: 35, 60, 39, 35, 12, 43, 16) | 85.1 (54.2 to 133.8) | 127.7 (79.5 to 205.0) | 254.5 (133.6 to 484.9) | 46.5 (32.4 to 66.7) | 76.9 (40.5 to 146.2) | 31.5 (26.6 to 37.3) | 26.5 (23.4 to 29.9) |
| Week 4 (N: 35, 57, 38, 31, 12, 43, 16) | 82.3 (52.8 to 128.4) | 123.4 (75.9 to 200.7) | 276.6 (143.3 to 533.6) | 48.2 (33.2 to 70.2) | 92.0 (46.7 to 181.1) | 33.2 (28.0 to 39.3) | 27.3 (24.0 to 30.9) |
| Week 6 (N: 36, 58, 37, 33, 12, 41, 16) | 626.5 (340.5 to 1152.8) | 1283.8 (742.6 to 2219.4) | 1736.6 (906.4 to 3327.1) | 72.3 (40.8 to 128.2) | 144.1 (55.9 to 371.6) | 31.1 (26.6 to 36.3) | 25.0 (25.0 to 25.0) |
| Week 8 (N: 33, 57, 39, 33, 12, 41, 17) | 758.9 (388.6 to 1482.4) | 1903.8 (1097.7 to 3301.9) | 2769.5 (1407.2 to 5450.9) | 70.8 (40.8 to 123.0) | 166.4 (60.3 to 459.3) | 31.0 (26.1 to 36.8) | 26.3 (23.6 to 29.4) |
| Week 10 (N: 34, 59, 40, 33, 12, 43, 17) | 595.2 (310.0 to 1143.0) | 1697.7 (980.8 to 2938.6) | 2598.1 (1382.6 to 4882.0) | 69.9 (38.3 to 127.6) | 157.1 (56.1 to 440.1) | 36.3 (28.0 to 47.9) | 27.3 (24.0 to 31.1) |
| Week 14 (N: 33, 52, 39, 31, 11, 33, 14) | 770.2 (416.1 to 1425.6) | 2721.0 (1608.3 to 4603.4) | 5271.3 (2904.4 to 9567.3) | 80.8 (40.2 to 162.3) | 290.7 (71.8 to 1177.7) | 31.0 (25.5 to 37.8) | 25.0 (25.0 to 25.0) |
| Week 16 (N: 33, 59, 38, 34, 12, 41, 16) | 727.3 (395.0 to 1339.0) | 3098.3 (1904.1 to 5041.2) | 5666.4 (3264.6 to 9835.3) | 93.4 (47.5 to 183.4) | 271.8 (70.5 to 1047.5) | 34.5 (27.6 to 43.0) | 25.0 (25.0 to 25.0) |
| Week 24 (N: 34, 58, 37, 33, 10, 40, 16) | 461.3 (260.4 to 817.2) | 1862.5 (1137.9 to 3048.3) | 2672.4 (1553.6 to 4597.0) | 90.8 (48.1 to 171.3) | 296.2 (56.3 to 1549.6) | 30.9 (26.1 to 36.7) | 26.6 (23.3 to 30.2) |
| Week 28 (N: 31, 51, 33, 29, 8, 36, 16) | 669.0 (388.0 to 1153.6) | 1915.3 (1256.2 to 2920.0) | 3593.2 (2050.4 to 6296.9) | 105.5 (50.2 to 221.6) | 590.9 (63.4 to 5511.6) | 31.3 (26.1 to 37.5) | 25.0 (25.0 to 25.0) |
| Week 30 (N: 33, 56, 36, 32, 10, 38, 16) | 717.3 (432.6 to 1189.5) | 2259.4 (1524.0 to 3349.6) | 4147.2 (2423.1 to 7098.1) | 128.4 (63.1 to 261.1) | 343.3 (49.9 to 2361.4) | 37.8 (27.7 to 51.6) | 25.0 (25.0 to 25.0) |
| Week 40 (N: 32, 54, 33, 33, 9, 37, 15) | 559.0 (350.7 to 891.0) | 1351.6 (885.3 to 2063.3) | 1855.9 (1074.3 to 3206.1) | 103.9 (54.2 to 199.3) | 311.9 (39.1 to 2491.7) | 34.2 (28.1 to 41.6) | 25.0 (25.0 to 25.0) |
| Week 50 (N: 29, 53, 33, 33, 9, 36, 16) | 351.3 (210.2 to 587.2) | 1049.6 (701.4 to 1570.8) | 1246.4 (707.2 to 2196.7) | 84.7 (45.6 to 157.3) | 294.6 (41.2 to 2104.6) | 32.2 (27.1 to 38.3) | 25.0 (25.0 to 25.0) |
| Week 54 (N: 27, 51, 30, 29, 9, 29, 14) | 477.7 (305.2 to 747.7) | 1529.1 (1045.4 to 2236.7) | 2479.5 (1373.5 to 4476.4) | 121.1 (52.1 to 281.7) | 436.9 (52.1 to 3662.2) | 36.2 (28.4 to 46.3) | 27.2 (22.7 to 32.5) |
| Week 56 (N: 31, 52, 34, 32, 9, 34, 15) | 598.7 (375.1 to 955.5) | 1696.1 (1173.6 to 2451.3) | 2681.8 (1480.7 to 4857.0) | 109.8 (49.4 to 244.1) | 438.5 (51.5 to 3734.3) | 34.3 (27.2 to 43.2) | 29.5 (22.6 to 38.6) |
| Week 66 (N: 31, 54, 34, 31, 9, 33, 15) | 457.6 (282.2 to 742.1) | 1422.0 (980.7 to 2061.9) | 1637.2 (961.9 to 2786.6) | 114.3 (51.6 to 253.1) | 342.1 (41.2 to 2839.9) | 36.1 (26.5 to 49.1) | 27.8 (23.8 to 32.6) |
| Week 78 (N: 31, 52, 32, 32, 8, 32, 14) | 368.2 (238.4 to 568.7) | 1204.4 (815.6 to 1778.6) | 1217.7 (706.1 to 2100.1) | 107.5 (52.2 to 221.4) | 346.0 (31.2 to 3832.0) | 34.6 (27.9 to 43.0) | 28.9 (23.4 to 35.8) |
| Week 91 (N: 15, 9, 3, 8, 2, 6, 2) | 391.2 (205.6 to 744.2) | 1203.4 (399.9 to 3621.9) | 679.2 (28.5 to 16208.4) | 98.9 (18.4 to 530.4) | 25.0 (25.0 to 25.0) | 28.3 (20.5 to 39.1) | 25.0 (25.0 to 25.0) |
| Week 104 (N: 15, 9, 4, 7, 1, 6, 2) | 299.1 (144.2 to 620.8) | 1561.8 (438.0 to 5569.0) | 620.3 (78.8 to 4882.2) | 176.7 (26.1 to 1197.0) | 25.0 (25.0 to 25.0) | 25.0 (25.0 to 25.0) | 25.0 (25.0 to 25.0) |
IgG subtypes were not assessed
No measurements were reported for this outcome.
Collected over Approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ACC 3 μg+QS-21 | — | 6/36 (16.7%) | 34/36 (94.4%) |
| ACC 10 μg+QS-21 | — | 11/60 (18.3%) | 48/60 (80%) |
| ACC 30 μg+QS-21 | — | 7/40 (17.5%) | 35/40 (87.5%) |
| ACC 10 μg | — | 5/35 (14.3%) | 28/35 (80%) |
| ACC 30 μg | — | 5/12 (41.7%) | 10/12 (83.3%) |
| QS-21 Alone | — | 5/44 (11.4%) | 40/44 (90.9%) |
| Phosphate Buffered Saline | — | 3/17 (17.6%) | 17/17 (100%) |
| Event | ACC 3 μg+QS-21 | ACC 10 μg+QS-21 | ACC 30 μg+QS-21 | ACC 10 μg | ACC 30 μg | QS-21 Alone | Phosphate Buffered Saline |
|---|---|---|---|---|---|---|---|
| Cerebrovascular accidentNervous system disorders | 0/36 | 0/60 | 0/40 | 0/35 | 1/12 | 0/44 | 0/17 |
| Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/36 | 0/60 | 0/40 | 0/35 | 1/12 | 0/44 | 0/17 |
| Decreased appetiteMetabolism and nutrition disorders | 0/36 | 0/60 | 0/40 | 0/35 | 1/12 | 0/44 | 0/17 |
| AgitationPsychiatric disorders | 0/36 | 0/60 | 0/40 | 0/35 | 1/12 | 0/44 | 0/17 |
| Confusional statePsychiatric disorders | 0/36 | 0/60 | 0/40 | 0/35 | 1/12 | 0/44 | 0/17 |
| HallucinationPsychiatric disorders | 0/36 | 0/60 | 0/40 | 0/35 | 1/12 | 0/44 | 0/17 |
| CholelithiasisHepatobiliary disorders | 0/36 | 0/60 | 0/40 | 0/35 | 1/12 | 0/44 | 0/17 |
| Carcinoid tumour pulmonaryNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/36 | 0/60 | 0/40 | 0/35 | 0/12 | 0/44 | 1/17 |
| Atrial fibrillationCardiac disorders | 0/36 | 0/60 | 0/40 | 0/35 | 0/12 | 0/44 | 1/17 |
| Urinary tract infectionInfections and infestations | 0/36 | 0/60 | 1/40 | 0/35 | 0/12 | 0/44 | 1/17 |
| Event | ACC 3 μg+QS-21 | ACC 10 μg+QS-21 | ACC 30 μg+QS-21 | ACC 10 μg | ACC 30 μg | QS-21 Alone | Phosphate Buffered Saline |
|---|---|---|---|---|---|---|---|
| Injection site painGeneral disorders | 7/36 | 17/60 | 9/40 | 4/35 | 1/12 | 6/44 | 0/17 |
| DiarrhoeaGastrointestinal disorders | 10/36 | 6/60 | 4/40 | 4/35 | 2/12 | 3/44 | 1/17 |
| DepressionPsychiatric disorders | 5/36 | 4/60 | 4/40 | 8/35 | 3/12 | 5/44 | 1/17 |
| Urinary tract infectionInfections and infestations | 3/36 | 6/60 | 2/40 | 4/35 | 0/12 | 2/44 | 4/17 |
| HeadacheNervous system disorders | 3/36 | 14/60 | 4/40 | 2/35 | 0/12 | 8/44 | 1/17 |
| FallInjury, poisoning and procedural complications | 3/36 | 3/60 | 3/40 | 4/35 | 1/12 | 9/44 | 0/17 |
| Injection site erythemaGeneral disorders | 7/36 | 9/60 | 6/40 | 0/35 | 0/12 | 1/44 | 0/17 |
| Back painMusculoskeletal and connective tissue disorders | 2/36 | 5/60 | 3/40 | 4/35 | 0/12 | 4/44 | 3/17 |
| Injection site swellingGeneral disorders | 2/36 | 6/60 | 7/40 | 0/35 | 0/12 | 0/44 | 1/17 |
| AstheniaGeneral disorders | 1/36 | 2/60 | 1/40 | 3/35 | 2/12 | 1/44 | 0/17 |
245 participants were randomized in both studies (86 participants in NCT00479557 and 159 participants in NCT00498602) are included in the analysis below. One participant of the randomized participants did not receive treatment.
| Age, Continuous(Years) | ACC 3 μg+QS-21 | ACC 10 μg+QS-21 | ACC 30 μg+QS-21 | ACC 10 μg | ACC 30 μg | QS-21 Alone | Phosphate Buffered Saline | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 65.7 ± 7.75 | 69.3 ± 9.57 | 69.0 ± 9.27 | 71.9 ± 8.96 | 70.9 ± 9.59 | 68.8 ± 8.07 | 69.4 ± 7.82 | 69.1 ± 8.87 |
| Sex: Female, Male(Participants) | ACC 3 μg+QS-21 | ACC 10 μg+QS-21 | ACC 30 μg+QS-21 | ACC 10 μg | ACC 30 μg | QS-21 Alone | Phosphate Buffered Saline | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 16 | 29 | 22 | 19 | 8 | 31 | 14 | 139 |
| Male | 20 | 32 | 18 | 16 | 4 | 13 | 3 | 106 |
| Race/Ethnicity, Customized(number of participants) | ACC 3 μg+QS-21 | ACC 10 μg+QS-21 | ACC 30 μg+QS-21 | ACC 10 μg | ACC 30 μg | QS-21 Alone | Phosphate Buffered Saline | Total |
|---|---|---|---|---|---|---|---|---|
| Asian | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Black or African American | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 3 |
| Other | 2 | 1 | 1 | 1 | 0 | 0 | 0 | 5 |
| White | 33 | 60 | 38 | 34 | 11 | 43 | 17 | 236 |
| Mini-Mental State Examination (MMSE) Score(score) | ACC 3 μg+QS-21 | ACC 10 μg+QS-21 | ACC 30 μg+QS-21 | ACC 10 μg | ACC 30 μg | QS-21 Alone | Phosphate Buffered Saline | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 21.4 ± 2.96 | 21.4 ± 3.38 | 21.0 ± 2.92 | 21.6 ± 3.16 | 21.8 ± 3.60 | 21.7 ± 3.11 | 21.2 ± 3.17 | 21.4 ± 3.13 |
| MMSE Stratum(number of participants) | ACC 3 μg+QS-21 | ACC 10 μg+QS-21 | ACC 30 μg+QS-21 | ACC 10 μg | ACC 30 μg | QS-21 Alone | Phosphate Buffered Saline | Total |
|---|---|---|---|---|---|---|---|---|
| High (21 - 26) | 26 | 40 | 24 | 23 | 8 | 29 | 11 | 161 |
| Low (16 - 20) | 10 | 21 | 16 | 12 | 4 | 15 | 6 | 84 |
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pfizer