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Long Term Extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01238991
Recruitment Status : Terminated
First Posted : November 11, 2010
Results First Posted : December 22, 2014
Last Update Posted : December 22, 2014
Sponsor:
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Intervention Biological: ACC-001
Enrollment 53
Recruitment Details  
Pre-assignment Details The study enrolled those who completed the preceding studies (NCT00752232 and NCT00959192), where active vaccine ACC-001 (3, 10 or 30 μg) + adjuvant QS-21 (50 μg), as well as ACC-001, QS-21 and phosphate buffered saline (PBS) alone, were administered at Day 1, month 3, 6, 9 and 12 and at Day 1, month 1, 3, 6 and 12, respectively.
Arm/Group Title 3 μg ACC-001+QS-21 QS-21+(3 μg ACC-001+QS-21) 10 μg ACC-001+QS-21 10 μg ACC-001+ (10 μg ACC-001+QS-21) QS-21+(10 μg ACC-001+QS-21) PBS+(10 μg ACC-001+QS-21) 30 μg ACC-001+QS-21 30 μg ACC-001+(30 μg ACC-001+QS-21) QS-21+(30 μg ACC-001+QS-21) PBS+(30 μg ACC-001+QS-21)
Hide Arm/Group Description A group of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of active vaccine ACC-001(10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
Period Title: Overall Study
Started 7 3 11 6 5 2 8 5 4 2
Received Treatment 7 3 11 6 5 2 8 5 4 2
Completed 5 3 5 4 3 2 0 0 0 0
Not Completed 2 0 6 2 2 0 8 5 4 2
Reason Not Completed
Adverse Event             1             0             3             1             1             0             1             1             0             0
Death             0             0             0             1             0             0             0             0             0             0
Lack of Efficacy             0             0             1             0             0             0             0             0             1             0
Withdrawal by Subject             0             0             1             0             0             0             0             0             0             0
Study Terminated by Sponsor             0             0             0             0             1             0             7             4             2             2
Caregiver's request             0             0             0             0             0             0             0             0             1             0
Admission to a nursing home             1             0             1             0             0             0             0             0             0             0
Arm/Group Title 3 μg ACC-001+QS-21 QS-21+(3 μg ACC-001+QS-21) 10 μg ACC-001+QS-21 10 μg ACC-001+ (10 μg ACC-001+QS-21) QS-21+(10 μg ACC-001+QS-21) PBS+(10 μg ACC-001+QS-21) 30 μg ACC-001+QS-21 30 μg ACC-001+(30 μg ACC-001+QS-21) QS-21+(30 μg ACC-001+QS-21) PBS+(30 μg ACC-001+QS-21) Total
Hide Arm/Group Description A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of active vaccine ACC-001(10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18) Total of all reporting groups
Overall Number of Baseline Participants 7 3 11 6 5 2 8 5 4 2 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 3 participants 11 participants 6 participants 5 participants 2 participants 8 participants 5 participants 4 participants 2 participants 53 participants
69  (9.8) 73.3  (9.2) 67.5  (9.8) 69.5  (6.9) 65.2  (6.7) 70.5  (7.8) 73.9  (5.4) 71.2  (2) 64  (7.1) 68.5  (2.1) 69.2  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 3 participants 11 participants 6 participants 5 participants 2 participants 8 participants 5 participants 4 participants 2 participants 53 participants
Female
4
  57.1%
3
 100.0%
8
  72.7%
4
  66.7%
3
  60.0%
2
 100.0%
4
  50.0%
3
  60.0%
4
 100.0%
1
  50.0%
36
  67.9%
Male
3
  42.9%
0
   0.0%
3
  27.3%
2
  33.3%
2
  40.0%
0
   0.0%
4
  50.0%
2
  40.0%
0
   0.0%
1
  50.0%
17
  32.1%
1.Primary Outcome
Title Number of Treatment Emergent Adverse Events (AEs) by Severity
Hide Description Number of mild, moderate, and severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)
Time Frame Baseline up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study.
Arm/Group Title 3 μg ACC-001 Treat 3 μg Control 10 μg ACC-001 Treat 10 μg Control 30 μg ACC-001 Treat 30 μg Control
Hide Arm/Group Description:
A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001(10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
Overall Number of Participants Analyzed 7 3 17 7 13 6
Measure Type: Number
Unit of Measure: Events
Mild 14 7 97 38 28 17
Moderate 2 0 14 2 3 4
Severe 0 0 6 0 2 0
2.Primary Outcome
Title Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
Hide Description Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.
Time Frame Baseline up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study. Since the study was early terminated and the data could not be obtained as planned, the MRI data were not summarized.
Arm/Group Title 3 μg ACC-001 Treat 3 μg Control 10 μg ACC-001 Treat 10 μg Control 30 μg ACC-001 Treat 30 μg Control
Hide Arm/Group Description:
A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001(10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Number of Participants With Abnormalities in Neurological Examination
Hide Description Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerve Function, Cranial Nerve II, Sensory Function, Motor Function, Coordination, Gait and Station, Reflexes and Deep Tendon Reflexes.
Time Frame Baseline of the preceding studies through 24 months of this study
Hide Outcome Measure Data
Hide Analysis Population Description
The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study.
Arm/Group Title 3 μg ACC-001 Treat 3 μg Control 10 μg ACC-001 Treat 10 μg Control 30 μg ACC-001 Treat 30 μg Control
Hide Arm/Group Description:
A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001(10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
Overall Number of Participants Analyzed 7 3 17 7 13 6
Measure Type: Number
Unit of Measure: Participants
Mental Status 0 0 2 0 0 1
Speech 0 0 1 0 0 0
Cranial Nerve Function 0 0 0 0 0 0
Cranial Nerve II 0 0 1 0 0 0
Sensory Function 0 0 0 0 0 1
Motor Function 0 0 0 0 0 0
Coordination 0 0 0 0 0 0
Gait and Station 0 0 2 0 1 0
Reflexes 0 0 0 0 0 0
Deep Tendon Reflexes 0 0 0 0 0 0
4.Other Pre-specified Outcome
Title Anti-A-beta IgG (Immunoglobulin G) Titer at Specified Visits
Hide Description Geometric mean of anti-a-beta IgG titer from baseline of the preceding studies through the end of this study
Time Frame Baseline of preceding studies to month 24 of this study (Week 210)
Hide Outcome Measure Data
Hide Analysis Population Description
The immunogenicity analysis population consisted of those in the safety analysis population who had baseline immunogenicity evaluation in the preceding study and at least one immunogenicity evaluation post injection.
Arm/Group Title 3 μg ACC-001+QS-21 QS-21+(3 μg ACC-001+QS-21) 10 μg ACC-001+QS-21 10 μg ACC-001+(10 μg ACC-001+QS-21) QS-21+(10 μg ACC-001+QS-21) PBS+(10 μg ACC-001+QS-21) 30 μg ACC-001+QS-21 30 μg ACC-001+(30 μg ACC-001+QS-21) QS-21+(30 μg ACC-001+QS-21) PBS+(30 μg ACC-001+QS-21)
Hide Arm/Group Description:
A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
Overall Number of Participants Analyzed 7 3 11 6 5 2 8 5 4 2
Geometric Mean (95% Confidence Interval)
Unit of Measure: Units/mL
Pre-study (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
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)
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)
Week 2 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
60.3
(38.1 to 95.5)
50.0
(50.0 to 50.0)
67.2
(34.7 to 130.1)
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)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
Week 4 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)
158.5
(18.2 to 1381.1)
50.0
(50.0 to 50.0)
73.5
(36.6 to 147.2)
NA [1] 
(NA to NA)
50.0
(50.0 to 50.0)
NA [1] 
(NA to NA)
50.0
(50.0 to 50.0)
NA [1] 
(NA to NA)
50.0
(50.0 to 50.0)
NA [1] 
(NA to NA)
Week 6 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
797.2
(49.7 to 12776.7)
50.0
(50.0 to 50.0)
1346.8
(289.6 to 6264.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
924.1
(142.2 to 6003.5)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
Week 8 (n=4, 2, 7, 0, 3, 0, 5, 0, 2, 0)
3202.0
(168.8 to 60744.5)
50.0
(50.0 to 50.0)
2950.3
(837.0 to 10399.3)
NA [1] 
(NA to NA)
50.0
(50.0 to 50.0)
NA [1] 
(NA to NA)
2543.1
(969.3 to 6672.1)
NA [1] 
(NA to NA)
50.0
(50.0 to 50.0)
NA [1] 
(NA to NA)
Week 10 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
494.2
(49.1 to 4970.9)
50.0
(50.0 to 50.0)
638.8
(160.2 to 2547.6)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
386.9
(87.7 to 1707.3)
61.3
(34.9 to 107.6)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
Week 14 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
6174.8
(1628.1 to 23419.5)
50.0
(50.0 to 50.0)
5696.9
(2541.3 to 12771.2)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
5266.4
(1852.1 to 14975.0)
207.5
(24.9 to 1726.5)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
Week 16 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
4239.5
(895.3 to 20075.3)
50.0
(50.0 to 50.0)
3471.2
(1569.0 to 7680.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
5014.4
(1788.3 to 14060.5)
166.0
(20.3 to 1355.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
Week 24 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
1292.4
(263.8 to 6331.1)
50.0
(50.0 to 50.0)
1122.5
(502.5 to 2507.3)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
1765.8
(638.5 to 4883.6)
133.6
(24.5 to 727.2)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
Week 28 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
6460.4
(1521.1 to 27438.5)
50.0
(50.0 to 50.0)
6712.0
(1862.9 to 24183.8)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
8383.3
(4000.7 to 17566.9)
471.9
(24.3 to 9181.4)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
Week 30 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
4928.0
(1015.9 to 23904.5)
50.0
(50.0 to 50.0)
5417.0
(1626.4 to 18042.7)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
7927.9
(4408.1 to 14258.0)
408.1
(19.8 to 8412.5)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
Week 34 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)
992.7
(9.5 to 103353.0)
50.0 [2] 
(NA to NA)
4480.4
(34.4 to 583150.4)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
7851.2
(1669.4 to 36923.6)
287.4
(21.2 to 3888.4)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
Week 38 (n=3, 1, 4, 6, 2, 2, 3, 5, 2, 2)
5444.2
(634.1 to 46744.1)
50.0 [2] 
(NA to NA)
4923.0
(65.7 to 368774.1)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
18040.4
(1536.5 to 211818.5)
522.7
(30.5 to 8951.6)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
Week 40 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
4584.4
(2315.0 to 9078.7)
50.0
(50.0 to 50.0)
2639.5
(839.1 to 8302.7)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
4899.8
(1919.8 to 12505.5)
408.9
(29.2 to 5733.6)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
Week 50 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
2153.0
(1108.4 to 4182.2)
50.0
(50.0 to 50.0)
1603.8
(528.8 to 4864.7)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
2587.5
(999.3 to 6699.7)
205.0
(27.1 to 1549.9)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
Week 54 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
5374.9
(2019.8 to 14303.3)
50.0
(50.0 to 50.0)
7559.6
(2614.6 to 21857.4)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
10900.6
(5915.4 to 20087.3)
611.2
(72.8 to 5131.5)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
Week 56 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
7811.2
(2656.5 to 22968.2)
50.0
(50.0 to 50.0)
6204.2
(1855.1 to 20749.6)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
8052.1
(4251.8 to 15249.1)
458.0
(65.9 to 3180.4)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
Week 66 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
4668.7
(1533.4 to 14214.4)
50.0
(50.0 to 50.0)
3877.2
(1217.4 to 12347.8)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
3885.1
(1951.3 to 7735.2)
227.2
(32.6 to 1582.8)
194.0
(2.6 to 14517.7)
50.0
(50.0 to 50.0)
Week 78 (n=7, 3, 11, 6, 5, 2, 8, 5, 4, 2)
2983.3
(954.1 to 9328.0)
50.0
(50.0 to 50.0)
2488.3
(836.1 to 7405.1)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
2272.0
(1192.1 to 4330.1)
231.0
(34.2 to 1559.2)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
Week 82 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)
16812.5
(2685.3 to 105259.9)
50.0
(50.0 to 50.0)
9783.0
(3283.5 to 29148.1)
108.7
(41.8 to 282.7)
110.7
(12.2 to 1006.4)
50.0
(50.0 to 50.0)
14160.9
(8518.5 to 23540.4)
975.6
(209.4 to 4546.5)
196.4
(30.3 to 1275.0)
385.1
(0.0 to 70941268874642)
Week 84 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)
14763.7
(3422.9 to 63679.1)
188.0
(188.0 to 188.0)
7058.6
(2484.5 to 20054.3)
94.9
(43.4 to 207.3)
136.0
(18.7 to 989.2)
109.3
(0.0 to 2265473.2)
9998.6
(5487.3 to 18218.7)
768.3
(126.4 to 4669.5)
383.9
(39.8 to 3700.8)
316.9
(0.0 to 4897026295844.7)
Week 91 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)
1030.3
(51.7 to 20540.2)
50.0 [2] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Week 92 (n=4, 2, 11, 6, 5, 2, 8, 5, 4, 2)
6100.2
(1730.5 to 21504.2)
277.1
(1.1 to 71502.3)
4142.3
(1719.9 to 9976.6)
67.6
(41.1 to 111.1)
169.3
(50.3 to 569.9)
50.0
(50.0 to 50.0)
4291.7
(2472.4 to 7449.7)
391.5
(56.2 to 2724.4)
299.8
(40.3 to 2229.5)
285.8
(0.0 to 1192613970596.0)
Week 104 (n=7, 3, 11, 6, 5, 2, 7, 4, 3, 2)
2173.6
(652.1 to 7244.7)
83.4
(9.2 to 753.5)
2224.8
(934.8 to 5295.0)
50.0
(50.0 to 50.0)
105.9
(40.1 to 279.5)
50.0
(50.0 to 50.0)
3167.0
(1460.6 to 6867.2)
464.0
(40.3 to 5344.9)
256.1
(7.6 to 8678.4)
213.8
(0.0 to 22254714647.2)
Week 108 (n=7, 3, 11, 6, 5, 2, 7, 4, 4, 2)
14800.8
(4544.9 to 48199.8)
872.2
(1.7 to 459286.2)
8306.6
(4126.8 to 16719.9)
688.8
(118.8 to 3993.8)
4818.1
(1026.0 to 22626.7)
1172.0
(0.0 to 54658314329.3)
13370.6
(6739.1 to 26527.7)
3596.0
(469.5 to 26042.1)
448.0
(4.4 to 45743.6)
14665.8
(0.0 to 2439205485421.2)
Week 110 (n=7, 3, 10, 6, 5, 2, 7, 4, 2, 2)
9185.4
(3237.8 to 26058.4)
1257.0
(15.9 to 99324.4)
8081.4
(4125.7 to 15829.8)
551.4
(81.2 to 3743.4)
3726.2
(1084.8 to 12799.5)
497.9
(0.0 to 39348525251.6)
12209.4
(6421.3 to 23215.2)
2504.2
(464.4 to 13505.3)
2670.5
(0.0 to 463269086196.1)
9454.1
(0.0 to 2972501787380.5)
Week 116 (n=4, 2, 10, 4, 5, 2, 7, 4, 2, 2)
1682.2
(38.5 to 73591.4)
1548.4
(1.3 to 1837780.1)
5926.3
(2682.3 to 13093.5)
831.0
(59.8 to 11548.2)
2335.3
(715.0 to 7628.0)
258.0
(0.0 to 292460133977.7)
8613.4
(4540.7 to 16339.2)
1136.1
(153.1 to 8429.8)
2929.2
(0.0 to 4137410775629.6)
5735.6
(0.0 to 50649360975.1)
Week 118 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)
4506.7
(59.6 to 340984.3)
50.0 [2] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Week 130 (n=6, 3, 10, 5, 5, 2, 7, 4, 2, 2)
3312.9
(918.1 to 11954.2)
323.7
(4.0 to 25932.8)
2251.0
(704.2 to 7195.9)
435.9
(45.5 to 4172.4)
1231.0
(471.1 to 3216.5)
185.1
(0.0 to 3083418082.5)
4197.4
(2224.2 to 7921.3)
516.8
(42.1 to 6345.2)
1427.2
(0.0 to 61098419244.5)
3359.9
(0.0 to 416391434.9)
Week 134 (n=5, 3, 8, 4, 5, 2, 6, 4, 1, 2)
5904.2
(2760.4 to 12628.6)
4418.8
(32.8 to 595262.2)
11064.6
(3340.9 to 36644.9)
2718.6
(83.6 to 88360.8)
5233.2
(2190.3 to 12503.5)
4957.3
(0.0 to 89132252682601)
6043.9
(1405.3 to 25993.5)
2189.8
(39.4 to 121572.0)
4629.0 [2] 
(NA to NA)
14525.7
(1101.4 to 191573.6)
Week 136 (n=6, 3, 8, 4, 5, 2, 2, 4, 0, 2)
7816.8
(2323.1 to 26302.4)
3706.5
(28.6 to 480359.1)
10195.4
(3243.3 to 32049.6)
2572.6
(101.9 to 64964.0)
4614.4
(1945.0 to 10947.8)
3490.4
(0.0 to 129808983536252)
18653.9
(20.0 to 17387177.2)
1799.7
(40.1 to 80796.0)
NA [1] 
(NA to NA)
6296.3
(3108.1 to 12754.9)
Week 142 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)
2353.6
(164.1 to 33761.9)
12571.0 [2] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Week 146 (n=3, 2, 9, 4, 5, 2, 2, 4, 0, 2)
6813.3
(1976.2 to 23490.5)
979.6
(447.2 to 2146.1)
7269.6
(2546.0 to 20756.9)
3252.9
(156.4 to 67657.2)
3163.7
(1153.6 to 8676.4)
1338.7
(0.0 to 2432477307830.6)
9664.4
(6383.5 to 14631.5)
1022.4
(41.4 to 25279.5)
NA [1] 
(NA to NA)
4277.9
(538.3 to 33999.7)
Week 156 (n=6, 3, 8, 4, 4, 2, 2, 4, 0, 2)
2998.5
(853.4 to 10536.3)
1410.5
(237.4 to 8381.7)
4600.8
(1798.3 to 11770.3)
2532.8
(97.0 to 66111.6)
2880.8
(1242.7 to 6678.3)
737.9
(0.0 to 11966762355531)
6706.3
(164.9 to 272699.3)
706.6
(41.7 to 11981.1)
NA [1] 
(NA to NA)
2643.6
(1902.1 to 3674.2)
Week 160 (n=5, 3, 7, 4, 2, 2, 1, 2, 0, 1)
6305.4
(2243.7 to 17719.5)
1833.3
(101.1 to 33260.5)
6945.3
(3865.8 to 12477.7)
4810.2
(366.0 to 63211.9)
4080.8
(0.0 to 11159747036.1)
3632.1
(434.2 to 30382.4)
7731.0 [2] 
(NA to NA)
1779.5
(362.3 to 8741.0)
NA [1] 
(NA to NA)
2518.0 [2] 
(NA to NA)
Week 162 (n=6, 3, 8, 4, 4, 2, 0, 0, 0, 0)
8513.5
(2074.4 to 34940.7)
1586.1
(125.6 to 20025.2)
10450.4
(5734.0 to 19046.0)
6398.1
(417.4 to 98070.7)
6453.5
(1202.3 to 34641.3)
2362.8
(0.4 to 13656178.6)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Week 171 (n=3, 2, 7, 4, 4, 2, 0, 0, 0, 0)
8602.3
(4440.7 to 16664.0)
739.7
(32.9 to 16622.6)
7551.2
(3117.9 to 18288.2)
7027.0
(485.8 to 101644.6)
4351.5
(1055.3 to 17944.0)
1404.9
(0.0 to 328577560.1)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Week 172 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)
1074.9
(0.1 to 8576667.2)
2981.0 [2] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Week 182 (n=3, 1, 0, 0, 0, 0, 0, 0, 0, 0)
1944.9
(81.6 to 46329.0)
2555.0 [2] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Week 184 (n=3, 2, 6, 4, 3, 2, 0, 0, 0, 0)
7062.8
(5311.4 to 9391.7)
636.6
(4.1 to 98882.9)
3378.1
(1687.3 to 6763.1)
5682.1
(345.0 to 93583.6)
5064.1
(3850.7 to 6659.9)
824.3
(0.0 to 32731187354.9)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Week 186 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)
3653.9
(0.0 to 8947070499.4)
13166.0 [2] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Week 188 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)
3033.0
(0.0 to 11447766146.8)
14096.0 [2] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Week 197 (n=3 1, 0, 0, 0, 0, 0, 0, 0, 0)
2074.7
(78.6 to 54786.4)
5502.0 [2] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Week 210 (n=2, 1, 0, 0, 0, 0, 0, 0, 0, 0)
1291.4
(0.0 to 404404006.6)
1997.0 [2] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Data were not analyzed as no participants were evaluable for the particular week.
[2]
95% confidence interval was not estimable since only one participant was evaluable.
5.Other Pre-specified Outcome
Title Anti-A-beta IgM (Immunoglobulin M) Titer at Specified Visits
Hide Description Geotmetric mean of anti-a-beta IgM titer from baseline of the preceding studies through the end of this study
Time Frame Baseline of preceding studies to month 24 of this study (Week 210)
Hide Outcome Measure Data
Hide Analysis Population Description
The immunogenicity analysis population consisted of those in the safety analysis population who had baseline immunogenicity evaluation in the preceding study and at least one immunogenicity evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the IgM data were not summarized.
Arm/Group Title 3 μg ACC-001+QS-21 QS-21+(3 μg ACC-001+QS-21) 10 μg ACC-001+QS-21 10 μg ACC-001+(10 μg ACC-001+QS-21) QS-21+(10 μg ACC-001+QS-21) PBS+(10 μg ACC-001+QS-21) 30 μg ACC-001+QS-21 30 μg ACC-001+(30 μg ACC-001+QS-21) QS-21+(30 μg ACC-001+QS-21) PBS+(30 μg ACC-001+QS-21)
Hide Arm/Group Description:
A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Other Pre-specified Outcome
Title The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 26, 52, 78 and 104.
Hide Description The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this study, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11, with higher scores indicating a greater degree of impairment. The total score ranges from 0 (no impairment) to 70 (worst impairment).
Time Frame Baseline up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the ADAS-Cog scores were not summarized.
Arm/Group Title 3 μg ACC-001+QS-21 QS-21+(3 μg ACC-001+QS-21) 10 μg ACC-001+QS-21 10 μg ACC-001+(10 μg ACC-001+QS-21) QS-21+(10 μg ACC-001+QS-21) PBS+(10 μg ACC-001+QS-21) 30 μg ACC-001+QS-21 30 μg ACC-001+(30 μg ACC-001+QS-21) QS-21+(30 μg ACC-001+QS-21) PBS+(30 μg ACC-001+QS-21)
Hide Arm/Group Description:
A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Other Pre-specified Outcome
Title The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 26, 52,78 and 104.
Hide Description The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction.
Time Frame Baseline up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the DAD scores were not summarized.
Arm/Group Title 3 μg ACC-001+QS-21 QS-21+(3 μg ACC-001+QS-21) 10 μg ACC-001+QS-21 10 μg ACC-001+(10 μg ACC-001+QS-21) QS-21+(10 μg ACC-001+QS-21) PBS+(10 μg ACC-001+QS-21) 30 μg ACC-001+QS-21 30 μg ACC-001+(30 μg ACC-001+QS-21) QS-21+(30 μg ACC-001+QS-21) PBS+(30 μg ACC-001+QS-21)
Hide Arm/Group Description:
A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Other Pre-specified Outcome
Title The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 26, 52, 78 and 104.
Hide Description The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMS-Verbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y_visit – y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants’ observed baseline scores in the study.
Time Frame Baseline up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the NTB scores were not summarized.
Arm/Group Title 3 μg ACC-001+QS-21 QS-21+(3 μg ACC-001+QS-21) 10 μg ACC-001+QS-21 10 μg ACC-001+(10 μg ACC-001+QS-21) QS-21+(10 μg ACC-001+QS-21) PBS+(10 μg ACC-001+QS-21) 30 μg ACC-001+QS-21 30 μg ACC-001+(30 μg ACC-001+QS-21) QS-21+(30 μg ACC-001+QS-21) PBS+(30 μg ACC-001+QS-21)
Hide Arm/Group Description:
A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Other Pre-specified Outcome
Title The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 12, 26, 36, 52, 66, 78, 91 and 104.
Hide Description The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points, and any score equal to or lower than 26 points indicates cognitive impairment.
Time Frame Baseline up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the MMSE scores were not summarized.
Arm/Group Title 3 μg ACC-001+QS-21 QS-21+(3 μg ACC-001+QS-21) 10 μg ACC-001+QS-21 10 μg ACC-001+(10 μg ACC-001+QS-21) QS-21+(10 μg ACC-001+QS-21) PBS+(10 μg ACC-001+QS-21) 30 μg ACC-001+QS-21 30 μg ACC-001+(30 μg ACC-001+QS-21) QS-21+(30 μg ACC-001+QS-21) PBS+(30 μg ACC-001+QS-21)
Hide Arm/Group Description:
A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title 3μg ACC-001 Treat 3μg Control 10ug ACC-001 Treat 10μg Control 30μg ACC-001 Treat 30μg Control Total
Hide Arm/Group Description A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and acctive vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of active vaccine ACC-001 (10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18) A group of participants who received IM injection of adjuvant QS-21(50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18) All participants
All-Cause Mortality
3μg ACC-001 Treat 3μg Control 10ug ACC-001 Treat 10μg Control 30μg ACC-001 Treat 30μg Control Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
3μg ACC-001 Treat 3μg Control 10ug ACC-001 Treat 10μg Control 30μg ACC-001 Treat 30μg Control Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/3 (0.00%)   7/17 (41.18%)   1/7 (14.29%)   2/13 (15.38%)   0/6 (0.00%)   10/53 (18.87%) 
Cardiac disorders               
Cardiac failure  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Myocardial infarction  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Gastrointestinal disorders               
Inguinal hernia  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Infections and infestations               
Pyelonephritis  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Injury, poisoning and procedural complications               
Subdural haematoma  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Musculoskeletal and connective tissue disorders               
Polychondritis  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Colon cancer  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Gastric cancer  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  1/53 (1.89%) 
Metastases to spine  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  1/53 (1.89%) 
Prostate cancer  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  1/53 (1.89%) 
Nervous system disorders               
Altered state of consciousness  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Brain oedema  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Cerebral atrophy  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Normal pressure hydrocephalus  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Psychiatric disorders               
Impulsive behaviour  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  1/7 (14.29%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
3μg ACC-001 Treat 3μg Control 10ug ACC-001 Treat 10μg Control 30μg ACC-001 Treat 30μg Control Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/7 (100.00%)   3/3 (100.00%)   15/17 (88.24%)   5/7 (71.43%)   10/13 (76.92%)   6/6 (100.00%)   46/53 (86.79%) 
Blood and lymphatic system disorders               
Iron deficiency anaemia  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  1/53 (1.89%) 
Congenital, familial and genetic disorders               
Hypertrophic cardiomyopathy  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Ear and labyrinth disorders               
Tinnitus  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  1/7 (14.29%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Vertigo  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Eye disorders               
Cataract  1  0/7 (0.00%)  0/3 (0.00%)  2/17 (11.76%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  2/53 (3.77%) 
Conjunctival haemorrhage  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  1/13 (7.69%)  1/6 (16.67%)  2/53 (3.77%) 
Glaucoma  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Gastrointestinal disorders               
Constipation  1  0/7 (0.00%)  0/3 (0.00%)  2/17 (11.76%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  2/53 (3.77%) 
Dental caries  1  0/7 (0.00%)  0/3 (0.00%)  2/17 (11.76%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  2/53 (3.77%) 
Diarrhoea  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  2/7 (28.57%)  0/13 (0.00%)  0/6 (0.00%)  3/53 (5.66%) 
Enterocolitis  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Epigastric discomfort  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  1/7 (14.29%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Eructation  1  1/7 (14.29%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Gastric ulcer  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  1/53 (1.89%) 
Gastritis  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  1/7 (14.29%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Gastrooesophageal reflux disease  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Haemorrhoids  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  1/7 (14.29%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Large intestine polyp  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  1/7 (14.29%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Nausea  1  0/7 (0.00%)  0/3 (0.00%)  2/17 (11.76%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  2/53 (3.77%) 
Rectal prolapse  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Vomiting  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  1/53 (1.89%) 
General disorders               
Gait disturbance  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Injection site erythema  1  2/7 (28.57%)  1/3 (33.33%)  2/17 (11.76%)  2/7 (28.57%)  2/13 (15.38%)  2/6 (33.33%)  11/53 (20.75%) 
Injection site haemorrhage  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Injection site nodule  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Injection site pain  1  1/7 (14.29%)  2/3 (66.67%)  1/17 (5.88%)  2/7 (28.57%)  2/13 (15.38%)  1/6 (16.67%)  9/53 (16.98%) 
Injection site pruritus  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  1/7 (14.29%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Injection site swelling  1  1/7 (14.29%)  0/3 (0.00%)  1/17 (5.88%)  1/7 (14.29%)  0/13 (0.00%)  1/6 (16.67%)  4/53 (7.55%) 
Irritability  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  2/53 (3.77%) 
Malaise  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  1/7 (14.29%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Puncture site pain  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Pyrexia  1  1/7 (14.29%)  0/3 (0.00%)  2/17 (11.76%)  1/7 (14.29%)  0/13 (0.00%)  0/6 (0.00%)  4/53 (7.55%) 
Hepatobiliary disorders               
Biliary cirrhosis primary  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  1/7 (14.29%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Infections and infestations               
Balanitis candida  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Bronchitis  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Cellulitis  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Cystitis  1  0/7 (0.00%)  1/3 (33.33%)  0/17 (0.00%)  0/7 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  2/53 (3.77%) 
Gastroenteritis  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Herpes zoster  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  2/53 (3.77%) 
Nasopharyngitis  1  1/7 (14.29%)  1/3 (33.33%)  4/17 (23.53%)  2/7 (28.57%)  3/13 (23.08%)  1/6 (16.67%)  12/53 (22.64%) 
Periodontitis  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Pharyngitis  1  0/7 (0.00%)  1/3 (33.33%)  0/17 (0.00%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Tinea pedis  1  0/7 (0.00%)  0/3 (0.00%)  3/17 (17.65%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  3/53 (5.66%) 
Urinary tract infection  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Injury, poisoning and procedural complications               
Animal bite  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Arthropod bite  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  1/53 (1.89%) 
Contusion  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Excoriation  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Fall  1  0/7 (0.00%)  0/3 (0.00%)  4/17 (23.53%)  0/7 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  5/53 (9.43%) 
Laceration  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Ligament sprain  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Radius fracture  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  1/53 (1.89%) 
Rib fracture  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Spinal compression fracture  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Subdural haematoma  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Investigations               
Blood creatinine increased  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Blood pressure increased  1  0/7 (0.00%)  0/3 (0.00%)  2/17 (11.76%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  2/53 (3.77%) 
Blood triglycerides increased  1  1/7 (14.29%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
C-reactive protein increased  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Liver function test abnormal  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  1/53 (1.89%) 
Lymphocyte morphology abnormal  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Metamyelocyte percentage increased  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  1/53 (1.89%) 
Platelet count decreased  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  1/7 (14.29%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Protein urine present  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  2/53 (3.77%) 
Metabolism and nutrition disorders               
Decreased appetite  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  1/53 (1.89%) 
Diabetes mellitus  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  1/7 (14.29%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Diabetes mellitus inadequate control  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Musculoskeletal and connective tissue disorders               
Arthralgia  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  1/53 (1.89%) 
Back pain  1  0/7 (0.00%)  0/3 (0.00%)  2/17 (11.76%)  1/7 (14.29%)  1/13 (7.69%)  1/6 (16.67%)  5/53 (9.43%) 
Bone cyst  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Joint swelling  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Limb discomfort  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  1/53 (1.89%) 
Osteoarthritis  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  1/53 (1.89%) 
Osteoporosis  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  1/7 (14.29%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Spinal osteoarthritis  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  2/13 (15.38%)  0/6 (0.00%)  2/53 (3.77%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Colon adenoma  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  1/53 (1.89%) 
Uterine leiomyoma  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Nervous system disorders               
Apraxia  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Cerebral microhaemorrhage  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  1/53 (1.89%) 
Cerebral ventricle dilatation  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Cognitive disorder  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  1/7 (14.29%)  0/13 (0.00%)  1/6 (16.67%)  3/53 (5.66%) 
Haemorrhagic cerebral infarction  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Headache  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  1/53 (1.89%) 
Intercostal neuralgia  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  1/53 (1.89%) 
Lacunar infarction  1  1/7 (14.29%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  1/13 (7.69%)  0/6 (0.00%)  2/53 (3.77%) 
Occipital neuralgia  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  1/7 (14.29%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Sciatica  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  1/7 (14.29%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Speech disorder  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Visual field defect  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Psychiatric disorders               
Abnormal behaviour  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Aggression  1  1/7 (14.29%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Anxiety  1  0/7 (0.00%)  0/3 (0.00%)  2/17 (11.76%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  2/53 (3.77%) 
Confusional state  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Delirium  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Insomnia  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  1/7 (14.29%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Intentional self-injury  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Logorrhoea  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Restlessness  1  0/7 (0.00%)  0/3 (0.00%)  2/17 (11.76%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  2/53 (3.77%) 
Suicidal ideation  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Renal and urinary disorders               
Calculus ureteric  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Cystitis noninfective  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Enuresis  1  1/7 (14.29%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Hydronephrosis  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Urinary incontinence  1  0/7 (0.00%)  0/3 (0.00%)  2/17 (11.76%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  2/53 (3.77%) 
Reproductive system and breast disorders               
Benign prostatic hyperplasia  1  1/7 (14.29%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Uterine prolapse  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Respiratory, thoracic and mediastinal disorders               
Bronchitis chronic  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  1/7 (14.29%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Cough  1  0/7 (0.00%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  0/13 (0.00%)  1/6 (16.67%)  1/53 (1.89%) 
Skin and subcutaneous tissue disorders               
Dermatitis contact  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Eczema  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  1/7 (14.29%)  0/13 (0.00%)  0/6 (0.00%)  2/53 (3.77%) 
Pruritus  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Swelling face  1  1/7 (14.29%)  0/3 (0.00%)  0/17 (0.00%)  0/7 (0.00%)  0/13 (0.00%)  0/6 (0.00%)  1/53 (1.89%) 
Vascular disorders               
Hypertension  1  0/7 (0.00%)  0/3 (0.00%)  1/17 (5.88%)  0/7 (0.00%)  2/13 (15.38%)  0/6 (0.00%)  3/53 (5.66%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Since the study was early terminated and the data could not be obtained as planned, only part of the immunogenicity and safety results were summarized.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01238991     History of Changes
Other Study ID Numbers: B2571001
3134K1-2207 ( Other Identifier: Alias Study Number )
First Submitted: October 21, 2010
First Posted: November 11, 2010
Results First Submitted: December 12, 2014
Results First Posted: December 22, 2014
Last Update Posted: December 22, 2014