Trial Outcomes & Findings for Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults (NCT NCT00560313)
NCT ID: NCT00560313
Last Updated: 2016-04-01
Results Overview
Geometric mean titers(GMT) and the respective confidence intervals measured after each vaccination against the three different meningococcal strains.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
One month after vaccinations
Results posted on
2016-04-01
Participant Flow
Participants were enrolled at one site in Italy and one site in Germany.
Approximately 250 adults were planned to be enrolled in this study but only a total of 54 subjects were enrolled after the screening for the inclusion and exclusion criteria.
Participant milestones
| Measure |
4CMenB
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
4CMenB
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB
|
|---|---|
|
Overall Study
Adverse Events or Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults
Baseline characteristics by cohort
| Measure |
4CMenB
n=54 Participants
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB
|
|---|---|
|
Age, Continuous
|
31.8 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One month after vaccinationsPopulation: The analysis was done on the per protocol population.
Geometric mean titers(GMT) and the respective confidence intervals measured after each vaccination against the three different meningococcal strains.
Outcome measures
| Measure |
4CMenB (44/76-SL)
n=46 Participants
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against (44/76-SL) strain
|
4CMenB (5/99)
n=46 Participants
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (5/99)strain
|
4CMen B (NZ98/254)
n=46 Participants
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (NZ98/254)strain.
|
MenACWY-CRM (Y)
1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
|---|---|---|---|---|
|
Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination.
Baseline titer
|
2.5 titer
Interval 1.7 to 3.5
|
2.3 titer
Interval 1.6 to 3.2
|
1.8 titer
Interval 1.3 to 2.6
|
—
|
|
Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination.
Post dose 1 titer (N=25)
|
33 titer
Interval 15.0 to 72.0
|
29 titer
Interval 14.0 to 60.0
|
23 titer
Interval 11.0 to 49.0
|
—
|
|
Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination.
Post dose 2 titer
|
93 titer
Interval 71.0 to 121.0
|
144 titer
Interval 108.0 to 193.0
|
32 titer
Interval 21.0 to 48.0
|
—
|
|
Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination.
Before dose 3 titer(N=24)
|
26 titer
Interval 15.0 to 47.0
|
37 titer
Interval 26.0 to 53.0
|
9.4 titer
Interval 4.1 to 21.0
|
—
|
|
Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination.
Post dose 3 titer (N=39)
|
95 titer
Interval 68.0 to 131.0
|
269 titer
Interval 205.0 to 354.0
|
30 titer
Interval 18.0 to 50.0
|
—
|
PRIMARY outcome
Timeframe: One month after vaccinationsPopulation: The analysis was done on the per protocol population.
Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains: * prior to the first vaccination * 30 days following the first, second, prior to the third and 30 days after the third vaccination
Outcome measures
| Measure |
4CMenB (44/76-SL)
n=46 Participants
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against (44/76-SL) strain
|
4CMenB (5/99)
n=46 Participants
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (5/99)strain
|
4CMen B (NZ98/254)
n=46 Participants
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (NZ98/254)strain.
|
MenACWY-CRM (Y)
1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
|---|---|---|---|---|
|
Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.
titer ≥4 (Baseline)
|
37 percentage
Interval 23.0 to 52.0
|
37 percentage
Interval 23.0 to 52.0
|
22 percentage
Interval 11.0 to 36.0
|
—
|
|
Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.
titer ≥4 (Post dose 1) N=25
|
84 percentage
Interval 64.0 to 95.0
|
88 percentage
Interval 69.0 to 97.0
|
80 percentage
Interval 59.0 to 93.0
|
—
|
|
Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.
titer ≥4 (Post dose 2)
|
100 percentage
Interval 92.0 to 100.0
|
100 percentage
Interval 92.0 to 100.0
|
91 percentage
Interval 79.0 to 98.0
|
—
|
|
Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.
titer ≥4 (Before dose 3) N=24
|
96 percentage
Interval 79.0 to 100.0
|
100 percentage
Interval 86.0 to 100.0
|
67 percentage
Interval 45.0 to 84.0
|
—
|
|
Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.
titer ≥4 (Post dose 3) N=39
|
97 percentage
Interval 87.0 to 100.0
|
100 percentage
Interval 91.0 to 100.0
|
92 percentage
Interval 79.0 to 98.0
|
—
|
|
Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.
titer ≥8 (Baseline)
|
26 percentage
Interval 14.0 to 41.0
|
15 percentage
Interval 6.0 to 29.0
|
15 percentage
Interval 6.0 to 29.0
|
—
|
|
Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.
titer ≥8 (Post dose 1) N=25
|
80 percentage
Interval 59.0 to 93.0
|
76 percentage
Interval 55.0 to 91.0
|
72 percentage
Interval 51.0 to 88.0
|
—
|
|
Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.
titer ≥8 (Post dose 2)
|
100 percentage
Interval 92.0 to 100.0
|
100 percentage
Interval 92.0 to 100.0
|
83 percentage
Interval 69.0 to 92.0
|
—
|
|
Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.
titer ≥8 (Before dose 3) N=24
|
75 percentage
Interval 53.0 to 90.0
|
100 percentage
Interval 86.0 to 100.0
|
54 percentage
Interval 33.0 to 74.0
|
—
|
|
Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.
titer ≥8 (Post dose 3) N=39
|
97 percentage
Interval 87.0 to 100.0
|
100 percentage
Interval 91.0 to 100.0
|
77 percentage
Interval 61.0 to 89.0
|
—
|
|
Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.
≥4 fold increase (Post dose 1) N=25
|
80 percentage
Interval 59.0 to 93.0
|
64 percentage
Interval 43.0 to 82.0
|
68 percentage
Interval 46.0 to 85.0
|
—
|
|
Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.
≥4 fold increase (Post dose 2)
|
100 percentage
Interval 92.0 to 100.0
|
100 percentage
Interval 92.0 to 100.0
|
78 percentage
Interval 64.0 to 89.0
|
—
|
|
Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.
≥4 fold increase (Before dose 3) N=24
|
71 percentage
Interval 49.0 to 87.0
|
75 percentage
Interval 53.0 to 90.0
|
46 percentage
Interval 26.0 to 67.0
|
—
|
|
Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination.
≥4 fold increase (Post dose 3) N=39
|
92 percentage
Interval 79.0 to 98.0
|
100 percentage
Interval 91.0 to 100.0
|
69 percentage
Interval 52.0 to 83.0
|
—
|
PRIMARY outcome
Timeframe: One month after vaccinationsPopulation: The analysis was done on the per protocol population.
Geometric mean titer (GMT) of the Meningococcal ACWY Vaccine at One Month After the Immunization against the A, C, W-135 and Y strains.
Outcome measures
| Measure |
4CMenB (44/76-SL)
n=23 Participants
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against (44/76-SL) strain
|
4CMenB (5/99)
n=23 Participants
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (5/99)strain
|
4CMen B (NZ98/254)
n=23 Participants
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (NZ98/254)strain.
|
MenACWY-CRM (Y)
n=23 Participants
1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination.
|
54 titer
Interval 34.0 to 85.0
|
42 titer
Interval 27.0 to 66.0
|
90 titer
Interval 58.0 to 139.0
|
36 titer
Interval 16.0 to 81.0
|
PRIMARY outcome
Timeframe: One month after vaccinationsPopulation: The analysis was done on the per protocol population.
Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥ 1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; % ≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains: * prior to the first vaccination * 30 days following the first, second, prior to the third and 30 days after the third vaccination
Outcome measures
| Measure |
4CMenB (44/76-SL)
n=23 Participants
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against (44/76-SL) strain
|
4CMenB (5/99)
n=23 Participants
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (5/99)strain
|
4CMen B (NZ98/254)
n=23 Participants
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (NZ98/254)strain.
|
MenACWY-CRM (Y)
n=23 Participants
1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
|---|---|---|---|---|
|
Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination
titers ≥ 4
|
96 percentage
Interval 78.0 to 100.0
|
100 percentage
Interval 85.0 to 100.0
|
100 percentage
Interval 85.0 to 100.0
|
83 percentage
Interval 61.0 to 95.0
|
|
Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination
titers ≥8
|
96 percentage
Interval 78.0 to 100.0
|
96 percentage
Interval 78.0 to 100.0
|
100 percentage
Interval 85.0 to 100.0
|
83 percentage
Interval 61.0 to 95.0
|
PRIMARY outcome
Timeframe: One month after vaccinationsPopulation: The analysis was done on the per protocol population.
The number of subjects who reported solicited reactions after the administration of the Meningococcal B vaccine at a 0, 2, 6-month schedule and the administration of the Meningococcal A, C, W, and Y vaccine at month 7.
Outcome measures
| Measure |
4CMenB (44/76-SL)
n=53 Participants
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against (44/76-SL) strain
|
4CMenB (5/99)
n=52 Participants
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (5/99)strain
|
4CMen B (NZ98/254)
n=50 Participants
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (NZ98/254)strain.
|
MenACWY-CRM (Y)
n=41 Participants
1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
|
|---|---|---|---|---|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
Injection pain (any)
|
52 participants
|
50 participants
|
50 participants
|
10 participants
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
Injection pain (severe)
|
8 participants
|
7 participants
|
9 participants
|
0 participants
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
Erythema (any)
|
22 participants
|
23 participants
|
28 participants
|
9 participants
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
Erythema (severe)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
Induration (any)
|
23 participants
|
24 participants
|
29 participants
|
5 participants
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
Induration (severe)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
Nausea (any)
|
7 participants
|
5 participants
|
9 participants
|
4 participants
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
Nausea (severe)
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
Malaise (any)
|
16 participants
|
17 participants
|
26 participants
|
11 participants
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
Malaise (severe)
|
3 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
Myalgia (any)
|
15 participants
|
19 participants
|
24 participants
|
5 participants
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
Myalgia (severe)
|
3 participants
|
3 participants
|
7 participants
|
1 participants
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
Arthralgia (any)
|
10 participants
|
12 participants
|
20 participants
|
6 participants
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
Arthralgia (severe)
|
0 participants
|
0 participants
|
3 participants
|
0 participants
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
Headache (any)
|
15 participants
|
13 participants
|
21 participants
|
9 participants
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
Headache (severe)
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
Fever (≥ 38°C)
|
2 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
Stayed home
|
5 participants
|
4 participants
|
5 participants
|
2 participants
|
|
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination.
Analgesic, antipyretic medicine used
|
10 participants
|
7 participants
|
5 participants
|
4 participants
|
Adverse Events
4CMenB (1st Vaccination)
Serious events: 0 serious events
Other events: 52 other events
Deaths: 0 deaths
4CMenB (2nd Vaccination)
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
4CMenB (3rd Vaccination)
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Men ACWY-CRM
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
4CMenB (1st Vaccination)
n=53 participants at risk
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.
Post dose 1.
|
4CMenB (2nd Vaccination)
n=52 participants at risk
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.
Post dose 2.
|
4CMenB (3rd Vaccination)
n=50 participants at risk
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.
Post dose 3.
|
Men ACWY-CRM
n=41 participants at risk
All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.
Post dose 1 MenACWY.
|
|---|---|---|---|---|
|
General disorders
Injection site pain
|
98.1%
52/53 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
96.2%
50/52 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
100.0%
50/50 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
24.4%
10/41 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
|
General disorders
Injection site induration
|
43.4%
23/53 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
46.2%
24/52 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
58.0%
29/50 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
12.2%
5/41 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
|
General disorders
Injection site erythema
|
41.5%
22/53 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
44.2%
23/52 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
56.0%
28/50 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
22.0%
9/41 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
|
Nervous system disorders
Headache
|
30.2%
16/53 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
25.0%
13/52 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
42.0%
21/50 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
22.0%
9/41 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
|
General disorders
Malaise
|
30.2%
16/53 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
32.7%
17/52 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
52.0%
26/50 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
26.8%
11/41 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.3%
15/53 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
36.5%
19/52 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
48.0%
24/50 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
12.2%
5/41 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.9%
10/53 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
23.1%
12/52 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
40.0%
20/50 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
14.6%
6/41 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
|
Gastrointestinal disorders
Nausea
|
13.2%
7/53 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
9.6%
5/52 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
18.0%
9/50 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
9.8%
4/41 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
|
General disorders
Pyrexia
|
5.7%
3/53 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
1.9%
1/52 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
0.00%
0/50 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
4.9%
2/41 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/53 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
5.8%
3/52 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
6.0%
3/50 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
2.4%
1/41 • Adverse events were collected throughout the duration of the study (8 months).
Adverse events categorized as systematic assessment is defined as solicited adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60