Trial Outcomes & Findings for Phase 1 Safety and Immunogenicity of Meningococcal Vaccine (NCT NCT00678652)
NCT ID: NCT00678652
Last Updated: 2017-12-18
Results Overview
Measure the bactericidal absolute values per dose group after vaccine injections, administered intramuscularly, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine at 10, 25, 50, or 75 μg with aluminum hydroxide adjuvant in healthy adult subjects.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
18 weeks. Days 0, 14, 56, 84, 98 and 126
Results posted on
2017-12-18
Participant Flow
Subjects recruited from CTC database if they have asked to be informed about upcoming studies. Posters//flyers, tv, internet, newspaper ads and word of mouth to recruit healthy subjects. Recruitment may include oral presentations and/or distribution of approved recruiting materials.
Participant milestones
| Measure |
10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant
10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 10 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant
25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 25 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant
50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 50 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant
75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 75 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
6
|
9
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant
10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 10 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant
25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 25 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant
50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 50 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant
75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 75 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
0
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
0
|
|
Overall Study
Relocation
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Phase 1 Safety and Immunogenicity of Meningococcal Vaccine
Baseline characteristics by cohort
| Measure |
10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=9 Participants
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant
10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 10 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=9 Participants
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant
25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 25 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=9 Participants
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant
50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 50 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=9 Participants
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant
75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 75 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
18 - 45
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
36 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 18 weeks. Days 0, 14, 56, 84, 98 and 126Measure the bactericidal absolute values per dose group after vaccine injections, administered intramuscularly, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine at 10, 25, 50, or 75 μg with aluminum hydroxide adjuvant in healthy adult subjects.
Outcome measures
| Measure |
10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=7 Participants
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant
10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 10 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=9 Participants
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant
25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 25 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=9 Participants
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant
50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 50 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=9 Participants
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant
75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 75 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
|---|---|---|---|---|
|
Bactericidal Absolute Values After Group B Meningococcal 8570 HOPS-G NOMV Vaccine Injections
Day 42
|
6.8 titers
Standard Deviation 5.8
|
13.1 titers
Standard Deviation 12.0
|
6.7 titers
Standard Deviation 5.6
|
5.3 titers
Standard Deviation 4.4
|
|
Bactericidal Absolute Values After Group B Meningococcal 8570 HOPS-G NOMV Vaccine Injections
Day 56
|
5.0 titers
Standard Deviation 3.0
|
11.6 titers
Standard Deviation 9.6
|
8.9 titers
Standard Deviation 9.7
|
8.4 titers
Standard Deviation 9.2
|
|
Bactericidal Absolute Values After Group B Meningococcal 8570 HOPS-G NOMV Vaccine Injections
Day 84
|
4.4 titers
Standard Deviation 2.7
|
10.9 titers
Standard Deviation 10.1
|
7.8 titers
Standard Deviation 5.5
|
6.9 titers
Standard Deviation 5.7
|
|
Bactericidal Absolute Values After Group B Meningococcal 8570 HOPS-G NOMV Vaccine Injections
Day 98
|
8.0 titers
Standard Deviation 6.0
|
19.3 titers
Standard Deviation 12.9
|
11.6 titers
Standard Deviation 9.6
|
11.1 titers
Standard Deviation 9.1
|
|
Bactericidal Absolute Values After Group B Meningococcal 8570 HOPS-G NOMV Vaccine Injections
Day 0
|
2.1 titers
Standard Deviation 1.5
|
3.0 titers
Standard Deviation 2.9
|
3.0 titers
Standard Deviation 2.3
|
2.4 titers
Standard Deviation 1.2
|
|
Bactericidal Absolute Values After Group B Meningococcal 8570 HOPS-G NOMV Vaccine Injections
Day 14
|
7.0 titers
Standard Deviation 5.6
|
20.4 titers
Standard Deviation 21.1
|
12.4 titers
Standard Deviation 11.9
|
8.4 titers
Standard Deviation 9.2
|
|
Bactericidal Absolute Values After Group B Meningococcal 8570 HOPS-G NOMV Vaccine Injections
Day 126
|
7.8 titers
Standard Deviation 6.8
|
10.2 titers
Standard Deviation 6.9
|
6.9 titers
Standard Deviation 4.7
|
6.0 titers
Standard Deviation 4.2
|
PRIMARY outcome
Timeframe: 42+7 days (visit 7)Population: Seroconversion is defined as a 4-fold or greater increase from baseline in antibody titer of bactericidal antibodies after 2 doses (the first and second) of vaccine.
Rate of seroconversion (fourfold increase from baseline in antibody titer of bactericidal antibodies) after the 2nd dose of vaccine
Outcome measures
| Measure |
10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=7 Participants
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant
10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 10 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=9 Participants
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant
25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 25 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=9 Participants
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant
50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 50 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=9 Participants
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant
75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 75 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
|---|---|---|---|---|
|
Rate of Seroconversion After the 2nd Dose of 8570 L3-5,7-5 Vaccine
Yes
|
3 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
|
Rate of Seroconversion After the 2nd Dose of 8570 L3-5,7-5 Vaccine
No
|
4 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 84+7 days (visit 11)Population: Seroconversion is defined as a 4-fold or greater increase from baseline in antibody titer of bactericidal antibodies after 3 doses of vaccine
Rate of seroconversion (fourfold increase from baseline in antibody titer of bactericidal antibodies) after the 3rd dose of vaccine
Outcome measures
| Measure |
10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=7 Participants
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant
10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 10 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=9 Participants
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant
25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 25 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=9 Participants
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant
50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 50 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=9 Participants
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant
75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 75 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
|---|---|---|---|---|
|
Rate of Seroconversion After the 3rd Dose of 8570 L3-5, 7-5 Vaccine
Yes
|
5 Participants
|
8 Participants
|
5 Participants
|
6 Participants
|
|
Rate of Seroconversion After the 3rd Dose of 8570 L3-5, 7-5 Vaccine
No
|
2 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 126 daysAssess and characterize bactericidal activity and total antibody response against the vaccine strain and other strains of Group B Meningococcus induced by 3 injections, administered intramuscularly, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine at 10, 25, 50, or 75 μg with aluminum hydroxide adjuvant in healthy adult subjects.
Outcome measures
| Measure |
10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=9 Participants
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant
10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 10 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=9 Participants
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant
25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 25 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=9 Participants
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant
50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 50 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=9 Participants
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant
75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 75 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
|---|---|---|---|---|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: Vaccine NOMV, Antibody Type: IgM - Day 56
|
10.4 ug/mL
Interval 2.6 to 16.2
|
10.5 ug/mL
Interval 1.8 to 12.8
|
11.7 ug/mL
Interval 3.5 to 14.7
|
8.0 ug/mL
Interval 1.9 to 11.7
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: Vaccine NOMV, Antibody Type: IgM - Day 84
|
7.4 ug/mL
Interval 3.0 to 10.8
|
8.6 ug/mL
Interval 1.4 to 17.8
|
11.4 ug/mL
Interval 3.2 to 15.7
|
7.1 ug/mL
Interval 1.3 to 14.1
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: Vaccine NOMV, Antibody Type: IgM - Day 98
|
9.8 ug/mL
Interval 3.3 to 12.6
|
10.8 ug/mL
Interval 1.7 to 14.7
|
10.7 ug/mL
Interval 4.1 to 18.5
|
6.6 ug/mL
Interval 2.8 to 14.1
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: Vaccine NOMV, Antibody Type: IgM - Day126
|
8.2 ug/mL
Interval 2.5 to 10.7
|
7.8 ug/mL
Interval 1.6 to 14.3
|
10.5 ug/mL
Interval 3.5 to 15.7
|
5.6 ug/mL
Interval 2.0 to 11.3
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: GNA1870, Antibody Type: IgG - Day 0
|
3.4 ug/mL
Interval 2.2 to 10.6
|
3.1 ug/mL
Interval 0.9 to 7.2
|
2.7 ug/mL
Interval 1.8 to 4.0
|
3.0 ug/mL
Interval 0.8 to 4.0
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: GNA1870, Antibody Type: IgG - Day 14
|
5.3 ug/mL
Interval 1.8 to 13.3
|
3.3 ug/mL
Interval 1.0 to 8.1
|
3.3 ug/mL
Interval 2.1 to 10.2
|
3.9 ug/mL
Interval 2.6 to 7.2
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: GNA1870, Antibody Type: IgG - Day 56
|
4.2 ug/mL
Interval 2.4 to 31.5
|
3.2 ug/mL
Interval 2.6 to 8.4
|
3.4 ug/mL
Interval 2.4 to 9.1
|
7.8 ug/mL
Interval 3.0 to 12.2
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: GNA1870, Antibody Type: IgG - Day 98
|
3.7 ug/mL
Interval 2.5 to 29.2
|
3.9 ug/mL
Interval 2.3 to 7.6
|
4.4 ug/mL
Interval 2.8 to 11.1
|
11.6 ug/mL
Interval 2.6 to 17.9
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: L3, 7 LOS, Antibody Type: IgG - Day 0
|
0.4 ug/mL
Interval 0.1 to 1.2
|
0.2 ug/mL
Interval 0.1 to 0.3
|
0.3 ug/mL
Interval 0.1 to 0.9
|
0.1 ug/mL
Interval 0.1 to 0.5
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: L3, 7 LOS, Antibody Type: IgG - Day 14
|
1.0 ug/mL
Interval 0.1 to 2.3
|
0.3 ug/mL
Interval 0.1 to 0.7
|
0.7 ug/mL
Interval 0.2 to 1.8
|
0.7 ug/mL
Interval 0.2 to 12.0
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: L3, 7 LOS, Antibody Type: IgG - Day 56
|
0.7 ug/mL
Interval 0.1 to 1.3
|
0.2 ug/mL
Interval 0.1 to 0.4
|
0.6 ug/mL
Interval 0.1 to 2.3
|
0.5 ug/mL
Interval 0.2 to 3.7
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: L3, 7 LOS, Antibody Type: IgG - Day 98
|
1.0 ug/mL
Interval 0.2 to 2.3
|
0.3 ug/mL
Interval 0.1 to 0.6
|
0.5 ug/mL
Interval 0.1 to 2.6
|
1.1 ug/mL
Interval 0.3 to 2.7
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: L8-5 LOS, Antibody Type: IgG - Day 0
|
0.3 ug/mL
Interval 0.1 to 0.8
|
0.1 ug/mL
Interval 0.0 to 0.5
|
0.2 ug/mL
Interval 0.1 to 2.7
|
0.1 ug/mL
Interval 0.1 to 0.2
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: L8-5 LOS, Antibody Type: IgG - Day 14
|
1.6 ug/mL
Interval 0.3 to 10.8
|
0.6 ug/mL
Interval 0.1 to 1.8
|
2.3 ug/mL
Interval 0.4 to 3.8
|
1.9 ug/mL
Interval 0.3 to 34.0
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: L8-5 LOS, Antibody Type: IgG - Day 56
|
1.2 ug/mL
Interval 0.4 to 2.9
|
0.5 ug/mL
Interval 0.1 to 1.8
|
1.4 ug/mL
Interval 0.3 to 3.7
|
1.3 ug/mL
Interval 0.3 to 8.3
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: L8-5 LOS, Antibody Type: IgG - Day 98
|
1.8 ug/mL
Interval 0.7 to 5.7
|
0.7 ug/mL
Interval 0.1 to 1.1
|
1.3 ug/mL
Interval 0.2 to 3.1
|
2.5 ug/mL
Interval 0.5 to 7.6
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen Type: OpeA, Antibody Type: IgG - Day 0
|
0.1 ug/mL
Interval 0.0 to 0.3
|
0.1 ug/mL
Interval 0.0 to 0.5
|
0.2 ug/mL
Interval 0.0 to 1.1
|
0.1 ug/mL
Interval 0.0 to 0.6
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen Type: OpeA, Antibody Type: IgG - Day 14
|
0.2 ug/mL
Interval 0.1 to 0.5
|
0.1 ug/mL
Interval 0.0 to 1.6
|
1.2 ug/mL
Interval 0.1 to 7.4
|
0.2 ug/mL
Interval 0.1 to 7.3
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen Type: OpeA, Antibody Type: IgG - Day 56
|
0.1 ug/mL
Interval 0.1 to 0.4
|
0.2 ug/mL
Interval 0.1 to 1.0
|
0.5 ug/mL
Interval 0.1 to 3.6
|
0.2 ug/mL
Interval 0.1 to 5.5
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen Type: OpeA, Antibody Type: IgG - Day 98
|
0.1 ug/mL
Interval 0.1 to 0.3
|
0.2 ug/mL
Interval 0.1 to 0.8
|
0.5 ug/mL
Interval 0.1 to 1.9
|
0.2 ug/mL
Interval 0.1 to 1.6
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: Vaccine NOMV, Antibody Type: IgG - Day 0
|
27.7 ug/mL
Interval 4.7 to 58.3
|
13.2 ug/mL
Interval 3.8 to 43.2
|
29.6 ug/mL
Interval 11.5 to 52.7
|
13.8 ug/mL
Interval 9.5 to 65.8
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: Vaccine NOMV, Antibody Type: IgG - Day 14
|
50.8 ug/mL
Interval 15.4 to 137.3
|
33.8 ug/mL
Interval 8.9 to 160.8
|
74.3 ug/mL
Interval 13.5 to 133.1
|
39.7 ug/mL
Interval 17.2 to 189.6
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: Vaccine NOMV, Antibody Type: IgG - Day 42
|
46.0 ug/mL
Interval 16.3 to 91.8
|
23.4 ug/mL
Interval 7.9 to 127.3
|
49.1 ug/mL
Interval 19.1 to 84.6
|
24.2 ug/mL
Interval 22.0 to 118.2
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: Vaccine NOMV, Antibody Type: IgG - Day 56
|
62.7 ug/mL
Interval 27.2 to 115.0
|
42.6 ug/mL
Interval 10.9 to 129.4
|
44.4 ug/mL
Interval 12.9 to 112.2
|
40.3 ug/mL
Interval 22.1 to 205.7
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: Vaccine NOMV, Antibody Type: IgG - Day 84
|
47.9 ug/mL
Interval 20.7 to 102.1
|
29.4 ug/mL
Interval 10.2 to 115.3
|
43.1 ug/mL
Interval 12.6 to 114.1
|
33.4 ug/mL
Interval 24.2 to 211.3
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: Vaccine NOMV, Antibody Type: IgG - Day 98
|
51.3 ug/mL
Interval 16.4 to 137.2
|
32.7 ug/mL
Interval 11.8 to 119.8
|
45.3 ug/mL
Interval 15.4 to 369.5
|
42.4 ug/mL
Interval 27.8 to 208.6
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: Vaccine NOMV, Antibody Type: IgG - Day126
|
50.7 ug/mL
Interval 17.1 to 140.5
|
31.7 ug/mL
Interval 14.1 to 129.3
|
45.6 ug/mL
Interval 14.0 to 126.3
|
49.6 ug/mL
Interval 21.7 to 164.0
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: Vaccine NOMV, Antibody Type: IgM - Day 0
|
4.1 ug/mL
Interval 2.4 to 10.7
|
7.8 ug/mL
Interval 1.4 to 10.4
|
11.1 ug/mL
Interval 2.7 to 14.1
|
3.8 ug/mL
Interval 1.3 to 6.4
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: Vaccine NOMV, Antibody Type: IgM - Day 14
|
6.3 ug/mL
Interval 3.3 to 24.3
|
9.8 ug/mL
Interval 2.1 to 41.9
|
14.2 ug/mL
Interval 3.1 to 75.5
|
10.8 ug/mL
Interval 2.6 to 40.2
|
|
Total Antibody Response to the Parent Strain of Group B Meningococcus
Antigen: Vaccine NOMV, Antibody Type: IgM - Day 42
|
7.5 ug/mL
Interval 2.8 to 14.0
|
9.9 ug/mL
Interval 1.5 to 13.2
|
12.2 ug/mL
Interval 3.1 to 14.2
|
7.4 ug/mL
Interval 1.6 to 9.7
|
Adverse Events
10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
10 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=9 participants at risk
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 10 μg with Adjuvant
10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 10 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
25 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=9 participants at risk
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 25 μg with Adjuvant
25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 25 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
50 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=9 participants at risk
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 50 μg with Adjuvant
50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 50 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
75 μg of Group B Meningococcal 8570 HOPS-G NOMV Vaccine
n=9 participants at risk
Three Injections, Given at 0, 6, and 12 Weeks, of Group B Meningococcal 8570 HOPS-G NOMV Vaccine Administered Intramuscularly to Healthy Subjects at 75 μg with Adjuvant
75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine: 75 μg of vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9 • Number of events 2 • 126 days +14
|
22.2%
2/9 • Number of events 2 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
General disorders
Fatigue
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
General disorders
Feeling Hot
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
General disorders
Injection site erythema
|
0.00%
0/9 • 126 days +14
|
22.2%
2/9 • Number of events 2 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
General disorders
Injection site pain
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
33.3%
3/9 • Number of events 3 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
General disorders
Injection site pruritus
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
General disorders
Injection site swelling
|
0.00%
0/9 • 126 days +14
|
22.2%
2/9 • Number of events 2 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
44.4%
4/9 • Number of events 4 • 126 days +14
|
|
General disorders
Injection site warmth
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
General disorders
Malaise
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
44.4%
4/9 • Number of events 4 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
22.2%
2/9 • Number of events 2 • 126 days +14
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Nervous system disorders
Headache
|
44.4%
4/9 • Number of events 4 • 126 days +14
|
55.6%
5/9 • Number of events 5 • 126 days +14
|
66.7%
6/9 • Number of events 6 • 126 days +14
|
77.8%
7/9 • Number of events 7 • 126 days +14
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
22.2%
2/9 • Number of events 2 • 126 days +14
|
|
Eye disorders
Asthenopia
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
22.2%
2/9 • Number of events 2 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Gastrointestinal disorders
Lip Blister
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Gastrointestinal disorders
Toothache
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
General disorders
Injection site rash
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Infections and infestations
Bronchitis
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Infections and infestations
Eyelid infection
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Infections and infestations
Upper Respiratory tract infection
|
22.2%
2/9 • Number of events 2 • 126 days +14
|
33.3%
3/9 • Number of events 3 • 126 days +14
|
55.6%
5/9 • Number of events 5 • 126 days +14
|
66.7%
6/9 • Number of events 6 • 126 days +14
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Injury, poisoning and procedural complications
Excoriaton
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Injury, poisoning and procedural complications
Muscle Injury
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Injury, poisoning and procedural complications
Post concussoin syndrome
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
33.3%
3/9 • Number of events 3 • 126 days +14
|
22.2%
2/9 • Number of events 2 • 126 days +14
|
|
Investigations
Blood bicarbonate decreased
|
44.4%
4/9 • Number of events 4 • 126 days +14
|
33.3%
3/9 • Number of events 3 • 126 days +14
|
88.9%
8/9 • Number of events 8 • 126 days +14
|
88.9%
8/9 • Number of events 8 • 126 days +14
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/9 • 126 days +14
|
22.2%
2/9 • Number of events 2 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Investigations
Blood creatinine increased
|
33.3%
3/9 • Number of events 3 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Investigations
Blood fibrinogen decreased
|
33.3%
3/9 • Number of events 3 • 126 days +14
|
55.6%
5/9 • Number of events 5 • 126 days +14
|
44.4%
4/9 • Number of events 4 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/9 • 126 days +14
|
22.2%
2/9 • Number of events 2 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
33.3%
3/9 • Number of events 3 • 126 days +14
|
|
Investigations
Blood glucose decreased
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
33.3%
3/9 • Number of events 3 • 126 days +14
|
55.6%
5/9 • Number of events 5 • 126 days +14
|
|
Investigations
Blood glucose increased
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Investigations
Blood potassium increased
|
0.00%
0/9 • 126 days +14
|
22.2%
2/9 • Number of events 2 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Investigations
Blood pressure dastolic increased
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Investigations
Blood pressure systolic increased
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Investigations
Blood sodium decreased
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Investigations
Haemoglobin decreased
|
33.3%
3/9 • Number of events 3 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
22.2%
2/9 • Number of events 2 • 126 days +14
|
|
Investigations
Platelet count decreased
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Investigations
Prothrombin time prolonged
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Investigations
Urine leukocyte esterase
|
0.00%
0/9 • 126 days +14
|
22.2%
2/9 • Number of events 2 • 126 days +14
|
33.3%
3/9 • Number of events 3 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Investigations
Urine leukocyte esterase positive
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Investigations
White blood cell count decreased
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
22.2%
2/9 • Number of events 2 • 126 days +14
|
|
Investigations
White blood cell count increased
|
22.2%
2/9 • Number of events 2 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
22.2%
2/9 • Number of events 2 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Nervous system disorders
Paraeshthesia
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Reproductive system and breast disorders
Menstrual discomfort
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
22.2%
2/9 • Number of events 2 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
22.2%
2/9 • Number of events 2 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
|
Skin and subcutaneous tissue disorders
Dermatitis papillaris capillitii
|
11.1%
1/9 • Number of events 1 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
0.00%
0/9 • 126 days +14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place