Trial Outcomes & Findings for Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non-pregnant Women 18-40 Years of Age. (NCT NCT02459262)
NCT ID: NCT02459262
Last Updated: 2021-01-14
Results Overview
Number of Participants with Treatment Emergent Adverse Events
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
240 participants
Primary outcome timeframe
12 weeks (to Day 85)
Results posted on
2021-01-14
Participant Flow
Part A: Healthy females were recruited to receive two doses of either GBS-NN vaccine with or without Alhydrogel® gel adjuvant at three dose levels (10mcg, 50mcg, 250mcg) or placebo. Part B: Doses of 50mcg (2 doses) and 100mcg (1 and 2 doses) were selected from the antibody levels at 8 weeks from Part A and vaccine was administered with Alhydrogel®. Participants were healthy females and did not include participants from Part A. They were followed up for 1 year.
Part A was the dose-finding part of the study and 60 healthy female participants received either 2 doses of GBS-NN 10mcg, 50mcg, 250mcg or placebo (4:1 ratio of active:placebo). Based on the 8 week (Day 57) antibody levels from Part A, 180 healthy female participants in Part B were recruited to receive either 2 doses of GBS-NN 50mcg, 2 doses of GBS-NN 100mcg, 1 dose of GBS-NN 100mcg or placebo (3:1 ratio of active to placebo). Participants in Part A were not allowed to participate In Part B.
Participant milestones
| Measure |
Part A GBS-NN Vaccine 10mcg
GBS-NN 10mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 50mcg
GBS-NN 50mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 250mcg
GBS-NN 250mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN 10mcg Vaccine Administered With Alhydrogel® Adjuvant
GBS-NN 10mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN 50mcg Vaccine Administered With Alhydrogel® Adjuvant
GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN 250mcg Vaccine Administered With Alhydrogel® Adjuvant
GBS-NN 250mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A Placebo
Alhydrogel® mixed with dilution buffer or buffer alone administered by intramuscular injection
|
Part B GBS-NN Vaccine 50mcg
GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part B GBS-NN Vaccine 100mcg 2 Dose Regimen
GBS-NN 100mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part B GBS-NN Vaccine 100mcg Single Dose
GBS-NN 100mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1
|
Part B Placebo
Alhydrogel® mixed with dilution buffer and administered by intramuscular injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
12
|
45
|
45
|
45
|
45
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
8
|
12
|
45
|
45
|
44
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Part A GBS-NN Vaccine 10mcg
GBS-NN 10mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 50mcg
GBS-NN 50mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 250mcg
GBS-NN 250mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN 10mcg Vaccine Administered With Alhydrogel® Adjuvant
GBS-NN 10mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN 50mcg Vaccine Administered With Alhydrogel® Adjuvant
GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN 250mcg Vaccine Administered With Alhydrogel® Adjuvant
GBS-NN 250mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A Placebo
Alhydrogel® mixed with dilution buffer or buffer alone administered by intramuscular injection
|
Part B GBS-NN Vaccine 50mcg
GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part B GBS-NN Vaccine 100mcg 2 Dose Regimen
GBS-NN 100mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part B GBS-NN Vaccine 100mcg Single Dose
GBS-NN 100mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1
|
Part B Placebo
Alhydrogel® mixed with dilution buffer and administered by intramuscular injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non-pregnant Women 18-40 Years of Age.
Baseline characteristics by cohort
| Measure |
Part A GBS-NN Vaccine 10mcg
n=8 Participants
GBS-NN 10mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 50mcg
n=8 Participants
GBS-NN 50mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 250mcg
n=8 Participants
GBS-NN 250mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 10mcg With Alhydrogel® Adjuvant
n=8 Participants
GBS-NN 10 mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 50mcg With Alhydrogel® Adjuvant
n=8 Participants
GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 250mcg With Alhydrogel® Adjuvant
n=8 Participants
GBS-NN 250mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A Placebo
n=12 Participants
Alhydrogel® mixed with dilution buffer or buffer alone administered by intramuscular injection
|
Part B GBS-NN Vaccine 50mcg
n=45 Participants
GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part B GBS-NN Vacine 100mcg 2 Dose Regimen
n=45 Participants
GBS-NN 100mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part B GBS-NN Vacine 100mcg Single Dose
n=45 Participants
GBS-NN 100mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1
|
Part B Placebo
n=45 Participants
Alhydrogel® mixed with dilution buffer and administered by intramuscular injection
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
28.6 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
29.3 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
30.4 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
28.3 years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
31.3 years
STANDARD_DEVIATION 4.5 • n=21 Participants
|
30.4 years
STANDARD_DEVIATION 5.7 • n=8 Participants
|
28.5 years
STANDARD_DEVIATION 6.6 • n=8 Participants
|
29.0 years
STANDARD_DEVIATION 6.3 • n=24 Participants
|
30.3 years
STANDARD_DEVIATION 6.0 • n=42 Participants
|
29.4 years
STANDARD_DEVIATION 6.5 • n=42 Participants
|
28.7 years
STANDARD_DEVIATION 6.5 • n=42 Participants
|
29.5 years
STANDARD_DEVIATION 6.3 • n=42 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
45 Participants
n=24 Participants
|
45 Participants
n=42 Participants
|
45 Participants
n=42 Participants
|
45 Participants
n=42 Participants
|
240 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
45 Participants
n=24 Participants
|
45 Participants
n=42 Participants
|
45 Participants
n=42 Participants
|
44 Participants
n=42 Participants
|
239 Participants
n=42 Participants
|
|
Ethnicity (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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
45 Participants
n=24 Participants
|
45 Participants
n=42 Participants
|
45 Participants
n=42 Participants
|
44 Participants
n=42 Participants
|
239 Participants
n=42 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
8 participants
n=21 Participants
|
8 participants
n=8 Participants
|
12 participants
n=8 Participants
|
45 participants
n=24 Participants
|
45 participants
n=42 Participants
|
45 participants
n=42 Participants
|
45 participants
n=42 Participants
|
240 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 12 weeks (to Day 85)Number of Participants with Treatment Emergent Adverse Events
Outcome measures
| Measure |
Part A GBS-NN Vaccine 10mcg
n=8 Participants
GBS-NN 10mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 50mcg
n=8 Participants
GBS-NN 50mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 250mcg
n=8 Participants
GBS-NN 250mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 10mcg With Alhydrogel® Adjuvant
n=8 Participants
GBS-NN 10 mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 50mcg With Alhydrogel® Adjuvant
n=8 Participants
GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 250mcg With Alhydrogel® Adjuvant
n=8 Participants
GBS-NN 250mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A Placebo
n=12 Participants
Alhydrogel® mixed with dilution buffer or buffer alone administered by intramuscular injection
|
|---|---|---|---|---|---|---|---|
|
Part A Number of Participants With Treatment Emergent Adverse Events
|
6 participants
|
5 participants
|
5 participants
|
6 participants
|
8 participants
|
8 participants
|
11 participants
|
PRIMARY outcome
Timeframe: 12 weeks (to Day 85)Number of Participants with Treatment Emergent Adverse Events
Outcome measures
| Measure |
Part A GBS-NN Vaccine 10mcg
n=45 Participants
GBS-NN 10mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 50mcg
n=45 Participants
GBS-NN 50mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 250mcg
n=45 Participants
GBS-NN 250mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 10mcg With Alhydrogel® Adjuvant
n=45 Participants
GBS-NN 10 mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 50mcg With Alhydrogel® Adjuvant
GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 250mcg With Alhydrogel® Adjuvant
GBS-NN 250mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A Placebo
Alhydrogel® mixed with dilution buffer or buffer alone administered by intramuscular injection
|
|---|---|---|---|---|---|---|---|
|
Part B Number of Participants With Treatment Emergent Adverse Events
|
41 participants
|
39 participants
|
31 participants
|
37 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeks (Day 85)Geometric mean antibody concentration
Outcome measures
| Measure |
Part A GBS-NN Vaccine 10mcg
n=8 Participants
GBS-NN 10mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 50mcg
n=8 Participants
GBS-NN 50mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 250mcg
n=8 Participants
GBS-NN 250mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 10mcg With Alhydrogel® Adjuvant
n=8 Participants
GBS-NN 10 mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 50mcg With Alhydrogel® Adjuvant
n=8 Participants
GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 250mcg With Alhydrogel® Adjuvant
n=8 Participants
GBS-NN 250mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A Placebo
n=12 Participants
Alhydrogel® mixed with dilution buffer or buffer alone administered by intramuscular injection
|
|---|---|---|---|---|---|---|---|
|
Part A Antibody Concentration
|
1.977 mcg/mL
Interval 0.021 to 35.8
|
2.926 mcg/mL
Interval 0.27 to 17.4
|
7.195 mcg/mL
Interval 0.865 to 106.0
|
16.864 mcg/mL
Interval 1.11 to 263.0
|
14.999 mcg/mL
Interval 2.95 to 83.0
|
25.431 mcg/mL
Interval 0.59 to 277.0
|
0.199 mcg/mL
Interval 0.03 to 1.61
|
SECONDARY outcome
Timeframe: 12 weeks (Day 85)Geometric mean antibody concentration
Outcome measures
| Measure |
Part A GBS-NN Vaccine 10mcg
n=45 Participants
GBS-NN 10mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 50mcg
n=45 Participants
GBS-NN 50mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 250mcg
n=43 Participants
GBS-NN 250mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 10mcg With Alhydrogel® Adjuvant
n=45 Participants
GBS-NN 10 mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 50mcg With Alhydrogel® Adjuvant
GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 250mcg With Alhydrogel® Adjuvant
GBS-NN 250mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A Placebo
Alhydrogel® mixed with dilution buffer or buffer alone administered by intramuscular injection
|
|---|---|---|---|---|---|---|---|
|
Part B Antibody Concentration
|
16.914 mcg/mL
Interval 0.9 to 247.0
|
15.459 mcg/mL
Interval 0.35 to 314.0
|
3.035 mcg/mL
Interval 0.17 to 50.2
|
0.234 mcg/mL
Interval 0.03 to 15.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 year (Day 365)Geometric mean antibody concentration
Outcome measures
| Measure |
Part A GBS-NN Vaccine 10mcg
n=45 Participants
GBS-NN 10mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 50mcg
n=45 Participants
GBS-NN 50mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 250mcg
n=43 Participants
GBS-NN 250mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 10mcg With Alhydrogel® Adjuvant
n=45 Participants
GBS-NN 10 mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 50mcg With Alhydrogel® Adjuvant
GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 250mcg With Alhydrogel® Adjuvant
GBS-NN 250mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A Placebo
Alhydrogel® mixed with dilution buffer or buffer alone administered by intramuscular injection
|
|---|---|---|---|---|---|---|---|
|
Part B Antibody Concentration
|
4.201 mcg/mL
Interval 0.24 to 58.4
|
5.934 mcg/mL
Interval 0.2 to 314.0
|
1.596 mcg/mL
Interval 0.06 to 117.0
|
0.263 mcg/mL
Interval 0.03 to 50.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 85 to Day 365Number of Participants with Treatment Emergent Adverse Events
Outcome measures
| Measure |
Part A GBS-NN Vaccine 10mcg
n=45 Participants
GBS-NN 10mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 50mcg
n=45 Participants
GBS-NN 50mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 250mcg
n=45 Participants
GBS-NN 250mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 10mcg With Alhydrogel® Adjuvant
n=45 Participants
GBS-NN 10 mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 50mcg With Alhydrogel® Adjuvant
GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 250mcg With Alhydrogel® Adjuvant
GBS-NN 250mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A Placebo
Alhydrogel® mixed with dilution buffer or buffer alone administered by intramuscular injection
|
|---|---|---|---|---|---|---|---|
|
Part B Number of Participants With Treatment Emergent Adverse Events
|
16 participants
|
23 participants
|
22 participants
|
21 participants
|
—
|
—
|
—
|
Adverse Events
Part A GBS-NN Vaccine 10mcg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A GBS-NN Vaccine 50mcg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A GBS-NN Vaccine 250mcg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A GBS-NN Vaccine 10mcg With Alhydrogel® Adjuvant
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A GBS-NN Vaccine 50mcg With Alhydrogel® Adjuvant
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part A GBS-NN Vaccine 250mcg With Alhydrogel® Adjuvant
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part A Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Part B GBS-NN Vaccine 50mcg
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Part B GBS-NN Vacine 100mcg 2 Dose Regimen
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Part B GBS-NN Vacine 100mcg Single Dose
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Part B Placebo
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A GBS-NN Vaccine 10mcg
n=8 participants at risk
GBS-NN 10mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 50mcg
n=8 participants at risk
GBS-NN 50mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 250mcg
n=8 participants at risk
GBS-NN 250mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 10mcg With Alhydrogel® Adjuvant
n=8 participants at risk
GBS-NN 10 mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 50mcg With Alhydrogel® Adjuvant
n=8 participants at risk
GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 250mcg With Alhydrogel® Adjuvant
n=8 participants at risk
GBS-NN 250mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A Placebo
n=12 participants at risk
Alhydrogel® mixed with dilution buffer or buffer alone administered by intramuscular injection
|
Part B GBS-NN Vaccine 50mcg
n=45 participants at risk
GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part B GBS-NN Vacine 100mcg 2 Dose Regimen
n=45 participants at risk
GBS-NN 100mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part B GBS-NN Vacine 100mcg Single Dose
n=45 participants at risk
GBS-NN 100mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1
|
Part B Placebo
n=45 participants at risk
Alhydrogel® mixed with dilution buffer and administered by intramuscular injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Spontaneous abortion
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/12 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
2.2%
1/45 • Number of events 1 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
Other adverse events
| Measure |
Part A GBS-NN Vaccine 10mcg
n=8 participants at risk
GBS-NN 10mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 50mcg
n=8 participants at risk
GBS-NN 50mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 250mcg
n=8 participants at risk
GBS-NN 250mcg vaccine administered without Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 10mcg With Alhydrogel® Adjuvant
n=8 participants at risk
GBS-NN 10 mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 50mcg With Alhydrogel® Adjuvant
n=8 participants at risk
GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A GBS-NN Vaccine 250mcg With Alhydrogel® Adjuvant
n=8 participants at risk
GBS-NN 250mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part A Placebo
n=12 participants at risk
Alhydrogel® mixed with dilution buffer or buffer alone administered by intramuscular injection
|
Part B GBS-NN Vaccine 50mcg
n=45 participants at risk
GBS-NN 50mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part B GBS-NN Vacine 100mcg 2 Dose Regimen
n=45 participants at risk
GBS-NN 100mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1 and Day 29
|
Part B GBS-NN Vacine 100mcg Single Dose
n=45 participants at risk
GBS-NN 100mcg vaccine administered with Alhydrogel® by intramuscular injection on Day 1
|
Part B Placebo
n=45 participants at risk
Alhydrogel® mixed with dilution buffer and administered by intramuscular injection
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
16.7%
2/12 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
4.4%
2/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
4.4%
2/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
2.2%
1/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
8.9%
4/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
8.3%
1/12 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
|
General disorders
Injection site reaction
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
25.0%
2/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
75.0%
6/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
25.0%
2/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
16.7%
2/12 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
4.4%
2/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
4.4%
2/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
11.1%
5/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
|
General disorders
Injection site erythema
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
37.5%
3/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/12 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
8.3%
1/12 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
4.4%
2/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
4.4%
2/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
4.4%
2/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
6.7%
3/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
8.3%
1/12 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
2.2%
1/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
2.2%
1/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
6.7%
3/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/12 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
4.4%
2/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
2.2%
1/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
2.2%
1/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
|
General disorders
Injection site pain
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
75.0%
6/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
50.0%
4/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
50.0%
4/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
33.3%
4/12 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
57.8%
26/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
57.8%
26/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
35.6%
16/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
40.0%
18/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
37.5%
3/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
25.0%
2/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
25.0%
2/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
33.3%
4/12 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
31.1%
14/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
20.0%
9/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
13.3%
6/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
24.4%
11/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
25.0%
3/12 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
4.4%
2/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
6.7%
3/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
4.4%
2/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
2.2%
1/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
8.3%
1/12 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
33.3%
15/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
15.6%
7/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
26.7%
12/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
11.1%
5/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
25.0%
2/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/12 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
2.2%
1/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
4.4%
2/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
2.2%
1/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
4.4%
2/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
12.5%
1/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
8.3%
1/12 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/12 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
8.9%
4/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
4.4%
2/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
4.4%
2/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/12 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
2.2%
1/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
2.2%
1/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
2.2%
1/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
2.2%
1/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/12 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
4.4%
2/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
4.4%
2/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
2.2%
1/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/12 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
4.4%
2/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
4.4%
2/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
6.7%
3/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
2.2%
1/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/8 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
0.00%
0/12 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
6.7%
3/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
2.2%
1/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
2.2%
1/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
6.7%
3/45 • Part A: to 12 weeks (D85) Part B: to 12 weeks (D85)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place