Trial Outcomes & Findings for Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults (NCT NCT00679172)
NCT ID: NCT00679172
Last Updated: 2024-04-09
Results Overview
Number and proportion of subjects reporting suspected unexpected serious adverse reactions (SUSARs).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
187 participants
Primary outcome timeframe
From start of dosing to 28 days post-dosing.
Results posted on
2024-04-09
Participant Flow
Participant milestones
| Measure |
M01ZH09 Vaccine Candidate Cohort 1
Dose of 5.0 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 2
Dose of 7.5 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 3
Dose of 1.1 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 4
Dose of 1.7 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
Pooled Placebo
Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
37
|
38
|
36
|
39
|
37
|
|
Overall Study
COMPLETED
|
36
|
37
|
35
|
38
|
37
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
M01ZH09 Vaccine Candidate Cohort 1
Dose of 5.0 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 2
Dose of 7.5 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 3
Dose of 1.1 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 4
Dose of 1.7 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
Pooled Placebo
Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
|
|---|---|---|---|---|---|
|
Overall Study
Non-compliance
|
1
|
1
|
0
|
1
|
0
|
|
Overall Study
Other not specified
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults
Baseline characteristics by cohort
| Measure |
M01ZH09 Vaccine Candidate Cohort 1
n=37 Participants
Dose of 5.0 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 2
n=38 Participants
Dose of 7.5 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 3
n=36 Participants
Dose of 1.1 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 4
n=39 Participants
Dose of 1.7 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
Pooled Placebo
n=37 Participants
Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
|
Total
n=187 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
183 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
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
|
|
Age, Continuous
|
33.2 years
STANDARD_DEVIATION 10.13 • n=5 Participants
|
33.1 years
STANDARD_DEVIATION 10.00 • n=7 Participants
|
32.0 years
STANDARD_DEVIATION 9.99 • n=5 Participants
|
31.3 years
STANDARD_DEVIATION 9.21 • n=4 Participants
|
32.3 years
STANDARD_DEVIATION 10.01 • n=21 Participants
|
32.4 years
STANDARD_DEVIATION 9.79 • n=8 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
94 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
93 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
38 participants
n=7 Participants
|
36 participants
n=5 Participants
|
39 participants
n=4 Participants
|
37 participants
n=21 Participants
|
187 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From start of dosing to 28 days post-dosing.Population: Safety Population: All subjects who received a dose of study medication.
Number and proportion of subjects reporting suspected unexpected serious adverse reactions (SUSARs).
Outcome measures
| Measure |
M01ZH09 Vaccine Candidate Cohort 1
n=37 Participants
Dose of 5.0 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 2
n=38 Participants
Dose of 7.5 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 3
n=36 Participants
Dose of 1.1 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 4
n=39 Participants
Dose of 1.7 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
Pooled Placebo
n=37 Participants
Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
|
|---|---|---|---|---|---|
|
Number and Proportion of Subjects Reporting Suspected Unexpected Serious Adverse Reactions.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of dosing to 14 days post-dosing.Population: Safety Population: All subjects who received a dose of study medication.
Number and proportion of subjects experiencing symptomatic (e.g., chills, rigors, sweating, headache, myalgia etc.) elevated body temperature of 38.0°C or more in the 14 days following dosing.
Outcome measures
| Measure |
M01ZH09 Vaccine Candidate Cohort 1
n=37 Participants
Dose of 5.0 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 2
n=38 Participants
Dose of 7.5 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 3
n=36 Participants
Dose of 1.1 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 4
n=39 Participants
Dose of 1.7 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
Pooled Placebo
n=37 Participants
Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
|
|---|---|---|---|---|---|
|
Number and Proportion of Subjects Experiencing Symptomatic Fever.
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of dosing to 28 days post-dosing.Population: Safety Population: All subjects who received a dose of study medication.
Number of subjects having clinically significant changes in clinical laboratory test parameters.
Outcome measures
| Measure |
M01ZH09 Vaccine Candidate Cohort 1
n=37 Participants
Dose of 5.0 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 2
n=38 Participants
Dose of 7.5 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 3
n=36 Participants
Dose of 1.1 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 4
n=39 Participants
Dose of 1.7 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
Pooled Placebo
n=37 Participants
Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
|
|---|---|---|---|---|---|
|
Number of Subjects Having Clinically Significant Changes in Laboratory Test Parameters.
Alanine aminotransferase
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Having Clinically Significant Changes in Laboratory Test Parameters.
Creatinine
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Having Clinically Significant Changes in Laboratory Test Parameters.
Eosinophils
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Having Clinically Significant Changes in Laboratory Test Parameters.
Haematocrit
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Subjects Having Clinically Significant Changes in Laboratory Test Parameters.
Haemoglobin
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Subjects Having Clinically Significant Changes in Laboratory Test Parameters.
Lymphocytes
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects Having Clinically Significant Changes in Laboratory Test Parameters.
Neutrophils
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects Having Clinically Significant Changes in Laboratory Test Parameters.
Platelet Count
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Having Clinically Significant Changes in Laboratory Test Parameters.
Red Blood Cell Count
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Subjects Having Clinically Significant Changes in Laboratory Test Parameters.
White Blood Cell Count
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: From start of dosing to 28 days post-dosing.Population: Safety Population: All subjects who received a dose of study medication.
Number of subjects having TEAEs considered by the principal investigator to be "possibly" or "probably" related to treatment.
Outcome measures
| Measure |
M01ZH09 Vaccine Candidate Cohort 1
n=37 Participants
Dose of 5.0 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 2
n=38 Participants
Dose of 7.5 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 3
n=36 Participants
Dose of 1.1 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 4
n=39 Participants
Dose of 1.7 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
Pooled Placebo
n=37 Participants
Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
|
|---|---|---|---|---|---|
|
Number of Subjects Reporting Treatment-related TEAEs.
Subjects with possibly related TEAEs
|
19 participants
|
12 participants
|
18 participants
|
10 participants
|
15 participants
|
|
Number of Subjects Reporting Treatment-related TEAEs.
Subjects with probably related TEAEs
|
7 participants
|
10 participants
|
6 participants
|
19 participants
|
9 participants
|
PRIMARY outcome
Timeframe: From start of dosing to 28 days post-dosing.Population: Safety Population: All subjects who received a dose of study medication.
Number and proportion of subjects experiencing a proven bacteraemia attributed to the vaccine strain S. typhi (Ty2 aroC-ssaV-) ZH9.
Outcome measures
| Measure |
M01ZH09 Vaccine Candidate Cohort 1
n=37 Participants
Dose of 5.0 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 2
n=38 Participants
Dose of 7.5 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 3
n=36 Participants
Dose of 1.1 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 4
n=39 Participants
Dose of 1.7 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
Pooled Placebo
n=37 Participants
Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
|
|---|---|---|---|---|---|
|
Number and Proportion of Subjects Experiencing Bacteraemia.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Beyond 7 days post-dosing through 14 days post-dosing (Cohorts 1-3) or through 21 days post-dosing (Cohort 4).Population: Safety Population: All subjects who received a dose of study medication.
Number of subjects having shedding in stool of S. typhi (Ty2 aroC-ssaV-) ZH9. Subjects were evaluated beyond Day 14 only in Cohort 4.
Outcome measures
| Measure |
M01ZH09 Vaccine Candidate Cohort 1
n=37 Participants
Dose of 5.0 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 2
n=38 Participants
Dose of 7.5 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 3
n=36 Participants
Dose of 1.1 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 4
n=39 Participants
Dose of 1.7 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
Pooled Placebo
n=37 Participants
Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
|
|---|---|---|---|---|---|
|
Number of Subjects Having Shedding in Stool of Salmonella Typhi (S. Typhi) (Ty2 aroC-ssaV-) ZH9.
Day 9
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Subjects Having Shedding in Stool of Salmonella Typhi (S. Typhi) (Ty2 aroC-ssaV-) ZH9.
Day 11
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Subjects Having Shedding in Stool of Salmonella Typhi (S. Typhi) (Ty2 aroC-ssaV-) ZH9.
Day 14
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Subjects Having Shedding in Stool of Salmonella Typhi (S. Typhi) (Ty2 aroC-ssaV-) ZH9.
Day 17
|
—
|
—
|
—
|
2 participants
|
0 participants
|
|
Number of Subjects Having Shedding in Stool of Salmonella Typhi (S. Typhi) (Ty2 aroC-ssaV-) ZH9.
Day 19
|
—
|
—
|
—
|
0 participants
|
0 participants
|
|
Number of Subjects Having Shedding in Stool of Salmonella Typhi (S. Typhi) (Ty2 aroC-ssaV-) ZH9.
Day 21
|
—
|
—
|
—
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: From baseline (pre-dose) to Days 14 or 28 (IgG) or to Days 7 or 14 (IgA).Population: ITT Population: all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.
Number and proportion of subjects with increase of 70% (fold change of 1.7) in S. typhi LPS-specific serum IgG at Days 14 or 28 AND/OR increase of 50% (fold change of 1.5) in S. typhi LPS-specific serum IgA at Days 7 or 14. Serum IgG and IgA were assayed using enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
M01ZH09 Vaccine Candidate Cohort 1
n=37 Participants
Dose of 5.0 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 2
n=38 Participants
Dose of 7.5 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 3
n=36 Participants
Dose of 1.1 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 4
n=39 Participants
Dose of 1.7 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
Pooled Placebo
n=37 Participants
Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
|
|---|---|---|---|---|---|
|
Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgG and/or IgA Antibodies for S. Typhi Lipopolysaccharide (LPS).
|
32 Participants
|
35 Participants
|
32 Participants
|
38 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From baseline (pre-dose) to Days 7 or 14.Population: ITT Population: all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.
Number and proportion of subjects with increase of 50% (fold change of 1.5) in S. typhi LPS-specific serum IgA at Days 7 or 14. Serum IgA was assayed using ELISA.
Outcome measures
| Measure |
M01ZH09 Vaccine Candidate Cohort 1
n=37 Participants
Dose of 5.0 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 2
n=38 Participants
Dose of 7.5 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 3
n=36 Participants
Dose of 1.1 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 4
n=39 Participants
Dose of 1.7 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
Pooled Placebo
n=37 Participants
Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
|
|---|---|---|---|---|---|
|
Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgA Antibodies for S. Typhi LPS.
|
31 Participants
|
35 Participants
|
30 Participants
|
38 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From baseline (pre-dose) to Days 14 or 28.Population: ITT Population: all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.
Number and proportion of subjects with increase of 70% (fold change of 1.7) in S. typhi LPS-specific serum IgG at Days 14 or 28. Serum IgG was assayed using ELISA.
Outcome measures
| Measure |
M01ZH09 Vaccine Candidate Cohort 1
n=37 Participants
Dose of 5.0 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 2
n=38 Participants
Dose of 7.5 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 3
n=36 Participants
Dose of 1.1 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 4
n=39 Participants
Dose of 1.7 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
Pooled Placebo
n=37 Participants
Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
|
|---|---|---|---|---|---|
|
Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgG Antibodies for S. Typhi LPS.
|
23 Participants
|
30 Participants
|
31 Participants
|
33 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From baseline (pre-dose) to Days 7, 14, or 28.Population: ITT Population: all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 14.
Number and proportion of subjects with an increase of 70% (fold change of 1.7) in S. typhi LPS-specific serum IgG at Days 7, 14 or 28. Serum IgG was assayed using ELISA.
Outcome measures
| Measure |
M01ZH09 Vaccine Candidate Cohort 1
n=37 Participants
Dose of 5.0 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 2
n=38 Participants
Dose of 7.5 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 3
n=36 Participants
Dose of 1.1 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 4
n=39 Participants
Dose of 1.7 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
Pooled Placebo
n=37 Participants
Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
|
|---|---|---|---|---|---|
|
Number and Proportion of Subjects Developing an Immune Response as Determined by the Level of IgG Antibodies for S. Typhi LPS.
|
25 Participants
|
30 Participants
|
31 Participants
|
33 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: At Day 7 (IgA); and from baseline (pre-dose) to Day 28 (IgG).Population: ITT Population (Cohort 2): all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.
Number and proportion of subjects with ≥ 4 ASCs per 10\^6 peripheral blood mononuclear cells (PBMCs) at Day 7 secreting IgA specific for S. typhi LPS (detected by enzyme-linked immunospot assay \[ELISPOT\]) AND/OR 4-fold increase for serum IgG on Day 28 compared to baseline (assay using endpoint titre ELISA).
Outcome measures
| Measure |
M01ZH09 Vaccine Candidate Cohort 1
n=38 Participants
Dose of 5.0 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 2
n=9 Participants
Dose of 7.5 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 3
Dose of 1.1 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 4
Dose of 1.7 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
Pooled Placebo
Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
|
|---|---|---|---|---|---|
|
Number and Proportion of Subjects Developing an Immune Response at the Target Dose of 7.5 x 10^9 CFU (Cohort 2) as Determined by the Number of Antibody Secreting Cells (ASCs) Secreting IgA and/or Fold Change in IgG.
|
36 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7.Population: ITT Population (Cohort 2): all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.
Number and proportion of subjects with ≥ 4 ASCs per 10\^6 PBMCs at Day 7 secreting IgA specific for S. typhi LPS (detected by ELISPOT).
Outcome measures
| Measure |
M01ZH09 Vaccine Candidate Cohort 1
n=38 Participants
Dose of 5.0 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 2
n=9 Participants
Dose of 7.5 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 3
Dose of 1.1 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 4
Dose of 1.7 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
Pooled Placebo
Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
|
|---|---|---|---|---|---|
|
Number and Proportion of Subjects Developing an Immune Response at the Target Dose of 7.5 x 10^9 CFU (Cohort 2) as Determined by the Number of ASCs Secreting IgA.
|
35 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline (pre-dose) to Day 28.Population: ITT Population (Cohort 2): all subjects who received study medication and had any postbaseline immunogenicity data available up to and including Day 28.
Number and proportion of subjects with 4-fold increase for serum IgG on Day 28 compared to baseline (assay using endpoint titre ELISA).
Outcome measures
| Measure |
M01ZH09 Vaccine Candidate Cohort 1
n=38 Participants
Dose of 5.0 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 2
n=9 Participants
Dose of 7.5 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 3
Dose of 1.1 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 4
Dose of 1.7 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
Pooled Placebo
Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
|
|---|---|---|---|---|---|
|
Number and Proportion of Subjects Developing an Immune Response at the Target Dose of 7.5 x 10^9 CFU (Cohort 2) as Determined by the Fold Change in IgG.
|
14 Participants
|
0 Participants
|
—
|
—
|
—
|
Adverse Events
M01ZH09 Vaccine Candidate Cohort 1
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
M01ZH09 Vaccine Candidate Cohort 2
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
M01ZH09 Vaccine Candidate Cohort 3
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
M01ZH09 Vaccine Candidate Cohort 4
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Pooled Placebo
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
M01ZH09 Vaccine Candidate Cohort 1
n=37 participants at risk
Dose of 5.0 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 2
n=38 participants at risk
Dose of 7.5 x 10\^9 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 3
n=36 participants at risk
Dose of 1.1 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
M01ZH09 Vaccine Candidate Cohort 4
n=39 participants at risk
Dose of 1.7 x 10\^10 CFU S. typhi (Ty2 aroC-ssaV-) ZH9.
|
Pooled Placebo
n=37 participants at risk
Placebo comparator comprised of excipients only, pooled across Cohorts 1-4.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
29.7%
11/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
31.6%
12/38 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
19.4%
7/36 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
30.8%
12/39 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
21.6%
8/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
|
Gastrointestinal disorders
Constipation
|
18.9%
7/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
10.5%
4/38 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
2.8%
1/36 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
12.8%
5/39 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
21.6%
8/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.5%
5/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
26.3%
10/38 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
16.7%
6/36 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
23.1%
9/39 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
27.0%
10/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
|
Gastrointestinal disorders
Flatulence
|
45.9%
17/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
39.5%
15/38 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
27.8%
10/36 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
25.6%
10/39 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
37.8%
14/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
|
Gastrointestinal disorders
Nausea
|
24.3%
9/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
15.8%
6/38 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
8.3%
3/36 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
25.6%
10/39 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
13.5%
5/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
|
General disorders
Asthenia
|
21.6%
8/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
34.2%
13/38 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
16.7%
6/36 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
17.9%
7/39 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
21.6%
8/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
|
Metabolism and nutrition disorders
Anorexia
|
8.1%
3/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
21.1%
8/38 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
2.8%
1/36 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
10.3%
4/39 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
18.9%
7/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.8%
4/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
15.8%
6/38 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
8.3%
3/36 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
17.9%
7/39 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
18.9%
7/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
|
Nervous system disorders
Headache
|
43.2%
16/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
13.2%
5/38 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
25.0%
9/36 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
38.5%
15/39 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
35.1%
13/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.7%
1/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
2.6%
1/38 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
5.6%
2/36 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
0.00%
0/39 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
0.00%
0/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
|
General disorders
Chills
|
5.4%
2/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
0.00%
0/38 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
5.6%
2/36 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
17.9%
7/39 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
2.7%
1/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
|
General disorders
Fatigue
|
0.00%
0/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
0.00%
0/38 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
0.00%
0/36 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
7.7%
3/39 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
2.7%
1/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
2.6%
1/38 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
5.6%
2/36 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
10.3%
4/39 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
8.1%
3/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
|
Investigations
Culture stool positive
|
2.7%
1/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
2.6%
1/38 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
2.8%
1/36 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
7.7%
3/39 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
0.00%
0/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
2/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
2.6%
1/38 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
2.8%
1/36 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
2.6%
1/39 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
2.7%
1/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
2/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
0.00%
0/38 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
0.00%
0/36 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
5.1%
2/39 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
5.4%
2/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
0.00%
0/38 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
8.3%
3/36 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
0.00%
0/39 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
2.7%
1/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
2.6%
1/38 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
5.6%
2/36 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
2.6%
1/39 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
2.7%
1/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/18 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
5.9%
1/17 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
10.5%
2/19 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
5.3%
1/19 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
4.8%
1/21 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.4%
2/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
2.6%
1/38 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
0.00%
0/36 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
5.1%
2/39 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
5.4%
2/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
0.00%
0/38 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
0.00%
0/36 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
0.00%
0/39 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
5.4%
2/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
0.00%
0/38 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
0.00%
0/36 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
2.6%
1/39 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
5.4%
2/37 • Up to Day 28.
Treatment-emergent adverse events (TEAEs) are defined as those adverse events which occurred postdose or which were present predose and became worse postdose. The proportions of subjects reported TEAEs and SAEs were pre-defined safety outcome variables.
|
Additional Information
Dr. Tim Babinchak
Emergent Product Development Gaithersburg
Phone: (240) 631-3585
Results disclosure agreements
- Principal investigator is a sponsor employee Any proposed publication was subject to review conditions and timelines agreed between Emergent Product Development UK Ltd and the site Principal Investigator and detailed in the agreements with these parties prior to the start of the study.
- Publication restrictions are in place
Restriction type: OTHER