Trial Outcomes & Findings for A Study of the Safety and Immune Response of 2 Doses of a New Shigella Vaccine in Kenyan Adults (NCT NCT02676895)
NCT ID: NCT02676895
Last Updated: 2019-02-18
Results Overview
Assessed solicited local adverse reactions were injection site erythema, induration, pain. Assessed systemic adverse reactions were headache, arthralgia, chills, fatigue, malaise, myalgia and temperature (body temperature measured axillary). Any = occurrence of the symptom regardless of intensity grade. Any temperature = body temperature ≥ 38.0°C. Severe symptom = pain, headache, arthralgia, chills, fatigue, malaise and myalgia that prevented normal activity. Severe redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Severe temperature = body temperature \> 40.0 °C.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
From 30 minutes up to 7 days following each vaccination
Results posted on
2019-02-18
Participant Flow
Out of the 74 enrolled subjects, 2 subjects were allocated numbers but were not administered the study vaccine, hence they did not start the study.
Participant milestones
| Measure |
1790GAHB 25 μg Group
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
|
1790GAHB 100 μg Group
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
|
Control Group
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
26
|
24
|
|
Overall Study
COMPLETED
|
20
|
23
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
3
|
Reasons for withdrawal
| Measure |
1790GAHB 25 μg Group
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
|
1790GAHB 100 μg Group
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
|
Control Group
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
|
|---|---|---|---|
|
Overall Study
Administrative reason
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
A Study of the Safety and Immune Response of 2 Doses of a New Shigella Vaccine in Kenyan Adults
Baseline characteristics by cohort
| Measure |
1790GAHB 25 μg Group
n=22 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
|
1790GAHB 100 μg Group
n=26 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
|
Control Group
n=24 Participants
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
24.6 Years
STANDARD_DEVIATION 5.81 • n=5 Participants
|
26.9 Years
STANDARD_DEVIATION 8.44 • n=7 Participants
|
28.3 Years
STANDARD_DEVIATION 8.23 • n=5 Participants
|
26.7 Years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
21 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From 30 minutes up to 7 days following each vaccinationPopulation: This analysis was performed on the Solicited Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited adverse event data were available. Less subjects were available to receive the second dose, hence the number or participants analysed is lower for the second dose results.
Assessed solicited local adverse reactions were injection site erythema, induration, pain. Assessed systemic adverse reactions were headache, arthralgia, chills, fatigue, malaise, myalgia and temperature (body temperature measured axillary). Any = occurrence of the symptom regardless of intensity grade. Any temperature = body temperature ≥ 38.0°C. Severe symptom = pain, headache, arthralgia, chills, fatigue, malaise and myalgia that prevented normal activity. Severe redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Severe temperature = body temperature \> 40.0 °C.
Outcome measures
| Measure |
1790GAHB 25 μg Group
n=22 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
|
1790GAHB 100 μg Group
n=26 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
|
Control Group
n=24 Participants
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
|
|---|---|---|---|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Malaise, Across Doses
|
3 Participants
|
3 Participants
|
10 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Myalgia, Across Doses
|
1 Participants
|
2 Participants
|
6 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Erythema, Across Doses
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Arthralgia, post-Dose 1
|
1 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Chills, post-Dose 1
|
4 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Chills, post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Malaise, post-Dose 1
|
3 Participants
|
3 Participants
|
6 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Myalgia, post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Temperature, post-Dose 1
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Temperature, post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Headache, post-Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Arthralgia, post-Dose 2
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Chills, post-Dose 2
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Malaise, post-Dose 2
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Malaise, post-Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Myalgia, post-Dose 2
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Temperature, post-Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Fatigue, Across Doses
|
3 Participants
|
9 Participants
|
9 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Chills, Across Doses
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Chills, Across Doses
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Malaise, Across Doses
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Myalgia, Across Doses
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Temperature, Across Doses
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Temperature, Across Doses
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Fatigue, Across Doses
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Arthralgia, Across Doses
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Headache, Across Doses
|
8 Participants
|
13 Participants
|
10 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Headache, Across Doses
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any adverse event(s)
|
21 Participants
|
25 Participants
|
21 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any solicited local adverse event(s)
|
21 Participants
|
25 Participants
|
19 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Pain, post-Dose 1
|
20 Participants
|
25 Participants
|
10 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Pain, post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Erythema, post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Erythema, post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Induration, post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Induration, post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Pain, post-Dose 2
|
15 Participants
|
15 Participants
|
17 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Pain, post-Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Erythema, post-Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Erythema, post-Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Induration, post-Dose 2
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Induration, post-Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Pain, Across doses
|
21 Participants
|
25 Participants
|
19 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Pain, Across Doses
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Erythema, Across Doses
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Induration, Across Doses
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Induration, Across Doses
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Solicited systemic adverse event(s)
|
9 Participants
|
16 Participants
|
14 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Headache, post-Dose 1
|
5 Participants
|
10 Participants
|
8 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Headache, post-Dose 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Arthralgia, post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Fatigue, post-Dose 1
|
2 Participants
|
8 Participants
|
7 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Fatigue, post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Malaise, post-Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Myalgia, post-Dose 1
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Headache, post-Dose 2
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Arthralgia, post-Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Any Fatigue, post-Dose 2
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Fatigue, post-Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Arthralgia, Across Doses
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Chills, post-Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Myalgia, post-Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Severe Temperature, post-Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During 28 days following each vaccinationPopulation: This analysis was performed on the Unsolicited Safety Set, which included all enrolled subjects who received a study vaccination and for whom unsolicited adverse event data were available.
An unsolicited AE is an AE that was not solicited using the Diary Card and that was spontaneously communicated by a subject who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject. Note: \*disruptions= dose reduction, interruption or delay in study vaccination.
Outcome measures
| Measure |
1790GAHB 25 μg Group
n=22 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
|
1790GAHB 100 μg Group
n=26 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
|
Control Group
n=24 Participants
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
|
|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Possibly or Probably related AE
|
13 Participants
|
16 Participants
|
12 Participants
|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Any AE
|
19 Participants
|
24 Participants
|
19 Participants
|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
AE leading to study vaccine withdrawal
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
AE leading to disruptions*
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
AE leading to hospitalization
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
AE of special interest (Neutropenia)
|
2 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Throughout the whole study period (from Day 1 up to Day 57)Population: This analysis was performed on the Unsolicited Safety Set, which included all enrolled subjects who received a study vaccination and for whom unsolicited adverse event data were available.
An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; is life-threatening (i.e., the subject was, in the opinion of the investigator, at immediate risk of death from the event as it occurred); it does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions); congenital anomaly/or birth defect; an important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.
Outcome measures
| Measure |
1790GAHB 25 μg Group
n=22 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
|
1790GAHB 100 μg Group
n=26 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
|
Control Group
n=24 Participants
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
Possibly or probably related SAE
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Serious Adverse Events (SAEs)
Any SAE
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Serious Adverse Events (SAEs)
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 8 (7 days after first vaccination)Population: This analysis was performed on the Overall Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited and/or unsolicited adverse event data were available. Less subjects were available with each subsequent visit, hence the number of subjects analysed is lower than in the previous timepoints.
The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase \[ALP\], Alanine Aminotransferase \[ALA\], Aspartate Aminotransferase \[AST\], Bilirubin \[BILI\], Blood Urea Nitrogen \[BUN\], Creatinine \[CREAT\], Gamma Glutamyl Transferase \[GGT\], Glucose \[GLUC\], Potassium \[K\], Lactate Dehydrogenase \[LDH\] and Sodium \[Na\]). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
1790GAHB 25 μg Group
n=22 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
|
1790GAHB 100 μg Group
n=26 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
|
Control Group
n=23 Participants
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
|
|---|---|---|---|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
GGT · Below (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Eosinophils · Above (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Eosinophils · Below (baseline) - within (Day 8)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Eosinophils · Within (baseline) - within (Day 8)
|
20 Participants
|
24 Participants
|
22 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Eosinophils · Above (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Eosinophils · Below (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Neutrophils · Within (baseline) - within (Day 8)
|
22 Participants
|
26 Participants
|
22 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Basophils · Below (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Basophils · Within (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Basophils · Above (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Basophils · Below (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Basophils · Within (baseline) - within (Day 8)
|
9 Participants
|
9 Participants
|
5 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Basophils · Above (baseline) - within (Day 8)
|
3 Participants
|
5 Participants
|
6 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Basophils · Below (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Basophils · Within (baseline) - above (Day 8)
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Neutrophils · Above (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Basophils · Above (baseline) - above (Day 8)
|
7 Participants
|
11 Participants
|
10 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Eosinophils · Below (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Eosinophils · Within (baseline) - below (Day 8)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Eosinophils · Within (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Eosinophils · Above (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Erythrocytes · Below (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Erythrocytes · Within (baseline) - below (Day 8)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Erythrocytes · Above (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Erythrocytes · Below (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Erythrocytes · Within (baseline) - within (Day 8)
|
20 Participants
|
24 Participants
|
22 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Erythrocytes · Above (baseline) - within (Day 8)
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Erythrocytes · Below (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Erythrocytes · Within (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Erythrocytes · Above (baseline) - above (Day 8)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Hematocrit · Below (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Hematocrit · Within (baseline) - below (Day 8)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Hematocrit · Above (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Hematocrit · Below (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Neutrophils · Below (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Neutrophils · Within (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Neutrophils · Above (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Platelets · Below (baseline) - below (Day 8)
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Platelets · Within (baseline) - below (Day 8)
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Platelets · Above (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Platelets · Below (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Platelets · Within (baseline) - within (Day 8)
|
19 Participants
|
21 Participants
|
21 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Platelets · Above (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Platelets · Below (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Platelets · Within (baseline) - above (Day 8)
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Platelets · Above (baseline) - above (Day 8)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
ALA · Below (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
ALA · Within (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
ALA · Above (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
ALA · Below (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
ALA · Within (baseline) - within (Day 8)
|
22 Participants
|
26 Participants
|
23 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
ALA · Above (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
ALA · Below (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
CREA · Below (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
ALA · Within (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
ALA · Above (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
ALP · Below (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
ALP · Within (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
ALP · Above (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
ALP · Below (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
ALP · Within (baseline) - within (Day 8)
|
21 Participants
|
25 Participants
|
21 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
ALP · Above (baseline) - within (Day 8)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
ALP · Below (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
ALP · Within (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
ALP · Above (baseline) - above (Day 8)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
AST · Below (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
AST · Within (baseline) - below (Day 8)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
AST · Above (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
AST · Below (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
AST · Within (baseline) - within (Day 8)
|
22 Participants
|
23 Participants
|
23 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
AST · Above (baseline) - within (Day 8)
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
AST · Below (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
AST · Within (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
AST · Above (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
BILI · Below (baseline) - below (Day 8)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
BILI · Within (baseline) - below (Day 8)
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
BILI · Above (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
BILI · Below (baseline) - within (Day 8)
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
BILI · Within (baseline) - within (Day 8)
|
17 Participants
|
22 Participants
|
20 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
BILI · Above (baseline) - within (Day 8)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
BILI · Below (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
BILI · Within (baseline) - above (Day 8)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
BILI · Above (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
BUN · Below (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
BUN · Within (baseline) - below (Day 8)
|
1 Participants
|
7 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
BUN · Above (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
BUN · Below (baseline) - within (Day 8)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
BUN · Within (baseline) - within (Day 8)
|
20 Participants
|
18 Participants
|
22 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
BUN · Above (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
BUN · Below (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
CREA · Within (baseline) - above (Day 8)
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
CREA · Above (baseline) - above (Day 8)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
BUN · Within (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
BUN · Above (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
CREA · Below (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
CREA · Within (baseline) - below (Day 8)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
CREA · Above (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
CREA · Below (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
CREA · Within (baseline) - within (Day 8)
|
20 Participants
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
CREA · Above (baseline) - within (Day 8)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Na · Within (baseline) - below (Day 8)
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Hematocrit · Within (baseline) - within (Day 8)
|
22 Participants
|
21 Participants
|
22 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Hematocrit · Above (baseline) - within (Day 8)
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Na · Above (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Hematocrit · Below (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Hematocrit · Within (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Hematocrit · Above (baseline) - above (Day 8)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Hemoglobin · Below (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Hemoglobin · Within (baseline) - below (Day 8)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Hemoglobin · Above (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Hemoglobin · Below (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Hemoglobin · Within (baseline) - within (Day 8)
|
22 Participants
|
24 Participants
|
23 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Hemoglobin · Above (baseline) - within (Day 8)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Hemoglobin · Below (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Hemoglobin · Within (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Hemoglobin · Above (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Leukocytes · Below (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Leukocytes · Within (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Leukocytes · Above (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Leukocytes · Below (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Leukocytes · Within (baseline) - within (Day 8)
|
21 Participants
|
25 Participants
|
22 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Leukocytes · Above (baseline) - within (Day 8)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Na · Below (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Leukocytes · Below (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Leukocytes · Within (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Leukocytes · Above (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Lymphocytes · Below (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Lymphocytes · Within (baseline) - below (Day 8)
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Lymphocytes · Above (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Lymphocytes · Below (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Na · Within (baseline) - within (Day 8)
|
21 Participants
|
23 Participants
|
21 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Na · Above (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Na · Below (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Na · Within (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Na · Above (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
GGT · Within (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
GGT · Above (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
GGT · Below (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
GGT · Within (baseline) - within (Day 8)
|
21 Participants
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
GGT · Above (baseline) - within (Day 8)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
GGT · Below (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Lymphocytes · Within (baseline) - within (Day 8)
|
19 Participants
|
26 Participants
|
22 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Lymphocytes · Above (baseline) - within (Day 8)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Lymphocytes · Below (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Lymphocytes · Within (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Lymphocytes · Above (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Monocytes · Below (baseline) - below (Day 8)
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Monocytes · Within (baseline) - below (Day 8)
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Monocytes · Above (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Monocytes · Below (baseline) - within (Day 8)
|
3 Participants
|
7 Participants
|
3 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Monocytes · Within (baseline) - within (Day 8)
|
15 Participants
|
15 Participants
|
13 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Monocytes · Above (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Monocytes · Below (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Monocytes · Within (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Monocytes · Above (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Neutrophils · Below (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Neutrophils · Within (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Neutrophils · Above (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Neutrophils · Below (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
GGT · Within (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
GGT · Above (baseline) - above (Day 8)
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
GLUC · Below (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
GLUC · Within (baseline) - below (Day 8)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
GLUC · Above (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
GLUC · Below (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
GLUC · Within (baseline) - within (Day 8)
|
21 Participants
|
26 Participants
|
21 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
GLUC · Above (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
GLUC · Below (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
GLUC · Within (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
GLUC · Above (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
LDH · Below (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
LDH · Within (baseline) - below (Day 8)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
LDH · Above (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
LDH · Below (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
LDH · Within (baseline) - within (Day 8)
|
21 Participants
|
26 Participants
|
22 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
LDH · Above (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
LDH · Below (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
LDH · Within (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
LDH · Above (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
K · Below (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
K · Within (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
K · Above (baseline) - below (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
K · Below (baseline) - within (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
K · Within (baseline) - within (Day 8)
|
15 Participants
|
16 Participants
|
19 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
K · Above (baseline) - within (Day 8)
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
K · Below (baseline) - above (Day 8)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
K · Within (baseline) - above (Day 8)
|
4 Participants
|
6 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
K · Above (baseline) - above (Day 8)
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Na · Below (baseline) - below (Day 8)
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 29 (28 days after the first vaccination)Population: This analysis was performed on the Overall Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited and/or unsolicited adverse event data were available. Less subjects were available with each subsequent visit, hence the number of subjects analysed is lower than in the previous timepoints.
The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase \[ALP\], Alanine Aminotransferase \[ALA\], Aspartate Aminotransferase \[AST\], Bilirubin \[BILI\], Blood Urea Nitrogen \[BUN\], Creatinine \[CREAT\], Gamma Glutamyl Transferase \[GGT\], Glucose \[GLUC\], Potassium \[K\], Lactate Dehydrogenase \[LDH\] and Sodium \[Na\]). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
1790GAHB 25 μg Group
n=22 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
|
1790GAHB 100 μg Group
n=26 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
|
Control Group
n=22 Participants
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
|
|---|---|---|---|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
CREA · Above (baseline) - above (Day 29)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
LDH · Below (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
LDH · Within (baseline) - above (Day 29)
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
K · Below (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
K · Within (baseline) - within (Day 29)
|
19 Participants
|
15 Participants
|
16 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
K · Above (baseline) - within (Day 29)
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
K · Below (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
K · Within (baseline) - above (Day 29)
|
0 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
K · Above (baseline) - above (Day 29)
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Na · Below (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Na · Within (baseline) - below (Day 29)
|
4 Participants
|
6 Participants
|
2 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Na · Above (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Na · Below (baseline) - within (Day 29)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Na · Within (baseline) - within (Day 29)
|
18 Participants
|
19 Participants
|
20 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Na · Within (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Na · Above (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Basophils · Below (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Basophils · Within (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Basophils · Above (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Basophils · Below (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Basophils · Within (baseline) - within (Day 29)
|
9 Participants
|
8 Participants
|
4 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Basophils · Above (baseline) - within (Day 29)
|
4 Participants
|
4 Participants
|
7 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Basophils · Below (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Basophils · Within (baseline) - above (Day 29)
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Basophils · Above (baseline) - above (Day 29)
|
6 Participants
|
12 Participants
|
8 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Eosinophils · Below (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Eosinophils · Within (baseline) - below (Day 29)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Eosinophils · Above (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Eosinophils · Below (baseline) - within (Day 29)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Eosinophils · Within (baseline) - within (Day 29)
|
20 Participants
|
24 Participants
|
20 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Eosinophils · Above (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Eosinophils · Below (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Eosinophils · Within (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Eosinophils · Above (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Erythrocytes · Below (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Erythrocytes · Within (baseline) - below (Day 29)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Erythrocytes · Above (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Erythrocytes · Below (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Erythrocytes · Within (baseline) - within (Day 29)
|
19 Participants
|
24 Participants
|
21 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Erythrocytes · Above (baseline) - within (Day 29)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Erythrocytes · Below (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Erythrocytes · Within (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Erythrocytes · Above (baseline) - above (Day 29)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Hematocrit · Below (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Hematocrit · Within (baseline) - below (Day 29)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Hematocrit · Above (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Hematocrit · Below (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Hematocrit · Within (baseline) - within (Day 29)
|
21 Participants
|
21 Participants
|
21 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Hematocrit · Above (baseline) - within (Day 29)
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Hematocrit · Below (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Hematocrit · Within (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Hematocrit · Above (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Hemoglobin · Below (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Hemoglobin · Within (baseline) - below (Day 29)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Hemoglobin · Above (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Hemoglobin · Below (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Hemoglobin · Within (baseline) - within (Day 29)
|
21 Participants
|
24 Participants
|
22 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Hemoglobin · Above (baseline) - within (Day 29)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Hemoglobin · Below (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Hemoglobin · Within (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Hemoglobin · Above (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Leukocytes · Below (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Leukocytes · Within (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Leukocytes · Above (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Leukocytes · Below (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Leukocytes · Within (baseline) - within (Day 29)
|
20 Participants
|
24 Participants
|
22 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Leukocytes · Above (baseline) - within (Day 29)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Leukocytes · Below (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Leukocytes · Within (baseline) - above (Day 29)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Leukocytes · Above (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Lymphocytes · Below (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Lymphocytes · Within (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Lymphocytes · Above (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Lymphocytes · Below (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Lymphocytes · Within (baseline) - within (Day 29)
|
20 Participants
|
24 Participants
|
21 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Lymphocytes · Above (baseline) - within (Day 29)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Lymphocytes · Below (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Lymphocytes · Within (baseline) - above (Day 29)
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Lymphocytes · Above (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Monocytes · Below (baseline) - below (Day 29)
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Monocytes · Within (baseline) - below (Day 29)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Monocytes · Above (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Monocytes · Below (baseline) - within (Day 29)
|
2 Participants
|
5 Participants
|
6 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Monocytes · Within (baseline) - within (Day 29)
|
15 Participants
|
15 Participants
|
14 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Monocytes · Above (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Monocytes · Below (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Monocytes · Within (baseline) - above (Day 29)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Monocytes · Above (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Neutrophils · Below (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Neutrophils · Within (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Neutrophils · Above (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Neutrophils · Below (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Neutrophils · Within (baseline) - within (Day 29)
|
21 Participants
|
25 Participants
|
22 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Neutrophils · Above (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Neutrophils · Below (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Neutrophils · Within (baseline) - above (Day 29)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Neutrophils · Above (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Platelets · Below (baseline) - below (Day 29)
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Platelets · Within (baseline) - below (Day 29)
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Platelets · Above (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Platelets · Below (baseline) - within (Day 29)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Platelets · Within (baseline) - within (Day 29)
|
19 Participants
|
22 Participants
|
20 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Platelets · Above (baseline) - within (Day 29)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Platelets · Below (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Platelets · Within (baseline) - above (Day 29)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Platelets · Above (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
ALA · Below (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
ALA · Within (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
ALA · Above (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
ALA · Below (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
ALA · Within (baseline) - within (Day 29)
|
22 Participants
|
26 Participants
|
22 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
ALA · Above (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
ALA · Below (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
ALA · Within (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
ALA · Above (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
ALP · Below (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
ALP · Within (baseline) - below (Day 29)
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
ALP · Above (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
ALP · Below (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
ALP · Within (baseline) - within (Day 29)
|
21 Participants
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
ALP · Above (baseline) - within (Day 29)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
ALP · Below (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
ALP · Within (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
ALP · Above (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
AST · Below (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
AST · Within (baseline) - below (Day 29)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
AST · Above (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
AST · Below (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
AST · Within (baseline) - within (Day 29)
|
21 Participants
|
22 Participants
|
22 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
AST · Above (baseline) - within (Day 29)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
AST · Below (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
AST · Within (baseline) - above (Day 29)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
AST · Above (baseline) - above (Day 29)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
BILI · Below (baseline) - below (Day 29)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
BILI · Within (baseline) - below (Day 29)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
BILI · Above (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
BILI · Below (baseline) - within (Day 29)
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
BILI · Within (baseline) - within (Day 29)
|
19 Participants
|
23 Participants
|
21 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
BILI · Above (baseline) - within (Day 29)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
BILI · Below (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
BILI · Within (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
BILI · Above (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
BUN · Below (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
BUN · Within (baseline) - below (Day 29)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
BUN · Above (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
BUN · Below (baseline) - within (Day 29)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
BUN · Within (baseline) - within (Day 29)
|
20 Participants
|
24 Participants
|
21 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
BUN · Above (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
BUN · Below (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
BUN · Within (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
BUN · Above (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
CREA · Below (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
CREA · Within (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
CREA · Above (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
CREA · Below (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
CREA · Within (baseline) - within (Day 29)
|
21 Participants
|
22 Participants
|
19 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
CREA · Above (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
CREA · Below (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
CREA · Within (baseline) - above (Day 29)
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
GGT · Below (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
GGT · Within (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
GGT · Above (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
GGT · Below (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
GGT · Within (baseline) - within (Day 29)
|
18 Participants
|
21 Participants
|
18 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
GGT · Above (baseline) - within (Day 29)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
GGT · Below (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
GGT · Within (baseline) - above (Day 29)
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
GGT · Above (baseline) - above (Day 29)
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
GLUC · Below (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
GLUC · Within (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
GLUC · Above (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
GLUC · Below (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
GLUC · Within (baseline) - within (Day 29)
|
22 Participants
|
26 Participants
|
21 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
GLUC · Above (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
GLUC · Below (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
GLUC · Within (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
GLUC · Above (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
LDH · Below (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
LDH · Within (baseline) - below (Day 29)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
LDH · Above (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
LDH · Within (baseline) - within (Day 29)
|
21 Participants
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
LDH · Above (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
LDH · Below (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
LDH · Above (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
K · Below (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
K · Within (baseline) - below (Day 29)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
K · Above (baseline) - below (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Na · Above (baseline) - within (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Na · Below (baseline) - above (Day 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 36 (7 days after the second vaccination)Population: This analysis was performed on the Overall Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited and/or unsolicited adverse event data were available. Less subjects were available with each subsequent visit, hence the number of subjects analysed is lower than in the previous timepoints.
The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase \[ALP\], Alanine Aminotransferase \[ALA\], Aspartate Aminotransferase \[AST\], Bilirubin \[BILI\], Blood Urea Nitrogen \[BUN\], Creatinine \[CREAT\], Gamma Glutamyl Transferase \[GGT\], Glucose \[GLUC\], Potassium \[K\], Lactate Dehydrogenase \[LDH\] and Sodium \[Na\]). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
1790GAHB 25 μg Group
n=22 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
|
1790GAHB 100 μg Group
n=24 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
|
Control Group
n=21 Participants
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
|
|---|---|---|---|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Platelet · Within (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Basophils · Below (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Basophils · Within (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Basophils · Below (baseline) - Within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Basophils · Within (baseline) - within (Day 36)
|
9 Participants
|
7 Participants
|
5 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Basophils · Above (baseline) - within (Day 36)
|
2 Participants
|
6 Participants
|
5 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Basophils · Within (baseline) - above (Day 36)
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Eosinophils · Below (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Eosinophils · Within (baseline) - below (Day 36)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Eosinophils · Above (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Eosinophils · Below (baseline) - Within (Day 36)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Eosinophils · Above (baseline) - within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Eosinophils · Below (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Eosinophils · Above (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Erythrocytes · Below (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Erythrocytes · Within (baseline) - below (Day 36)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Erythrocytes · Above (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Erythrocytes · Below (baseline) - Within (Day 36)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Erythrocytes · Within (baseline) - within (Day 36)
|
20 Participants
|
22 Participants
|
20 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Erythrocytes · Above (baseline) - within (Day 36)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Erythrocytes · Below (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Erythrocytes · Within (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Erythrocytes · Above (baseline) - above (Day 36)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Hematocrit · Below (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Hematocrit · Within (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Hematocrit · Above (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Hematocrit · Below (baseline) - Within (Day 36)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Hematocrit · Within (baseline) - within (Day 36)
|
22 Participants
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Hematocrit · Within (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Hematocrit · Above (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Hemoglobin · Below (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Hemoglobin · Below (baseline) - Within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Hemoglobin · Within (baseline) - within (Day 36)
|
22 Participants
|
23 Participants
|
21 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Hemoglobin · Above (baseline) - within (Day 36)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Hemoglobin · Below (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Hemoglobin · Within (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Hemoglobin · Above (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Leukocytes · Below (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Leukocytes · Within (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Leukocytes · Above (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Leukocytes · Below (baseline) - Within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Leukocytes · Within (baseline) - within (Day 36)
|
21 Participants
|
22 Participants
|
21 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Leukocytes · Above (baseline) - within (Day 36)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Leukocytes · Below (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Leukocytes · Within (baseline) - above (Day 36)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Leukocytes · Above (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Lymphocytes · Below (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Lymphocytes · Within (baseline) - below (Day 36)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Lymphocytes · Above (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Lymphocytes · Below (baseline) - Within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Lymphocytes · Within (baseline) - within (Day 36)
|
20 Participants
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Lymphocytes · Above (baseline) - within (Day 36)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Lymphocytes · Below (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Lymphocytes · Within (baseline) - above (Day 36)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Lymphocytes · Above (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Monocytes · Below (baseline) - below (Day 36)
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Monocytes · Within (baseline) - below (Day 36)
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Monocytes · Above (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Monocytes · Below (baseline) - Within (Day 36)
|
4 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Monocytes · Within (baseline) - within (Day 36)
|
15 Participants
|
15 Participants
|
11 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Monocytes · Above (baseline) - within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Monocytes · Below (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Monocytes · Within (baseline) - above (Day 36)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Monocytes · Above (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Neutrophils · Below (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Neutrophils · Within (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Neutrophils · Above (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Neutrophils · Below (baseline) - Within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Neutrophils · Within (baseline) - within (Day 36)
|
22 Participants
|
24 Participants
|
21 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Neutrophils · Above (baseline) - within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Neutrophils · Below (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Neutrophils · Within (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Neutrophils · Above (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Platelet · Below (baseline) - below (Day 36)
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Platelet · Within (baseline) - below (Day 36)
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Platelet · Above (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Platelet · Below (baseline) - Within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Platelet · Within (baseline) - within (Day 36)
|
20 Participants
|
22 Participants
|
19 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Platelet · Above (baseline) - within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Platelet · Below (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Platelet · Above (baseline) - above (Day 36)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
ALA · Below (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
ALA · Within (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
ALA · Above (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
ALA · Below (baseline) - Within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
ALA · Within (baseline) - within (Day 36)
|
22 Participants
|
24 Participants
|
21 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
ALA · Above (baseline) - within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
ALA · Below (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
ALA · Within (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
ALA · Above (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
ALP · Below (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
ALP · Within (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
ALP · Above (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
ALP · Below (baseline) - Within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
ALP · Within (baseline) - within (Day 36)
|
20 Participants
|
22 Participants
|
19 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
ALP · Above (baseline) - within (Day 36)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
ALP · Below (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
ALP · Within (baseline) - above (Day 36)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
ALP · Above (baseline) - above (Day 36)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
AST · Below (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
AST · Within (baseline) - below (Day 36)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
AST · Above (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
AST · Below (baseline) - Within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
AST · Within (baseline) - within (Day 36)
|
20 Participants
|
21 Participants
|
20 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
AST · Above (baseline) - within (Day 36)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
AST · Below (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
AST · Within (baseline) - above (Day 36)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
AST · Above (baseline) - above (Day 36)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
BILI · Below (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
K · Below (baseline) - Within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
BILI · Within (baseline) - below (Day 36)
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
BILI · Above (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
BILI · Below (baseline) - Within (Day 36)
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
BILI · Within (baseline) - within (Day 36)
|
16 Participants
|
21 Participants
|
20 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
BILI · Above (baseline) - within (Day 36)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
BILI · Below (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
BILI · Within (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
BILI · Above (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
BUN · Below (baseline) - below (Day 36)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
BUN · Within (baseline) - below (Day 36)
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
BUN · Above (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
BUN · Below (baseline) - Within (Day 36)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
BUN · Within (baseline) - within (Day 36)
|
19 Participants
|
23 Participants
|
20 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
BUN · Above (baseline) - within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
BUN · Below (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
BUN · Within (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
BUN · Above (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
CREA · Below (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
CREA · Within (baseline) - below (Day 36)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
CREA · Above (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
CREA · Below (baseline) - Within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
CREA · Within (baseline) - within (Day 36)
|
20 Participants
|
17 Participants
|
18 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
CREA · Above (baseline) - within (Day 36)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
CREA · Below (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
CREA · Within (baseline) - above (Day 36)
|
1 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
CREA · Above (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
GGT · Below (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
GGT · Within (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
GGT · Above (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
GGT · Below (baseline) - Within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
GGT · Within (baseline) - within (Day 36)
|
19 Participants
|
19 Participants
|
18 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
GGT · Above (baseline) - within (Day 36)
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
GGT · Below (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
GGT · Within (baseline) - above (Day 36)
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
GGT · Above (baseline) - above (Day 36)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
GLUC · Below (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
GLUC · Within (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
GLUC · Above (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
GLUC · Below (baseline) - Within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
GLUC · Within (baseline) - within (Day 36)
|
22 Participants
|
24 Participants
|
21 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
GLUC · Above (baseline) - within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
GLUC · Below (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
GLUC · Within (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
GLUC · Above (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
LDH · Below (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
LDH · Within (baseline) - below (Day 36)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
LDH · Above (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
LDH · Below (baseline) - Within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
LDH · Within (baseline) - within (Day 36)
|
20 Participants
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
LDH · Above (baseline) - within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
LDH · Below (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
LDH · Above (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
K · Below (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
K · Within (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
K · Above (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
K · Within (baseline) - within (Day 36)
|
8 Participants
|
13 Participants
|
15 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
K · Above (baseline) - within (Day 36)
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
K · Below (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
K · Within (baseline) - above (Day 36)
|
11 Participants
|
7 Participants
|
3 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
K · Above (baseline) - above (Day 36)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Na · Below (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Na · Within (baseline) - below (Day 36)
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Na · Above (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Na · Below (baseline) - Within (Day 36)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Na · Within (baseline) - within (Day 36)
|
21 Participants
|
20 Participants
|
21 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Na · Above (baseline) - within (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Na · Below (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Na · Within (baseline) - above (Day 36)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Na · Above (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Basophils · Above (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Basophils · Below (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Basophils · Above (baseline) - above (Day 36)
|
8 Participants
|
10 Participants
|
9 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Eosinophils · Within (baseline) - within (Day 36)
|
21 Participants
|
22 Participants
|
18 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Eosinophils · Within (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Hematocrit · Above (baseline) - within (Day 36)
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Hematocrit · Below (baseline) - above (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Hemoglobin · Within (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Hemoglobin · Above (baseline) - below (Day 36)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
LDH · Within (baseline) - above (Day 36)
|
1 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At Day 57 (28 days after the second vaccination)Population: This analysis was performed on the Overall Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited and/or unsolicited adverse event data were available. Less subjects were available with each subsequent visit, hence the number of subjects analysed is lower than in the previous timepoints.
The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase \[ALP\], Alanine Aminotransferase \[ALA\], Aspartate Aminotransferase \[AST\], Bilirubin \[BILI\], Blood Urea Nitrogen \[BUN\], Creatinine \[CREAT\], Gamma Glutamyl Transferase \[GGT\], Glucose \[GLUC\], Potassium \[K\], Lactate Dehydrogenase \[LDH\] and Sodium \[Na\]). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
1790GAHB 25 μg Group
n=21 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
|
1790GAHB 100 μg Group
n=23 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
|
Control Group
n=21 Participants
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
|
|---|---|---|---|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Basophils · Below (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Basophils · Within (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Basophils · Above (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Basophils · Within (baseline) - within (Day 57)
|
8 Participants
|
7 Participants
|
6 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Basophils · Above (baseline) - within (Day 57)
|
5 Participants
|
7 Participants
|
8 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Basophils · Below (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Basophils · Within (baseline) - above (Day 57)
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Basophils · Above (baseline) - above (Day 57)
|
4 Participants
|
8 Participants
|
6 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Eosinophils · Below (baseline) - below (Day 57)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Eosinophils · Within (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Basophils · Below (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Eosinophils · Above (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Eosinophils · Below (baseline) - within (Day 57)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Eosinophils · Within (baseline) - within (Day 57)
|
20 Participants
|
22 Participants
|
18 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Eosinophils · Above (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Eosinophils · Below (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Eosinophils · Within (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Eosinophils · Above (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Erythrocytes · Below (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Erythrocytes · Within (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Erythrocytes · Above (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Erythrocytes · Below (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Erythrocytes · Within (baseline) - within (Day 57)
|
20 Participants
|
21 Participants
|
20 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Erythrocytes · Above (baseline) - within (Day 57)
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Erythrocytes · Below (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Erythrocytes · Within (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Erythrocytes · Above (baseline) - above (Day 57)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Hematocrit · Below (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Hematocrit · Within (baseline) - below (Day 57)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Hematocrit · Above (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Hematocrit · Below (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Hematocrit · Within (baseline) - within (Day 57)
|
20 Participants
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Hematocrit · Above (baseline) - within (Day 57)
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Hematocrit · Below (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Hematocrit · Within (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Hematocrit · Above (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Hemoglobin · Below (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Hemoglobin · Within (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Hemoglobin · Above (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Hemoglobin · Below (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Hemoglobin · Within (baseline) - within (Day 57)
|
21 Participants
|
22 Participants
|
21 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Hemoglobin · Above (baseline) - within (Day 57)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Hemoglobin · Below (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Hemoglobin · Within (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Hemoglobin · Above (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Leukocytes · Below (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Monocytes · Above (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Leukocytes · Within (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Leukocytes · Above (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Leukocytes · Below (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Leukocytes · Within (baseline) - within (Day 57)
|
20 Participants
|
22 Participants
|
21 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Leukocytes · Above (baseline) - within (Day 57)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Leukocytes · Below (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Leukocytes · Within (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Leukocytes · Above (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Lymphocytes · Below (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Lymphocytes · Within (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Lymphocytes · Above (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Lymphocytes · Below (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Lymphocytes · Within (baseline) - within (Day 57)
|
20 Participants
|
21 Participants
|
20 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Lymphocytes · Above (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Lymphocytes · Below (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Lymphocytes · Within (baseline) - above (Day 57)
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Lymphocytes · Above (baseline) - above (Day 57)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Monocytes · Below (baseline) - below (Day 57)
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Monocytes · Within (baseline) - below (Day 57)
|
3 Participants
|
1 Participants
|
6 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Monocytes · Below (baseline) - within (Day 57)
|
4 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Monocytes · Within (baseline) - within (Day 57)
|
13 Participants
|
15 Participants
|
8 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Monocytes · Above (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Monocytes · Below (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Monocytes · Within (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Monocytes · Above (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Neutrophils · Below (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Neutrophils · Within (baseline) - below (Day 57)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Neutrophils · Above (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Neutrophils · Below (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Neutrophils · Within (baseline) - within (Day 57)
|
21 Participants
|
22 Participants
|
21 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Neutrophils · Above (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Neutrophils · Below (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Neutrophils · Within (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Neutrophils · Above (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Platelets · Below (baseline) - below (Day 57)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Platelets · Within (baseline) - below (Day 57)
|
2 Participants
|
1 Participants
|
6 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Platelets · Above (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Platelets · Below (baseline) - within (Day 57)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Platelets · Within (baseline) - within (Day 57)
|
18 Participants
|
19 Participants
|
15 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Platelets · Above (baseline) - within (Day 57)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Platelets · Below (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Platelets · Within (baseline) - above (Day 57)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Platelets · Above (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
ALT · Below (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
ALT · Within (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
ALT · Above (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
ALT · Below (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
ALT · Within (baseline) - within (Day 57)
|
21 Participants
|
23 Participants
|
21 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
ALT · Above (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
ALT · Below (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
ALT · Within (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
ALT · Above (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
ALP · Below (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
ALP · Within (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
ALP · Above (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
ALP · Below (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
ALP · Within (baseline) - within (Day 57)
|
21 Participants
|
22 Participants
|
20 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
ALP · Above (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
ALP · Below (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
ALP · Within (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
ALP · Above (baseline) - above (Day 57)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
AST · Below (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
AST · Within (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
AST · Above (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
AST · Below (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
AST · Within (baseline) - within (Day 57)
|
20 Participants
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
AST · Above (baseline) - within (Day 57)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
AST · Below (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
AST · Within (baseline) - above (Day 57)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
AST · Above (baseline) - above (Day 57)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
BILI · Below (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
BILI · Within (baseline) - below (Day 57)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
BILI · Above (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
BILI · Below (baseline) - within (Day 57)
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
BILI · Within (baseline) - within (Day 57)
|
17 Participants
|
20 Participants
|
20 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
BILI · Above (baseline) - within (Day 57)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
BILI · Below (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
BILI · Within (baseline) - above (Day 57)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
BILI · Above (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
BUN · Within (baseline) - within (Day 57)
|
20 Participants
|
22 Participants
|
19 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
BUN · Below (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
BUN · Above (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
BUN · Within (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
BUN · Below (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
BUN · Above (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
CREAT · Below (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
CREAT · Within (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
CREAT · Above (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
CREAT · Below (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
CREAT · Within (baseline) - within (Day 57)
|
18 Participants
|
19 Participants
|
19 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
CREAT · Above (baseline) - within (Day 57)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
CREAT · Below (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
CREAT · Within (baseline) - above (Day 57)
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
CREAT · Above (baseline) - above (Day 57)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
GGT · Below (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
GGT · Within (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
GGT · Above (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
GGT · Below (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
GGT · Within (baseline) - within (Day 57)
|
19 Participants
|
19 Participants
|
16 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
GGT · Above (baseline) - within (Day 57)
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
GGT · Below (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
GGT · Within (baseline) - above (Day 57)
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
GGT · Above (baseline) - above (Day 57)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
GLUC · Below (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
GLUC · Within (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
GLUC · Above (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
GLUC · Below (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
GLUC · Within (baseline) - within (Day 57)
|
18 Participants
|
22 Participants
|
19 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
GLUC · Above (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
GLUC · Below (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
GLUC · Within (baseline) - above (Day 57)
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
GLUC · Above (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
LDH · Below (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
LDH · Within (baseline) - below (Day 57)
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
LDH · Above (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
LDH · Below (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
LDH · Within (baseline) - within (Day 57)
|
20 Participants
|
21 Participants
|
16 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
LDH · Above (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
LDH · Below (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
LDH · Within (baseline) - above (Day 57)
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
LDH · Above (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
K · Below (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
K · Within (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
K · Above (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
K · Below (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
K · Within (baseline) - within (Day 57)
|
15 Participants
|
12 Participants
|
17 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
K · Above (baseline) - within (Day 57)
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
K · Below (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
K · Within (baseline) - above (Day 57)
|
3 Participants
|
7 Participants
|
2 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
K · Above (baseline) - above (Day 57)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Na · Below (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Na · Within (baseline) - below (Day 57)
|
4 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Na · Above (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Na · Below (baseline) - within (Day 57)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Na · Within (baseline) - within (Day 57)
|
17 Participants
|
20 Participants
|
17 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Na · Above (baseline) - within (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Na · Below (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Na · Within (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Na · Above (baseline) - above (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
BUN · Within (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
BUN · Above (baseline) - below (Day 57)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
BUN · Below (baseline) - within (Day 57)
|
1 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Throughout the whole study period (from Day 1 up to Day 57)Population: This analysis was performed on the Unsolicited Safety Set, which included all enrolled subjects who received a study vaccination and for whom unsolicited adverse event data were available.
Reactive arthritis is defined as non-purulent joint inflammation that develops in response to an infection in another part of the body. Since the inflammation is triggered by a previous condition, it is termed "reactive". Intestinal pathogens that have been associated with reactive arthritis include Campylobacter, Salmonella, Yersinia, Clostridium difficile, and Shigella. If reactive arthritis is caused by an auto immune response, there is at least a possibility that it could be initiated by vaccination of susceptible people with the 1790GAHB vaccine.
Outcome measures
| Measure |
1790GAHB 25 μg Group
n=22 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
|
1790GAHB 100 μg Group
n=26 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
|
Control Group
n=24 Participants
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
|
|---|---|---|---|
|
Number of Subjects With Reported Reactive Arthritis or Neutropenia (AESIs)
Reactive Arthritis
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Reported Reactive Arthritis or Neutropenia (AESIs)
Neutropenia
|
2 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination)Population: This analysis was performed on the Full Analysis Set, including subjects with at least 1 dose of study vaccine administered. Numbers decreased over time, hence at study Visit 5 (Day 57), not all subjects from study Visit 1 (Day 1) had available immunogenicity results.
Anti-LPS S.Sonnei IgG ELISA concentrations were tabulated as unadjusted geometric mean concentrations (GMCs) and expressed as ELISA units (EU) per milliliter (mL), presented with their 95% confidence intervals (CIs). Since all subjects in the study were from an endemic country, they had pre-vaccination titers equal to or above (≥) LLOQ (limit of detection).
Outcome measures
| Measure |
1790GAHB 25 μg Group
n=22 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
|
1790GAHB 100 μg Group
n=26 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
|
Control Group
n=24 Participants
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
|
|---|---|---|---|
|
Anti-LPS S.Sonnei IgG ELISA Geometric Mean Concentrations (GMCs), by Baseline Titer
Day 1
|
971 EU/mL
Interval 519.0 to 1817.0
|
1196 EU/mL
Interval 750.0 to 1909.0
|
994 EU/mL
Interval 547.0 to 1809.0
|
|
Anti-LPS S.Sonnei IgG ELISA Geometric Mean Concentrations (GMCs), by Baseline Titer
Day 29
|
2038 EU/mL
Interval 1324.0 to 3135.0
|
5301 EU/mL
Interval 3598.0 to 7810.0
|
1100 EU/mL
Interval 572.0 to 2115.0
|
|
Anti-LPS S.Sonnei IgG ELISA Geometric Mean Concentrations (GMCs), by Baseline Titer
Day 57
|
3030 EU/mL
Interval 1909.0 to 4809.0
|
4706 EU/mL
Interval 3391.0 to 6531.0
|
987 EU/mL
Interval 507.0 to 1922.0
|
SECONDARY outcome
Timeframe: At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination)Population: This analysis was performed on the Full Analysis Set, including subjects with at least 1 dose of study vaccine administered. Numbers decreased over time, hence at study Visit 5 (Day 57), not all subjects from study Visit 1 (Day 1) had available immunogenicity results.
The ratio was expressed as unadjusted geometric mean ratio (GMR) and presented with its 95% confidence interval (CI).
Outcome measures
| Measure |
1790GAHB 25 μg Group
n=22 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
|
1790GAHB 100 μg Group
n=26 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
|
Control Group
n=22 Participants
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
|
|---|---|---|---|
|
Anti-LPS S. Sonnei Geometric Mean Ratios (GMRs) Between Post- and Pre-vaccination Samples
At Day 29 versus Day 1
|
2.1 Geometric mean ratio
Interval 1.31 to 3.36
|
4.43 Geometric mean ratio
Interval 2.94 to 6.67
|
1.06 Geometric mean ratio
Interval 0.91 to 1.24
|
|
Anti-LPS S. Sonnei Geometric Mean Ratios (GMRs) Between Post- and Pre-vaccination Samples
At Day 57 versus Day 1
|
3.1 Geometric mean ratio
Interval 2.29 to 4.2
|
4.3 Geometric mean ratio
Interval 3.02 to 6.12
|
1.07 Geometric mean ratio
Interval 0.91 to 1.25
|
|
Anti-LPS S. Sonnei Geometric Mean Ratios (GMRs) Between Post- and Pre-vaccination Samples
At Day 57 versus Day 29
|
1.44 Geometric mean ratio
Interval 1.09 to 1.89
|
1.02 Geometric mean ratio
Interval 0.9 to 1.16
|
1.01 Geometric mean ratio
Interval 0.8 to 1.26
|
SECONDARY outcome
Timeframe: At Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination)Population: This analysis was based on the Full Analysis Set, including subjects with at least 1 dose of study vaccine administered. Some subjects were excluded due to implausible values from all study visits.
Seroresponse was defined as: if the baseline value was greater than 50 EU then an increase of at least 50% in the post-vaccination sample as compared to baseline (i.e., \[{post-vac minus baseline}/baseline\]100% ≥ 50%); if the baseline value was less or equal to 50 EU then an increase of at least 25 EU in the post-vaccination sample as compared to baseline (i.e., \[post-vac minus baseline\] ≥ 25 EU). Since all subjects in the study were from an endemic country, they had pre-vaccination titers equal to or above (≥) LLOQ (limit of detection).
Outcome measures
| Measure |
1790GAHB 25 μg Group
n=22 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
|
1790GAHB 100 μg Group
n=26 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
|
Control Group
n=22 Participants
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
|
|---|---|---|---|
|
Number of Subjects With Seroresponse to Anti-LPS S. Sonnei IgG ELISA, by Baseline Titer
Anti-LPS, Day 57
|
19 Participants
|
22 Participants
|
1 Participants
|
|
Number of Subjects With Seroresponse to Anti-LPS S. Sonnei IgG ELISA, by Baseline Titer
Anti-LPS, Day 29
|
15 Participants
|
25 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination)Population: This analysis was performed on the Full Analysis Set, including subjects with at least 1 dose of study vaccine administered. Numbers decreased over time, hence at study Visit 5 (Day 57), not all subjects from study Visit 1 (Day 1) had available immunogenicity results.
The analysis cut-off value (121 U/mL) was expressed in units per milliliter (U/mL), as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA).
Outcome measures
| Measure |
1790GAHB 25 μg Group
n=22 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
|
1790GAHB 100 μg Group
n=26 Participants
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
|
Control Group
n=22 Participants
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
|
|---|---|---|---|
|
Number of Subjects With Titers Post Vaccination Concentration for Anti-LPS S. Sonnei ≥ 121 U/mL
Day 57
|
21 Participants
|
23 Participants
|
19 Participants
|
|
Number of Subjects With Titers Post Vaccination Concentration for Anti-LPS S. Sonnei ≥ 121 U/mL
Day 1
|
21 Participants
|
24 Participants
|
21 Participants
|
|
Number of Subjects With Titers Post Vaccination Concentration for Anti-LPS S. Sonnei ≥ 121 U/mL
Day 29
|
22 Participants
|
26 Participants
|
19 Participants
|
Adverse Events
1790GAHB 25 μg Group
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
1790GAHB 100 μg Group
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Control Group
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1790GAHB 25 μg Group
n=22 participants at risk
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
|
1790GAHB 100 μg Group
n=26 participants at risk
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
|
Control Group
n=24 participants at risk
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
9.1%
2/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
11.5%
3/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
4.2%
1/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
Other adverse events
| Measure |
1790GAHB 25 μg Group
n=22 participants at risk
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
|
1790GAHB 100 μg Group
n=26 participants at risk
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
|
Control Group
n=24 participants at risk
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
|
|---|---|---|---|
|
Gastrointestinal disorders
Dental caries
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
4.2%
1/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Gastrointestinal disorders
Diarrhoea
|
18.2%
4/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
7.7%
2/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
8.3%
2/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
7.7%
2/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
4.2%
1/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Gastrointestinal disorders
Food poisoning
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
4.2%
1/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
3.8%
1/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
3.8%
1/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
4.2%
1/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
General disorders
Chills
|
22.7%
5/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
19.2%
5/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
20.8%
5/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
General disorders
Fatigue
|
13.6%
3/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
34.6%
9/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
37.5%
9/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
General disorders
Induration
|
0.00%
0/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
3.8%
1/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
General disorders
Injection site pain
|
95.5%
21/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
96.2%
25/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
79.2%
19/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
General disorders
Malaise
|
13.6%
3/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
11.5%
3/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
41.7%
10/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
General disorders
Pyrexia
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
3.8%
1/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
4.2%
1/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Infections and infestations
Bone tuberculosis
|
0.00%
0/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
3.8%
1/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
4.2%
1/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Infections and infestations
Folliculitis
|
0.00%
0/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
8.3%
2/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Infections and infestations
Furuncle
|
0.00%
0/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
8.3%
2/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Infections and infestations
Gastroenteritis
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
8.3%
2/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Infections and infestations
Genital herpes
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Infections and infestations
Malaria
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
3.8%
1/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
4.2%
1/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
4.2%
1/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
8.3%
2/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Infections and infestations
Pyuria
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
8.3%
2/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Infections and infestations
Rhinitis
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
3.8%
1/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
8.3%
2/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Infections and infestations
Sinusitis
|
13.6%
3/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
11.5%
3/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
4.2%
1/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Infections and infestations
Subcutaneous abscess
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Infections and infestations
Tinea versicolour
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Infections and infestations
Tonsillitis
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
3.8%
1/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
3.8%
1/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
2/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
19.2%
5/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
4.2%
1/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Infections and infestations
Urinary tract infection
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
15.4%
4/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
4.2%
1/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Injury, poisoning and procedural complications
Joint injury
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
4.2%
1/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
3.8%
1/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
4.2%
1/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
19.2%
5/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
20.8%
5/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
22.7%
5/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
26.9%
7/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
25.0%
6/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
11.5%
3/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
29.2%
7/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Nervous system disorders
Dizziness
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
7.7%
2/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
8.3%
2/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Nervous system disorders
Headache
|
50.0%
11/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
53.8%
14/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
45.8%
11/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
3.8%
1/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
4.2%
1/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
3.8%
1/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
General disorders
Injection site erythema
|
68.2%
15/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
69.2%
18/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
58.3%
14/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
General disorders
Injection site induration
|
77.3%
17/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
84.6%
22/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
75.0%
18/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
3.8%
1/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
4.2%
1/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
3.8%
1/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
1/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
7.7%
2/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
4.2%
1/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/22 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
0.00%
0/26 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
4.2%
1/24 • Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER