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A Study of the Safety and Immune Response of 2 Doses of a New Shigella Vaccine in Kenyan Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02676895
Recruitment Status : Completed
First Posted : February 8, 2016
Results First Posted : February 18, 2019
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Shigella Sonnei Infection
Interventions Biological: GVGH S. sonnei (1790GAHB) vaccine 25 μg
Biological: GVGH S. sonnei (1790GAHB) vaccine 100 μg
Biological: Menveo
Biological: Boostrix
Enrollment 74
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title 1790GAHB 25 μg Group 1790GAHB 100 μg Group Control Group
Hide Arm/Group Description Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei. Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei. Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
Period Title: Overall Study
Started 22 26 24
Completed 20 23 21
Not Completed 2 3 3
Reason Not Completed
Administrative reason             1             0             0
Protocol Violation             1             0             0
Adverse Event             0             3             1
Lost to Follow-up             0             0             1
Withdrawal by Subject             0             0             1
Arm/Group Title 1790GAHB 25 μg Group 1790GAHB 100 μg Group Control Group Total
Hide Arm/Group Description Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei. Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei. Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine. Total of all reporting groups
Overall Number of Baseline Participants 22 26 24 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 26 participants 24 participants 72 participants
24.6  (5.81) 26.9  (8.44) 28.3  (8.23) 26.7  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 26 participants 24 participants 72 participants
Female
2
   9.1%
3
  11.5%
3
  12.5%
8
  11.1%
Male
20
  90.9%
23
  88.5%
21
  87.5%
64
  88.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 26 participants 24 participants 72 participants
Black/African American
21
  95.5%
26
 100.0%
24
 100.0%
71
  98.6%
White
1
   4.5%
0
   0.0%
0
   0.0%
1
   1.4%
1.Primary Outcome
Title Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Hide Description 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.
Time Frame From 30 minutes up to 7 days following each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 1790GAHB 25 μg Group 1790GAHB 100 μg Group Control Group
Hide Arm/Group Description:
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
Overall Number of Participants Analyzed 22 26 24
Measure Type: Count of Participants
Unit of Measure: Participants
Any adverse event(s) Number Analyzed 22 participants 26 participants 24 participants
21
  95.5%
25
  96.2%
21
  87.5%
Any solicited local adverse event(s) Number Analyzed 22 participants 26 participants 24 participants
21
  95.5%
25
  96.2%
19
  79.2%
Any Pain, post-Dose 1 Number Analyzed 22 participants 26 participants 24 participants
20
  90.9%
25
  96.2%
10
  41.7%
Severe Pain, post-Dose 1 Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Erythema, post-Dose 1 Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Severe Erythema, post-Dose 1 Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Induration, post-Dose 1 Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Severe Induration, post-Dose 1 Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Pain, post-Dose 2 Number Analyzed 22 participants 23 participants 21 participants
15
  68.2%
15
  65.2%
17
  81.0%
Severe Pain, post-Dose 2 Number Analyzed 22 participants 23 participants 21 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Erythema, post-Dose 2 Number Analyzed 22 participants 23 participants 21 participants
0
   0.0%
0
   0.0%
0
   0.0%
Severe Erythema, post-Dose 2 Number Analyzed 22 participants 23 participants 21 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Induration, post-Dose 2 Number Analyzed 22 participants 23 participants 21 participants
0
   0.0%
0
   0.0%
1
   4.8%
Severe Induration, post-Dose 2 Number Analyzed 22 participants 23 participants 21 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Pain, Across doses Number Analyzed 22 participants 26 participants 24 participants
21
  95.5%
25
  96.2%
19
  79.2%
Severe Pain, Across Doses Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Erythema, Across Doses Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Severe Erythema, Across Doses Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Induration, Across Doses Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
1
   4.2%
Severe Induration, Across Doses Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Solicited systemic adverse event(s) Number Analyzed 22 participants 26 participants 24 participants
9
  40.9%
16
  61.5%
14
  58.3%
Any Headache, post-Dose 1 Number Analyzed 22 participants 26 participants 24 participants
5
  22.7%
10
  38.5%
8
  33.3%
Severe Headache, post-Dose 1 Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
1
   3.8%
0
   0.0%
Any Arthralgia, post-Dose 1 Number Analyzed 22 participants 26 participants 24 participants
1
   4.5%
4
  15.4%
4
  16.7%
Severe Arthralgia, post-Dose 1 Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Fatigue, post-Dose 1 Number Analyzed 22 participants 26 participants 24 participants
2
   9.1%
8
  30.8%
7
  29.2%
Severe Fatigue, post-Dose 1 Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Chills, post-Dose 1 Number Analyzed 22 participants 26 participants 24 participants
4
  18.2%
4
  15.4%
3
  12.5%
Severe Chills, post-Dose 1 Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Malaise, post-Dose 1 Number Analyzed 22 participants 26 participants 24 participants
3
  13.6%
3
  11.5%
6
  25.0%
Severe Malaise, post-Dose 1 Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Myalgia, post-Dose 1 Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
2
   7.7%
2
   8.3%
Severe Myalgia, post-Dose 1 Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Temperature, post-Dose 1 Number Analyzed 22 participants 26 participants 24 participants
1
   4.5%
1
   3.8%
0
   0.0%
Severe Temperature, post-Dose 1 Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Headache, post-Dose 2 Number Analyzed 22 participants 23 participants 21 participants
4
  18.2%
5
  21.7%
4
  19.0%
Severe Headache, post-Dose 2 Number Analyzed 22 participants 23 participants 21 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Arthralgia, post-Dose 2 Number Analyzed 22 participants 23 participants 21 participants
0
   0.0%
0
   0.0%
1
   4.8%
Severe Arthralgia, post-Dose 2 Number Analyzed 22 participants 23 participants 21 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Fatigue, post-Dose 2 Number Analyzed 22 participants 23 participants 21 participants
2
   9.1%
1
   4.3%
4
  19.0%
Severe Fatigue, post-Dose 2 Number Analyzed 22 participants 23 participants 21 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Chills, post-Dose 2 Number Analyzed 22 participants 23 participants 21 participants
3
  13.6%
1
   4.3%
2
   9.5%
Severe Chills, post-Dose 2 Number Analyzed 22 participants 23 participants 21 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Malaise, post-Dose 2 Number Analyzed 22 participants 23 participants 21 participants
2
   9.1%
0
   0.0%
4
  19.0%
Severe Malaise, post-Dose 2 Number Analyzed 22 participants 23 participants 21 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Myalgia, post-Dose 2 Number Analyzed 22 participants 23 participants 21 participants
1
   4.5%
0
   0.0%
4
  19.0%
Severe Myalgia, post-Dose 2 Number Analyzed 22 participants 23 participants 21 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Temperature, post-Dose 2 Number Analyzed 22 participants 23 participants 21 participants
0
   0.0%
0
   0.0%
0
   0.0%
Severe Temperature, post-Dose 2 Number Analyzed 22 participants 23 participants 21 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Headache, Across Doses Number Analyzed 22 participants 26 participants 24 participants
8
  36.4%
13
  50.0%
10
  41.7%
Severe Headache, Across Doses Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
1
   3.8%
0
   0.0%
Any Arthralgia, Across Doses Number Analyzed 22 participants 26 participants 24 participants
1
   4.5%
4
  15.4%
5
  20.8%
Severe Arthralgia, Across Doses Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Fatigue, Across Doses Number Analyzed 22 participants 26 participants 24 participants
3
  13.6%
9
  34.6%
9
  37.5%
Severe Fatigue, Across Doses Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Chills, Across Doses Number Analyzed 22 participants 26 participants 24 participants
5
  22.7%
5
  19.2%
5
  20.8%
Severe Chills, Across Doses Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Malaise, Across Doses Number Analyzed 22 participants 26 participants 24 participants
3
  13.6%
3
  11.5%
10
  41.7%
Severe Malaise, Across Doses Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Myalgia, Across Doses Number Analyzed 22 participants 26 participants 24 participants
1
   4.5%
2
   7.7%
6
  25.0%
Severe Myalgia, Across Doses Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Temperature, Across Doses Number Analyzed 22 participants 26 participants 24 participants
1
   4.5%
1
   3.8%
0
   0.0%
Severe Temperature, Across Doses Number Analyzed 22 participants 26 participants 24 participants
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Subjects With Any Unsolicited Adverse Events (AEs)
Hide Description

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.

Time Frame During 28 days following each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 1790GAHB 25 μg Group 1790GAHB 100 μg Group Control Group
Hide Arm/Group Description:
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
Overall Number of Participants Analyzed 22 26 24
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
19
  86.4%
24
  92.3%
19
  79.2%
Possibly or Probably related AE
13
  59.1%
16
  61.5%
12
  50.0%
AE leading to study vaccine withdrawal
0
   0.0%
3
  11.5%
1
   4.2%
AE leading to disruptions*
0
   0.0%
3
  11.5%
0
   0.0%
AE leading to hospitalization
0
   0.0%
0
   0.0%
0
   0.0%
AE of special interest (Neutropenia)
2
   9.1%
3
  11.5%
1
   4.2%
Deaths
0
   0.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame Throughout the whole study period (from Day 1 up to Day 57)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 1790GAHB 25 μg Group 1790GAHB 100 μg Group Control Group
Hide Arm/Group Description:
Subjects who received 2 injections 1790GAHB vaccine containing 25 μg of S. sonnei
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
Overall Number of Participants Analyzed 22 26 24
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE
2
   9.1%
3
  11.5%
1
   4.2%
Possibly or probably related SAE
2
   9.1%
3
  11.5%
1
   4.2%
Deaths
0
   0.0%
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Hide Description

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.

Time Frame At Day 8 (7 days after first vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 1790GAHB 25 μg Group 1790GAHB 100 μg Group Control Group
Hide Arm/Group Description:
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
Overall Number of Participants Analyzed 22 26 23
Measure Type: Count of Participants
Unit of Measure: Participants
Basophils Below (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 8)
9
  40.9%
9
  34.6%
5
  21.7%
Above (baseline) - within (Day 8)
3
  13.6%
5
  19.2%
6
  26.1%
Below (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 8)
3
  13.6%
1
   3.8%
2
   8.7%
Above (baseline) - above (Day 8)
7
  31.8%
11
  42.3%
10
  43.5%
Eosinophils Below (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
1
   4.3%
Within (baseline) - below (Day 8)
1
   4.5%
1
   3.8%
0
   0.0%
Above (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 8)
1
   4.5%
1
   3.8%
0
   0.0%
Within (baseline) - within (Day 8)
20
  90.9%
24
  92.3%
22
  95.7%
Above (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Erythrocytes Below (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
1
   4.3%
Within (baseline) - below (Day 8)
1
   4.5%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 8)
20
  90.9%
24
  92.3%
22
  95.7%
Above (baseline) - within (Day 8)
0
   0.0%
2
   7.7%
0
   0.0%
Below (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 8)
1
   4.5%
0
   0.0%
0
   0.0%
Hematocrit Below (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 8)
0
   0.0%
1
   3.8%
0
   0.0%
Above (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
1
   4.3%
Within (baseline) - within (Day 8)
22
 100.0%
21
  80.8%
22
  95.7%
Above (baseline) - within (Day 8)
0
   0.0%
3
  11.5%
0
   0.0%
Below (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 8)
0
   0.0%
1
   3.8%
0
   0.0%
Hemoglobin Below (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 8)
0
   0.0%
1
   3.8%
0
   0.0%
Above (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 8)
22
 100.0%
24
  92.3%
23
 100.0%
Above (baseline) - within (Day 8)
0
   0.0%
1
   3.8%
0
   0.0%
Below (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Leukocytes Below (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 8)
21
  95.5%
25
  96.2%
22
  95.7%
Above (baseline) - within (Day 8)
1
   4.5%
1
   3.8%
0
   0.0%
Below (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
1
   4.3%
Above (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes Below (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 8)
2
   9.1%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 8)
19
  86.4%
26
 100.0%
22
  95.7%
Above (baseline) - within (Day 8)
1
   4.5%
0
   0.0%
1
   4.3%
Below (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Monocytes Below (baseline) - below (Day 8)
2
   9.1%
2
   7.7%
4
  17.4%
Within (baseline) - below (Day 8)
2
   9.1%
2
   7.7%
3
  13.0%
Above (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 8)
3
  13.6%
7
  26.9%
3
  13.0%
Within (baseline) - within (Day 8)
15
  68.2%
15
  57.7%
13
  56.5%
Above (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils Below (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 8)
22
 100.0%
26
 100.0%
22
  95.7%
Above (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
1
   4.3%
Above (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Platelets Below (baseline) - below (Day 8)
0
   0.0%
3
  11.5%
0
   0.0%
Within (baseline) - below (Day 8)
2
   9.1%
0
   0.0%
2
   8.7%
Above (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 8)
19
  86.4%
21
  80.8%
21
  91.3%
Above (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 8)
0
   0.0%
2
   7.7%
0
   0.0%
Above (baseline) - above (Day 8)
1
   4.5%
0
   0.0%
0
   0.0%
ALA Below (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 8)
22
 100.0%
26
 100.0%
23
 100.0%
Above (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
ALP Below (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 8)
21
  95.5%
25
  96.2%
21
  91.3%
Above (baseline) - within (Day 8)
1
   4.5%
0
   0.0%
1
   4.3%
Below (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
1
   4.3%
Above (baseline) - above (Day 8)
0
   0.0%
1
   3.8%
0
   0.0%
AST Below (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 8)
0
   0.0%
1
   3.8%
0
   0.0%
Above (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 8)
22
 100.0%
23
  88.5%
23
 100.0%
Above (baseline) - within (Day 8)
0
   0.0%
2
   7.7%
0
   0.0%
Below (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
BILI Below (baseline) - below (Day 8)
1
   4.5%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 8)
2
   9.1%
1
   3.8%
2
   8.7%
Above (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 8)
2
   9.1%
1
   3.8%
1
   4.3%
Within (baseline) - within (Day 8)
17
  77.3%
22
  84.6%
20
  87.0%
Above (baseline) - within (Day 8)
0
   0.0%
1
   3.8%
0
   0.0%
Below (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 8)
0
   0.0%
1
   3.8%
0
   0.0%
Above (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
BUN Below (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 8)
1
   4.5%
7
  26.9%
0
   0.0%
Above (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 8)
1
   4.5%
1
   3.8%
1
   4.3%
Within (baseline) - within (Day 8)
20
  90.9%
18
  69.2%
22
  95.7%
Above (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
CREA Below (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 8)
0
   0.0%
1
   3.8%
0
   0.0%
Above (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 8)
20
  90.9%
23
  88.5%
19
  82.6%
Above (baseline) - within (Day 8)
1
   4.5%
0
   0.0%
1
   4.3%
Below (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 8)
1
   4.5%
1
   3.8%
3
  13.0%
Above (baseline) - above (Day 8)
0
   0.0%
1
   3.8%
0
   0.0%
GGT Below (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 8)
21
  95.5%
23
  88.5%
20
  87.0%
Above (baseline) - within (Day 8)
1
   4.5%
0
   0.0%
1
   4.3%
Below (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 8)
0
   0.0%
3
  11.5%
2
   8.7%
GLUC Below (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 8)
1
   4.5%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 8)
21
  95.5%
26
 100.0%
21
  91.3%
Above (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
2
   8.7%
Above (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
LDH Below (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 8)
1
   4.5%
0
   0.0%
1
   4.3%
Above (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 8)
21
  95.5%
26
 100.0%
22
  95.7%
Above (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
K Below (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 8)
15
  68.2%
16
  61.5%
19
  82.6%
Above (baseline) - within (Day 8)
2
   9.1%
2
   7.7%
3
  13.0%
Below (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 8)
4
  18.2%
6
  23.1%
1
   4.3%
Above (baseline) - above (Day 8)
1
   4.5%
2
   7.7%
0
   0.0%
Na Below (baseline) - below (Day 8)
0
   0.0%
1
   3.8%
0
   0.0%
Within (baseline) - below (Day 8)
1
   4.5%
2
   7.7%
2
   8.7%
Above (baseline) - below (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 8)
21
  95.5%
23
  88.5%
21
  91.3%
Above (baseline) - within (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 8)
0
   0.0%
0
   0.0%
0
   0.0%
5.Primary Outcome
Title Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Hide Description

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.

Time Frame At Day 29 (28 days after the first vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 1790GAHB 25 μg Group 1790GAHB 100 μg Group Control Group
Hide Arm/Group Description:
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
Overall Number of Participants Analyzed 22 26 22
Measure Type: Count of Participants
Unit of Measure: Participants
Basophils Number Analyzed 21 participants 26 participants 22 participants
Below (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 29)
9
  42.9%
8
  30.8%
4
  18.2%
Above (baseline) - within (Day 29)
4
  19.0%
4
  15.4%
7
  31.8%
Below (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 29)
2
   9.5%
2
   7.7%
3
  13.6%
Above (baseline) - above (Day 29)
6
  28.6%
12
  46.2%
8
  36.4%
Eosinophils Number Analyzed 21 participants 26 participants 22 participants
Below (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
1
   4.5%
Within (baseline) - below (Day 29)
0
   0.0%
1
   3.8%
0
   0.0%
Above (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 29)
1
   4.8%
1
   3.8%
0
   0.0%
Within (baseline) - within (Day 29)
20
  95.2%
24
  92.3%
20
  90.9%
Above (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
1
   4.5%
Above (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Erythrocytes Number Analyzed 21 participants 26 participants 22 participants
Below (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 29)
1
   4.8%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
1
   4.5%
Within (baseline) - within (Day 29)
19
  90.5%
24
  92.3%
21
  95.5%
Above (baseline) - within (Day 29)
0
   0.0%
1
   3.8%
0
   0.0%
Below (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 29)
1
   4.8%
1
   3.8%
0
   0.0%
Hematocrit Number Analyzed 21 participants 26 participants 22 participants
Below (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 29)
0
   0.0%
1
   3.8%
0
   0.0%
Above (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
1
   4.5%
Within (baseline) - within (Day 29)
21
 100.0%
21
  80.8%
21
  95.5%
Above (baseline) - within (Day 29)
0
   0.0%
4
  15.4%
0
   0.0%
Below (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin Number Analyzed 21 participants 26 participants 22 participants
Below (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 29)
0
   0.0%
1
   3.8%
0
   0.0%
Above (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 29)
21
 100.0%
24
  92.3%
22
 100.0%
Above (baseline) - within (Day 29)
0
   0.0%
1
   3.8%
0
   0.0%
Below (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Leukocytes Number Analyzed 21 participants 26 participants 22 participants
Below (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 29)
20
  95.2%
24
  92.3%
22
 100.0%
Above (baseline) - within (Day 29)
1
   4.8%
1
   3.8%
0
   0.0%
Below (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 29)
0
   0.0%
1
   3.8%
0
   0.0%
Above (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes Number Analyzed 21 participants 26 participants 22 participants
Below (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 29)
20
  95.2%
24
  92.3%
21
  95.5%
Above (baseline) - within (Day 29)
1
   4.8%
0
   0.0%
1
   4.5%
Below (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 29)
0
   0.0%
2
   7.7%
0
   0.0%
Above (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Monocytes Number Analyzed 21 participants 26 participants 22 participants
Below (baseline) - below (Day 29)
3
  14.3%
4
  15.4%
1
   4.5%
Within (baseline) - below (Day 29)
1
   4.8%
1
   3.8%
1
   4.5%
Above (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 29)
2
   9.5%
5
  19.2%
6
  27.3%
Within (baseline) - within (Day 29)
15
  71.4%
15
  57.7%
14
  63.6%
Above (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 29)
0
   0.0%
1
   3.8%
0
   0.0%
Above (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils Number Analyzed 21 participants 26 participants 22 participants
Below (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 29)
21
 100.0%
25
  96.2%
22
 100.0%
Above (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 29)
0
   0.0%
1
   3.8%
0
   0.0%
Above (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Platelets Number Analyzed 21 participants 26 participants 22 participants
Below (baseline) - below (Day 29)
0
   0.0%
2
   7.7%
0
   0.0%
Within (baseline) - below (Day 29)
1
   4.8%
0
   0.0%
2
   9.1%
Above (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 29)
0
   0.0%
1
   3.8%
0
   0.0%
Within (baseline) - within (Day 29)
19
  90.5%
22
  84.6%
20
  90.9%
Above (baseline) - within (Day 29)
1
   4.8%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 29)
0
   0.0%
1
   3.8%
0
   0.0%
Above (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
ALA Number Analyzed 22 participants 26 participants 22 participants
Below (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 29)
22
 100.0%
26
 100.0%
22
 100.0%
Above (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
ALP Number Analyzed 22 participants 26 participants 22 participants
Below (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 29)
0
   0.0%
2
   7.7%
1
   4.5%
Above (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 29)
21
  95.5%
23
  88.5%
19
  86.4%
Above (baseline) - within (Day 29)
1
   4.5%
1
   3.8%
0
   0.0%
Below (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
1
   4.5%
Above (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
1
   4.5%
AST Number Analyzed 22 participants 26 participants 22 participants
Below (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 29)
1
   4.5%
1
   3.8%
0
   0.0%
Above (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 29)
21
  95.5%
22
  84.6%
22
 100.0%
Above (baseline) - within (Day 29)
0
   0.0%
1
   3.8%
0
   0.0%
Below (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 29)
0
   0.0%
1
   3.8%
0
   0.0%
Above (baseline) - above (Day 29)
0
   0.0%
1
   3.8%
0
   0.0%
BILI Number Analyzed 22 participants 26 participants 22 participants
Below (baseline) - below (Day 29)
1
   4.5%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 29)
0
   0.0%
1
   3.8%
0
   0.0%
Above (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 29)
2
   9.1%
1
   3.8%
1
   4.5%
Within (baseline) - within (Day 29)
19
  86.4%
23
  88.5%
21
  95.5%
Above (baseline) - within (Day 29)
0
   0.0%
1
   3.8%
0
   0.0%
Below (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
BUN Number Analyzed 22 participants 26 participants 22 participants
Below (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 29)
1
   4.5%
1
   3.8%
0
   0.0%
Above (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 29)
1
   4.5%
1
   3.8%
1
   4.5%
Within (baseline) - within (Day 29)
20
  90.9%
24
  92.3%
21
  95.5%
Above (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
CREA Number Analyzed 22 participants 26 participants 22 participants
Below (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 29)
21
  95.5%
22
  84.6%
19
  86.4%
Above (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
1
   4.5%
Below (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 29)
0
   0.0%
3
  11.5%
2
   9.1%
Above (baseline) - above (Day 29)
1
   4.5%
1
   3.8%
0
   0.0%
GGT Number Analyzed 22 participants 26 participants 22 participants
Below (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 29)
18
  81.8%
21
  80.8%
18
  81.8%
Above (baseline) - within (Day 29)
1
   4.5%
0
   0.0%
1
   4.5%
Below (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 29)
3
  13.6%
2
   7.7%
1
   4.5%
Above (baseline) - above (Day 29)
0
   0.0%
3
  11.5%
2
   9.1%
GLUC Number Analyzed 22 participants 26 participants 22 participants
Below (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 29)
22
 100.0%
26
 100.0%
21
  95.5%
Above (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
1
   4.5%
Above (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
LDH Number Analyzed 22 participants 26 participants 22 participants
Below (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 29)
0
   0.0%
1
   3.8%
1
   4.5%
Above (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 29)
21
  95.5%
23
  88.5%
19
  86.4%
Above (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 29)
1
   4.5%
2
   7.7%
2
   9.1%
Above (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
K Number Analyzed 22 participants 26 participants 22 participants
Below (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 29)
0
   0.0%
1
   3.8%
0
   0.0%
Above (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 29)
19
  86.4%
15
  57.7%
16
  72.7%
Above (baseline) - within (Day 29)
1
   4.5%
4
  15.4%
2
   9.1%
Below (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 29)
0
   0.0%
6
  23.1%
4
  18.2%
Above (baseline) - above (Day 29)
2
   9.1%
0
   0.0%
0
   0.0%
Na Number Analyzed 22 participants 26 participants 22 participants
Below (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 29)
4
  18.2%
6
  23.1%
2
   9.1%
Above (baseline) - below (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - within (Day 29)
0
   0.0%
1
   3.8%
0
   0.0%
Within (baseline) - within (Day 29)
18
  81.8%
19
  73.1%
20
  90.9%
Above (baseline) - within (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 29)
0
   0.0%
0
   0.0%
0
   0.0%
6.Primary Outcome
Title Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Hide Description 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.
Time Frame At Day 36 (7 days after the second vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 1790GAHB 25 μg Group 1790GAHB 100 μg Group Control Group
Hide Arm/Group Description:
Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei.
Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei.
Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine.
Overall Number of Participants Analyzed 22 24 21
Measure Type: Count of Participants
Unit of Measure: Participants
Basophils Below (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - Within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 36)
9
  40.9%
7
  29.2%
5
  23.8%
Above (baseline) - within (Day 36)
2
   9.1%
6
  25.0%
5
  23.8%
Below (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 36)
3
  13.6%
1
   4.2%
2
   9.5%
Above (baseline) - above (Day 36)
8
  36.4%
10
  41.7%
9
  42.9%
Eosinophils Below (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 36)
0
   0.0%
1
   4.2%
1
   4.8%
Above (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - Within (Day 36)
1
   4.5%
1
   4.2%
1
   4.8%
Within (baseline) - within (Day 36)
21
  95.5%
22
  91.7%
18
  85.7%
Above (baseline) - within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
1
   4.8%
Above (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Erythrocytes Below (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 36)
1
   4.5%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - Within (Day 36)
0
   0.0%
0
   0.0%
1
   4.8%
Within (baseline) - within (Day 36)
20
  90.9%
22
  91.7%
20
  95.2%
Above (baseline) - within (Day 36)
0
   0.0%
1
   4.2%
0
   0.0%
Below (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 36)
1
   4.5%
1
   4.2%
0
   0.0%
Hematocrit Below (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - Within (Day 36)
0
   0.0%
0
   0.0%
1
   4.8%
Within (baseline) - within (Day 36)
22
 100.0%
20
  83.3%
20
  95.2%
Above (baseline) - within (Day 36)
0
   0.0%
4
  16.7%
0
   0.0%
Below (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin Below (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - Within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 36)
22
 100.0%
23
  95.8%
21
 100.0%
Above (baseline) - within (Day 36)
0
   0.0%
1
   4.2%
0
   0.0%
Below (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Leukocytes Below (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - Within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 36)
21
  95.5%
22
  91.7%
21
 100.0%
Above (baseline) - within (Day 36)
1
   4.5%
1
   4.2%
0
   0.0%
Below (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 36)
0
   0.0%
1
   4.2%
0
   0.0%
Above (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes Below (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 36)
1
   4.5%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - Within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 36)
20
  90.9%
23
  95.8%
19
  90.5%
Above (baseline) - within (Day 36)
1
   4.5%
0
   0.0%
1
   4.8%
Below (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 36)
0
   0.0%
1
   4.2%
1
   4.8%
Above (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Monocytes Below (baseline) - below (Day 36)
1
   4.5%
2
   8.3%
3
  14.3%
Within (baseline) - below (Day 36)
2
   9.1%
0
   0.0%
3
  14.3%
Above (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - Within (Day 36)
4
  18.2%
6
  25.0%
4
  19.0%
Within (baseline) - within (Day 36)
15
  68.2%
15
  62.5%
11
  52.4%
Above (baseline) - within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 36)
0
   0.0%
1
   4.2%
0
   0.0%
Above (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils Below (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - Within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 36)
22
 100.0%
24
 100.0%
21
 100.0%
Above (baseline) - within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Platelet Below (baseline) - below (Day 36)
0
   0.0%
2
   8.3%
0
   0.0%
Within (baseline) - below (Day 36)
1
   4.5%
0
   0.0%
2
   9.5%
Above (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - Within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 36)
20
  90.9%
22
  91.7%
19
  90.5%
Above (baseline) - within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 36)
1
   4.5%
0
   0.0%
0
   0.0%
ALA Below (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - Within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 36)
22
 100.0%
24
 100.0%
21
 100.0%
Above (baseline) - within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
ALP Below (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
1
   4.8%
Above (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - Within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 36)
20
  90.9%
22
  91.7%
19
  90.5%
Above (baseline) - within (Day 36)
1
   4.5%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 36)
1
   4.5%
1
   4.2%
0
   0.0%
Above (baseline) - above (Day 36)
0
   0.0%
1
   4.2%
1
   4.8%
AST Below (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 36)
1
   4.5%
1
   4.2%
0
   0.0%
Above (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - Within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 36)
20
  90.9%
21
  87.5%
20
  95.2%
Above (baseline) - within (Day 36)
0
   0.0%
1
   4.2%
0
   0.0%
Below (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 36)
1
   4.5%
0
   0.0%
1
   4.8%
Above (baseline) - above (Day 36)
0
   0.0%
1
   4.2%
0
   0.0%
BILI Below (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 36)
3
  13.6%
1
   4.2%
0
   0.0%
Above (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - Within (Day 36)
3
  13.6%
1
   4.2%
1
   4.8%
Within (baseline) - within (Day 36)
16
  72.7%
21
  87.5%
20
  95.2%
Above (baseline) - within (Day 36)
0
   0.0%
1
   4.2%
0
   0.0%
Below (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
BUN Below (baseline) - below (Day 36)
0
   0.0%
1
   4.2%
0
   0.0%
Within (baseline) - below (Day 36)
2
   9.1%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - Within (Day 36)
1
   4.5%
0
   0.0%
1
   4.8%
Within (baseline) - within (Day 36)
19
  86.4%
23
  95.8%
20
  95.2%
Above (baseline) - within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
CREA Below (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 36)
0
   0.0%
1
   4.2%
0
   0.0%
Above (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - Within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 36)
20
  90.9%
17
  70.8%
18
  85.7%
Above (baseline) - within (Day 36)
1
   4.5%
1
   4.2%
0
   0.0%
Below (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 36)
1
   4.5%
5
  20.8%
2
   9.5%
Above (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
1
   4.8%
GGT Below (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - Within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 36)
19
  86.4%
19
  79.2%
18
  85.7%
Above (baseline) - within (Day 36)
0
   0.0%
2
   8.3%
1
   4.8%
Below (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 36)
2
   9.1%
3
  12.5%
1
   4.8%
Above (baseline) - above (Day 36)
1
   4.5%
0
   0.0%
1
   4.8%
GLUC Below (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - Within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 36)
22
 100.0%
24
 100.0%
21
 100.0%
Above (baseline) - within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Above (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
LDH Below (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 36)
1
   4.5%
0
   0.0%
1
   4.8%
Above (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - Within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 36)
20
  90.9%
23
  95.8%
19
  90.5%
Above (baseline) - within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 36)
1
   4.5%
1
   4.2%
1
   4.8%
Above (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
K Below (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
1
   4.8%
Above (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - Within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - within (Day 36)
8
  36.4%
13
  54.2%
15
  71.4%
Above (baseline) - within (Day 36)
2
   9.1%
4
  16.7%
2
   9.5%
Below (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 36)
11
  50.0%
7
  29.2%
3
  14.3%
Above (baseline) - above (Day 36)
1
   4.5%
0
   0.0%
0
   0.0%
Na Below (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - below (Day 36)
1
   4.5%
2
   8.3%
0
   0.0%
Above (baseline) - below (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - Within (Day 36)
0
   0.0%
1
   4.2%
0
   0.0%
Within (baseline) - within (Day 36)
21
  95.5%
20
  83.3%
21
 100.0%
Above (baseline) - within (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Below (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
Within (baseline) - above (Day 36)
0
   0.0%
1
   4.2%
0
   0.0%
Above (baseline) - above (Day 36)
0
   0.0%
0
   0.0%
0
   0.0%
7.Primary Outcome
Title Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Hide Description 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.
Time Frame At Day 57 (28 days after the second vaccination)
Hide Outcome Measure Data</