Shigellosis
Conditions
Keywords
prevention, Shigella sonnei
Brief summary
This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of 5 sequentially escalating dosages of a candidate vaccine against Shigella sonnei (1790GAHB vaccine) administered by intramuscular route in healthy adults (18 to 45 years of age at enrollment). The safety profile of the 1790GAHB vaccine is evaluated in comparison to that of placebo (GAHB-Placebo), constituted by an aluminum hydroxide suspension having the same concentration as study vaccine formulations. A total of 50 eligible subjects will be assigned to one of five sequential cohorts of 10 subjects each. Within each cohort, in an observer-blind fashion, subjects will be randomized to receive three vaccinations, four weeks apart, of either 1790GAHB vaccine (at five antigen concentrations) or GAHB placebo. A Data Safety Monitoring Board will be in place to receive a summary of all safety data obtained during one week follow-up post-first vaccination with the lower dose. Based on evaluation of the safety data, the Data Safety Monitoring Board will make a recommendation, as to whether the next cohort should be vaccinated with higher antigen concentration or not. Expected duration of the study for an individual subject is 9 months. Each subject will be followed-up for 6 months after the 3rd vaccination.
Interventions
BIOLOGICALS. sonnei 1790GAHB
BIOLOGICALPlacebo
Sponsors
GSK Vaccines Institute For Global Health S.r.l.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and females of age ≥18 years to ≤45 years. 2. Individuals who, after the nature of the study has been explained to them, and prior to any protocol specific procedures being performed, have given written consent according to local regulatory requirements. 3. Individuals in good health as determined by the outcome of medical history, physical examination, hematological / hematochemical blood tests (including presence of high antibody titers against S. sonnei by agglutination test), urinalysis and clinical judgment of the investigator. 4. If women of child-bearing potential, have a negative pregnancy test prior study vaccination and willingness to use acceptable birth control measures for the entire study duration. 5. Individuals affiliated to a social security regimen.
Exclusion criteria
1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study. 2. Individuals with any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome. 3. Individuals who are not able to understand and to follow all required study procedures for the whole period of the study. 4. Individuals with history of any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study. 5. Individuals human leukocyte antigen (HLA) -B27 positive and/or with history of reactive arthritis. 6. Individuals with known or suspected HIV infection or HIV related disease, with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy including use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids (i.e. prednisone, or equivalent ≥10 mg/day) within the previous 28 days, or in chemotherapy treatment within the past 168 days. 7. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. 8. Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease). 9. Individuals who have any malignancy or lymphoproliferative disorder. 10. Individuals with history of allergy to vaccine components. 11. Individuals participating in any clinical trial with another investigational product 28 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study. 12. Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within the entire study duration except influenza vaccination, which is not allowed within the period included between 28 days before 1st vaccination and 28 days after 3rd vaccination. 13. Individuals who have received blood, blood products, and/or plasma derivatives including parenteral immunoglobulin preparations in the past 12 weeks. 14. Individuals who are part of study personnel or close family members to the personnel conducting this study or employees of the clinical trial site institution. 15. Individuals with body temperature \> 38.0 degrees Celsius within 3 days of intended study vaccination. 16. Individuals with Body Mass Index (BMI)\> 30 kg/m2 17. Individuals with history of substance or alcohol abuse within the past 2 years. 18. Women who are pregnant or are breast-feeding, or are of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. 19. Females with history of stillbirth, neonatal loss, or previous infant with anomaly. 20. Individuals who have a previously laboratory confirmed or suspected disease caused by S. sonnei. 21. Individuals who have had household contact with/and or intimate exposure to an individual with laboratory confirmed S. sonnei. 22. Any condition, which, in the opinion of the investigator may pose an increased and unreasonable safety risk to the subject if participating to the present study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Solicited Local Reaction After Any Vaccination | During a 7-day (Days 1-7) post vaccination period following any injection | Any erythema/induration refers to: ≥25 mm in diameter. Grade 3 (severe) refers to erythema/induration \>100 mm in diameter. Grade 3 (severe) for injection site pain refers to: prevents daily activity |
| Number of Subjects With Solicited Systemic Reaction After Any Vaccination | During a 7-day (Days 1 to 7) post vaccination period following any injection | Any= Incidence of any symptom regardless of intensity grade. Grade 3 = symptom that prevented daily activities |
| Number of Subjects With Neutrophils Results Below and Above the Normal Ranges | At Day 8 | Day 8: VISIT 2 (D7 post 1st vac) |
| Number of Subjects With Neutrophils Results Below and Above the Normal | At Day 36 | Day 36: VISIT 3.1 (D7 post 2nd vac.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | At 28 days after each vaccination and 168 days after last vaccination | Seroresponse is defined as: If half of the baseline value is greater than 25 ELISA Unit (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 half of the baseline value is less or equal to 25 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) |
| Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | At baseline, at 28 days after each vaccination and at 168 days after last vaccination | High seroresponse is defined as a post vaccination titer ≥X anti-LPS serum IgG units in the GSK (former Novartis) ELISA that correspond to a titer of 1:800 in the ELISA method used by Cohen et al. To determine the value for 'X' the GSK (former Novartis) anti-LPS ELISA was calibrated against the Cohen ELISA and it was found that a concentration of 121 EU EU/mL corresponds to a titer of 1:800 in the Cohen assay |
| Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | At baseline, at 28 days after each vaccination and at 168 days after last vaccination | — |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| S. Sonnei 1790GAHB - 1 mcg Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg
S. sonnei 1790GAHB | 8 |
| S. Sonnei 1790GAHB - 5 mcg Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg
S. sonnei 1790GAHB | 9 |
| S. Sonnei 1790GAHB - 25 mcg Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg
S. sonnei 1790GAHB | 8 |
| S. Sonnei 1790GAHB - 50 mcg Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg
S. sonnei 1790GAHB | 8 |
| S. Sonnei 1790GAHB - 100 mcg Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg
S. sonnei 1790GAHB | 9 |
| Placebo 2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses
Placebo | 8 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | S. Sonnei 1790GAHB - 1 mcg | S. Sonnei 1790GAHB - 5 mcg | S. Sonnei 1790GAHB - 25 mcg | S. Sonnei 1790GAHB - 50 mcg | S. Sonnei 1790GAHB - 100 mcg |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 50 Participants | 8 Participants | 9 Participants | 8 Participants | 8 Participants | 9 Participants |
| Age, Continuous | 33.1 years STANDARD_DEVIATION 8.2 | 30.2 years STANDARD_DEVIATION 6.9 | 32.1 years STANDARD_DEVIATION 6.7 | 29.8 years STANDARD_DEVIATION 7 | 26.8 years STANDARD_DEVIATION 5.7 | 32.9 years STANDARD_DEVIATION 7.7 | 26.9 years STANDARD_DEVIATION 4.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 4 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 6 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 40 Participants | 7 Participants | 6 Participants | 6 Participants | 5 Participants | 9 Participants |
| Region of Enrollment France | 8 participants | 50 participants | 8 participants | 9 participants | 8 participants | 8 participants | 9 participants |
| Sex: Female, Male Female | 7 Participants | 28 Participants | 4 Participants | 4 Participants | 5 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 1 Participants | 22 Participants | 4 Participants | 5 Participants | 3 Participants | 4 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 8 | 9 / 9 | 8 / 8 | 8 / 8 | 9 / 9 | 8 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 | 0 / 8 | 0 / 8 | 0 / 9 | 0 / 8 |
Outcome results
Primary
Number of Subjects With Neutrophils Results Below and Above the Normal
Day 85: VISIT 5 (1 month post 3rd vac.)
Time frame: At Day 85
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 1 Participants |
| Placebo | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| Placebo | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
Primary
Number of Subjects With Neutrophils Results Below and Above the Normal
Day 225: VISIT 6 (6 months post 3rd vac.)
Time frame: At Day 225
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 1 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 1 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 1 Participants |
| Placebo | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| Placebo | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 1 Participants |
Primary
Number of Subjects With Neutrophils Results Below and Above the Normal
Day 36: VISIT 3.1 (D7 post 2nd vac.)
Time frame: At Day 36
Population: Some Arms have zero subjects attending visit 3.1, as complete blood counts testing 7 days after 2nd and 3rd vaccination was introduced following a protocol amendment while the study was ongoing.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 1 Participants |
| Placebo | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| Placebo | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
Primary
Number of Subjects With Neutrophils Results Below and Above the Normal
Day 57: VISIT 4 (3rd vac.)
Time frame: At Day 57
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 1 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 1 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 1 Participants |
| Placebo | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| Placebo | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
Primary
Number of Subjects With Neutrophils Results Below and Above the Normal
Day 64: VISIT 4.1 (D7 post 3rd vac.)
Time frame: At Day 64
Population: Some arms have zero subjects attending visit 3.1, as complete blood counts testing 7 days after 2nd and 3rd vaccination was introduced following a protocol amendment while the study was ongoing.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 1 Participants |
| Placebo | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Below Normal Ranges | 0 Participants |
| Placebo | Number of Subjects With Neutrophils Results Below and Above the Normal | Neutrophils Results Above Normal Ranges | 0 Participants |
Primary
Number of Subjects With Neutrophils Results Below and Above the Normal Ranges
Day 8: VISIT 2 (D7 post 1st vac)
Time frame: At Day 8
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal Ranges | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal Ranges | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal Ranges | Neutrophils Results Below Normal Ranges | 1 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal Ranges | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal Ranges | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal Ranges | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal Ranges | Neutrophils Results Below Normal Ranges | 1 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal Ranges | Neutrophils Results Above Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal Ranges | Neutrophils Results Below Normal Ranges | 0 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Neutrophils Results Below and Above the Normal Ranges | Neutrophils Results Above Normal Ranges | 1 Participants |
| Placebo | Number of Subjects With Neutrophils Results Below and Above the Normal Ranges | Neutrophils Results Below Normal Ranges | 0 Participants |
| Placebo | Number of Subjects With Neutrophils Results Below and Above the Normal Ranges | Neutrophils Results Above Normal Ranges | 0 Participants |
Primary
Number of Subjects With Solicited Local Reaction After Any Vaccination
Any erythema/induration refers to: ≥25 mm in diameter. Grade 3 (severe) refers to erythema/induration \>100 mm in diameter. Grade 3 (severe) for injection site pain refers to: prevents daily activity
Time frame: During a 7-day (Days 1-7) post vaccination period following any injection
Population: Analysis was done on as treated safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Any Pain | 8 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Grade 3 Pain | 0 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Any Erythema | 0 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Grade 3 Erythema | 0 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Any Induration | 0 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Grade 3 Induration | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Grade 3 Pain | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Grade 3 Erythema | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Grade 3 Induration | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Any Pain | 9 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Any Erythema | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Any Induration | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Grade 3 Induration | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Any Induration | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Grade 3 Erythema | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Any Erythema | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Any Pain | 8 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Grade 3 Pain | 0 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Grade 3 Erythema | 0 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Grade 3 Pain | 1 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Any Erythema | 0 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Grade 3 Induration | 1 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Any Induration | 2 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Any Pain | 8 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Any Pain | 9 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Any Induration | 2 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Grade 3 Pain | 1 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Any Erythema | 3 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Grade 3 Erythema | 1 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Solicited Local Reaction After Any Vaccination | Grade 3 Induration | 0 Participants |
| Placebo | Number of Subjects With Solicited Local Reaction After Any Vaccination | Grade 3 Erythema | 0 Participants |
| Placebo | Number of Subjects With Solicited Local Reaction After Any Vaccination | Any Erythema | 1 Participants |
| Placebo | Number of Subjects With Solicited Local Reaction After Any Vaccination | Any Induration | 0 Participants |
| Placebo | Number of Subjects With Solicited Local Reaction After Any Vaccination | Grade 3 Induration | 0 Participants |
| Placebo | Number of Subjects With Solicited Local Reaction After Any Vaccination | Grade 3 Pain | 0 Participants |
| Placebo | Number of Subjects With Solicited Local Reaction After Any Vaccination | Any Pain | 6 Participants |
Primary
Number of Subjects With Solicited Systemic Reaction After Any Vaccination
Any= Incidence of any symptom regardless of intensity grade. Grade 3 = symptom that prevented daily activities
Time frame: During a 7-day (Days 1 to 7) post vaccination period following any injection
Population: Analysis was done on as treated population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Fatigue | 4 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Fever (≥38.0°C) | 1 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Myalgia | 5 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Headache | 0 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Arthralgia | 0 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Myalgia | 0 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Headache | 3 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Malaise | 0 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Arthralgia | 2 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Malaise | 0 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Chills | 2 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Chills | 0 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Fever (≥40.0°C) | 0 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Fatigue | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Fatigue | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Fatigue | 3 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Chills | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Fever (≥38.0°C) | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Headache | 1 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Headache | 3 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Myalgia | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Arthralgia | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Fever (≥40.0°C) | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Myalgia | 1 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Malaise | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Arthralgia | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Malaise | 1 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Chills | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Arthralgia | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Headache | 2 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Headache | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Arthralgia | 2 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Chills | 1 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Chills | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Fatigue | 6 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Fatigue | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Malaise | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Malaise | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Myalgia | 3 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Myalgia | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Fever (≥38.0°C) | 0 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Fever (≥40.0°C) | 0 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Headache | 4 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Malaise | 1 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Chills | 1 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Fever (≥40.0°C) | 0 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Fever (≥38.0°C) | 0 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Arthralgia | 3 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Myalgia | 4 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Fatigue | 5 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Fatigue | 1 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Malaise | 1 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Chills | 1 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Headache | 1 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Arthralgia | 1 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Myalgia | 1 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Chills | 0 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Fatigue | 1 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Arthralgia | 0 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Headache | 2 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Malaise | 2 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Malaise | 0 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Arthralgia | 3 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Myalgia | 5 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Headache | 0 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Myalgia | 0 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Fever (≥40.0°C) | 0 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Chills | 0 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Fever (≥38.0°C) | 0 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Fatigue | 5 Participants |
| Placebo | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Chills | 1 Participants |
| Placebo | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Myalgia | 0 Participants |
| Placebo | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Malaise | 0 Participants |
| Placebo | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Headache | 3 Participants |
| Placebo | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Fatigue | 5 Participants |
| Placebo | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Arthralgia | 0 Participants |
| Placebo | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Fever (≥38.0°C) | 0 Participants |
| Placebo | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Fever (≥40.0°C) | 0 Participants |
| Placebo | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Chills | 0 Participants |
| Placebo | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Myalgia | 3 Participants |
| Placebo | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Headache | 0 Participants |
| Placebo | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Fatigue | 0 Participants |
| Placebo | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Grade 3 Malaise | 0 Participants |
| Placebo | Number of Subjects With Solicited Systemic Reaction After Any Vaccination | Any Arthralgia | 1 Participants |
Secondary
Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs)
Time frame: At baseline, at 28 days after each vaccination and at 168 days after last vaccination
Population: Analysis was done on the Full Analysis Set (FAS), ie, subjects in All Enrolled Set who: received a study vaccination, provided evaluable serum, with results available \& who was not excluded due to protocol deviations or other reasons defined before unblinding or analysis
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| S. Sonnei 1790GAHB - 1 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | One month after third vac. | 32 Titers |
| S. Sonnei 1790GAHB - 1 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | One month after first vac. | 6.2 Titers |
| S. Sonnei 1790GAHB - 1 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | Baseline (Day 1) | 4.71 Titers |
| S. Sonnei 1790GAHB - 1 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | Six months after third vac. | 12 Titers |
| S. Sonnei 1790GAHB - 1 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | One month after second vac. | 18 Titers |
| S. Sonnei 1790GAHB - 5 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | One month after first vac. | 23 Titers |
| S. Sonnei 1790GAHB - 5 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | One month after third vac. | 67 Titers |
| S. Sonnei 1790GAHB - 5 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | Baseline (Day 1) | 7.74 Titers |
| S. Sonnei 1790GAHB - 5 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | Six months after third vac. | 42 Titers |
| S. Sonnei 1790GAHB - 5 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | One month after second vac. | 41 Titers |
| S. Sonnei 1790GAHB - 25 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | One month after first vac. | 141 Titers |
| S. Sonnei 1790GAHB - 25 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | One month after third vac. | 486 Titers |
| S. Sonnei 1790GAHB - 25 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | Six months after third vac. | 418 Titers |
| S. Sonnei 1790GAHB - 25 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | One month after second vac. | 314 Titers |
| S. Sonnei 1790GAHB - 25 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | Baseline (Day 1) | 27 Titers |
| S. Sonnei 1790GAHB - 50 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | One month after second vac. | 111 Titers |
| S. Sonnei 1790GAHB - 50 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | Baseline (Day 1) | 8.78 Titers |
| S. Sonnei 1790GAHB - 50 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | One month after first vac. | 186 Titers |
| S. Sonnei 1790GAHB - 50 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | One month after third vac. | 149 Titers |
| S. Sonnei 1790GAHB - 50 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | Six months after third vac. | 106 Titers |
| S. Sonnei 1790GAHB - 100 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | One month after third vac. | 159 Titers |
| S. Sonnei 1790GAHB - 100 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | Baseline (Day 1) | 6.91 Titers |
| S. Sonnei 1790GAHB - 100 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | Six months after third vac. | 102 Titers |
| S. Sonnei 1790GAHB - 100 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | One month after first vac. | 157 Titers |
| S. Sonnei 1790GAHB - 100 mcg | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | One month after second vac. | 193 Titers |
| Placebo | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | Baseline (Day 1) | 6.37 Titers |
| Placebo | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | One month after third vac. | 7.71 Titers |
| Placebo | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | One month after first vac. | 6.35 Titers |
| Placebo | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | Six months after third vac. | 5.05 Titers |
| Placebo | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | One month after second vac. | 6.56 Titers |
Secondary
Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU)
High seroresponse is defined as a post vaccination titer ≥X anti-LPS serum IgG units in the GSK (former Novartis) ELISA that correspond to a titer of 1:800 in the ELISA method used by Cohen et al. To determine the value for 'X' the GSK (former Novartis) anti-LPS ELISA was calibrated against the Cohen ELISA and it was found that a concentration of 121 EU EU/mL corresponds to a titer of 1:800 in the Cohen assay
Time frame: At baseline, at 28 days after each vaccination and at 168 days after last vaccination
Population: Analysis was done on the Full Analysis Set (FAS), ie, subjects in All Enrolled Set who: received a study vaccination, provided evaluable serum, with results available \& who was not excluded due to protocol deviations or other reasons defined before unblinding or analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | One month after third vac. | 2 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | One month after first vac. | 0 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | Baseline | 0 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | Six months after third vac. | 2 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | One month after second vac. | 1 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | One month after first vac. | 2 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | One month after third vac. | 5 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | Baseline | 0 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | Six months after third vac. | 2 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | One month after second vac. | 3 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | One month after first vac. | 6 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | One month after third vac. | 6 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | Six months after third vac. | 5 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | One month after second vac. | 6 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | Baseline | 2 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | One month after second vac. | 3 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | Baseline | 2 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | One month after first vac. | 4 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | One month after third vac. | 4 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | Six months after third vac. | 3 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | One month after third vac. | 4 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | Baseline | 1 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | Six months after third vac. | 3 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | One month after first vac. | 4 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | One month after second vac. | 5 Participants |
| Placebo | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | Baseline | 0 Participants |
| Placebo | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | One month after third vac. | 0 Participants |
| Placebo | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | One month after first vac. | 0 Participants |
| Placebo | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | Six months after third vac. | 0 Participants |
| Placebo | Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU) | One month after second vac. | 0 Participants |
Secondary
Number of Subjects With Seroresponse for Anti-LPS S. Sonnei
Seroresponse is defined as: If half of the baseline value is greater than 25 ELISA Unit (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 half of the baseline value is less or equal to 25 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)
Time frame: At 28 days after each vaccination and 168 days after last vaccination
Population: Analysis was done on the Full Analysis Set (FAS), ie, subjects in All Enrolled Set who: received a study vaccination, provided evaluable serum, with results available \& who was not excluded due to protocol deviations or other reasons defined before unblinding or analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | One month after first vac. | 1 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | One month after second vac. | 2 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | One month after third vac. | 3 Participants |
| S. Sonnei 1790GAHB - 1 mcg | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | Six months after third vac. | 2 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | One month after third vac. | 7 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | One month after second vac. | 5 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | One month after first vac. | 3 Participants |
| S. Sonnei 1790GAHB - 5 mcg | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | Six months after third vac. | 6 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | Six months after third vac. | 6 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | One month after third vac. | 6 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | One month after second vac. | 7 Participants |
| S. Sonnei 1790GAHB - 25 mcg | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | One month after first vac. | 5 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | One month after first vac. | 6 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | Six months after third vac. | 4 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | One month after second vac. | 4 Participants |
| S. Sonnei 1790GAHB - 50 mcg | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | One month after third vac. | 4 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | One month after third vac. | 7 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | Six months after third vac. | 6 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | One month after second vac. | 7 Participants |
| S. Sonnei 1790GAHB - 100 mcg | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | One month after first vac. | 8 Participants |
| Placebo | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | One month after second vac. | 0 Participants |
| Placebo | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | One month after third vac. | 1 Participants |
| Placebo | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | Six months after third vac. | 0 Participants |
| Placebo | Number of Subjects With Seroresponse for Anti-LPS S. Sonnei | One month after first vac. | 0 Participants |