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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S. sonnei 1790GAHB - 1 mcg | Experimental | Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg |
|
| S. sonnei 1790GAHB - 5 mcg | Experimental | Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg |
|
| S. sonnei 1790GAHB - 25 mcg | Experimental | Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg |
|
| S. sonnei 1790GAHB - 50 mcg | Experimental | Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg |
|
| S. sonnei 1790GAHB - 100 mcg | Experimental | Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg |
|
| Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S. sonnei 1790GAHB | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During a 7-day (Days 1-7) post vaccination period following any injection |
| 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 | During a 7-day (Days 1 to 7) post vaccination period following any injection |
| Number of Subjects With Neutrophils Results Below and Above the Normal Ranges | Day 8: VISIT 2 (D7 post 1st vac) | At Day 8 |
| Number of Subjects With Neutrophils Results Below and Above the Normal | Day 36: VISIT 3.1 (D7 post 2nd vac.) | At Day 36 |
| Number of Subjects With Neutrophils Results Below and Above the Normal | Day 57: VISIT 4 (3rd vac.) | At Day 57 |
| Number of Subjects With Neutrophils Results Below and Above the Normal | Day 64: VISIT 4.1 (D7 post 3rd vac.) | At Day 64 |
| Number of Subjects With Neutrophils Results Below and Above the Normal | Day 85: VISIT 5 (1 month post 3rd vac.) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Odile Launay, Prof | Centre d'Investigation Clinique en Vaccinologie Cochin-Pasteur (CIC1417) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Investigation Clinique en Vaccinologie Cochin-Pasteur (CIC1417) | Paris | Paris Cedex 14 | 75679 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34017343 | Derived | Micoli F, Rossi O, Conti V, Launay O, Scire AS, Aruta MG, Nakakana UN, Marchetti E, Rappuoli R, Saul A, Martin LB, Necchi F, Podda A. Antibodies Elicited by the Shigella sonnei GMMA Vaccine in Adults Trigger Complement-Mediated Serum Bactericidal Activity: Results From a Phase 1 Dose Escalation Trial Followed by a Booster Extension. Front Immunol. 2021 May 4;12:671325. doi: 10.3389/fimmu.2021.671325. eCollection 2021. | |
| 28735965 |
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| ID | Title | Description |
|---|---|---|
| FG000 | S. Sonnei 1790GAHB - 1 mcg | Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg S. sonnei 1790GAHB |
| FG001 | S. Sonnei 1790GAHB - 5 mcg | Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg S. sonnei 1790GAHB |
| FG002 | S. Sonnei 1790GAHB - 25 mcg | Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg S. sonnei 1790GAHB |
| FG003 | S. Sonnei 1790GAHB - 50 mcg | Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg S. sonnei 1790GAHB |
| FG004 | S. Sonnei 1790GAHB - 100 mcg | Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg S. sonnei 1790GAHB |
| FG005 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | S. Sonnei 1790GAHB - 1 mcg | Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg S. sonnei 1790GAHB |
| BG001 | S. Sonnei 1790GAHB - 5 mcg | Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg S. sonnei 1790GAHB |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Analysis was done on as treated safety population | Posted | Count of Participants | Participants | No | During a 7-day (Days 1-7) post vaccination period following any injection |
|
Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | S. Sonnei 1790GAHB - 1 mcg | Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg S. sonnei 1790GAHB |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinoplasty | Surgical and medical procedures | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Audino Podda | GSK Vaccines Institute for Global Health S.r.l. | +39 0577 243496 | audino.p.podda@gsk.com |
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| ID | Term |
|---|---|
| D004405 | Dysentery, Bacillary |
| ID | Term |
|---|---|
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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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 | Biological |
|
| At Day 85 |
| Number of Subjects With Neutrophils Results Below and Above the Normal | Day 225: VISIT 6 (6 months post 3rd vac.) | At Day 225 |
| At 28 days after each vaccination and 168 days after last vaccination |
| 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 | At baseline, at 28 days after each vaccination and at 168 days after last vaccination |
| Derived |
| Launay O, Lewis DJM, Anemona A, Loulergue P, Leahy J, Scire AS, Maugard A, Marchetti E, Zancan S, Huo Z, Rondini S, Marhaba R, Finco O, Martin LB, Auerbach J, Cohen D, Saul A, Gerke C, Podda A. Safety Profile and Immunologic Responses of a Novel Vaccine Against Shigella sonnei Administered Intramuscularly, Intradermally and Intranasally: Results From Two Parallel Randomized Phase 1 Clinical Studies in Healthy Adult Volunteers in Europe. EBioMedicine. 2017 Aug;22:164-172. doi: 10.1016/j.ebiom.2017.07.013. Epub 2017 Jul 15. |
| 27490698 | Derived | Muturi-Kioi V, Lewis D, Launay O, Leroux-Roels G, Anemona A, Loulergue P, Bodinham CL, Aerssens A, Groth N, Saul A, Podda A. Neutropenia as an Adverse Event following Vaccination: Results from Randomized Clinical Trials in Healthy Adults and Systematic Review. PLoS One. 2016 Aug 4;11(8):e0157385. doi: 10.1371/journal.pone.0157385. eCollection 2016. |
| BG002 | S. Sonnei 1790GAHB - 25 mcg | Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg S. sonnei 1790GAHB |
| BG003 | S. Sonnei 1790GAHB - 50 mcg | Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg S. sonnei 1790GAHB |
| BG004 | S. Sonnei 1790GAHB - 100 mcg | Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg S. sonnei 1790GAHB |
| BG005 | 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 |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg
S. sonnei 1790GAHB
| OG002 | S. Sonnei 1790GAHB - 25 mcg | Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg S. sonnei 1790GAHB |
| OG003 | S. Sonnei 1790GAHB - 50 mcg | Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg S. sonnei 1790GAHB |
| OG004 | S. Sonnei 1790GAHB - 100 mcg | Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg S. sonnei 1790GAHB |
| OG005 | 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 |
|
|
| 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 | Analysis was done on as treated population | Posted | Count of Participants | Participants | No | During a 7-day (Days 1 to 7) post vaccination period following any injection |
|
|
|
| Primary | Number of Subjects With Neutrophils Results Below and Above the Normal Ranges | Day 8: VISIT 2 (D7 post 1st vac) | Posted | Count of Participants | Participants | No | At Day 8 |
|
|
|
| Primary | Number of Subjects With Neutrophils Results Below and Above the Normal | Day 36: VISIT 3.1 (D7 post 2nd vac.) | 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. | Posted | Count of Participants | Participants | No | At Day 36 |
|
|
|
| Primary | Number of Subjects With Neutrophils Results Below and Above the Normal | Day 57: VISIT 4 (3rd vac.) | Posted | Count of Participants | Participants | No | At Day 57 |
|
|
|
| Primary | Number of Subjects With Neutrophils Results Below and Above the Normal | Day 64: VISIT 4.1 (D7 post 3rd vac.) | 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. | Posted | Count of Participants | Participants | No | At Day 64 |
|
|
|
| Primary | Number of Subjects With Neutrophils Results Below and Above the Normal | Day 85: VISIT 5 (1 month post 3rd vac.) | Posted | Count of Participants | Participants | No | At Day 85 |
|
|
|
| Primary | Number of Subjects With Neutrophils Results Below and Above the Normal | Day 225: VISIT 6 (6 months post 3rd vac.) | Posted | Count of Participants | Participants | No | At Day 225 |
|
|
|
| Secondary | Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs) | 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 | Posted | Geometric Mean | 95% Confidence Interval | Titers | At baseline, at 28 days after each vaccination and at 168 days after last vaccination |
|
|
|
| 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) | 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 | Posted | Count of Participants | Participants | No | At 28 days after each vaccination and 168 days after last vaccination |
|
|
|
| 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 | 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 | Posted | Count of Participants | Participants | No | At baseline, at 28 days after each vaccination and at 168 days after last vaccination |
|
|
|
| 0 |
| 8 |
| 8 |
| 8 |
| EG001 | S. Sonnei 1790GAHB - 5 mcg | Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg S. sonnei 1790GAHB | 0 | 9 | 9 | 9 |
| EG002 | S. Sonnei 1790GAHB - 25 mcg | Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg S. sonnei 1790GAHB | 0 | 8 | 8 | 8 |
| EG003 | S. Sonnei 1790GAHB - 50 mcg | Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg S. sonnei 1790GAHB | 0 | 8 | 8 | 8 |
| EG004 | S. Sonnei 1790GAHB - 100 mcg | Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg S. sonnei 1790GAHB | 0 | 9 | 9 | 9 |
| EG005 | 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 | 0 | 8 | 8 | 8 |
| Chills | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Injection site erythema | General disorders | Systematic Assessment |
|
| Injection site induration | General disorders | Systematic Assessment |
|
| Injection site pain | General disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Microcytic anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Morton's neuralgia | Nervous system disorders | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | Non-systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | Non-systematic Assessment |
|
| Myopia | Eye disorders | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Influenza | Infections and infestations | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
Principal Investigators are NOT employed by the organization sponsoring the study.
There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Trial results may not be published or disclosed in any other way by the Institution, without the prior written consent by the Sponsor.
| D007239 | Infections |
| D004403 | Dysentery |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| Grade 3 Headache |
|
| Any Arthralgia |
|
| Grade 3 Arthralgia |
|
| Any Chills |
|
| Grade 3 Chills |
|
| Any Fatigue |
|
| Grade 3 Fatigue |
|
| Any Malaise |
|
| Grade 3 Malaise |
|
| Any Myalgia |
|
| Grade 3 Myalgia |
|
| Fever (≥38.0°C) |
|
| Fever (≥40.0°C) |
|
| Neutrophils Results Above Normal Ranges |
|
| Neutrophils Results Above Normal Ranges |
|
| Neutrophils Results Above Normal Ranges |
|
| Neutrophils Results Above Normal Ranges |
|
| Neutrophils Results Above Normal Ranges |
|
| Neutrophils Results Above Normal Ranges |
|
|
| One month after first vac. |
|
|
| One month after second vac. |
|
|
| One month after third vac. |
|
|
| Six months after third vac. |
|
|
|
| One month after second vac. |
|
|
| One month after third vac. |
|
|
| Six months after third vac. |
|
|
|
| One month after first vac. |
|
|
| One month after second vac. |
|
|
| One month after third vac. |
|
|
| Six months after third vac. |
|
|