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| ID | Type | Description | Link |
|---|---|---|---|
| H03_04TP | Other Identifier | Novartis |
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The purpose of this study is to evaluate the safety and the immunogenicity of two different doses of the GVGH S. sonnei vaccine in healthy adults and represents the first step towards testing of the GMMA vaccine in the vaccine target population of children from developing countries where shigellosis is endemic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1790GAHB 25 μg Group | Experimental | Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei. |
|
| 1790GAHB 100 μg Group | Experimental | Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei. |
|
| Control Group | Active Comparator | Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GVGH S. sonnei (1790GAHB) vaccine 25 μg | Biological | Two injections of the study vaccine were administered 28 days apart. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination | 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. | From 30 minutes up to 7 days following each vaccination |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | 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. | During 28 days following each vaccination |
| Number of Subjects With Serious Adverse Events (SAEs) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-LPS S.Sonnei IgG ELISA Geometric Mean Concentrations (GMCs), by Baseline Titer | Anti-LPS S.Sonnei IgG ELISA concentrations were tabulated as unadjusted geometric mean concentrations (GMCs) and expressed as ELISA units (EU) per milliliter (mL), presented with their 95% confidence intervals (CIs). Since all subjects in the study were from an endemic country, they had pre-vaccination titers equal to or above (≥) LLOQ (limit of detection). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Kilifi | 80108 | Kenya |
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| Label | URL |
|---|---|
| IPD for this study will be made available via the Clinical Study Data Request site. | View source |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1790GAHB 25 μg Group | Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei. |
| FG001 | 1790GAHB 100 μg Group | Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei. |
| FG002 | Control Group | Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1790GAHB 25 μg Group | Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei. |
| BG001 | 1790GAHB 100 μg Group | Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 and Systemic Adverse Reactions After Each Vaccination | 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. | 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. | Posted | Count of Participants | Participants | From 30 minutes up to 7 days following each vaccination |
|
Solicited symptoms: during 7 days following each vaccination; Unsolicited AEs: during 28 days following each vaccination; SAEs: throughout the whole study period (from Day 1 up to Day 57).
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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 | 1790GAHB 25 μg Group | Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment | Neutropenia was considered as an AE of specific interest and for reporting purpose systematically reported as an SAE |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | antonella.s.scire@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 28, 2015 | Mar 9, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 5, 2016 | Mar 9, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| D022401 | Meningococcal Vaccines |
| C505143 | Boostrix |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001428 | Bacterial Vaccines |
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| GVGH S. sonnei (1790GAHB) vaccine 100 μg | Biological | Two injections of the study vaccine were administered 28 days apart. |
|
| Menveo | Biological | One injection of Menveo was administered in subjects in the Control Group. |
|
| Boostrix | Biological | One injection of Boostrix was administered in subjects in the Control Group. |
|
| Throughout the whole study period (from Day 1 up to Day 57) |
| Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | 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. | At Day 8 (7 days after first vaccination) |
| Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | 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. | At Day 29 (28 days after the first vaccination) |
| Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | 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. | At Day 36 (7 days after the second vaccination) |
| Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | 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. | At Day 57 (28 days after the second vaccination) |
| Number of Subjects With Reported Reactive Arthritis or Neutropenia (AESIs) | Reactive arthritis is defined as non-purulent joint inflammation that develops in response to an infection in another part of the body. Since the inflammation is triggered by a previous condition, it is termed "reactive". Intestinal pathogens that have been associated with reactive arthritis include Campylobacter, Salmonella, Yersinia, Clostridium difficile, and Shigella. If reactive arthritis is caused by an auto immune response, there is at least a possibility that it could be initiated by vaccination of susceptible people with the 1790GAHB vaccine. | Throughout the whole study period (from Day 1 up to Day 57) |
| At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination) |
| Anti-LPS S. Sonnei Geometric Mean Ratios (GMRs) Between Post- and Pre-vaccination Samples | The ratio was expressed as unadjusted geometric mean ratio (GMR) and presented with its 95% confidence interval (CI). | At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination) |
| Number of Subjects With Seroresponse to Anti-LPS S. Sonnei IgG ELISA, by Baseline Titer | Seroresponse was defined as: if the baseline value was greater than 50 EU then an increase of at least 50% in the post-vaccination sample as compared to baseline (i.e., [{post-vac minus baseline}/baseline]100% ≥ 50%); if the baseline value was less or equal to 50 EU then an increase of at least 25 EU in the post-vaccination sample as compared to baseline (i.e., [post-vac minus baseline] ≥ 25 EU). Since all subjects in the study were from an endemic country, they had pre-vaccination titers equal to or above (≥) LLOQ (limit of detection). | At Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination) |
| Number of Subjects With Titers Post Vaccination Concentration for Anti-LPS S. Sonnei ≥ 121 U/mL | The analysis cut-off value (121 U/mL) was expressed in units per milliliter (U/mL), as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA). | At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination) |
| Adverse Event |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| BG002 | Control Group | Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | 1790GAHB 25 μg Group | Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei. |
| OG001 | 1790GAHB 100 μg Group | Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei. |
| OG002 | Control Group | Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine. |
|
|
| Primary | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 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. | 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. | Posted | Count of Participants | Participants | During 28 days following each vaccination |
|
|
|
| Primary | Number of Subjects With Serious Adverse Events (SAEs) | 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. | 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. | Posted | Count of Participants | Participants | Throughout the whole study period (from Day 1 up to Day 57) |
|
|
|
| Primary | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges | 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. | 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. | Posted | Count of Participants | Participants | At Day 8 (7 days after first vaccination) |
|
|
|
| Primary | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges | 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. | 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. | Posted | Count of Participants | Participants | At Day 29 (28 days after the first vaccination) |
|
|
|
| Primary | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges | 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. | 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. | Posted | Count of Participants | Participants | At Day 36 (7 days after the second vaccination) |
|
|
|
| Primary | Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges | 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. | 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. | Posted | Count of Participants | Participants | At Day 57 (28 days after the second vaccination) |
|
|
|
| Primary | Number of Subjects With Reported Reactive Arthritis or Neutropenia (AESIs) | Reactive arthritis is defined as non-purulent joint inflammation that develops in response to an infection in another part of the body. Since the inflammation is triggered by a previous condition, it is termed "reactive". Intestinal pathogens that have been associated with reactive arthritis include Campylobacter, Salmonella, Yersinia, Clostridium difficile, and Shigella. If reactive arthritis is caused by an auto immune response, there is at least a possibility that it could be initiated by vaccination of susceptible people with the 1790GAHB vaccine. | 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. | Posted | Count of Participants | Participants | Throughout the whole study period (from Day 1 up to Day 57) |
|
|
|
| Secondary | Anti-LPS S.Sonnei IgG ELISA Geometric Mean Concentrations (GMCs), by Baseline Titer | Anti-LPS S.Sonnei IgG ELISA concentrations were tabulated as unadjusted geometric mean concentrations (GMCs) and expressed as ELISA units (EU) per milliliter (mL), presented with their 95% confidence intervals (CIs). Since all subjects in the study were from an endemic country, they had pre-vaccination titers equal to or above (≥) LLOQ (limit of detection). | This analysis was performed on the Full Analysis Set, including subjects with at least 1 dose of study vaccine administered. Numbers decreased over time, hence at study Visit 5 (Day 57), not all subjects from study Visit 1 (Day 1) had available immunogenicity results. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination) |
|
|
|
| Secondary | Anti-LPS S. Sonnei Geometric Mean Ratios (GMRs) Between Post- and Pre-vaccination Samples | The ratio was expressed as unadjusted geometric mean ratio (GMR) and presented with its 95% confidence interval (CI). | This analysis was performed on the Full Analysis Set, including subjects with at least 1 dose of study vaccine administered. Numbers decreased over time, hence at study Visit 5 (Day 57), not all subjects from study Visit 1 (Day 1) had available immunogenicity results. | Posted | Geometric Mean | 95% Confidence Interval | Geometric mean ratio | At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination) |
|
|
|
| Secondary | Number of Subjects With Seroresponse to Anti-LPS S. Sonnei IgG ELISA, by Baseline Titer | Seroresponse was defined as: if the baseline value was greater than 50 EU then an increase of at least 50% in the post-vaccination sample as compared to baseline (i.e., [{post-vac minus baseline}/baseline]100% ≥ 50%); if the baseline value was less or equal to 50 EU then an increase of at least 25 EU in the post-vaccination sample as compared to baseline (i.e., [post-vac minus baseline] ≥ 25 EU). Since all subjects in the study were from an endemic country, they had pre-vaccination titers equal to or above (≥) LLOQ (limit of detection). | This analysis was based on the Full Analysis Set, including subjects with at least 1 dose of study vaccine administered. Some subjects were excluded due to implausible values from all study visits. | Posted | Count of Participants | Participants | At Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination) |
|
|
|
| Secondary | Number of Subjects With Titers Post Vaccination Concentration for Anti-LPS S. Sonnei ≥ 121 U/mL | The analysis cut-off value (121 U/mL) was expressed in units per milliliter (U/mL), as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA). | This analysis was performed on the Full Analysis Set, including subjects with at least 1 dose of study vaccine administered. Numbers decreased over time, hence at study Visit 5 (Day 57), not all subjects from study Visit 1 (Day 1) had available immunogenicity results. | Posted | Count of Participants | Participants | At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination) |
|
|
|
| 0 |
| 22 |
| 2 |
| 22 |
| 22 |
| 22 |
| EG001 | 1790GAHB 100 μg Group | Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei. | 0 | 26 | 3 | 26 | 26 | 26 |
| EG002 | Control Group | Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine. | 0 | 24 | 1 | 24 | 24 | 24 |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Induration | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Bone tuberculosis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Genital herpes | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Malaria | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Pyuria | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Tinea versicolour | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 20.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
|
| AE leading to study vaccine withdrawal |
|
| AE leading to disruptions* |
|
| AE leading to hospitalization |
|
| AE of special interest (Neutropenia) |
|
| Deaths |
|
| Title | Measurements |
|---|---|
|
| Deaths |
|
| Above (baseline) - below (Day 8) |
|
| Below (baseline) - within (Day 8) |
|
| Within (baseline) - within (Day 8) |
|
| Above (baseline) - within (Day 8) |
|
| Below (baseline) - above (Day 8) |
|
| Within (baseline) - above (Day 8) |
|
| Above (baseline) - above (Day 8) |
|
| Eosinophils |
|
| Erythrocytes |
|
| Hematocrit |
|
| Hemoglobin |
|
| Leukocytes |
|
| Lymphocytes |
|
| Monocytes |
|
| Neutrophils |
|
| Platelets |
|
| ALA |
|
| ALP |
|
| AST |
|
| BILI |
|
| BUN |
|
| CREA |
|
| GGT |
|
| GLUC |
|
| LDH |
|
| K |
|
| Na |
|
| Within (baseline) - below (Day 29) |
|
| Above (baseline) - below (Day 29) |
|
| Below (baseline) - within (Day 29) |
|
| Within (baseline) - within (Day 29) |
|
| Above (baseline) - within (Day 29) |
|
| Below (baseline) - above (Day 29) |
|
| Within (baseline) - above (Day 29) |
|
| Above (baseline) - above (Day 29) |
|
| Eosinophils |
|
|
| Erythrocytes |
|
|
| Hematocrit |
|
|
| Hemoglobin |
|
|
| Leukocytes |
|
|
| Lymphocytes |
|
|
| Monocytes |
|
|
| Neutrophils |
|
|
| Platelets |
|
|
| ALA |
|
|
| ALP |
|
|
| AST |
|
|
| BILI |
|
|
| BUN |
|
|
| CREA |
|
|
| GGT |
|
|
| GLUC |
|
|
| LDH |
|
|
| K |
|
|
| Na |
|
|
| Above (baseline) - below (Day 36) |
|
| Below (baseline) - Within (Day 36) |
|
| Within (baseline) - within (Day 36) |
|
| Above (baseline) - within (Day 36) |
|
| Below (baseline) - above (Day 36) |
|
| Within (baseline) - above (Day 36) |
|
| Above (baseline) - above (Day 36) |
|
| Eosinophils |
|
| Erythrocytes |
|
| Hematocrit |
|
| Hemoglobin |
|
| Leukocytes |
|
| Lymphocytes |
|
| Monocytes |
|
| Neutrophils |
|
| Platelet |
|
| ALA |
|
| ALP |
|
| AST |
|
| BILI |
|
| BUN |
|
| CREA |
|
| GGT |
|
| GLUC |
|
| LDH |
|
| K |
|
| Na |
|
| Above (baseline) - below (Day 57) |
|
| Below (baseline) - within (Day 57) |
|
| Within (baseline) - within (Day 57) |
|
| Above (baseline) - within (Day 57) |
|
| Below (baseline) - above (Day 57) |
|
| Within (baseline) - above (Day 57) |
|
| Above (baseline) - above (Day 57) |
|
| Eosinophils |
|
| Erythrocytes |
|
| Hematocrit |
|
| Hemoglobin |
|
| Leukocytes |
|
| Lymphocytes |
|
| Monocytes |
|
| Neutrophils |
|
| Platelets |
|
| ALT |
|
| ALP |
|
| AST |
|
| BILI |
|
| BUN |
|
| CREAT |
|
| GGT |
|
| GLUC |
|
| LDH |
|
| K |
|
| Na |
|
| Title | Measurements |
|---|---|
|
| Day 29 |
|
|
| Day 57 |
|
|
| At Day 57 versus Day 1 |
|
|
| At Day 57 versus Day 29 |
|
|
| Anti-LPS, Day 57 |
|
|
| Day 29 |
|
|
| Day 57 |
|
|