Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H03_03TP | Other Identifier | GSK Vaccines Institute for Global Health |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the GSK3536852A vaccine, which was designed to protect against shigellosis caused by Shigella sonnei (S. sonnei) and is using the new Generalized Modules for Membrane Antigens (GMMA) platform technology developed by GlaxoSmithKline (GSK) Vaccines Institute for Global Health (GVGH).
The study vaccine could be the stepping stone for the development of a multivalent broadly protective Shigella vaccine for vaccination of impoverished communities where shigellosis is endemic. However, a standalone monovalent vaccine against S. sonnei could be used to protect travelers against diarrheal shigellosis, as the vast majority of travelers' shigellosis is caused by S. sonnei, and even to protect infants in endemic regions where shigellosis is primarily caused by S. sonnei.
The GSK3536852A vaccine has been tested in two Phase I dose escalation studies in Europe to assess its safety and immunogenicity via three routes of administration: intramuscular (IM), intranasal (IN) and intradermal (ID). The results from the first study (dose escalation with IM vaccination) have shown that the vaccine has an acceptable safety profile and is well-tolerated up to a dose of 100 micrograms (µg). The results from the second study (dose escalation with ID, IN and IM vaccination) showed that GSK3536852A vaccine is well-tolerated also when administered by the ID and IN routes of vaccination. However, immunogenicity data have shown that GSK3536852A vaccine administered by the ID and IN routes is not as immunogenic as GSK3536852A vaccine administered by the IM route. Therefore, it has been decided to proceed with the clinical development program of this vaccine only using the IM vaccination route. In terms of dosage, the regimen tested in Phase I studies (three doses given one month apart) did not show any significant benefit from the third dose in terms of immunogenicity, therefore a two dose schedule was selected for next studies.
A Phase IIa study, conducted in endemic regions of Africa (i.e., Kenya), has been completed and confirmed the acceptable safety profile and immunogenicity of GSK3536852A vaccine.
Performing this vaccine-human challenge study may give the opportunity to establish evidence of clinical protection induced by the candidate S. sonnei vaccine (GSK3536852A vaccine) at an early development stage.
The original study protocol has been amended due to requests from the Food and Drug Administration (FDA), requests from the funder of the study, Bill & Melinda Gates Foundation (BMGF), to add an additional interim analysis for immunogenicity data that will accelerate the release of key results to help the planning of other studies, and to further align the protocol to other GSK studies and to the challenge model established at the Cincinnati Children's Hospital Medical Centre.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S. sonnei Group | Experimental | Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally. |
|
| Placebo Group | Placebo Comparator | Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S.sonnei vaccine | Biological | Subjects receiving 2 doses of the study vaccine by intramuscular route, 28 days apart (at Day 1 and Day 29). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With at Least One Episode of Shigellosis According to the Protocol Primary Case Definition | Attack rate of shigellosis expressed as percentage of subjects with at least one episode of shigellosis after challenge, and 90% confidence interval (CI) (Clopper-Pearson method). Episodes of shigellosis fulfilling primary case definition: Shedding of S. sonnei 53G accompanied by moderate or severe diarrhea OR shedding with oral temperature greater than or equal to (≥) 38.5°C. Moderate diarrhea consists of 4 to 5 loose or watery (Grade [G]3 to 5) stools or 400 to 800 grams of G3 to 5 stools within 24 hours. Severe diarrhea consists of 6 or more loose or watery (G3 to 5) stools or > 800 grams of G3 to 5 stools within 24 hours or required medical intervention. In case of severe diarrhea, medical intervention is defined as intravenous fluids administration or anticipation of antibiotic treatment before the 5th day after challenge. G3 = viscous opaque liquid or semi-liquid which assumes the shape of the bowl; G4 = watery opaque liquid; G5 = clear watery or mucoid liquid. | Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With at Least One Episode of Shigellosis According to Controlled Human Infection Model (CHIM) Working Group Case Definition for Shigellosis | Percentage of subjects with shigellosis fulfilling the CHIM expert working group case definition for shigellosis, and 90% confidence interval (CI) (Clopper-Pearson method). According to the working group, the participant must fulfil any of the three following possible endpoints to qualify as having reached the CHIM case definition for this objective: 1. Severe diarrhea defined as [[≥ 6 loose stools in 24 hours] OR [˃800 grams loose stools in 24 hours]; 2. Moderate diarrhea defined as [4-5 loose stools in 24 hours OR 400-800 grams loose stools in 24 hours] AND [oral temperature [≥ 38.0°C OR [≥ 1 moderate constitutional/enteric symptom OR [≥ 2 episodes of vomiting in 24 hours]; 3. Dysentery defined as [[≥ 2 loose stools with gross blood (hemoccult positive) in 24 hours] AND [oral temperature [≥ 38.0°C OR [≥ 1 moderate constitutional/enteric symptom OR [≥ 2 episodes of vomiting in 24 hours].](streamdown:incomplete-link) |
Not provided
Inclusion Criteria:
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject prior to performing any study specific procedure.
Individuals who, after the nature of the study has been explained to them, have shown adequate comprehension of the study procedures and knowledge of study.
A male or female between, and including, 18 and 50 years of age at the time of the first vaccination.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Seronegative for human immunodeficiency virus (HIV), hepatitis B and C.
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cincinnati | Ohio | 45229 | United States |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
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.
All 71 subjects enrolled in the study, received a study vaccination and were included in the All Exposed Set.
This study was conducted at one center in the United States of America (USA).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | S. Sonnei Group | Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 23, 2019 | Apr 30, 2020 |
Not provided
Not provided
Not provided
Not provided
Observer-blind The subject, the site and sponsor personnel involved in the clinical evaluation of the subjects are blinded while other study personnel may be aware of the treatment assignment.
| Placebo | Drug | Subjects receiving 2 doses of placebo by intramuscular route, 28 days apart (at Day 1 and Day 29). |
|
|
| S. sonnei 53G challenge strain | Biological | Subjects receiving the challenge dose of S. sonnei 53G strain, orally, at Day 57. |
|
| Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64) |
| Percentage of Subjects With at Least One Episode of Shigellosis | Percentage of subjects with shigellosis fulfilling the following definition of shigellosis (with 90% confidence interval (CI) - Clopper-Pearson method): 1) severe diarrhea OR 2) moderate diarrhea AND oral temperature ≥ 38.0 °C OR ≥ 1 moderate constitutional/enteric symptom OR 3) dysentery [[≥ 2 loose stools with gross blood (hemoccult positive) in 24 hours] AND [≥ 1 reportable constitutional/enteric symptom]]. | Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64) |
| Percentage of Subjects With at Least One Episode of More Severe Shigellosis | Percentage of subjects with more severe shigellosis fulfilling the following definition of more severe shigellosis (with 90% confidence interval (CI) - Clopper-Pearson method): 1) moderate OR severe diarrhea AND oral temperature ≥ 38.0 °C OR ≥ 1 severe constitutional/enteric symptom OR 2) dysentery [[≥ 2 loose stools with gross blood (hemoccult positive) in 24 hours] AND [oral temperature ≥ 38.0°C OR ≥ 1 severe constitutional/enteric symptom]]. | Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64) |
| Percentage of Subjects With Specific Disease Symptoms | Percentage of subjects with 90% CI-Clopper-Pearson method was also measured for: shedding of S.sonnei strain 53G (defined as positivity of ≥1 stool sample by culture/quantitative Polymerase Chain Reaction/both); severe diarrhea; more severe diarrhea; dysentery; confirmed S.sonnei 53G shedding AND moderate or severe diarrhea OR dysentery OR presence of oral temperature ≥ 38.5°C OR presence of 1 or more severe intestinal symptoms (abdominal pain, cramping, nausea, vomiting, gas, and anorexia) abbreviated as "shedding of S.sonnei 53G and […"; disease not fulfilling the protocol primary case definition for shigellosis associated or not with mild to moderate symptoms including: ≥1 stool and no moderate or severe diarrhea evidence, abdominal pain, abdominal cramps, gas, anorexia, nausea, headache, myalgia, malaise, arthralgia, fever, vomiting and intravenous fluid administration. Any=any symptom regardless of intensity grade or relation to study vaccination and/or challenge administration.](streamdown:incomplete-link) | Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64) |
| Mean Number of Grade 3-5 Stools Per Subject | The mean number of grade 3-5 stools (and standard deviation) were calculated per subject from challenge to discharge. | Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64) |
| Weight of Grade 3-5 Stools | Mean and standard deviation (SD) of weights were expressed in grams. The following measures were calculated: mean and SD of the weight of grade 3-5 stools calculated on all subjects (Weight/all subjects), mean and SD of the weight of grade 3-5 stools calculated on subjects with at least one grade 3-5 stool (Weight/subj.with at least 1 grade 3-5 stool), Cumulative mean and SD weight of grade 3-5 stools per subjects, accumulated from challenge to discharge (Cumulative weight/all subjects). | Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64) |
| Time (Days) From Challenge Administration to Onset of Shigellosis, According to the Primary Case Definition | Median time to onset of shigellosis was to be estimated with Kaplan-Meier method among subjects who received the challenge agent. The day associated to the first shigellosis was the time of onset of shigellosis. Subjects who did not have shigellosis were censored at the time on the day of discharge. Median time (in days) to onset of shigellosis and 90% confidence interval (CI) could not be calculated in any of the groups because less than 50% of subjects experienced the event (shigellosis) during the observation period. | Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64) |
| Number of Subjects With Any Solicited Local Adverse Events (AEs) | Solicited local AEs include: pain, erythema and induration at injection site. Any = occurrence of local adverse event regardless of intensity grade. Any erythema or induration at injection site is any symptom with a surface diameter greater than 25 millimeters. | During the 7-day period after each vaccination (vaccine/placebo administered at Day 1 and Day 29) |
| Number of Subjects With Any Solicited Systemic AEs | Solicited systemic AEs include: arthralgia, chills, fatigue, headache, malaise, myalgia, fever (oral temperature ≥ 38.0°C). Any = occurrence of systemic adverse event regardless of intensity and relation to study vaccination. | During the 7-day period after each vaccination (vaccine/placebo administered at Day 1 and Day 29) |
| Number of Subjects With Any Unsolicited AEs During the 28-day Post-vaccination Period | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination. | During the 28-day period across doses (vaccine/placebo administered at Day 1 and Day 29) |
| Number of Subjects With Any Unsolicited AEs During the 28-day Follow-up Period After Challenge | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination and/or challenge agent administration. | During the 28-day follow-up period after challenge (challenge administered at Day 57) |
| Number of Subjects With Any Serious Adverse Events (SAEs) and Related SAEs | Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs = SAEs assessed by the investigator as related to the study vaccination and/or challenge agent administration. | From Day 1 up to study end at Day 237 |
| Number of Subjects With Any Adverse Events of Special Interest (AESI) (i.e., Symptomatic Neutropenia) | AESI are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it. | From Day 1 up to study end at Day 237 |
| Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges | Among hematological parameters assessed are: Basophils, Eosinophils, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets. Below = below the normal laboratory range defined for the specified laboratory parameter; Above = above the normal laboratory range defined for the specified laboratory parameter; Within = within the normal laboratory range defined for the specified laboratory parameter. Category naming has been defined as follows: Parameter, time point, range indicator at Baseline, range indicator at the specified time point: e.g.: "Basophils, Day 8, Within, Within ". Note: All subjects whose neutrophil value was below the threshold defined in the Protocol, at any time during the study, were re-tested until neutropenia resolution. | At Day 8, at Day 36 and at Day 237 |
| Anti-S. Sonnei Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Antibody Concentrations at Pre-vaccination and After the First and Second Vaccination | Anti-S. sonnei LPS IgG antibody concentrations are presented as geometric mean concentrations (GMCs), determined by Enzyme-linked immunosorbent assay (ELISA) and expressed in ELISA units per milliliter (EU/mL). Note: regarding the "28 days after second vaccination" protocol timing, sample collection could have been performed either at Day 56 or at Day 57. For all the subjects, samples were collected at Day 56, and therefore, results are presented for "Day 56 (27 days after the second vaccination)" timing. | At Day 1 (pre-vaccination), at Day 8 (7 days after the first vaccination), at Day 29 (28 days after the first vaccination), at Day 36 (7 days after the second vaccination) and at Day 56 (27 days after the second vaccination) |
| Anti-S. Sonnei LPS IgG Antibody Concentrations at Pre-challenge and After Challenge | Anti-S. sonnei LPS IgG antibody concentrations are presented as GMCs, as determined by ELISA and expressed in EU/mL. Note: regarding the "28 days after second vaccination" protocol timing, sample collection could have been performed either at Day 56 or at Day 57. For all the subjects, samples were collected at Day 56, and therefore, results are presented for "Day 56 (27 days after the second vaccination)" timing. | At Day 56 (pre-challenge), at Day 64 (7 days after challenge) and at Day 85 (28 days after challenge) |
| Number of Subjects Achieving a Post-vaccination Anti-S. Sonnei LPS Concentration ≥ 268 EU/mL | This antibody response cut-off was based on the results of the previous Phase I studies and estimated results of the median antibody titer after natural infection by S. sonnei. The threshold 121 EU/mL planned per protocol has been recalibrated to 268 EU/mL following an investigation of reliability of the ELISA assay. Note: regarding the "28 days after second vaccination" protocol timing, sample collection could have been performed either at Day 56 or at Day 57. For all the subjects, samples were collected at Day 56, and therefore, results are presented for "Day 56 (27 days after the second vaccination)" timing. | At Day 29 (28 days after the first vaccination) and at Day 56 (27 days after the second vaccination) |
| Number of Seroresponders for Anti-S. Sonnei LPS | Seroresponse definition as reported in the protocol was assay specific and specifically related to assay, as run in Marburg Lab for the previous GVGH Shigella studies. This assay was further characterized and optimized before being used in GVGH for the current Phase 2b study. Since the assay used in current study is not comparable with the assay used in previous GVGH studies, the seroresponse definition is no longer appropriate (as it is valid only for Marburg assay). With the acknowledgment that seroresponse results are no longer meaningful, the study team choose to report the results for transparency. Note: regarding the "28 days after second vaccination" protocol timing, sample collection could have been performed either at Day 56 or at Day 57. For all the subjects, samples were collected at Day 56, and therefore, results are presented for "Day 56 (27 days after the second vaccination" timing. | At Day 29 (28 days after the first vaccination) and at Day 56 (27 days after the second vaccination) |
| FG001 | Placebo Group | Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | S. Sonnei Group | Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally. |
| BG001 | Placebo Group | Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | 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 | Percentage of Subjects With at Least One Episode of Shigellosis According to the Protocol Primary Case Definition | Attack rate of shigellosis expressed as percentage of subjects with at least one episode of shigellosis after challenge, and 90% confidence interval (CI) (Clopper-Pearson method). Episodes of shigellosis fulfilling primary case definition: Shedding of S. sonnei 53G accompanied by moderate or severe diarrhea OR shedding with oral temperature greater than or equal to (≥) 38.5°C. Moderate diarrhea consists of 4 to 5 loose or watery (Grade [G]3 to 5) stools or 400 to 800 grams of G3 to 5 stools within 24 hours. Severe diarrhea consists of 6 or more loose or watery (G3 to 5) stools or > 800 grams of G3 to 5 stools within 24 hours or required medical intervention. In case of severe diarrhea, medical intervention is defined as intravenous fluids administration or anticipation of antibiotic treatment before the 5th day after challenge. G3 = viscous opaque liquid or semi-liquid which assumes the shape of the bowl; G4 = watery opaque liquid; G5 = clear watery or mucoid liquid. | The analysis is performed on the Per-protocol set (PPS) for efficacy, which includes all subjects who received the study vaccine or placebo according to protocol, were not excluded due to other reasons defined prior to unblinding or analysis and who received the challenge agent. | Posted | Number | 90% Confidence Interval | Percentage of subjects | Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With at Least One Episode of Shigellosis According to Controlled Human Infection Model (CHIM) Working Group Case Definition for Shigellosis | Percentage of subjects with shigellosis fulfilling the CHIM expert working group case definition for shigellosis, and 90% confidence interval (CI) (Clopper-Pearson method). According to the working group, the participant must fulfil any of the three following possible endpoints to qualify as having reached the CHIM case definition for this objective: 1. Severe diarrhea defined as [[≥ 6 loose stools in 24 hours] OR [˃800 grams loose stools in 24 hours]; 2. Moderate diarrhea defined as [4-5 loose stools in 24 hours OR 400-800 grams loose stools in 24 hours] AND [oral temperature [≥ 38.0°C OR [≥ 1 moderate constitutional/enteric symptom OR [≥ 2 episodes of vomiting in 24 hours]; 3. Dysentery defined as [[≥ 2 loose stools with gross blood (hemoccult positive) in 24 hours] AND [oral temperature [≥ 38.0°C OR [≥ 1 moderate constitutional/enteric symptom OR [≥ 2 episodes of vomiting in 24 hours].](streamdown:incomplete-link) | The analysis is performed on the Per-protocol set (PPS) for efficacy, which includes all subjects who received the study vaccine or placebo according to protocol, were not excluded due to other reasons defined prior to unblinding or analysis and who received the challenge agent. | Posted | Number | 90% Confidence Interval | Percentage of subjects | Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With at Least One Episode of Shigellosis | Percentage of subjects with shigellosis fulfilling the following definition of shigellosis (with 90% confidence interval (CI) - Clopper-Pearson method): 1) severe diarrhea OR 2) moderate diarrhea AND oral temperature ≥ 38.0 °C OR ≥ 1 moderate constitutional/enteric symptom OR 3) dysentery [[≥ 2 loose stools with gross blood (hemoccult positive) in 24 hours] AND [≥ 1 reportable constitutional/enteric symptom]]. | The analysis is performed on the Per-protocol set (PPS) for efficacy, which includes all subjects who received the study vaccine or placebo according to protocol, were not excluded due to other reasons defined prior to unblinding or analysis and who received the challenge agent. | Posted | Number | 90% Confidence Interval | Percentage of subjects | Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With at Least One Episode of More Severe Shigellosis | Percentage of subjects with more severe shigellosis fulfilling the following definition of more severe shigellosis (with 90% confidence interval (CI) - Clopper-Pearson method): 1) moderate OR severe diarrhea AND oral temperature ≥ 38.0 °C OR ≥ 1 severe constitutional/enteric symptom OR 2) dysentery [[≥ 2 loose stools with gross blood (hemoccult positive) in 24 hours] AND [oral temperature ≥ 38.0°C OR ≥ 1 severe constitutional/enteric symptom]]. | The analysis is performed on the Per-protocol set (PPS) for efficacy, which includes all subjects who received the study vaccine or placebo according to protocol, were not excluded due to other reasons defined prior to unblinding or analysis and who received the challenge agent. | Posted | Number | 90% Confidence Interval | Percentage of subjects | Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Specific Disease Symptoms | Percentage of subjects with 90% CI-Clopper-Pearson method was also measured for: shedding of S.sonnei strain 53G (defined as positivity of ≥1 stool sample by culture/quantitative Polymerase Chain Reaction/both); severe diarrhea; more severe diarrhea; dysentery; confirmed S.sonnei 53G shedding AND moderate or severe diarrhea OR dysentery OR presence of oral temperature ≥ 38.5°C OR presence of 1 or more severe intestinal symptoms (abdominal pain, cramping, nausea, vomiting, gas, and anorexia) abbreviated as "shedding of S.sonnei 53G and […"; disease not fulfilling the protocol primary case definition for shigellosis associated or not with mild to moderate symptoms including: ≥1 stool and no moderate or severe diarrhea evidence, abdominal pain, abdominal cramps, gas, anorexia, nausea, headache, myalgia, malaise, arthralgia, fever, vomiting and intravenous fluid administration. Any=any symptom regardless of intensity grade or relation to study vaccination and/or challenge administration.](streamdown:incomplete-link) | The analysis is performed on the Per-protocol set (PPS) for efficacy, which includes all subjects who received the study vaccine or placebo according to protocol, were not excluded due to other reasons defined prior to unblinding or analysis and who received the challenge agent. | Posted | Number | 90% Confidence Interval | Percentage of subjects | Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Number of Grade 3-5 Stools Per Subject | The mean number of grade 3-5 stools (and standard deviation) were calculated per subject from challenge to discharge. | The analysis is performed on the Per-protocol set (PPS) for efficacy, which includes all subjects who received the study vaccine or placebo according to protocol, were not excluded due to other reasons defined prior to unblinding or analysis and who received the challenge agent. | Posted | Mean | Standard Deviation | grade 3-5 stools | Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Weight of Grade 3-5 Stools | Mean and standard deviation (SD) of weights were expressed in grams. The following measures were calculated: mean and SD of the weight of grade 3-5 stools calculated on all subjects (Weight/all subjects), mean and SD of the weight of grade 3-5 stools calculated on subjects with at least one grade 3-5 stool (Weight/subj.with at least 1 grade 3-5 stool), Cumulative mean and SD weight of grade 3-5 stools per subjects, accumulated from challenge to discharge (Cumulative weight/all subjects). | The analysis is performed on the Per-protocol set (PPS) for efficacy, which includes all subjects who received the study vaccine or placebo according to protocol, were not excluded due to other reasons defined prior to unblinding or analysis and who received the challenge agent. | Posted | Mean | Standard Deviation | Grams | Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time (Days) From Challenge Administration to Onset of Shigellosis, According to the Primary Case Definition | Median time to onset of shigellosis was to be estimated with Kaplan-Meier method among subjects who received the challenge agent. The day associated to the first shigellosis was the time of onset of shigellosis. Subjects who did not have shigellosis were censored at the time on the day of discharge. Median time (in days) to onset of shigellosis and 90% confidence interval (CI) could not be calculated in any of the groups because less than 50% of subjects experienced the event (shigellosis) during the observation period. | The analysis was not performed because less than 50% of subjects experienced the event (shigellosis) during the observation period. Therefore, the Median time to onset of shigellosis and 90% confidence interval (CI) could not be calculated in any of the groups. | Posted | Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any Solicited Local Adverse Events (AEs) | Solicited local AEs include: pain, erythema and induration at injection site. Any = occurrence of local adverse event regardless of intensity grade. Any erythema or induration at injection site is any symptom with a surface diameter greater than 25 millimeters. | The analysis is performed on Solicited Safety Set, which includes all enrolled subjects who received the study vaccine or placebo, with valid data on solicited AEs and with the Subject Diary completed. | Posted | Count of Participants | Participants | During the 7-day period after each vaccination (vaccine/placebo administered at Day 1 and Day 29) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any Solicited Systemic AEs | Solicited systemic AEs include: arthralgia, chills, fatigue, headache, malaise, myalgia, fever (oral temperature ≥ 38.0°C). Any = occurrence of systemic adverse event regardless of intensity and relation to study vaccination. | The analysis is performed on Solicited Safety Set, which includes all enrolled subjects who received the study vaccine or placebo, with valid data on solicited AEs and with the Subject Diary completed. | Posted | Count of Participants | Participants | During the 7-day period after each vaccination (vaccine/placebo administered at Day 1 and Day 29) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any Unsolicited AEs During the 28-day Post-vaccination Period | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination. | The analysis is performed on the Unsolicited Safety Set, which includes all enrolled subjects who received the study vaccine or placebo, with unsolicited AE data. | Posted | Count of Participants | Participants | During the 28-day period across doses (vaccine/placebo administered at Day 1 and Day 29) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any Unsolicited AEs During the 28-day Follow-up Period After Challenge | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination and/or challenge agent administration. | The analysis is performed on the Unsolicited Safety Set, which includes all enrolled subjects who received the study vaccine or placebo, and the challenge agent administration, and with unsolicited AE data. | Posted | Count of Participants | Participants | During the 28-day follow-up period after challenge (challenge administered at Day 57) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any Serious Adverse Events (SAEs) and Related SAEs | Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs = SAEs assessed by the investigator as related to the study vaccination and/or challenge agent administration. | The analysis is performed on the Overall Safety Set, which includes all enrolled subjects who received the study vaccine or placebo, and who are in the Solicited Safety Set and/or Unsolicited Safety Set. | Posted | Count of Participants | Participants | From Day 1 up to study end at Day 237 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any Adverse Events of Special Interest (AESI) (i.e., Symptomatic Neutropenia) | AESI are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it. | The analysis is performed on the Overall Safety Set, which includes all enrolled subjects who received the study vaccine or placebo, and who are in the Solicited Safety Set and/or Unsolicited Safety Set. | Posted | Count of Participants | Participants | From Day 1 up to study end at Day 237 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges | Among hematological parameters assessed are: Basophils, Eosinophils, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets. Below = below the normal laboratory range defined for the specified laboratory parameter; Above = above the normal laboratory range defined for the specified laboratory parameter; Within = within the normal laboratory range defined for the specified laboratory parameter. Category naming has been defined as follows: Parameter, time point, range indicator at Baseline, range indicator at the specified time point: e.g.: "Basophils, Day 8, Within, Within ". Note: All subjects whose neutrophil value was below the threshold defined in the Protocol, at any time during the study, were re-tested until neutropenia resolution. | The analysis is performed on the Exposed Set, which includes all enrolled subjects who received the study vaccination and with laboratory data for the specified time points. | Posted | Count of Participants | Participants | At Day 8, at Day 36 and at Day 237 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Anti-S. Sonnei Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Antibody Concentrations at Pre-vaccination and After the First and Second Vaccination | Anti-S. sonnei LPS IgG antibody concentrations are presented as geometric mean concentrations (GMCs), determined by Enzyme-linked immunosorbent assay (ELISA) and expressed in ELISA units per milliliter (EU/mL). Note: regarding the "28 days after second vaccination" protocol timing, sample collection could have been performed either at Day 56 or at Day 57. For all the subjects, samples were collected at Day 56, and therefore, results are presented for "Day 56 (27 days after the second vaccination)" timing. | The analysis is performed on the Per protocol Set for immunogenicity, which includes all subjects who correctly received the study vaccine or placebo, have no protocol deviations leading to exclusion and provide post-vaccination immunogenicity data at the specified time points. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | At Day 1 (pre-vaccination), at Day 8 (7 days after the first vaccination), at Day 29 (28 days after the first vaccination), at Day 36 (7 days after the second vaccination) and at Day 56 (27 days after the second vaccination) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Anti-S. Sonnei LPS IgG Antibody Concentrations at Pre-challenge and After Challenge | Anti-S. sonnei LPS IgG antibody concentrations are presented as GMCs, as determined by ELISA and expressed in EU/mL. Note: regarding the "28 days after second vaccination" protocol timing, sample collection could have been performed either at Day 56 or at Day 57. For all the subjects, samples were collected at Day 56, and therefore, results are presented for "Day 56 (27 days after the second vaccination)" timing. | The analysis is performed on the Per protocol Set for immunogenicity, which includes all subjects who correctly received the study vaccine or placebo and challenge agent, have no protocol deviations leading to exclusion and provide post-vaccination immunogenicity data at the specified time points. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | At Day 56 (pre-challenge), at Day 64 (7 days after challenge) and at Day 85 (28 days after challenge) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Achieving a Post-vaccination Anti-S. Sonnei LPS Concentration ≥ 268 EU/mL | This antibody response cut-off was based on the results of the previous Phase I studies and estimated results of the median antibody titer after natural infection by S. sonnei. The threshold 121 EU/mL planned per protocol has been recalibrated to 268 EU/mL following an investigation of reliability of the ELISA assay. Note: regarding the "28 days after second vaccination" protocol timing, sample collection could have been performed either at Day 56 or at Day 57. For all the subjects, samples were collected at Day 56, and therefore, results are presented for "Day 56 (27 days after the second vaccination)" timing. | The analysis is performed on the Per protocol Set for immunogenicity, which includes all subjects who correctly received the study vaccine or placebo, have no protocol deviations leading to exclusion and provide post-vaccination immunogenicity data at the specified time points. | Posted | Count of Participants | Participants | At Day 29 (28 days after the first vaccination) and at Day 56 (27 days after the second vaccination) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Seroresponders for Anti-S. Sonnei LPS | Seroresponse definition as reported in the protocol was assay specific and specifically related to assay, as run in Marburg Lab for the previous GVGH Shigella studies. This assay was further characterized and optimized before being used in GVGH for the current Phase 2b study. Since the assay used in current study is not comparable with the assay used in previous GVGH studies, the seroresponse definition is no longer appropriate (as it is valid only for Marburg assay). With the acknowledgment that seroresponse results are no longer meaningful, the study team choose to report the results for transparency. Note: regarding the "28 days after second vaccination" protocol timing, sample collection could have been performed either at Day 56 or at Day 57. For all the subjects, samples were collected at Day 56, and therefore, results are presented for "Day 56 (27 days after the second vaccination" timing. | The analysis is performed on the Per protocol Set for immunogenicity, which includes all subjects who correctly received the study vaccine or placebo, have no protocol deviations leading to exclusion and provide post-vaccination immunogenicity data at the specified time points. | Posted | Count of Participants | Participants | At Day 29 (28 days after the first vaccination) and at Day 56 (27 days after the second vaccination) |
|
Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237.
Not provided
Not provided
| 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 Group | Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally. | 0 | 36 | 0 | 36 | 34 | 36 |
| EG001 | Placebo Group | Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally. | 0 | 35 | 1 | 35 | 33 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Carotid artery aneurysm | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymph node pain | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Ear congestion | Ear and labyrinth disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Induration | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Anal injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Burns third degree | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 22.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 3, 2019 | Apr 30, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D004405 | Dysentery, Bacillary |
| ID | Term |
|---|---|
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D004403 | Dysentery |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| Male |
|
| OTHER - UNSPECIFIED |
|
| WHITE |
|
VE in reduction of shigellosis is demonstrated if lower limit (LL) of 90% CI of VE estimated with Miettinen-Nurminen (M-N) method is above 0. This estimated CI was complemented with Barnard test. The LL of the 90% CI for VE calculated with M-N method is above 0 if the p-value of the one-sided Barnard test is below 5%.
| OG001 | Placebo Group | Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally. |
|
|
|
|
|
|
| OG001 | Placebo Group | Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Placebo Group |
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally. |
|
|
| OG001 | Placebo Group | Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally. |
|
|
|
|
| Placebo Group |
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally. |
|
|
| OG001 | Placebo Group | Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally. |
|
|