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| Name | Class |
|---|---|
| Emergent BioSolutions | INDUSTRY |
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VAXCHORA (Cholera Vaccine, Live, Oral) is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1. VAXCHORA is approved for use in adults 18 through 64 years of age travelling to cholera-affected areas. The primary goals of this Phase 4 study are to evaluate the safety and immunogenicity of a single dose of VAXCHORA (1 x 10e9 cfu/dose) in children ages 2 years to <18 years of age in developed countries.
This is a randomized, placebo-controlled, double-blind, single-crossover study with three age cohorts and two treatment groups within each cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (active, 12-17 yrs) | Experimental | Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730. |
|
| Cohort 1 (placebo, 12 - 17 yrs) | Placebo Comparator | Subjects aged 12 - 17 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181. |
|
| Cohort 2 (active, 6 - 11 yrs) | Experimental | Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. |
|
| Cohort 2 (placebo, 6 - 11 yrs) | Placebo Comparator | Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181. |
|
| Cohort 3 (active, 2 - 5 yrs) | Experimental | Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VAXCHORA (Cholera Vaccine, Live, Oral) | Biological | VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR. |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1 (12-17 Yrs) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae | The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer | Day 11 |
| Cohort 2 (6 to <12 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae | The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer. | Day 11 |
| Cohort 3 (2 to <6 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae | The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer. | Day 11 |
| Cohort 1 (12-17 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years | The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years. | Day 11 |
| Cohort 2 (6-11 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 29 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects | Day 29 |
| Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 91 |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 1 | Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 1 for the subjects in the active treatment group and the placebo crossover group | Day 1 |
| Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 91 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Andre de Lame, MD | Emergent BioSolutions | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States | ||
| Johnson County Clin-Trials, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31769402 | Derived | McCarty JM, Gierman EC, Bedell L, Lock MD, Bennett S. Safety and Immunogenicity of Live Oral Cholera Vaccine CVD 103-HgR in Children and Adolescents Aged 6-17 Years. Am J Trop Med Hyg. 2020 Jan;102(1):48-57. doi: 10.4269/ajtmh.19-0241. |
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This study included healthy volunteers (2 - 17 years) who were not previously immunized against cholera. A total of 574 subjects were screened, of which 24 were screen failures. A total of 550 subjects randomized, of which 471 received study treatment and 506 and 62 completed the main and sub studies, respectively. Recruitment July 2017-July 2018.
The historical control subjects are not included in the protocol enrollment number for PXVX-VC-200-006. They are solely a comparator population.
This study included healthy volunteers (2 - 17 years) who were not previously immunized against cholera. A total of 574 subjects were screened, of which 24 were screen failures. A total of 550 subjects randomized, of which 471 received study treatment and 433 and 73 completed the main study for treatment and placebo, respectively. Recruitment July 2017-July 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (Active, 12-17 Yrs) | Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730. VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR. |
| FG001 | Cohort 1 (Placebo, 12 - 17 Yrs) | Subjects aged 12 - 17 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181. Placebo: Placebo control for this study is normal (0.9%) saline. |
| FG002 | Cohort 2 (Active, 6 - 11 Yrs) | Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR. |
| FG003 | Cohort 2 (Placebo, 6 - 11 Yrs) | Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181. Placebo: Placebo control for this study is normal (0.9%) saline. |
| FG004 | Cohort 3 (Active, 2 - 5 Yrs) | Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR. |
| FG005 | Cohort 3 (Placebo, 2 - 5 Yrs) | Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181. Placebo: Placebo control for this study is normal (0.9%) saline. |
| FG006 | Historical Control: Adult Bridging Population | This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-006 as a comparator bridging population for the Day 11 seroconversion. NCT02094586 PubMed ID:29317118 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Study (Day 1 - 181) |
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| ||||||||||||||||||
| Placebo Crossover (Day 181-365) |
| |||||||||||||||||||
| Long-term Follow-up (Day 365-730) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 (Active, 12-17 Yrs) | Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730. VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cohort 1 (12-17 Yrs) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae | The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer | Immunogenicity Evaluable Population (IEP) | Posted | Number | 98.3% Confidence Interval | percentage of participants | Day 11 |
|
All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.
The Historical Control population is not included in this section as comparisons between the pediatric and adult populations were not specified to be conducted in the protocol.
The data below is not for randomized subjects, but for those included in the safety population.
For cohort 1, 2 subjects received Vaxchora instead of placebo; the subject count is 165 Vaxchora : 24 placebo.
For cohort 2, 1 subject received Vaxchora instead of placebo; the subject count is 157 Vaxchora : 25 placebo.
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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 | Cohort 1 (Active, 12-17 Yrs) | Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730. VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment | Solicited Day 1 - 8 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Cassie, Scientist, Clinical Research | Emergent BioSolutions Canada Inc. | 204-275-4589 | dcassie@ebsi.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 | Nov 15, 2017 | Sep 8, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 28, 2017 | Sep 8, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002771 | Cholera |
| ID | Term |
|---|---|
| D014735 | Vibrio Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C000613802 | Vaxchora |
| D022121 | Cholera Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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This is a randomized, placebo-controlled, double-blind, single-crossover study with three age cohorts and two treatment groups within each cohort.
The main study consists of a screening period of 30 days, a treatment period from Day 1 to Day 29, and a follow-up period through Day 181. Cohort 1 has an optional sub-study consisting of a long-term follow-up period through Day 730.
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The study will be conducted as a double-blind study through 181, where neither the sponsor, the statistical team, study volunteer subjects, nor clinical site personnel (except for the unblinded administration staff) will know subjects' treatment assignment. Once each subject has reached their Day 181 visit they will be individually unblinded.
|
| Cohort 3 (placebo, 2 - 5 yrs) | Placebo Comparator | Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181. |
|
| Historical Control: Adult Bridging Population | Other | This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-006 as a comparator bridging population for the Day 11 seroconversion. NCT02094586 PubMed ID:29317118 |
|
| Placebo | Other | Placebo control for this study is normal (0.9%) saline. |
|
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
| Day 11 |
| Cohort 3 (2-5 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years | The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of18 and 45 years. | Day 11 |
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 91 for all subjects
| Day 91 |
| Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 181 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 181 for all subjects | Day 181 |
| Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 365 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 365 for all subjects | Day 365 |
| Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 547 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 547 for all subjects | Day 547 |
| Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 730 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 730 for all subjects | Day 730 |
| Cohort 2 (6 to <12 Years) - Seroconversion of SVA - Day 29 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects | Day 29 |
| Cohort 3 (2 to <6 Years) - Seroconversion of SVA - Day 29 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects | Day 29 |
Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 91 for the subjects in the active treatment group and the placebo crossover group |
| Day 91 |
| Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 181 | Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 181 for the subjects in the active treatment group and the placebo crossover group | Day 181 |
| Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 365 | Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 365 for the subjects in the active treatment group who participate in the substudy. | Day 365 |
| Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 547 | Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 547 for the subjects in the active treatment group who participate in the substudy. | Day 547 |
| Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 730 | Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 730 for the subjects in the active treatment group who participate in the substudy. | Day 730 |
| Safety - Solicited Adverse Events | Evaluate the safety and tolerability of VAXCHORA by collecting solicited adverse events (abdominal pain, headache, lack of appetite, tiredness, diarrhea, nausea, vomiting and fever) by age cohort and overall through Day 8 | Through Day 8 |
| Safety - Unsolicited Adverse Events | Evaluate the safety and tolerability of VAXCHORA by collecting unsolicited adverse events by age cohort and overall through Day 29 | Through Day 29 |
| Safety - Serious Adverse Events | Evaluate the safety and tolerability of VAXCHORA by collecting serious adverse events by age cohort and overall through Day 181 | Through Day 181 |
| Acceptability | Evaluate the acceptability of VAXCHORA using the percent of subjects in each age cohort able to complete the dosing according to protocol. | Day 1 |
| Lenexa |
| Kansas |
| 66219 |
| United States |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| The Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | United States |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | United States |
| Aventiv Research Inc. | Columbus | Ohio | 43123 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | United States |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Failed Exl 8 and randomized in error |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | Cohort 1 (Placebo, 12 - 17 Yrs) | Subjects aged 12 - 17 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181. Placebo: Placebo control for this study is normal (0.9%) saline. |
| BG002 | Cohort 2 (Active, 6 - 11 Yrs) | Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR. |
| BG003 | Cohort 2 (Placebo, 6 - 11 Yrs) | Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181. Placebo: Placebo control for this study is normal (0.9%) saline. |
| BG004 | Cohort 3 (Active, 2 - 5 Yrs) | Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR. |
| BG005 | Cohort 3 (Placebo, 2 - 5 Yrs) | Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181. Placebo: Placebo control for this study is normal (0.9%) saline. |
| BG006 | Historical Control: Adult Bridging Population | This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-006 as a comparator bridging population for the Day 11 seroconversion. NCT02094586, PubMed ID: 29317118 |
| BG007 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Cohort 1 (Placebo, 12-17 Yrs) | Subjects aged 12 - 17 were administered a 100 mL oral dose of placebo on Day 1, and had study visits on Day 11, 29, 91 and 181. |
|
|
|
| Primary | Cohort 2 (6 to <12 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae | The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer. | Immunogenicity Evaluable Population (IEP) | Posted | Number | 98.3% Confidence Interval | percentage of participants | Day 11 |
|
|
|
|
| Primary | Cohort 3 (2 to <6 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae | The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer. | Immunogenicity Evaluable Population (IEP) | Posted | Number | 98.3% Confidence Interval | percentage of participants | Day 11 |
|
|
|
|
| Primary | Cohort 1 (12-17 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years | The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years. | Immunogenicity Evaluable Population (IEP) | Posted | Number | 98.3% Confidence Interval | percentage of participants | Day 11 |
|
|
|
|
| Primary | Cohort 2 (6-11 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years | The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years. | Immunogenicity Evaluable Population (IEP) | Posted | Number | 98.3% Confidence Interval | percentage of participants | Day 11 |
|
|
|
|
| Primary | Cohort 3 (2-5 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years | The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of18 and 45 years. | Immunogenicity Evaluable Population (IEP) | Posted | Number | 98.3% Confidence Interval | percentage of participants | Day 11 |
|
|
|
|
| Secondary | Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 29 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects | Immunogenicity Evaluable Population (IEP) | Posted | Number | 95% Confidence Interval | percentage of participants | Day 29 |
|
|
|
|
| Secondary | Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 91 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 91 for all subjects | Immunogenicity Evaluable Population (IEP) | Posted | Number | 95% Confidence Interval | percentage of participants | Day 91 |
|
|
|
|
| Secondary | Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 181 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 181 for all subjects | Immunogenicity Evaluable Population (IEP) | Posted | Number | 95% Confidence Interval | percentage of participants | Day 181 |
|
|
|
|
| Secondary | Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 365 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 365 for all subjects | Immunogenicity Evaluable Population (IEP) | Posted | Number | 95% Confidence Interval | percentage of participants | Day 365 |
|
|
|
| Secondary | Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 547 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 547 for all subjects | Immunogenicity Evaluable Population (IEP) | Posted | Number | 95% Confidence Interval | percentage of participants | Day 547 |
|
|
|
| Secondary | Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 730 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 730 for all subjects | Immunogenicity Evaluable Population (IEP) | Posted | Number | 95% Confidence Interval | percentage of participants | Day 730 |
|
|
|
| Secondary | Cohort 2 (6 to <12 Years) - Seroconversion of SVA - Day 29 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects | Immunogenicity Evaluable Population (IEP) | Posted | Number | 95% Confidence Interval | percentage of participants | Day 29 |
|
|
|
|
| Secondary | Cohort 3 (2 to <6 Years) - Seroconversion of SVA - Day 29 | Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects | Immunogenicity Evaluable Population (IEP) | Posted | Number | 95% Confidence Interval | percentage of participants | Day 29 |
|
|
|
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| Other Pre-specified | Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 1 | Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 1 for the subjects in the active treatment group and the placebo crossover group | Not Posted | Day 1 | Participants |
| Other Pre-specified | Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 91 | Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 91 for the subjects in the active treatment group and the placebo crossover group | Not Posted | Day 91 | Participants |
| Other Pre-specified | Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 181 | Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 181 for the subjects in the active treatment group and the placebo crossover group | Not Posted | Day 181 | Participants |
| Other Pre-specified | Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 365 | Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 365 for the subjects in the active treatment group who participate in the substudy. | Not Posted | Day 365 | Participants |
| Other Pre-specified | Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 547 | Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 547 for the subjects in the active treatment group who participate in the substudy. | Not Posted | Day 547 | Participants |
| Other Pre-specified | Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 730 | Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 730 for the subjects in the active treatment group who participate in the substudy. | Not Posted | Day 730 | Participants |
| Other Pre-specified | Safety - Solicited Adverse Events | Evaluate the safety and tolerability of VAXCHORA by collecting solicited adverse events (abdominal pain, headache, lack of appetite, tiredness, diarrhea, nausea, vomiting and fever) by age cohort and overall through Day 8 | Not Posted | Through Day 8 | Participants |
| Other Pre-specified | Safety - Unsolicited Adverse Events | Evaluate the safety and tolerability of VAXCHORA by collecting unsolicited adverse events by age cohort and overall through Day 29 | Not Posted | Through Day 29 | Participants |
| Other Pre-specified | Safety - Serious Adverse Events | Evaluate the safety and tolerability of VAXCHORA by collecting serious adverse events by age cohort and overall through Day 181 | Not Posted | Through Day 181 | Participants |
| Other Pre-specified | Acceptability | Evaluate the acceptability of VAXCHORA using the percent of subjects in each age cohort able to complete the dosing according to protocol. | The data presented is for the population that was randomized and received treatment. For Cohort 2, 2 Vaxchora subjects and 1 placebo subject were randomized, but not treated. For Cohort 3, 4 Vaxchora subjects were randomized, but not treated. | Posted | Number | percent of participants | Day 1 |
|
|
|
| 0 |
| 165 |
| 4 |
| 165 |
| 116 |
| 165 |
| EG001 | Cohort 1 (Placebo, 12 - 17 Yrs) | Subjects aged 12 - 17 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181. Placebo: Placebo control for this study is normal (0.9%) saline. | 0 | 24 | 0 | 24 | 13 | 24 |
| EG002 | Cohort 2 (Active, 6 - 11 Yrs) | Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR. | 0 | 157 | 0 | 157 | 93 | 157 |
| EG003 | Cohort 2 (Placebo, 6 - 11 Yrs) | Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181. Placebo: Placebo control for this study is normal (0.9%) saline. | 0 | 25 | 0 | 25 | 15 | 25 |
| EG004 | Cohort 3 (Active, 2 - 5 Yrs) | Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. VAXCHORA (Cholera Vaccine, Live, Oral): VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR. | 0 | 146 | 0 | 146 | 74 | 146 |
| EG005 | Cohort 3 (Placebo, 2 - 5 Yrs) | Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181. Placebo: Placebo control for this study is normal (0.9%) saline. | 0 | 26 | 1 | 26 | 12 | 26 |
| Intentional Overdose | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Local Swelling | General disorders | MedDRA | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment | Solicited Day 1 - 8 |
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| Lack of Appetite | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment | Solicited Day 1 - 8 |
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| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment | Solicited Day 1 - 8 |
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| Diarrhea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment | Solicited Day 1 - 8 |
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| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment | Solicited Day 1 - 8 |
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| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment | Solicited Day 1 - 8 |
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| Fever | General disorders | MedDRA (15.0) | Systematic Assessment | Solicited Day 1 - 8 |
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| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment | Unsolicited Day 29 |
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| Lack of Appetite | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment | Unsolicited Day 29 |
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| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment | Unsolicited Day 29 |
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| Diarrhea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment | Unsolicited Day 29 |
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| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment | Unsolicited Day 29 |
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| Laceration | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment | Unsolicited Day 29 |
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| Joint Injury | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment | Unsolicited Day 29 |
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| Arthropod Bite | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment | Unsolicited Day 29 |
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| Vessel Puncture site pain | General disorders | MedDRA (15.0) | Systematic Assessment | Unsolicited Day 29 |
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| Insomnia | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment | Unsolicited Day 29 |
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| Loose Stool | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment | Unsolicited Day 29 |
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| Rectal Tenesmus | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment | Unsolicited Day 29 |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment | Unsolicited Day 29 |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment | Unsolicited Day 29 |
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| Furuncle | Infections and infestations | MedDRA (15.0) | Systematic Assessment | Unsolicited Day 29 |
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| Nasopharyngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment | Unsolicited Day 29 |
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| Otitis Media | Infections and infestations | MedDRA (15.0) | Systematic Assessment | Unsolicited Day 29 |
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| Ear Infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment | Unsolicited Day 29 |
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| Bronchitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment | Unsolicited Day 29 |
|
Not provided
| D007239 | Infections |