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| Name | Class |
|---|---|
| Emergent BioSolutions | INDUSTRY |
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The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.
The primary goal of this Phase III study is to compare three lots for consistency of manufacture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PXVX0200 Lot A | Experimental | PXVX0200 (Lot P700-1CA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension |
|
| PXVX0200 Lot B | Experimental | PXVX0200 (Lot P700-3CA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension |
|
| PXVX0200 Lot C | Experimental | PXVX0200 (Lot P700-6BA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension |
|
| Placebo | Placebo Comparator | Placebo physiological saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PXVX0200 Lot A | Biological | Lot P700-1CA03 |
| |
| PXVX0200 Lot B |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B | The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5. Placebo GMT values were not included in the primary analysis. | Day 11 |
| Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots B and C | The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5. | Day 11 |
| Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and C | The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5. |
| Measure | Description | Time Frame |
|---|---|---|
| SVA Seroconversion at Day 11 | Percentage of subjects who demonstrated a ≥4-fold rise over baseline in serum vibriocidal antibody (SVA) at Day 11 | Day 11 |
| SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James McCarty, MD | Emergent Travel Health Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Clinical Research | Mobile | Alabama | 36608 | United States | ||
| Clinical Reseach Consortium Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29317118 | Result | McCarty JM, Lock MD, Hunt KM, Simon JK, Gurwith M. Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR in healthy adults age 18-45. Vaccine. 2018 Feb 1;36(6):833-840. doi: 10.1016/j.vaccine.2017.12.062. Epub 2018 Jan 6. |
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Following assignment to either receive PXVX0200 or placebo, subjects in the PXVX0200 arm were randomized to receive Lot A, B or C. Subjects in each of these Arms/Groups add up to the number of subjects in the PXVX0200 (Lot A, B and C) Arm/Group.
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| ID | Title | Description |
|---|---|---|
| FG000 | PXVX0200 Lot A | PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension |
| FG001 | PXVX0200 Lot B | PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Biological |
Lot P700-3CA03 |
|
| PXVX0200 Lot C | Biological | Lot P700-6BA03 |
|
| Placebo | Biological | Placebo |
|
| Day 11 |
GMTs of vibriocidal antibody and anti-CT IgG concentrations at Days 1, 11, 29, 91, and 181.
| Day 1 - 181 |
| SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181 | Proportion of subjects who demonstrated a ≥4-fold rise over baseline in vibriocidal antibody and anti-CT IgG concentration from baseline at Days 1, 11, 29, 91, and 181. Day 1 not reported as seroconversion on Day 1 not applicable. | Day 1 - 181 |
| Adverse Events | Incidence and severity of signs and symptoms of reactogenicity such as diarrhea, fever & vomiting were collected from Day 1 - 8. Incidence and severity of unsolicited adverse events were collected till Day 29. | Day 1 - 29 |
| Phoenix |
| Arizona |
| 85004 |
| United States |
| Avail Clinical Research | DeLand | Florida | 32720 | United States |
| Miami Research Associates | Miami | Florida | 33143 | United States |
| Palm Beach Research | West Palm Beach | Florida | 33409 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Johnson County Clin-Trials | Lenexa | Kansas | 66219 | United States |
| Heartland Research Associates | Wichita | Kansas | 67207 | United States |
| Central Kentucky Research | Lexington | Kentucky | 40509 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Boston University | Boston | Massachusetts | 02218 | United States |
| Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | United States |
| St. Louis University | St Louis | Missouri | 63104 | United States |
| Clinical Research Consortium Las Vegas | Las Vegas | Nevada | 89119 | United States |
| Rochester Clinical Research | Rochester | New York | 14609 | United States |
| Lion Research | Norman | Oklahoma | 73069 | United States |
| Coastal Carolina Research | Mt. Pleasant | South Carolina | 29464 | United States |
| Research Across America | Dallas | Texas | 75234 | United States |
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
| QIMR Berghofer Medical Research Institiue | Herston | Queensland | 4006 | Australia |
| AUS Trials Pty Ltd | Sherwood | Queensland | 4035 | Australia |
| CMAX | Adelaide | South Australia | 5000 | Australia |
| Emeritis Research | Malvern East | Victoria | 3145 | Australia |
| Nucleus Network | Melbourne | Victoria | 3004 | Australia |
| Linear Clinical Research | Nedlands | Western Australia | 6009 | Australia |
| FG002 | PXVX0200 Lot C | PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension |
| FG003 | Placebo | Placebo physiological saline Placebo |
| COMPLETED | Study Completion (Day 181) - Completion of study is based upon the Study Completion/Early Term eCRF |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PXVX0200 Lot A | PXVX0200 (Lot P700-1CA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension |
| BG001 | PXVX0200 Lot B | PXVX0200 (Lot P700-3CA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension |
| BG002 | PXVX0200 Lot C | PXVX0200 (Lot P700-6BA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension |
| BG003 | Placebo | Placebo physiological saline |
| BG004 | 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, Categorical | Count of Participants | 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 |
|
| 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 | Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B | The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5. Placebo GMT values were not included in the primary analysis. | The Immunogenicity Evaluable Population (IEP) comprises all randomized subjects who had evaluable vibriocidal antibody results from Day 11 and had no major protocol violations that affected immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Titer | Day 11 |
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| Secondary | SVA Seroconversion at Day 11 | Percentage of subjects who demonstrated a ≥4-fold rise over baseline in serum vibriocidal antibody (SVA) at Day 11 | IEP - comprises all randomized subjects who had evaluable vibriocidal antibody results from Day 11 and had no major protocol violations that affected immunogenicity | Posted | Number | 95% Confidence Interval | % of participants | Day 11 |
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| Secondary | SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | GMTs of vibriocidal antibody and anti-CT IgG concentrations at Days 1, 11, 29, 91, and 181. | The subgroup examining long-term and specific functional immunogenicity was formed to examine specific behavior of Vaxchora based a smaller total sample size than the total study due to the complexity of the assays needed for the endpoints. As such, an analysis by lot would have rendered any examination severely underpowered and was not necessary due to the objective to examine Vaxchora vs placebo rather than the affect of lot on those endpoints. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 1 - 181 |
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| Secondary | SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181 | Proportion of subjects who demonstrated a ≥4-fold rise over baseline in vibriocidal antibody and anti-CT IgG concentration from baseline at Days 1, 11, 29, 91, and 181. Day 1 not reported as seroconversion on Day 1 not applicable. | The subgroup examining long-term and specific functional immunogenicity was formed to examine specific behavior of Vaxchora based a smaller total sample size than the total study due to the complexity of the assays needed for the endpoints. As such, an analysis by lot would have rendered any examination severely underpowered and was not necessary due to the objective to examine Vaxchora vs placebo rather than the affect of lot on those endpoints. | Posted | Number | 95% Confidence Interval | % of participants | Day 1 - 181 |
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| Secondary | Adverse Events | Incidence and severity of signs and symptoms of reactogenicity such as diarrhea, fever & vomiting were collected from Day 1 - 8. Incidence and severity of unsolicited adverse events were collected till Day 29. | Safety population - the population of randomized subjects who received study treatment and was analyzed according to the treatment actually received. | Posted | Number | % of participants | Day 1 - 29 |
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| Primary | Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots B and C | The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5. | The Immunogenicity Evaluable Population (IEP) comprises all randomized subjects who had evaluable vibriocidal antibody results from Day 11 and had no major protocol violations that affected immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Titer | Day 11 |
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| Primary | Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and C | The primary analysis consisted of three between-lot equivalence tests of serum vibriocidal antibody titer measured at Day 11. The GMT of each lot - µA, µB, and µC - was calculated by first log-transforming (base 10) the serum vibriocidal antibody titers, computing the means of the transformed data by lot, and then exponentiating the log-scale means to return to the original, untransformed scale. The resulting GMTs were combined to form three geometric mean ratios: µA/µB, µA/µC, and µB/µC.The ratios were required to be within +/- 50% of each other lot with 95% confidence, which implied that the limits of the 95% confidence interval on each pairwise GMR had to be within 0.67 - 1.5. | The Immunogenicity Evaluable Population (IEP) comprises all randomized subjects who had evaluable vibriocidal antibody results from Day 11 and had no major protocol violations that affected immunogenicity. | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Titer | Day 11 |
|
Unsolicited AEs, serious adverse events (SAEs), medically attended events, and new onset of chronic medical conditions were assessed for 180 days post-vaccination.
Totals presented are the number of subjects with at least one AE. Analysis of all cause mortality, SAEs and other serious events were performed for the safety population (N=2789) and not the randomized population. Only the SAEs were analyzed per lot while the analysis for the AEs was not completed for subjects that received each lot. This covers the entire safety of Vaxchora to provide the overall profile. The larger sample size afforded better estimates of risk for the observed events.
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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 | PXVX0200 Lot A | PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension | 1 | 926 | 7 | 926 | 0 | 0 |
| EG001 | PXVX0200 Lot B | PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension | 0 | 928 | 9 | 928 | 0 | 0 |
| EG002 | PXVX0200 Lot C | PXVX0200 Single dose; liquid suspension after reconstitution with buffer; 1x10^9 CFU in a liquid suspension | 0 | 935 | 4 | 935 | 0 | 0 |
| EG003 | All PXVX0200 Lots | All PXVX0200 Lots | 1 | 2,789 | 20 | 2,789 | 290 | 2,789 |
| EG004 | Placebo | Placebo physiological saline | 0 | 350 | 3 | 350 | 33 | 350 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Kidney Infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Jaw Fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Patella Fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Stress Fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Completed Suicide | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Cassie, Scientist, Clinical Research | Emergent BioSolutions Canada Inc. | 204-275-4589 | dcassie@ebsi.com |
| ID | Term |
|---|---|
| D002771 | Cholera |
| ID | Term |
|---|---|
| D014735 | Vibrio Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Australia |
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| Units | Counts |
|---|---|
| Participants |
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| OG004 | Placebo | Placebo physiological saline Placebo |
|
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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