Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PXVX0200 Lot A · 1 trial · 1 indication
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 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 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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| PXVX0200 Lot A | BIOLOGICAL | Lot P700-1CA03 |
| PXVX0200 Lot B | BIOLOGICAL | Lot P700-3CA03 |
| PXVX0200 Lot C | BIOLOGICAL | Lot P700-6BA03 |
| Placebo | BIOLOGICAL | Placebo |
Inclusion Criteria: * healthy men or women, * age 18 to 45 years inclusive; * normal medical history and physical examination * Women must have a negative pregnancy test. Exclusion Criteria: * travel to a cholera endemic area in the previous 5 years; * abnormal stool pattern or regular use of lax...
PXVX0200 Lot A is an investigational live oral cholera vaccine being studied for the prevention of cholera, an infectious disease caused by Vibrio cholerae. It is currently in Phase 3 clinical development and has not been approved by the FDA.
PXVX0200 Lot A is being developed by Emergent BioSolutions Inc. (NYSE: EBS). The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in healthy adults.
PXVX0200 Lot A is in Phase 3 clinical development. It is an investigational vaccine and has not yet received regulatory approval. A Phase 3 study has been completed to assess lot-to-lot consistency in healthy adults.
PXVX0200 Lot A was evaluated in a Phase 3 trial with the identifier NCT02094586, titled 'A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults.' The study enrolled 3,146 participants in the United States and Australia and has been completed.
PXVX0200 Lot A is a specific lot of the live oral cholera vaccine PXVX0200. The Phase 3 study NCT02094586 was designed to compare different lots of PXVX0200 to ensure consistency in manufacturing and immune response.