Cholera
Conditions
Brief summary
The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.
Detailed description
The primary goal of this Phase III study is to compare three lots for consistency of manufacture.
Interventions
BIOLOGICALPXVX0200 Lot A
Lot P700-1CA03
BIOLOGICALPXVX0200 Lot B
Lot P700-3CA03
BIOLOGICALPXVX0200 Lot C
Lot P700-6BA03
BIOLOGICALPlacebo
Placebo
Sponsors
Emergent BioSolutions
Bavarian Nordic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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 laxatives; * Currently active unstable or undiagnosed medical conditions * current or recent antibiotic use; * pregnancy or nursing; * Previously received a licensed or investigational cholera vaccine * History of cholera or enterotoxigenic E. coli infection * History of Guillain-Barré Syndrome * Received or plans to receive any other licensed vaccines, except for seasonal influenza * Recipient of bone marrow or solid organ transplant * Malignancy (excluding non-melanotic skin cancers) or lymphoproliferative disorders diagnosed or treated during the past 5 years * Use of systemic chemotherapy in the previous 5 years prior to the study * any immunosuppressive medical condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B | Day 11 | 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. |
| Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots B and C | Day 11 | 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. |
| Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and C | Day 11 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SVA Seroconversion at Day 11 | Day 11 | Percentage of subjects who demonstrated a ≥4-fold rise over baseline in serum vibriocidal antibody (SVA) at Day 11 |
| Adverse Events | Day 1 - 29 | 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. |
| SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | Day 1 - 181 | GMTs of vibriocidal antibody and anti-CT IgG concentrations at Days 1, 11, 29, 91, and 181. |
| SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181 | Day 1 - 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. |
Countries
Australia, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| PXVX0200 Lot A PXVX0200 (Lot P700-1CA03) Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension | 927 |
| PXVX0200 Lot B PXVX0200 (Lot P700-3CA03) Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension | 933 |
| PXVX0200 Lot C PXVX0200 (Lot P700-6BA03) Single dose; liquid suspension after reconstitution with buffer; \> 2x10\^8 CFU in a liquid suspension | 935 |
| Placebo Placebo physiological saline | 351 |
| Total | 3,146 |
Baseline characteristics
| Characteristic | PXVX0200 Lot A | PXVX0200 Lot B | PXVX0200 Lot C | Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical Between 18 and 45 years inclusive <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 45 years inclusive >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 45 years inclusive Between 18 and 65 years | 927 Participants | 933 Participants | 935 Participants | 351 Participants | 3146 Participants |
| Age, Continuous | 29.8 years STANDARD_DEVIATION 7.78 | 29.9 years STANDARD_DEVIATION 7.54 | 30.2 years STANDARD_DEVIATION 7.72 | 29.5 years STANDARD_DEVIATION 7.54 | 29.9 years STANDARD_DEVIATION 7.76 |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 5 Participants | 2 Participants | 1 Participants | 13 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 27 Participants | 19 Participants | 5 Participants | 64 Participants |
| Race (NIH/OMB) Black or African American | 222 Participants | 238 Participants | 231 Participants | 115 Participants | 806 Participants |
| Race (NIH/OMB) More than one race | 20 Participants | 20 Participants | 14 Participants | 7 Participants | 61 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 2 Participants | 3 Participants | 1 Participants | 9 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 15 Participants | 11 Participants | 4 Participants | 45 Participants |
| Race (NIH/OMB) White | 649 Participants | 626 Participants | 655 Participants | 218 Participants | 2148 Participants |
| Region of Enrollment Australia | 118 Participants | 128 Participants | 118 Participants | 51 Participants | 415 Participants |
| Region of Enrollment United States | 809 Participants | 805 Participants | 817 Participants | 300 Participants | 2731 Participants |
| Sex: Female, Male Female | 510 Participants | 503 Participants | 514 Participants | 155 Participants | 1682 Participants |
| Sex: Female, Male Male | 417 Participants | 430 Participants | 421 Participants | 196 Participants | 1464 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 926 | 0 / 928 | 0 / 935 | 1 / 2,789 | 0 / 350 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 290 / 2,789 | 33 / 350 |
| serious Total, serious adverse events | 7 / 926 | 9 / 928 | 4 / 935 | 20 / 2,789 | 3 / 350 |
Outcome results
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.
Time frame: Day 11
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PXVX0200 Lot A | Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B | 9220 Geometric Mean Titer |
| PXVX0200 Lot B | Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B | 10034 Geometric Mean Titer |
Comparison: Lot A vs. Lot B95% CI: [0.78, 1.08]
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.
Time frame: Day 11
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PXVX0200 Lot A | Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and C | 9220 Geometric Mean Titer |
| PXVX0200 Lot B | Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and C | 9827 Geometric Mean Titer |
Comparison: Lot A vs. Lot C95% CI: [0.8, 1.1]
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.
Time frame: Day 11
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PXVX0200 Lot A | Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots B and C | 10034 Geometric Mean Titer |
| PXVX0200 Lot B | Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots B and C | 9827 Geometric Mean Titer |
Comparison: Lot B vs Lot C95% CI: [0.87, 1.2]
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.
Time frame: Day 1 - 29
Population: Safety population - the population of randomized subjects who received study treatment and was analyzed according to the treatment actually received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PXVX0200 Lot A | Adverse Events | % of Subjects with Nausea/Vomiting | 18.03 % of participants |
| PXVX0200 Lot A | Adverse Events | % of Subjects with any Reactogenicity | 52.99 % of participants |
| PXVX0200 Lot A | Adverse Events | % of Subjects with Headache | 30.09 % of participants |
| PXVX0200 Lot A | Adverse Events | % of Subjects with Diarrhea Symptoms | 4.31 % of participants |
| PXVX0200 Lot A | Adverse Events | % of Subjects with Fever Symptoms | 0.77 % of participants |
| PXVX0200 Lot B | Adverse Events | % of Subjects with Nausea/Vomiting | 18.94 % of participants |
| PXVX0200 Lot B | Adverse Events | % of Subjects with Fever Symptoms | 0.77 % of participants |
| PXVX0200 Lot B | Adverse Events | % of Subjects with Diarrhea Symptoms | 3.96 % of participants |
| PXVX0200 Lot B | Adverse Events | % of Subjects with Headache | 26.43 % of participants |
| PXVX0200 Lot B | Adverse Events | % of Subjects with any Reactogenicity | 50.44 % of participants |
| PXVX0200 Lot C | Adverse Events | % of Subjects with Fever Symptoms | 0.33 % of participants |
| PXVX0200 Lot C | Adverse Events | % of Subjects with any Reactogenicity | 52.28 % of participants |
| PXVX0200 Lot C | Adverse Events | % of Subjects with Diarrhea Symptoms | 3.36 % of participants |
| PXVX0200 Lot C | Adverse Events | % of Subjects with Nausea/Vomiting | 18.00 % of participants |
| PXVX0200 Lot C | Adverse Events | % of Subjects with Headache | 30.26 % of participants |
| Placebo | Adverse Events | % of Subjects with Headache | 28.93 % of participants |
| Placebo | Adverse Events | % of Subjects with any Reactogenicity | 51.90 % of participants |
| Placebo | Adverse Events | % of Subjects with Nausea/Vomiting | 18.32 % of participants |
| Placebo | Adverse Events | % of Subjects with Fever Symptoms | 0.62 % of participants |
| Placebo | Adverse Events | % of Subjects with Diarrhea Symptoms | 3.88 % of participants |
| Placebo | Adverse Events | % of Subjects with Fever Symptoms | 1.17 % of participants |
| Placebo | Adverse Events | % of Subjects with Nausea/Vomiting | 15.16 % of participants |
| Placebo | Adverse Events | % of Subjects with any Reactogenicity | 43.15 % of participants |
| Placebo | Adverse Events | % of Subjects with Headache | 23.62 % of participants |
| Placebo | Adverse Events | % of Subjects with Diarrhea Symptoms | 1.17 % of participants |
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.
Time frame: Day 1 - 181
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| PXVX0200 Lot A | SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | SVA GMT at Day 29 | 6170 Titer |
| PXVX0200 Lot A | SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | Anti-CT IgG GMT at Day 1 | 445 Titer |
| PXVX0200 Lot A | SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | SVA GMT at Day 11 | 9922 Titer |
| PXVX0200 Lot A | SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | Anti-CT IgG GMT at Day 11 | 1780 Titer |
| PXVX0200 Lot A | SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | SVA GMT at Day 91 | 560 Titer |
| PXVX0200 Lot A | SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | Anti-CT IgG GMT at Day 29 | 2007 Titer |
| PXVX0200 Lot A | SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | SVA GMT at Day 1 | 91 Titer |
| PXVX0200 Lot A | SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | Anti-CT IgG GMT at Day 91 | 1276 Titer |
| PXVX0200 Lot A | SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | SVA GMT at Day 181 | 386 Titer |
| PXVX0200 Lot A | SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | Anti-CT IgG GMT at Day 181 | 1116 Titer |
| PXVX0200 Lot B | SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | SVA GMT at Day 181 | 53 Titer |
| PXVX0200 Lot B | SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | SVA GMT at Day 1 | 143 Titer |
| PXVX0200 Lot B | SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | SVA GMT at Day 11 | 320 Titer |
| PXVX0200 Lot B | SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | SVA GMT at Day 29 | 127 Titer |
| PXVX0200 Lot B | SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | SVA GMT at Day 91 | 127 Titer |
| PXVX0200 Lot B | SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | Anti-CT IgG GMT at Day 181 | 528 Titer |
| PXVX0200 Lot B | SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | Anti-CT IgG GMT at Day 1 | 951 Titer |
| PXVX0200 Lot B | SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | Anti-CT IgG GMT at Day 11 | 800 Titer |
| PXVX0200 Lot B | SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | Anti-CT IgG GMT at Day 29 | 848 Titer |
| PXVX0200 Lot B | SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181 | Anti-CT IgG GMT at Day 91 | 599 Titer |
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.
Time frame: Day 1 - 181
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PXVX0200 Lot A | SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181 | SVA Seroconversion at Day 11 | 91 % of participants |
| PXVX0200 Lot A | SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181 | SVA Seroconversion at Day 29 | 96 % of participants |
| PXVX0200 Lot A | SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181 | SVA Seroconversion at Day 91 | 69 % of participants |
| PXVX0200 Lot A | SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181 | SVA Seroconversion at Day 181 | 50 % of participants |
| PXVX0200 Lot A | SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181 | Anti-CT IgG Seroconversion at Day 11 | 42 % of participants |
| PXVX0200 Lot A | SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181 | Anti-CT IgG Seroconversion at Day 29 | 46 % of participants |
| PXVX0200 Lot A | SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181 | Anti-CT IgG Seroconversion at Day 91 | 42 % of participants |
| PXVX0200 Lot A | SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181 | Anti-CT IgG Seroconversion at Day 181 | 35 % of participants |
| PXVX0200 Lot B | SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181 | Anti-CT IgG Seroconversion at Day 181 | 0 % of participants |
| PXVX0200 Lot B | SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181 | SVA Seroconversion at Day 11 | 0 % of participants |
| PXVX0200 Lot B | SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181 | Anti-CT IgG Seroconversion at Day 11 | 0 % of participants |
| PXVX0200 Lot B | SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181 | SVA Seroconversion at Day 29 | 0 % of participants |
| PXVX0200 Lot B | SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181 | Anti-CT IgG Seroconversion at Day 91 | 0 % of participants |
| PXVX0200 Lot B | SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181 | SVA Seroconversion at Day 91 | 0 % of participants |
| PXVX0200 Lot B | SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181 | Anti-CT IgG Seroconversion at Day 29 | 0 % of participants |
| PXVX0200 Lot B | SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181 | SVA Seroconversion at Day 181 | 0 % of participants |
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
Time frame: Day 11
Population: IEP - comprises all randomized subjects who had evaluable vibriocidal antibody results from Day 11 and had no major protocol violations that affected immunogenicity
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PXVX0200 Lot A | SVA Seroconversion at Day 11 | 94 % of participants |
| PXVX0200 Lot B | SVA Seroconversion at Day 11 | 93 % of participants |
| PXVX0200 Lot C | SVA Seroconversion at Day 11 | 94 % of participants |
| Placebo | SVA Seroconversion at Day 11 | 4 % of participants |