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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02094586
Registration number
NCT02094586
Ethics application status
Date submitted
20/03/2014
Date registered
24/03/2014
Date last updated
28/06/2023
Titles & IDs
Public title
A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults
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Scientific title
Phase 3 Randomized, Double-blind, Placebo-Controlled 3-Lot Study in Healthy Volunteers to Assess Immunogenicity, & Acceptability of a Single-dose of Live Oral Cholera Vaccine, Vibrio Cholerae O1 Serotype Inaba Vaccine Strain CVD 103-HgR
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Secondary ID [1]
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PXVX-VC-200-004
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cholera
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Condition category
Condition code
Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - PXVX0200 Lot A
Other interventions - PXVX0200 Lot B
Other interventions - PXVX0200 Lot C
Other interventions - Placebo
Experimental: PXVX0200 Lot A - PXVX0200 (Lot P700-1CA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension
Experimental: PXVX0200 Lot B - PXVX0200 (Lot P700-3CA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension
Experimental: PXVX0200 Lot C - PXVX0200 (Lot P700-6BA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension
Placebo Comparator: Placebo - Placebo physiological saline
Other interventions: PXVX0200 Lot A
Lot P700-1CA03
Other interventions: PXVX0200 Lot B
Lot P700-3CA03
Other interventions: PXVX0200 Lot C
Lot P700-6BA03
Other interventions: Placebo
Placebo
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B
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Assessment method [1]
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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.
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Timepoint [1]
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Day 11
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Primary outcome [2]
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Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots B and C
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Assessment method [2]
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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.
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Timepoint [2]
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Day 11
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Primary outcome [3]
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Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and C
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Assessment method [3]
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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.
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Timepoint [3]
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Day 11
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Secondary outcome [1]
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SVA Seroconversion at Day 11
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Assessment method [1]
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Percentage of subjects who demonstrated a =4-fold rise over baseline in serum vibriocidal antibody (SVA) at Day 11
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Timepoint [1]
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Day 11
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Secondary outcome [2]
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SVA and Anti-CT IgG GMT at Day 1, 11, 29, 91 and 181
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Assessment method [2]
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GMTs of vibriocidal antibody and anti-CT IgG concentrations at Days 1, 11, 29, 91, and 181.
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Timepoint [2]
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Day 1 - 181
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Secondary outcome [3]
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SVA and Anti-CT IgG Seroconversion at Day 1, 11, 29, 91 & 181
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Assessment method [3]
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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.
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Timepoint [3]
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Day 1 - 181
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Secondary outcome [4]
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Adverse Events
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Assessment method [4]
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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.
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Timepoint [4]
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Day 1 - 29
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Eligibility
Key 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.
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Minimum age
18
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Maximum age
45
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2015
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Sample size
Target
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Accrual to date
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Final
3146
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
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Recruitment hospital [1]
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QIMR Berghofer Medical Research Institiue - Herston
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Recruitment hospital [2]
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AUS Trials Pty Ltd - Sherwood
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Recruitment hospital [3]
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CMAX - Adelaide
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Recruitment hospital [4]
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Emeritis Research - Malvern East
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Recruitment hospital [5]
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Nucleus Network - Melbourne
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Recruitment hospital [6]
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Linear Clinical Research - Nedlands
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Recruitment postcode(s) [1]
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4006 - Herston
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Recruitment postcode(s) [2]
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4035 - Sherwood
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3145 - Malvern East
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment postcode(s) [6]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arizona
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United States of America
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Florida
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United States of America
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Georgia
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Country [5]
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United States of America
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Kansas
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Country [6]
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United States of America
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State/province [6]
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Kentucky
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Country [7]
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United States of America
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State/province [7]
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Massachusetts
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Country [8]
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United States of America
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State/province [8]
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Missouri
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United States of America
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Nevada
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Country [10]
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United States of America
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New York
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Country [11]
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United States of America
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State/province [11]
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Oklahoma
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Country [12]
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United States of America
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South Carolina
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United States of America
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Texas
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United States of America
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State/province [14]
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Utah
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bavarian Nordic
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Emergent BioSolutions
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02094586
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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James McCarty, MD
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Address
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Emergent Travel Health Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02094586
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