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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/NCT03220737
Registration number
NCT03220737
Ethics application status
Date submitted
11/07/2017
Date registered
18/07/2017
Date last updated
28/06/2023
Titles & IDs
Public title
VAXCHORA Pediatric Study to Assess Safety and Immunogenicity
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Scientific title
A Phase 4 Study to Assess the Safety and Immunogenicity of VAXCHORA (Cholera Vaccine, Live, Oral) in Children 2 to <18 Years of Age
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Secondary ID [1]
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PXVX-VC-200-006
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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 (Disorder)
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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 - VAXCHORA (Cholera Vaccine, Live, Oral)
Other interventions - Placebo
Experimental: 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.
Placebo Comparator: 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.
Experimental: 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.
Placebo Comparator: 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.
Experimental: 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.
Placebo Comparator: 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.
Other: 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
Other interventions: 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.
Other interventions: Placebo
Placebo control for this study is normal (0.9%) saline.
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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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Cohort 1 (12-17 Yrs) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
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Assessment method [1]
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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
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Timepoint [1]
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Day 11
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Primary outcome [2]
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Cohort 2 (6 to <12 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
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Assessment method [2]
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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.
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Timepoint [2]
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Day 11
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Primary outcome [3]
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Cohort 3 (2 to <6 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
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Assessment method [3]
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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.
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Timepoint [3]
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Day 11
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Primary outcome [4]
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Cohort 1 (12-17 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
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Assessment method [4]
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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.
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Timepoint [4]
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Day 11
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Primary outcome [5]
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Cohort 2 (6-11 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
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Assessment method [5]
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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.
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Timepoint [5]
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Day 11
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Primary outcome [6]
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Cohort 3 (2-5 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
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Assessment method [6]
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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.
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Timepoint [6]
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Day 11
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Secondary outcome [1]
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Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 29
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Assessment method [1]
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Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
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Timepoint [1]
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Day 29
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Secondary outcome [2]
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Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 91
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Assessment method [2]
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Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 91 for all subjects
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Timepoint [2]
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Day 91
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Secondary outcome [3]
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Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 181
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Assessment method [3]
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Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 181 for all subjects
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Timepoint [3]
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Day 181
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Secondary outcome [4]
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Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 365
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Assessment method [4]
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Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 365 for all subjects
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Timepoint [4]
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Day 365
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Secondary outcome [5]
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Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 547
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Assessment method [5]
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Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 547 for all subjects
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Timepoint [5]
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Day 547
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Secondary outcome [6]
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Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 730
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Assessment method [6]
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Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 730 for all subjects
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Timepoint [6]
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Day 730
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Secondary outcome [7]
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Cohort 2 (6 to <12 Years) - Seroconversion of SVA - Day 29
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Assessment method [7]
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Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
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Timepoint [7]
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Day 29
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Secondary outcome [8]
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Cohort 3 (2 to <6 Years) - Seroconversion of SVA - Day 29
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Assessment method [8]
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Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
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Timepoint [8]
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Day 29
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Eligibility
Key inclusion criteria
- Male or Female
- Between 2 and <18 years of age on Day 1
- In general good health
- Able and willing to provide informed assent for study participation
- Primary caregiver is able and willing to provide informed consent for study
participation
- (for females of childbearing potential) Using an acceptable method of contraception
through Day 29
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Minimum age
2
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Maximum age
17
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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
- Current acute gastrointestinal illness or loose stools within 3 days of Day 1 visit
- Current acute febrile illness
- History of cholera infection
- History of cholera vaccination
- History of severe allergic reaction (e.g. anaphylaxis) to any ingredient of VAXCHORA
- Congenital or acquired immunodeficiency
- Pregnancy (for females of childbearing potential)
- Any other condition that, in the opinion of the Investigator, creates an unacceptable
risk to the subject
- Any other condition that, in the opinion of the Investigator, will interfere with the
conduct of the study or the validity of the data
- Duration of >2 weeks of abnormal stool pattern, defined as <3 stools per week or >2
stools per day in the past 6 months
- Regular use of laxatives in the past 6 months
- History of enterotoxigenic E. coli infection
- Travel to cholera-endemic area in the previous 5 years
- Nursing/Breastfeeding
- Received or plans to receive the following from 14 days prior to the study vaccination
through 11 days after vaccination: Any other licensed vaccines, antibiotics, or
chloroquine
- Received or plans to receive any other investigational agent throughout the main study
(Day 181)
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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
Other
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Other design features
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Phase
Phase 4
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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
21/07/2017
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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
6/03/2020
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Sample size
Target
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Accrual to date
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Final
550
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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State/province [1]
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Georgia
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United States of America
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State/province [2]
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Kansas
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United States of America
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State/province [3]
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Kentucky
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United States of America
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Massachusetts
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United States of America
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Missouri
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United States of America
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New York
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United States of America
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Ohio
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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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Tennessee
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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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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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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03220737
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Paul Andre de Lame, MD
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Address
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Emergent BioSolutions
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03220737
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