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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
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
Secondary ID [1] 0 0
PXVX-VC-200-006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cholera (Disorder) 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cohort 1 (12-17 Yrs) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
Timepoint [1] 0 0
Day 11
Primary outcome [2] 0 0
Cohort 2 (6 to <12 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
Timepoint [2] 0 0
Day 11
Primary outcome [3] 0 0
Cohort 3 (2 to <6 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
Timepoint [3] 0 0
Day 11
Primary outcome [4] 0 0
Cohort 1 (12-17 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
Timepoint [4] 0 0
Day 11
Primary outcome [5] 0 0
Cohort 2 (6-11 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
Timepoint [5] 0 0
Day 11
Primary outcome [6] 0 0
Cohort 3 (2-5 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
Timepoint [6] 0 0
Day 11
Secondary outcome [1] 0 0
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 29
Timepoint [1] 0 0
Day 29
Secondary outcome [2] 0 0
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 91
Timepoint [2] 0 0
Day 91
Secondary outcome [3] 0 0
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 181
Timepoint [3] 0 0
Day 181
Secondary outcome [4] 0 0
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 365
Timepoint [4] 0 0
Day 365
Secondary outcome [5] 0 0
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 547
Timepoint [5] 0 0
Day 547
Secondary outcome [6] 0 0
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 730
Timepoint [6] 0 0
Day 730
Secondary outcome [7] 0 0
Cohort 2 (6 to <12 Years) - Seroconversion of SVA - Day 29
Timepoint [7] 0 0
Day 29
Secondary outcome [8] 0 0
Cohort 3 (2 to <6 Years) - Seroconversion of SVA - Day 29
Timepoint [8] 0 0
Day 29

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
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Other
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/03/2020
Sample size
Target
Accrual to date
Final
550
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bavarian Nordic
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Emergent BioSolutions
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03220737
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Paul Andre de Lame, MD
Address 0 0
Emergent BioSolutions
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries