Cholera (Disorder)Phase 4NCT03220737

VAXCHORA Pediatric Study to Assess Safety and Immunogenicity

A Phase 4 study testing VAXCHORA (Cholera Vaccine, Live, Oral) in people with Cholera (Disorder), run by Bavarian Nordic at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Cholera (Disorder)
What is being tested?: VAXCHORA (Cholera Vaccine, Live, Oral)
Type of treatment: Vaccines, Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 550 participants
Where: 10 sitesUnited States
Study dates: 21 Jul 2017to 6 Mar 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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

Show all 16Show fewer

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)

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Emory University
Atlanta, Georgia, 30322
Boston Medical Center
Boston, Massachusetts, 02118
Aventiv Research Inc.
Columbus, Ohio, 43123
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Johnson County Clin-Trials, Inc.
Lenexa, Kansas, 66219
University of Kentucky
Lexington, Kentucky, 40536
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Heartland Research Associates, LLC
Wichita, Kansas, 67207

Other trials in United States

About this study

Official 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

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.

Read the detailed description

This is a randomized, placebo-controlled, double-blind, single-crossover study with three age cohorts and two treatment groups within each cohort.

Conditions: Cholera (Disorder)
Being tested: VAXCHORA (Cholera Vaccine, Live, Oral), Placebo
Medical subject headings: Cholera

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VAXCHORA (Cholera Vaccine, Live, Oral)Biological
VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
PlaceboOther
Placebo control for this study is normal (0.9%) saline.

Study groups in NCT03220737
Study group	Role	What they receive
Cohort 1 (active, 12-17 yrs)	Experimental	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. Receives: Biological: VAXCHORA (Cholera Vaccine, Live, Oral)
Cohort 1 (placebo, 12 - 17 yrs)	Placebo comparator	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. Receives: Other: Placebo
Cohort 2 (active, 6 - 11 yrs)	Experimental	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. Receives: Biological: VAXCHORA (Cholera Vaccine, Live, Oral)
Cohort 2 (placebo, 6 - 11 yrs)	Placebo comparator	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. Receives: Other: Placebo
Cohort 3 (active, 2 - 5 yrs)	Experimental	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. Receives: Biological: VAXCHORA (Cholera Vaccine, Live, Oral)
Cohort 3 (placebo, 2 - 5 yrs)	Placebo comparator	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. Receives: Other: Placebo
Historical Control: Adult Bridging Population	Other	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 Receives: Biological: VAXCHORA (Cholera Vaccine, Live, Oral)

What is being measured

The primary outcome is the main question the study is designed to answer.

Cohort 1 (12-17 Yrs) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
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
Measured: Day 11
Cohort 2 (6 to <12 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
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.
Measured: Day 11
Cohort 3 (2 to <6 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
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.
Measured: Day 11
Cohort 1 (12-17 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
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.
Measured: Day 11
Cohort 2 (6-11 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
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.
Measured: Day 11
Cohort 3 (2-5 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
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.
Measured: Day 11

Secondary outcomes (8)

Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 29
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
Measured: Day 29
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 91
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 91 for all subjects
Measured: Day 91
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 181
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 181 for all subjects
Measured: Day 181
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 365
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 365 for all subjects
Measured: Day 365
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 547
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 547 for all subjects
Measured: Day 547
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 730
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 730 for all subjects
Measured: Day 730
Cohort 2 (6 to <12 Years) - Seroconversion of SVA - Day 29
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
Measured: Day 29
Cohort 3 (2 to <6 Years) - Seroconversion of SVA - Day 29
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
Measured: Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jul 20176 Mar 2020

First posted18 Jul 2017
Study start21 Jul 2017
Primary completion10 Sep 2019
Study completion6 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cholera (Disorder)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Model description: This is a randomized, placebo-controlled, double-blind, single-crossover study with three age cohorts and two treatment groups within each cohort. The main study consists of a screening period of 30 days, a treatment period from Day 1 to Day 29, and a follow-up period through Day 181. Cohort 1 has an optional sub-study consisting of a long-term follow-up period through Day 730.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 550 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03220737
Sponsor's protocol ID: PXVX-VC-200-006
Status last verified: Jun 2023
First submitted: 11 Jul 2017
Last updated: 28 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

McCarty JM, Gierman EC, Bedell L, Lock MD, Bennett S. Safety and Immunogenicity of Live Oral Cholera Vaccine CVD 103-HgR in Children and Adolescents Aged 6-17 Years. Am J Trop Med Hyg. 2020 Jan;102(1):48-57. doi: 10.4269/ajtmh.19-0241.
PubMed 31769402

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cholera (Disorder) trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT03220737
Acronym / sponsor ID: PXVX-VC-200-006
Conditions: Cholera (Disorder)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 550 participants (actual)
Lead sponsor: Bavarian NordicIndustry (pharma, biotech, devices)
Collaborators: Emergent BioSolutions
Study start: 21 Jul 2017 (actual)
Primary completion: 10 Sep 2019 (actual)
Study completion: 6 Mar 2020 (actual)
First posted: 18 Jul 2017 (actual)
Results: Posted 19 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is a randomized, placebo-controlled, double-blind, single-crossover study with three age cohorts and two treatment groups within each cohort.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7
Model description: This is a randomized, placebo-controlled, double-blind, single-crossover study with three age cohorts and two treatment groups within each cohort. The main study consists of a screening period of 30 days, a treatment period from Day 1 to Day 29, and a follow-up period through Day 181. Cohort 1 has an optional sub-study consisting of a long-term follow-up period through Day 730.

Arm	Type	Receives
Cohort 1 (active, 12-17 yrs)	Experimental	Biological: VAXCHORA (Cholera Vaccine, Live, Oral)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.
Cohort 1 (placebo, 12 - 17 yrs)	Placebo comparator	Other: PlaceboSubjects 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.
Cohort 2 (active, 6 - 11 yrs)	Experimental	Biological: VAXCHORA (Cholera Vaccine, Live, Oral)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.
Cohort 2 (placebo, 6 - 11 yrs)	Placebo comparator	Other: PlaceboSubjects 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.
Cohort 3 (active, 2 - 5 yrs)	Experimental	Biological: VAXCHORA (Cholera Vaccine, Live, Oral)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.
Cohort 3 (placebo, 2 - 5 yrs)	Placebo comparator	Other: PlaceboSubjects 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.
Historical Control: Adult Bridging Population	Other	Biological: VAXCHORA (Cholera Vaccine, Live, Oral)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

Who may qualify

Ages: 2 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Biological	Cohort 1 (active, 12-17 yrs), Cohort 2 (active, 6 - 11 yrs), Cohort 3 (active, 2 - 5 yrs), Historical Control: Adult Bridging Population
PlaceboPlacebo control for this study is normal (0.9%) saline.	Other	Cohort 1 (placebo, 12 - 17 yrs), Cohort 2 (placebo, 6 - 11 yrs), Cohort 3 (placebo, 2 - 5 yrs)

Primary outcome

Cohort 1 (12-17 Yrs) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
Time frame: Day 11
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
Cohort 2 (6 to <12 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
Time frame: Day 11
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.
Cohort 3 (2 to <6 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
Time frame: Day 11
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.
Cohort 1 (12-17 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
Time frame: Day 11
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.
Cohort 2 (6-11 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
Time frame: Day 11
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.
Cohort 3 (2-5 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
Time frame: Day 11
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.

8 secondary outcomes

Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 29
Time frame: Day 29
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 91
Time frame: Day 91
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 181
Time frame: Day 181
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 365
Time frame: Day 365
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 547
Time frame: Day 547
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 730
Time frame: Day 730
Cohort 2 (6 to <12 Years) - Seroconversion of SVA - Day 29
Time frame: Day 29
Cohort 3 (2 to <6 Years) - Seroconversion of SVA - Day 29
Time frame: Day 29

Results and safety

Results posted to the registry on 19 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 (Active, 12-17 Yrs)	163	157
Cohort 1 (Placebo, 12 - 17 Yrs)	26	24
Cohort 2 (Active, 6 - 11 Yrs)	158	146
Cohort 2 (Placebo, 6 - 11 Yrs)	27	24
Cohort 3 (Active, 2 - 5 Yrs)	150	130
Cohort 3 (Placebo, 2 - 5 Yrs)	26	25
Historical Control: Adult Bridging Population	2,688	2,687

Primary outcome: Cohort 1 (12-17 Yrs) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae

Time frame: Day 11. Number (98.3% Confidence Interval). Unit: percentage of participants

Measure	Cohort 1 (Active, 12-17 Yrs) n = 157	Cohort 1 (Placebo, 12-17 Yrs) n = 23
Value	99.4 (95.4 to 99.9)	0 (0.0 to 14.3)

Cohort 1 (Active, 12-17 Yrs): Proportion: 0.985

Population analysed: Immunogenicity Evaluable Population (IEP)

Primary outcome: Cohort 2 (6 to <12 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae

Time frame: Day 11. Number (98.3% Confidence Interval). Unit: percentage of participants

Measure	Cohort 2 (Active, 6 - 11 Yrs) n = 139	Cohort 2 (Placebo, 6-11 Yrs) n = 24
Value	97.8 (92.5 to 99.4)	4.2 (0.7 to 20.2)

Cohort 2 (Active, 6 - 11 Yrs) vs Cohort 2 (Placebo, 6-11 Yrs): Proportion: 0.985

Population analysed: Immunogenicity Evaluable Population (IEP)

Primary outcome: Cohort 3 (2 to <6 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae

Time frame: Day 11. Number (98.3% Confidence Interval). Unit: percentage of participants

Measure	Cohort 3 (Active, 2 - 5 Yrs) n = 103	Cohort 3 (Placebo, 2-5 Yrs) n = 20
Value	98.1 (91.5 to 99.6)	0 (0.0 to 16.1)

Cohort 3 (Active, 2 - 5 Yrs) vs Cohort 3 (Placebo, 2-5 Yrs): Proportion: 0.985

Population analysed: Immunogenicity Evaluable Population (IEP)

Primary outcome: Cohort 1 (12-17 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years

Time frame: Day 11. Number (98.3% Confidence Interval). Unit: percentage of participants

Measure	Cohort 1 (Active, 12-17 Yrs) n = 157	Historical Control: Adult Bridging Population n = 2687
Value	99.4 (95.4 to 99.9)	93.5 (92.3 to 94.6)

Cohort 1 (Active, 12-17 Yrs) vs Historical Control: Adult Bridging Population: Risk Difference (RD): 5.8 (96.7% CI 2.4 to 7.1)

Population analysed: Immunogenicity Evaluable Population (IEP)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events were collected for 28 days post vaccination. Serious adverse events were followed until the end of the end of the subject's participation in the study (2 years for adolescents in the long term sub-study and 6 months for all others). Solicited adverse events were collected for daily for 8 consecutive days following vaccination (Days 1-8). Events that continued past Day 8 were recorded as unsolicited adverse events.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 (Active, 12-17 Yrs)	4 of 165 (2.4%)	116 of 165 (70.3%)	0 of 165
Cohort 1 (Placebo, 12 - 17 Yrs)	0 of 24 (0%)	13 of 24 (54.2%)	0 of 24
Cohort 2 (Active, 6 - 11 Yrs)	0 of 157 (0%)	93 of 157 (59.2%)	0 of 157
Cohort 2 (Placebo, 6 - 11 Yrs)	0 of 25 (0%)	15 of 25 (60%)	0 of 25
Cohort 3 (Active, 2 - 5 Yrs)	0 of 146 (0%)	74 of 146 (50.7%)	0 of 146
Cohort 3 (Placebo, 2 - 5 Yrs)	1 of 26 (3.8%)	12 of 26 (46.2%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31769402McCarty JM, Gierman EC, Bedell L, Lock MD, Bennett S. Safety and Immunogenicity of Live Oral Cholera Vaccine CVD 103-HgR in Children and Adolescents Aged 6-17 Years. Am J Trop Med Hyg. 2020 Jan;102(1):48-57. doi: 10.4269/ajtmh.19-0241.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paul Andre de Lame, MD study director

Emergent BioSolutions

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing VAXCHORA (Cholera Vaccine, Live, Oral) in people with Cholera (Disorder), run by Bavarian Nordic at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1 (12-17 Yrs) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae (time frame: Day 11). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03220737, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.