VAXCHORA Pediatric Study to Assess Safety and Immunogenicity
NCT ID: NCT03220737
Last Updated: 2023-06-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
550 participants
INTERVENTIONAL
2017-07-21
2020-03-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Immunologic Responses to a Live Attenuated Oral Cholera Vaccine
NCT03251495
Safety and Immunogenicity of Locally Manufactured Oral Cholera Vaccine
NCT02742558
A Post-marketing Observational Study of Oral Cholera Vaccine
NCT07300462
Safety and Immunogenicity of Locally Manufactured New (HL-OCV) Oral Cholera Vaccine
NCT02823899
A Study to Evaluate Safety and Immunogenicity of the Bivalent Killed Whole Cell Oral Cholera Vaccine in Adults and Children
NCT00760825
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
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.
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
Placebo
Placebo control for this study is normal (0.9%) saline.
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.
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.
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.
Placebo
Placebo control for this study is normal (0.9%) saline.
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.
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.
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.
Placebo
Placebo control for this study is normal (0.9%) saline.
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Placebo
Placebo control for this study is normal (0.9%) saline.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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)
2 Years
17 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Emergent BioSolutions
INDUSTRY
Bavarian Nordic
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Paul Andre de Lame, MD
Role: STUDY_DIRECTOR
Emergent BioSolutions
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Emory University
Atlanta, Georgia, United States
Johnson County Clin-Trials, Inc.
Lenexa, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Boston Medical Center
Boston, Massachusetts, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Aventiv Research Inc.
Columbus, Ohio, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PXVX-VC-200-006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.