DiarrheaPhase 4NCT07300462
A Post-marketing Observational Study of Oral Cholera Vaccine
A Phase 4 study testing Recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) in people with Diarrhea, run by Shanghai United Cell Biotechnology Co., Ltd at 5 sites in China.
Trial summary
Chinese survey data indicate that the incidence rate of diarrhea in the general population ranges from 0.17 to 0.70 episodes per person-year, whereas among children under five years of age, the rate is significantly higher, ranging from 2.50 to 3.38 episodes per person-year. Read more about this study
- Who is it for?
- Ages 2 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- Recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules)
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,000 participants
- Where
- 5 sitesChina
- Study dates
- 10 Apr 2026to Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age ≥ 2 years old, ≤ 14 years old, male or female.
- Not vaccinated against cholera.
- Obtain the consent of the study subject or guardian and sign the informed consent form.
- The subjects and their guardians were able to comply with the requirements of the clinical study protocol.
- Axillary temperature < 37.0 °C was measured on the day of inoculation.
Who cannot join
- Patients with febrile illness (axillary temperature ≥ 37.0 °C on the day of vaccination), other acute diseases, and diarrhea within 7 days before vaccination.
- Use of antibiotics within 7 days prior to vaccination.
- Patients with gastric ulcer, abnormal gastric acid secretion and other gastric diseases or discomfort.
- History of allergy to vaccinations and oral medications.
- Patients with congenital malformations, developmental disorders, or severe chronic diseases.
- Suspected progressive neurological disorder, epilepsy, or long-term use of antibiotics.
Show all 20Show fewer
- Received blood products within 3 months prior to vaccination.
- Received other investigational drugs within 30 days prior to vaccination.
- Received any Rotavirus vaccine within 12 months prior to vaccination.
- Live attenuated vaccine within 14 days or subunit or inactivated vaccine within 7 days prior to vaccination.
- Asthma requiring urgent treatment, hospitalization, intubation, oral or intravenous corticosteroids for unstable past two years.
- Patients with severe hypertension, heart, liver, kidney disease, and severe infectious diseases (acquired immunodeficiency syndrome and active tuberculosis).
- Has a malignancy, is active or has been treated without definitive cure, or has the potential to relapse during the study.
- Epilepsy, excluding epilepsy that has been discontinued within the past 3 years and has not recurred.
- Patients with coagulation disorders.
- Those who have had or are currently suffering from mental illness that have not been well controlled within the past two years due to psychological conditions that do not comply with protocol requirements, and who need to take drugs for psychosis.
- In the judgment of the investigator, it is contrary to the protocol due to various medical, psychological, social or other conditions, or affects the subject to sign the informed consent.
- Those who have an allergic reaction at the time of the first or second vaccination.
- Occurring in any of the first dose exclusion criteria after inclusion.
- Serious adverse event causally related to first or second dose of study vaccine.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
National Institute for Communicable Disease Control and Prevention, China
Beijing, Beijing Municipality
Anhui Provincial Center for Disease Control and Prevention
Hefei, Anhui
Shandong Provincial Center for Disease Control and Prevention
Jinan, Shandong
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate the Protective Efficacy of Oral Recombinant Subunit B/Bacterial Cholera Vaccine (Enteric-coated Capsules) Against Infectious Diarrhea Caused by Non-Vibrio Cholerae in Healthy People Aged 2 to 14 Years
Chinese survey data indicate that the incidence rate of diarrhea in the general population ranges from 0.17 to 0.70 episodes per person-year, whereas among children under five years of age, the rate is significantly higher, ranging from 2.50 to 3.38 episodes per person-year. Over recent decades, rapid economic development has contributed substantially to the reduction of mortality associated with infectious diseases. However, emerging challenges-such as increasing antimicrobial resistance and heightened population mobility-have complicated efforts in infectious disease prevention and control. In a phase III clinical trial of the recombinant B subunit/bacterial whole-cell cholera vaccine (enteric-coated capsule), a statistically significant difference was observed in the overall incidence of diarrhea between the vaccinated group (12.9%) and the control group (26.7%) (P < 0.01). Findings from similar vaccine studies conducted in Sweden have demonstrated cross-protection against diarrhea caused by enterotoxigenic Escherichia coli (ETEC) and other intestinal pathogens. Specifically, the vaccine conferred a 50% protection rate against Salmonella enterica infections, 82% against mixed infections involving ETEC and Salmonella, and 71% against mixed infections involving ETEC and other pathogens. Evidence from relevant studies suggests that the recombinant B subunit/bacterial whole-cell cholera vaccine may offer protective benefits against non-cholera infectious diarrhea. Nevertheless, there remains a paucity of real-world effectiveness data, particularly in pediatric populations who bear a disproportionately high burden of diarrheal disease.
- Conditions
- Diarrhea
- Being tested
- Recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules), Placebo
- Keywords
- IV
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules)Biological
The participants in the experimental group will be given three oral doses of recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) on D0, D7, and D28 .
PlaceboBiological
The participants in the Control group will be given three oral doses of recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) Placebo on D0, D7, and D28 .
| Study group | Role | What they receive |
|---|---|---|
| Recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) | Experimental | Not described Receives: Biological: Recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) |
| Recombinant B subunit/bacterial cholera vaccine (enteric-coated capsule) placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of infectious diarrhea in the vaccinated group and placebo group
Protective effect of recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) against infectious diarrhea due to enteropathogens (except Vibrio cholerae) (Day 7 after full immunization to the end of the study).
Measured: The incidence of diarrhea in the experimental group and the control group within 180 days starting from 7 days after full immunization (the baseline day for diarrhea)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start10 Apr 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai United Cell Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300462
- Sponsor's protocol ID
- OCV-YJFA-2024-001
- Status last verified
- Jul 2026
- First submitted
- 10 Dec 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate the Protective Efficacy of Oral Recombinant Subunit B/Bacterial Cholera Vaccine (Enteric-coated Capsules) Against Infectious Diarrhea Caused by Non-Vibrio Cholerae in Healthy People Aged 2 to 14 Years
- ClinicalTrials.gov ID
- NCT07300462
- Acronym / sponsor ID
- OCV-YJFA-2024-001
- Conditions
- Diarrhea
- Keywords
- IV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Shanghai United Cell Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chinese survey data indicate that the incidence rate of diarrhea in the general population ranges from 0.17 to 0.70 episodes per person-year, whereas among children under five years of age, the rate is significantly higher, ranging from 2.50 to 3.38 episodes per person-year. Over recent decades, rapid economic development has contributed substantially to the reduction of mortality associated with infectious diseases. However, emerging challenges-such as increasing antimicrobial resistance and heightened population mobility-have complicated efforts in infectious disease prevention and control. In a phase III clinical trial of the recombinant B subunit/bacterial whole-cell cholera vaccine (enteric-coated capsule), a statistically significant difference was observed in the overall incidence of diarrhea between the vaccinated group (12.9%) and the control group (26.7%) (P < 0.01). Findings from similar vaccine studies conducted in Sweden have demonstrated cross-protection against diarrhea caused by enterotoxigenic Escherichia coli (ETEC) and other intestinal pathogens. Specifically, the vaccine conferred a 50% protection rate against Salmonella enterica infections, 82% against mixed infections involving ETEC and Salmonella, and 71% against mixed infections involving ETEC and other pathogens. Evidence from relevant studies suggests that the recombinant B subunit/bacterial whole-cell cholera vaccine may offer protective benefits against non-cholera infectious diarrhea. Nevertheless, there remains a paucity of real-world effectiveness data, particularly in pediatric populations who bear a disproportionately high burden of diarrheal disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) | Experimental | Biological: Recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) |
| Recombinant B subunit/bacterial cholera vaccine (enteric-coated capsule) placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age ≥ 2 years old, ≤ 14 years old, male or female.
- Not vaccinated against cholera.
- Obtain the consent of the study subject or guardian and sign the informed consent form.
- The subjects and their guardians were able to comply with the requirements of the clinical study protocol.
- Axillary temperature < 37.0 °C was measured on the day of inoculation.
Key exclusion criteria (20 listed)
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 |
|---|---|---|
| Recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules)The participants in the experimental group will be given three oral doses of recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) on D0, D7, and D28 . | Biological | Recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) |
| PlaceboThe participants in the Control group will be given three oral doses of recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) Placebo on D0, D7, and D28 . | Biological | Recombinant B subunit/bacterial cholera vaccine (enteric-coated capsule) placebo |
Primary outcome
the incidence of infectious diarrhea in the vaccinated group and placebo group
Time frame: The incidence of diarrhea in the experimental group and the control group within 180 days starting from 7 days after full immunization (the baseline day for diarrhea)
Protective effect of recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) against infectious diarrhea due to enteropathogens (except Vibrio cholerae) (Day 7 after full immunization to the end of the study).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Diarrhea
Not yet recruiting
Comparison of Two Probiotics for Reducing Diarrhea Frequency in Children Aged 6-24 Months
Acute Watery Diarrhea, Acute Watery Diarrhoea
RecruitingPhase 2
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
Diarrhoea
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Recruiting
Lactic Acid Bacteria in Functional Diarrheal Disorders
IBS-D (Diarrhea-predominant), IBS (Irritable Bowel Syndrome)
RecruitingPhase 2
Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)
Immune-related Adverse Event, Diarrhea
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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 Recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) in people with Diarrhea, run by Shanghai United Cell Biotechnology Co., Ltd at 5 sites in China.
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 5 inclusion and 20 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: enrolling by invitation, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
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?
the incidence of infectious diarrhea in the vaccinated group and placebo group (time frame: The incidence of diarrhea in the experimental group and the control group within 180 days starting from 7 days after full immunization (the baseline day for diarrhea)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2026.