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Enrolling by invitationNCT07300462Updated Jul 10, 2026

A Post-marketing Observational Study of Oral Cholera Vaccine

A Phase 4 interventional study of Recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) and Placebo in Diarrhea, sponsored by Shanghai United Cell Biotechnology Co., Ltd. Enrolling by invitation at 5 sites in China. Open to participants aged 2 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by Shanghai United Cell Biotechnology Co., Ltd · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
6,000
Allocation
Randomized
Ages
2 Years to 14 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Diarrhea

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Keywords

  • IV
03

In context

Diarrhea

877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.

This study's planned enrollment of 6,000 is above the median of 137 across 738 interventional studies indexed under Diarrhea.

Browse Diarrhea studies →

Lead sponsor

This is the only study on the registry with Shanghai United Cell Biotechnology Co., Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  1. Age ≥ 2 years old, ≤ 14 years old, male or female.
  2. Not vaccinated against cholera.
  3. Obtain the consent of the study subject or guardian and sign the form.
  4. The subjects and their guardians were able to comply with the requirements of the clinical study protocol.
  5. Axillary temperature \< 37.0 °C was measured on the day of inoculation.

Exclusion Criteria:

  • Exclusion Criteria for First Inoculation：

    1. Patients with febrile illness (axillary temperature ≥ 37.0 °C on the day of vaccination), other acute diseases, and diarrhea within 7 days before vaccination.
    2. Use of antibiotics within 7 days prior to vaccination.
    3. Patients with gastric ulcer, abnormal gastric acid secretion and other gastric diseases or discomfort.
    4. History of allergy to vaccinations and oral medications.
    5. Patients with congenital malformations, developmental disorders, or severe chronic diseases.
    6. Suspected progressive neurological disorder, epilepsy, or long-term use of antibiotics.
    7. Received blood products within 3 months prior to vaccination.
    8. Received other drugs within 30 days prior to vaccination.
    9. Received any Rotavirus vaccine within 12 months prior to vaccination.
    10. within 14 days or subunit or inactivated vaccine within 7 days prior to vaccination.
    11. Asthma requiring urgent treatment, hospitalization, intubation, oral or intravenous for unstable past two years.
    12. Patients with severe hypertension, heart, liver, kidney disease, and severe infectious diseases (acquired immunodeficiency syndrome and active tuberculosis).
    13. Has a , is active or has been treated without definitive cure, or has the potential to relapse during the study.
    14. Epilepsy, excluding epilepsy that has been discontinued within the past 3 years and has not recurred.
    15. Patients with coagulation disorders.
    16. 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.
    17. 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.

  • Exclusion Criteria for Second and Third Oral Vaccines：

    1. Those who have an allergic reaction at the time of the first or second vaccination.
    2. Occurring in any of the first dose exclusion criteria after inclusion.
    3. Serious adverse event causally related to first or second dose of study vaccine.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
6,000 participants (estimated)

Study arms

  • Experimental
    Recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules)

    Biological: Recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules)

  • Placebo comparator
    Recombinant B subunit/bacterial cholera vaccine (enteric-coated capsule) placebo

    Biological: Placebo

Interventions

  • BiologicalRecombinant 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 .

  • BiologicalPlacebo

    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 .

06

What researchers measure

Primary outcomes

  1. 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).

    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)

07

Study locations

5 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Jan 2027, 9 months after the start.

Of 37 phase 4 interventional studies under Diarrhea, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 46. This study's planned 9 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 10, 2025
First posted
Dec 23, 2025
StartActual
Apr 10, 2026
Primary completionEst.
Jan 2027
CompletionEst.
Jan 2027
Last update
Jul 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07300462
Lead sponsor
Shanghai United Cell Biotechnology Co., Ltd
Responsible party
Sponsor
First posted
Dec 23, 2025
Start date
Apr 10, 2026
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Jul 10, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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