infectious diarrhea
Conditions
Interventions
Experimental group: The subjects of Experimental group will be received a recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) at D0, D7, and D28
Placebo group: The subjects of group will be received a recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) placebo at D0, D7, and D28
Sponsors
Jiangsu Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
2 Years to 14 Years
Inclusion 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 informed consent 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: 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 investigational drugs within 30 days prior to vaccination. 9. Received any Rotavirus vaccine within 12 months prior to vaccination. 10. Live attenuated vaccine within 14 days or subunit or inactivated vaccine within 7 days prior to vaccination. 11. Asthma requiring urgent treatment, hospitalization, intubation, oral or intravenous corticosteroids 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 malignancy, 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of infectious diarrhea (except Vibrio cholerae, any pathogen can be positive); | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of infectious diarrhea caused by ETEC;the incidence of infectious diarrhea caused by different pathogens(such as Escherichia coli, Salmonella, Shigella, Vibrio parahaemolyticus);serum anti-CT antibody, serum vibriocidal antibody and serum-LPS antibody;Changes of intestinal flora;adverse reaction; | — |
Countries
China
Contacts
Public ContactBao Changjun
Jiangsu Provincial Center for Disease Control and Prevention
Outcome results
None listed