Clinical Trial of the S. Flexneri-S. Sonnei Bivalent Conjugate Vaccine
NCT ID: NCT06838195
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
8000 participants
INTERVENTIONAL
2025-04-15
2028-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Vaccine group
4000 subjects aged 6 months to 5 years are enrolled in this group.
S. Flexneri-S. Sonnei bivalent conjugate vaccine
Subjects receive two doses of the vaccine on the day of randomisation (day 0) and day 30.
Placebo group
4000 subjects aged 6 months to 5 years are enrolled in this group.
Placebo
Subjects receive two doses of the placebo on the day of randomisation (day 0) and day 30.
Interventions
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S. Flexneri-S. Sonnei bivalent conjugate vaccine
Subjects receive two doses of the vaccine on the day of randomisation (day 0) and day 30.
Placebo
Subjects receive two doses of the placebo on the day of randomisation (day 0) and day 30.
Eligibility Criteria
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Inclusion Criteria
* Legal guardians voluntarily agree to participate in the study and sign an informed consent form.
* Legal guardians agree to comply with the requirements of the clinical trial protocol and are willing and able to participate in all planned follow-ups.
* The subject's guardian agrees that the subject should not abuse antibiotics. If needed，antibiotics should be used under the guidance of a doctor and avoid taking antibiotics on their own during the clinical trial.
* Based on medical history, physical examination, and the investigator's judgment, the subject is determined to be in good health.
Exclusion Criteria
* Serious allergy to tetanus toxoid, history of severe allergies, fever above 39.5°C following previous vaccination with a prophylactic biological product.
* Currently suffering from serious intestinal diseases, symptoms of diarrhea, abdominal pain, or bloody purulent stools in the past 15 days.
* Diagnosed pathological jaundice currently.
* Confirmed diagnosis of thrombocytopenia or other coagulation disorders.
* Known or suspected immunological deficiencies (e.g., perianal abscesses indicating potential immune deficiency in infants and young children), long-term treatment (≥14 days) with immunosuppressants within half a year before vaccination (radiotherapy, chemotherapy, systemic corticosteroids ≥2 mg/kg/day, antimetabolites, cytotoxic drugs), or parents confirmed to have HIV infection.
* Receipt of immunoglobulins/blood products (except hepatitis B immunoglobulin) within 3 months before vaccination.
* Severe congenital anomalies (important organ function impairment), severe malnutrition, developmental disorders, severe hereditary diseases.
* Currently suffering from the following diseases:
1. Severe liver or kidney diseases, cardiovascular diseases, malignant tumors, and other severe chronic diseases.
2. Diagnosed serious infectious diseases, such as tuberculosis, viral hepatitis, etc.
3. Severe asthma.
4. Generalized rashes, dermatophytosis, skin suppuration, or blistering.
5. Convulsions, epilepsy, encephalopathy, psychiatric disorders or family history of psychiatric disorders.
* Planning to participate or currently participating in other vaccine or drug clinical trials.
* Any condition that the investigators believe may affect the evaluation of the study.
6 Months
5 Years
ALL
Yes
Sponsors
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Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Lin Du
Role: STUDY_CHAIR
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Locations
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Icddr,B
Dhaka, , Bangladesh
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PR-24079
Identifier Type: -
Identifier Source: org_study_id
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