Efficacy, Immunogenicity and Safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 6 Months to 5 Years

January 6, 2022 updated by: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 6 Months to 5 Years

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in infants and children aged from 6 months to 5 years.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

21000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • Hezhou, Guangxi, China, 542899
        • Recruiting
        • Hezhou Center for Disease Control and Prevention
        • Contact:
      • Luzhai, Guangxi, China, 545699
        • Not yet recruiting
        • Luzhai Center for Disease Control and Prevention
        • Contact:
      • Sanjiang, Guangxi, China, 545500
        • Not yet recruiting
        • Sanjiang Center for Disease Control and Prevention
        • Contact:
      • Zhongshan, Guangxi, China, 542600
        • Recruiting
        • Zhongshan Center for Disease Control and Prevention
        • Contact:
    • Hebei
      • Handan, Hebei, China, 056011
        • Not yet recruiting
        • Yongnian Center for Disease Control and Prevention
        • Contact:
      • Yuanshi, Hebei, China, 051130
        • Not yet recruiting
        • Yuanshi Center for Disease Control and Prevention
        • Contact:
    • Sichuan
      • Panzhihua, Sichuan, China, 617000
        • Not yet recruiting
        • Panzhihua Center for Disease Control and Prevention
        • Contact:
      • Zigong, Sichuan, China, 643000
        • Not yet recruiting
        • Zigong Center for Disease Control and Prevention
        • Contact:
      • Zigong, Sichuan, China, 643299
        • Not yet recruiting
        • Fushun Center for Disease Control and Prevention
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infants and children aged from 3 months to 5 years old;
  • The legal representative voluntarily agrees to participate in the study and signed the informed consent form;
  • The legal representative voluntarily agrees to comply with the requirements of the clinical study protocol, and they can participate in all planned follow-up;
  • Subjects who didn't immuned with attenuated live vaccine within 14 days and inactivated vaccine within 7 days before vaccination;
  • Axillary temperature ≤37.0℃;
  • According to the medical history, physical examination and the judgment of the researcher, it is determined that the subject is in good physical condition.

Exclusion Criteria:

  • Previous proven history of bacillary dysentery;
  • Subjects who are allergic to tetanus toxoid, and have any history of other vaccination or drug allergy, or a fever above 39.5 ℃ after previous vaccination;
  • Within 3 days before vaccination, suffering from acute diseases or in the acute episode of chronic disease or using antipyretic, analgesic and antiallergic drugs (such as acetaminophen, ibuprofen, etc.);
  • Had severe bowel disease, and had symptoms such as diarrhea, abdominal pain, pus and blood stool and other symptoms in the past 3 days;
  • With pathological jaundice confirmed by existing diagnosis;
  • History of thrombocytopenia or other coagulation disorders with definite diagnosis;
  • Known or suspected immunological deficiency (such as perianal abscess, which indicates that infants may have immune deficiency), and received long-term (≥14 days) immunosuppressive therapy (radiotherapy, chemotherapy, systemic glucocorticosteroids≥2 mg/kg/day, antimetabolic drugs and cytotoxic drugs) within half a year before vaccination, or confirmed that the parents were HIV infected;
  • Received immunoglobulin / blood products treatment within 3 months before vaccination;
  • Severe congenital malformations (functional impairment of important organs), severe malnutrition, developmental disorders and serious genetic diseases (such as severe thalassemia);

  • Subjects with the following diseases:

    1. Serious liver and kidney diseases, cardiovascular diseases, malignant tumors and other chronic diseases;
    2. Diagnosis with infectious diseases such as tuberculosis, viral hepatitis and so on;
    3. Severe asthma;
    4. Systemic rash, dermatophyte, skin suppuration or blister;
    5. History or family history of convulsion, epilepsy, encephalopathy, mental illness;
  • Planning to participate or currently participating in clinical trials of other vaccines or drugs;
  • Any situation that the investigator believed may affect the study evaluation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine, 0.5ml/dose, 2 doses with an interval of 30 days.
Biological: S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine
Single intramuscular dose contains 10 µg of S. flexneri 2a polysaccharide and S. sonnei polysaccharide respectively.
Placebo Comparator: Placebo group
Aluminium phosphate adjuvant, 0.5ml/dose, 2 doses with an interval of 30 days.
Biological: Placebo
Single intramuscular dose contains 0.15~0.25 mg of aluminum ion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy study of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine as assessed by protective rate
Time Frame: 30 day after each vaccination
Evaluate the protective rate for bacillary dysentery
30 day after each vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Investigators

  • Study Chair: Lin Du, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2021

Primary Completion (Anticipated)

January 11, 2024

Study Completion (Anticipated)

January 11, 2024

Study Registration Dates

First Submitted

December 8, 2021

First Submitted That Met QC Criteria

December 12, 2021

First Posted (Actual)

December 14, 2021

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 6, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021080C

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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