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

Phase 3

• Conditions: Dysentery; Shigellosis
• Interventions: Biological: Placebo; Biological: S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine

• Registration Number: NCT05156528
• Lead Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-08
• Study Start: 2021-12-11
• Study First Submitted QC: 2021-12-12
• Study First Posted: 2021-12-14
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-11
• Primary Completion: 2024-01-11
• Study Completion: 2024-01-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 21000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Aluminium phosphate adjuvant, 0.5ml/dose, 2 doses with an interval of 30 days.
Experimental group	S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine	S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine, 0.5ml/dose, 2 doses with an interval of 30 days.

Primary Outcome Measures

Name	Time	Method
Efficacy study of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine as assessed by protective rate	30 day after each vaccination	Evaluate the protective rate for bacillary dysentery

Trial Locations

Locations (9)

Hezhou Center for Disease Control and Prevention; 🇨🇳 Hezhou, Guangxi, China

Yuanshi Center for Disease Control and Prevention; 🇨🇳 Yuanshi, Hebei, China

Panzhihua Center for Disease Control and Prevention; 🇨🇳 Panzhihua, Sichuan, China

Luzhai Center for Disease Control and Prevention; 🇨🇳 Luzhai, Guangxi, China

Sanjiang Center for Disease Control and Prevention; 🇨🇳 Sanjiang, Guangxi, China

Zigong Center for Disease Control and Prevention; 🇨🇳 Zigong, Sichuan, China

Zhongshan Center for Disease Control and Prevention; 🇨🇳 Zhongshan, Guangxi, China

Yongnian Center for Disease Control and Prevention; 🇨🇳 Handan, Hebei, China

Fushun Center for Disease Control and Prevention; 🇨🇳 Zigong, Sichuan, China