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

Shigellosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05156528
• Other study ID #: 2021080C
• Status: Recruiting
• Phase: Phase 3
• Start date: December 11, 2021
• Est. completion date: January 11, 2024

Study information

• Verified date: January 2022
• Source: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21000
• Est. completion date: January 11, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysentery
• Dysentery, Bacillary
• Shigellosis

Intervention

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
Single intramuscular dose contains 0.15~0.25 mg of aluminum ion

Locations

Country	Name	City	State
China	Yongnian Center for Disease Control and Prevention	Handan	Hebei
China	Hezhou Center for Disease Control and Prevention	Hezhou	Guangxi
China	Luzhai Center for Disease Control and Prevention	Luzhai	Guangxi
China	Panzhihua Center for Disease Control and Prevention	Panzhihua	Sichuan
China	Sanjiang Center for Disease Control and Prevention	Sanjiang	Guangxi
China	Yuanshi Center for Disease Control and Prevention	Yuanshi	Hebei
China	Zhongshan Center for Disease Control and Prevention	Zhongshan	Guangxi
China	Fushun Center for Disease Control and Prevention	Zigong	Sichuan
China	Zigong Center for Disease Control and Prevention	Zigong	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy study of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine as assessed by protective rate	Evaluate the protective rate for bacillary dysentery	30 day after each vaccination