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

NCT05156528 | Unknown Phase 3

• 1 other identifier: 2021080C
• Study Type: interventional
• Target: 21,000
• Locations: 1 country
• Sites: 9

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.

Conditions

Dysentery; Shigellosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

Aluminium phosphate adjuvant, 0.5ml/dose, 2 doses with an interval of 30 days.

Biological: Placebo

Interventions

S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine BIOLOGICAL

Single intramuscular dose contains 10 µg of S. flexneri 2a polysaccharide and S. sonnei polysaccharide respectively.

Experimental group

Placebo BIOLOGICAL

Single intramuscular dose contains 0.15\~0.25 mg of aluminum ion

Placebo group

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Serious liver and kidney diseases, cardiovascular diseases, malignant tumors and other chronic diseases;
• Diagnosis with infectious diseases such as tuberculosis, viral hepatitis and so on;
• Severe asthma;
• Systemic rash, dermatophyte, skin suppuration or blister;
• History or family history of convulsion, epilepsy, encephalopathy, mental illness;

Sponsors & Collaborators

• Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd: lead

Study Sites (9)

Hezhou Center for Disease Control and Prevention

Hezhou, Guangxi, 542899, China

RECRUITING

Luzhai Center for Disease Control and Prevention

Luzhai, Guangxi, 545699, China

NOT YET RECRUITING

Sanjiang Center for Disease Control and Prevention

Sanjiang, Guangxi, 545500, China

NOT YET RECRUITING

Zhongshan Center for Disease Control and Prevention

Zhongshan, Guangxi, 542600, China

RECRUITING

Yongnian Center for Disease Control and Prevention

Handan, Hebei, 056011, China

NOT YET RECRUITING

Yuanshi Center for Disease Control and Prevention

Huaiyang, Hebei, 051130, China

NOT YET RECRUITING

Panzhihua Center for Disease Control and Prevention

Panzhihua, Sichuan, 617000, China

NOT YET RECRUITING

Zigong Center for Disease Control and Prevention

Zigong, Sichuan, 643000, China

NOT YET RECRUITING

Fushun Center for Disease Control and Prevention

Zigong, Sichuan, 643299, China

NOT YET RECRUITING

MeSH Terms

Conditions

Dysentery; Dysentery, Bacillary

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Lin Du

  Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 14, 2021
• Study Start: December 11, 2021
• Primary Completion: January 11, 2024
• Study Completion: January 11, 2024
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

CN (9)