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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

21000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-11

Study Completion Date

2024-01-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 3 Months to 5 Years Old

NCT04865497

Dysentery Dysentery, Bacillary

COMPLETED PHASE2

Safety Study of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months

NCT03561181

Dysentery Dysentery, Bacillary

COMPLETED PHASE1

Clinical Trial of the S. Flexneri-S. Sonnei Bivalent Conjugate Vaccine

NCT06838195

Dysentery Dysentery, Shigella

NOT_YET_RECRUITING PHASE3

Phase I Clinical Trial of Inactivated Rotavirus Vaccine in a Population Aged 6 Weeks-49 Years Old

NCT06350058

Healthy Volunteers

ACTIVE_NOT_RECRUITING PHASE1

A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants

NCT06663436

Diarrhoea

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dysentery Shigellosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental group

S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine, 0.5ml/dose, 2 doses with an interval of 30 days.

Group Type EXPERIMENTAL

S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine

Intervention Type BIOLOGICAL

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

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine

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

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lin Du

Role: STUDY_CHAIR

Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hezhou Center for Disease Control and Prevention

Hezhou, Guangxi, China

Site Status RECRUITING