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

NCT05156528 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21000

Last updated 2022-01-11

No results posted yet for this study

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

Interventions

BIOLOGICAL

S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine

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

BIOLOGICAL

Placebo

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

Sponsors & Collaborators

  • Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Lin Du · Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-11
Primary Completion
2024-01-11
Completion
2024-01-11

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05156528 on ClinicalTrials.gov