Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2025-12-28 @ 7:51 PM
Study NCT ID:
NCT06838195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-20
First Post:
2025-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of the S. Flexneri-S. Sonnei Bivalent Conjugate Vaccine
Sponsor:
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating the Protective Efficacy, Immunogenicity, and Safety of the S. Flexneri-S. Sonnei Bivalent Conjugate Vaccine in Infants and Children Aged 6 Months to 5 Years in Bangladesh
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the protective efficacy of S. Flexneri-S. Sonnei bivalent conjugate vaccine against diarrhea caused by Shigella infection in infants and children aged 6 months to 5 years. Researchers will observe the incidence of diarrhea of any severity due to Shigella flexneri and Shigella sonnei infection 30 days after full immunization. The subjects will receive 2 doses of vaccination.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: