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Immune Non-Inferiority, Safety and Lot-to-Lot Consistency of Oral Cholera Vaccine-Simplified Compared to Shanchol™

NCT04760236 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2530

Last updated 2023-06-22

No results posted yet for this study

Summary

This study is to evaluate immune non-inferiority, safety and lot-to-lot consistency of OCV-S compared to Shanchol™ in 1 to 40 years old healthy Nepalese participants. The investigators hypothesize that the simplified formulation is able to induce non-inferior immunogenicity compared to licensed OCV, Shanchol™.

Conditions

  • Cholera

Interventions

BIOLOGICAL

Oral Cholera Vaccine Simplified (OCV-S)

* Manufacturer: EuBiologics Co., Ltd. * Oral administration

BIOLOGICAL

Shanchol™

* Manufacturer: Shantha Biotechnics * Oral administration

Sponsors & Collaborators

  • EuBiologics Co.,Ltd

    collaborator INDUSTRY

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Julia Lynch, MD · International Vaccine Institution

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-06
Primary Completion
2022-12-22
Completion
2023-03-21

Countries

  • Nepal

Study Locations

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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 NCT04760236 on ClinicalTrials.gov