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A Study of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in Dominican Republic

NCT02434822 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2018-03-26

No results posted yet for this study

Summary

The aim of the study is to generate safety and immunogenicity data with Shanchol in The Philippines

Objectives:

* To describe the safety after each dose of Shanchol vaccine.
* To describe the immunogenicity after each dose of Shanchol vaccine.

Conditions

  • Cholera

Interventions

BIOLOGICAL

Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell

1.5 mL, Oral administration

BIOLOGICAL

Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell

1.5 mL, Oral administration

BIOLOGICAL

Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell

1.5 mL, Oral administration

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur SA

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-09-30
Completion
2016-07-31

Countries

  • Dominican Republic

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 NCT02434822 on ClinicalTrials.gov