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To Evaluate the Efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children

NCT ID: NCT02164110

Last Updated: 2014-12-08

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3632 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-10-31

Brief Summary

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The purpose of this study is to evaluate the efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children.

Detailed Description

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A randomized, single blind, multicenter, therapeutic confirmatory study to assess the efficacy (immunogenicity) and safety of Euvichol in healthy adults and children

Conditions

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Prevention Harmful Effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Euvichol

* Number of doses and intervals: two doses/Weeks 0 and 2
* Method of administration: oral administration
* Dose of drug to be administered: 1.5 mL/dose

Group Type EXPERIMENTAL

Euvichol

Intervention Type BIOLOGICAL

* Number of doses and intervals: two doses/Weeks 0 and 2
* Method of administration: oral administration
* Dose of drug to be administered: 1.5 mL/dose

Shanchol

* Number of doses and intervals: two doses/Weeks 0 and 2
* Method of administration: oral administration
* Dose of drug to be administered: 1.5 mL/dose

Group Type ACTIVE_COMPARATOR

Shanchol

Intervention Type BIOLOGICAL

* Number of doses and intervals: two doses/Weeks 0 and 2
* Method of administration: oral administration
* Dose of drug to be administered: 1.5 mL/dose

Interventions

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Euvichol

* Number of doses and intervals: two doses/Weeks 0 and 2
* Method of administration: oral administration
* Dose of drug to be administered: 1.5 mL/dose

Intervention Type BIOLOGICAL

Shanchol

* Number of doses and intervals: two doses/Weeks 0 and 2
* Method of administration: oral administration
* Dose of drug to be administered: 1.5 mL/dose

Intervention Type BIOLOGICAL

Other Intervention Names

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Oral Cholerae Vaccine Oral cholera vaccine

Eligibility Criteria

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Inclusion Criteria

1. Written informed consent to study participation voluntarily provided by an individual or his/her legally acceptable representative.
2. Age of 1 \~ 40 years
3. An individual who can be followed up during the study period and is capable of complying with the study requirements.

Exclusion Criteria

1. History of hypersensitivity reactions to other preventative vaccinations.
2. Immune function disorders including immunodeficiency diseases.
3. An individual thought to have difficulty participating in the study due to severe chronic diseases, based on the judgment of the investigator.
4. 38℃ or higher body temperature measured prior to investigational product dosing.
5. Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours prior to study initiation.
6. Diarrhea or administration of antidiarrheal drugs or antibiotics to treat diarrhea within 1 week prior to study initiation.
7. Other vaccination within 1 week prior to study initiation or planned vaccination during the study.
8. Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study initiation.
9. Participation in another clinical trial with investigational product dosing within 1 month prior to study initiation.
10. Pregnant or lactating women.
11. An individual thought to have difficulty participating in the study due to other reasons, based on the judgment of the investigator
12. Applicable to the Pivotal study only: history of cholera vaccinations or history of cholera.
Minimum Eligible Age

1 Year

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Universitario IVI

OTHER

Sponsor Role collaborator

EuBiologics Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roberto A. Espos, MD

Role: PRINCIPAL_INVESTIGATOR

De La Salle University Hospital Medical Center

Locations

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Antonio D. Ligsay, MD

Quezon City, , Philippines

Site Status

Countries

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Philippines

Other Identifiers

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UBC301

Identifier Type: -

Identifier Source: org_study_id