NCT02164110

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,632

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

4 months

First QC Date

April 27, 2014

Last Update Submit

December 4, 2014

Conditions

Prevention Harmful Effects

Outcome Measures

Primary Outcomes (2)

  • Efficacy

    Proportion of subjects exhibiting 4-fold or greater rises in titers of anti-V. cholera O1 antibody, relative to baseline

    14 days after second doses

  • Safety

    Type and frequency of solicited adverse event type (Day 0 \~ 6), Type and frequency of unsolicited adverse event type (Day 0 \~ Day 28)

    From first shot to 14 days after second dose

Secondary Outcomes (4)

  • Efficacy

    14 days after second doses

  • Safety

    From first shot to 14 days after second dose

  • Efficacy

    14 days after second doses

  • Safety

    14 days after second doses

Study Arms (2)

Euvichol

EXPERIMENTAL

* 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

Biological: Euvichol

Shanchol

ACTIVE COMPARATOR

* 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

Biological: Shanchol

Interventions

EuvicholBIOLOGICAL

* 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

Also known as: Oral Cholerae Vaccine
Euvichol
ShancholBIOLOGICAL

* 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

Also known as: Oral cholera vaccine
Shanchol

Eligibility Criteria

Age1 Year - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antonio D. Ligsay, MD

Quezon City, 4332, Philippines

Location

MeSH Terms

Interventions

shancholCholera Vaccines

Intervention Hierarchy (Ancestors)

Bacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Roberto A. Espos, MD

    De La Salle University Hospital Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2014

First Posted

June 16, 2014

Study Start

May 1, 2014

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations

PH(1)