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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02164110
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : December 8, 2014
Sponsor:
Collaborator:
Instituto Universitario IVI
Information provided by (Responsible Party):
EuBiologics Co.,Ltd

Tracking Information
First Submitted Date  ICMJE April 27, 2014
First Posted Date  ICMJE June 16, 2014
Last Update Posted Date December 8, 2014
Study Start Date  ICMJE May 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2014)
  • Efficacy [ Time Frame: 14 days after second doses ]
    Proportion of subjects exhibiting 4-fold or greater rises in titers of anti-V. cholera O1 antibody, relative to baseline
  • Safety [ Time Frame: From first shot to 14 days after second dose ]
    Type and frequency of solicited adverse event type (Day 0 ~ 6), Type and frequency of unsolicited adverse event type (Day 0 ~ Day 28)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02164110 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2014)
  • Efficacy [ Time Frame: 14 days after second doses ]
    1. Proportion of subjects exhibiting 4-fold or greater rises in titers of anti-V. cholera O139 antibody, relative to baseline
  • Safety [ Time Frame: From first shot to 14 days after second dose ]
    1. Change from baseline in vital signs and physical examination
  • Efficacy [ Time Frame: 14 days after second doses ]
    1. Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) as measured by each anti-V. cholera antibody titer at Week 2 (Visit 3) after the second dose as compared to prior to investigational product dosing (Visit 1).
  • Safety [ Time Frame: 14 days after second doses ]
    1. Change from baseline in laboratory tests (hematologic test, blood chemistry test, urinalysis) to be performed only in subjects who participate in the Pivotal study.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Evaluate the Efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children
Official Title  ICMJE A Randomized, Single Blind, Multicenter, Therapeutic Confirmatory Study to Assess the Efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children
Brief Summary The purpose of this study is to evaluate the efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children.
Detailed Description A randomized, single blind, multicenter, therapeutic confirmatory study to assess the efficacy (immunogenicity) and safety of Euvichol in healthy adults and children
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Prevention Harmful Effects
Intervention  ICMJE
  • Biological: 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
    Other Name: Oral Cholerae Vaccine
  • 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
    Other Name: Oral cholera vaccine
Study Arms  ICMJE
  • Experimental: 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: Biological: Euvichol
  • Active Comparator: 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: Biological: Shanchol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 12, 2014)
3632
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Philippines
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02164110
Other Study ID Numbers  ICMJE UBC301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EuBiologics Co.,Ltd
Study Sponsor  ICMJE EuBiologics Co.,Ltd
Collaborators  ICMJE Instituto Universitario IVI
Investigators  ICMJE
Principal Investigator: Roberto A. Espos, MD De La Salle University Hospital Medical Center
PRS Account EuBiologics Co.,Ltd
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP