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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

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

Condition or disease Intervention/treatment Phase
Prevention Harmful Effects Biological: Euvichol Biological: Shanchol Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3632 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Randomized, Single Blind, Multicenter, Therapeutic Confirmatory Study to Assess the Efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children
Study Start Date : May 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
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
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

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
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




Primary Outcome Measures :
  1. 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

  2. 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)


Secondary Outcome Measures :
  1. 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

  2. Safety [ Time Frame: From first shot to 14 days after second dose ]
    1. Change from baseline in vital signs and physical examination

  3. 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).

  4. 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.



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Ages Eligible for Study:   1 Year to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164110


Locations
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Philippines
Antonio D. Ligsay, MD
Quezon City, Philippines, 4332
Sponsors and Collaborators
EuBiologics Co.,Ltd
Instituto Universitario IVI
Investigators
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Principal Investigator: Roberto A. Espos, MD De La Salle University Hospital Medical Center

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Responsible Party: EuBiologics Co.,Ltd
ClinicalTrials.gov Identifier: NCT02164110     History of Changes
Other Study ID Numbers: UBC301
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs