Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults

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: NCT03956524
Recruitment Status : Active, not recruiting
First Posted : May 20, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
EuBiologics Co.,Ltd

Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of EuTCV, in comparison to TCV (Typbar-TCV™, Bharat Biotech) and Vi-Polysaccharide vaccine (Typhim Vi®, Sanofi Pasteur) in healthy adult volunteers.

Condition or disease Intervention/treatment Phase
Typhoid Fever Biological: EuTCV Biological: Typbar-TCV™ Biological: Typhim Vi® Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Healthy adult volunteers will be randomized in a 1:1:1 ratio to receive single dose of test or the comparator vaccines.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Comparative, Clinical Phase 1 Study to Assess the Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults
Actual Study Start Date : March 16, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test group
Single dose of EuTCV will be administered intramuscularly
Biological: EuTCV
Single 0.5 mL dose of TCV of EuBiologics co., Ltd.

Active Comparator: Comparator group 1
Single dose of Typbar-TCV™ will be administered intramuscularly
Biological: Typbar-TCV™
Single 0.5 mL dose of TCV of Bharat Biotech

Active Comparator: Comparator group 2
Single dose of Typhim Vi® will be administered intramuscularly
Biological: Typhim Vi®
Single 0.5 mL dose of Vi capsular polysaccharide vaccine of Sanofi Pasteur




Primary Outcome Measures :
  1. Local and systemic solicited adverse events [ Time Frame: Day 7 ]
  2. Unsolicited adverse events [ Time Frame: up to 6 weeks ]
  3. Serious adverse events [ Time Frame: up to 6 weeks ]

Secondary Outcome Measures :
  1. Proportion of subjects with seroconversion [ Time Frame: Baseline to Day 42 ]
    Defined as a 4-fold or more rise in anti-Vi antibody titers



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects aged between and including 18 and 45 years at time of Visit 1
  2. Subjects willing to give written informed consent to participate in the trial
  3. Subjects who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests

Exclusion Criteria:

  1. Subjects unwilling to give his/her consent to participate in the trial
  2. Subjects who have received Typhoid containing vaccines
  3. Subjects who have past history of Typhoid
  4. Subjects already immunized with any licensed vaccine within 4 weeks
  5. Subjects with known hypersensitivity to any component of the study vaccine
  6. Subjects who are pregnant, lactating or childbearing age not using a reliable method of contraception
  7. Subjects with any abnormality or chronic disease
  8. Subjects with evidence of acute illness within past 7 days requiring systemic antibiotic or antiviral therapy
  9. Subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or typhoid
  10. Subjects who have known history of immune function disorders
  11. Subjects who have known history of administration of blood or blood-derived products
  12. Subjects who have history of alcohol or substance abuse

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): NCT03956524


Locations
Layout table for location information
Philippines
De La Salle Health Sciences Institute
Dasmariñas, Cavite, Philippines, 4114
Sponsors and Collaborators
EuBiologics Co.,Ltd

Layout table for additonal information
Responsible Party: EuBiologics Co.,Ltd
ClinicalTrials.gov Identifier: NCT03956524     History of Changes
Other Study ID Numbers: UTCV_101
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Typhoid Fever
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs