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Non-inferiority and Safety Study of EuTCV Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants

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: NCT04830371
Recruitment Status : Completed
First Posted : April 5, 2021
Last Update Posted : October 7, 2021
Sponsor:
Information provided by (Responsible Party):
EuBiologics Co.,Ltd

Brief Summary:
This is an observer-blinded, comparative, single dose, clinical phase II/III study to assess the immunogenicity and safety of EuTCV compared to Typhoid conjugate vaccine in healthy Filipino participants aged 6 months to 45 years.

Condition or disease Intervention/treatment Phase
Typhoid Fever Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine) Biological: Typbar-TCV Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 444 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase II/III, Multicenter, Observer-Blinded, Randomized, Non-inferiority and Safety Study of Typhoid Conjugate Vaccine (EuTCV) Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants
Actual Study Start Date : September 7, 2020
Actual Primary Completion Date : March 18, 2021
Actual Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arm Intervention/treatment
Experimental: Arm A (Vi-CRM197, Batch #1)
Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #1 will be intramuscularly administered at Day 0.
Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine)
Single dose, Intramuscular administration

Experimental: Arm A (Vi-CRM197, Batch #2)
Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #2 will be intramuscularly administered at Day 0.
Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine)
Single dose, Intramuscular administration

Experimental: Arm A (Vi-CRM197, Batch #3)
Single dose of Typhoid Conjugate Vaccine (Vi-CRM197) Batch #3 will be intramuscularly administered at Day 0.
Biological: EuTCV (Vi-CRM Typhoid conjugate vaccine)
Single dose, Intramuscular administration

Active Comparator: Arm D (Typbar-TCV)
Single dose of Typhoid Conjugate Vaccine (Typbar-TCV) will be intramuscularly administered at Day 0.
Biological: Typbar-TCV
Single dose, Intramuscular administration




Primary Outcome Measures :
  1. Seroconversion rate [ Time Frame: 4 weeks after vaccination of EuTCV (pooled of 3 batches)/Typbar-TCV compared to baseline ]
  2. Proportion of Solicited local and systemic AEs [ Time Frame: 7 days after vaccination ]
  3. Proportion of unsolicited AEs [ Time Frame: within 28 days after vaccination ]


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Ages Eligible for Study:   6 Months to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy participants ≥6 months and ≤45 years of age at enrolment
  2. Participants/Parents/Legally Authorized Representative(LAR) willing to give written informed consent/assent to participate in the trial
  3. Participants/Parents/LAR willing to follow the study procedures of the study and available for the entire duration of the study
  4. Participants who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests
  5. Female participants must have a negative serum (at Screening) and negative urinary (at Day 1) pregnancy test and agree to use 2 methods of contraception from dosing until 90 days after vaccination.

Exclusion Criteria:

  1. Participants/Parents/LAR unwilling to give his/her consent/assent to participate in the trial
  2. Participants concomitantly enrolled or scheduled to be enrolled in another trial
  3. Children and infants with a congenital abnormality
  4. Known history of immune function disorders including immunodeficiency disease, or chronic use of systemic steroids, cytotoxic or other immunosuppressive drugs
  5. Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
  6. History of uncontrolled coagulopathy or blood disorders
  7. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the trial objectives
  8. 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): NCT04830371


Locations
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Philippines
De La Salle Medical and Health Sciences Institute
Cavite, Philippines
University of the East Ramon Magsaysay Memorial Medical Center
Quezon City, Philippines
Sponsors and Collaborators
EuBiologics Co.,Ltd
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Responsible Party: EuBiologics Co.,Ltd
ClinicalTrials.gov Identifier: NCT04830371    
Other Study ID Numbers: EuVCT_TCV301
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Typhoid Fever
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections