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

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Brief Title

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

Official Title

An Open-label, Comparative, Clinical Phase 1 Study to Assess the Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults

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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Local and systemic solicited adverse events

Secondary Outcome

 Proportion of subjects with seroconversion

Condition

Typhoid Fever

Intervention

EuTCV

Study Arms / Comparison Groups

 Test group
Description:  Single dose of EuTCV will be administered intramuscularly

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

75

Start Date

March 16, 2019

Completion Date

August 31, 2019

Primary Completion Date

August 31, 2019

Eligibility 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
      

Gender

All

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

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Location Countries

Philippines

Location Countries

Philippines

Administrative Informations


NCT ID

NCT03956524

Organization ID

UTCV_101


Responsible Party

Sponsor

Study Sponsor

EuBiologics Co.,Ltd


Study Sponsor

, , 


Verification Date

December 2019