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

Typhoid Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956524
• Other study ID #: UTCV_101
• Status: Completed
• Phase: Phase 1
• Start date: March 16, 2019
• Est. completion date: August 31, 2019

Study information

• Verified date: December 2019
• Source: EuBiologics Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Typhoid Fever

Intervention

Biological:
• EuTCV
Single 0.5 mL dose of TCV of EuBiologics co., Ltd.
• Typbar-TCV™
Single 0.5 mL dose of TCV of Bharat Biotech
• Typhim Vi®
Single 0.5 mL dose of Vi capsular polysaccharide vaccine of Sanofi Pasteur

Locations

Country	Name	City	State
Philippines	De La Salle Health Sciences Institute	Dasmariñas	Cavite

Sponsors (1)

Lead Sponsor	Collaborator
EuBiologics Co.,Ltd

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local and systemic solicited adverse events		Day 7
Primary	Unsolicited adverse events		up to 6 weeks
Primary	Serious adverse events		up to 6 weeks
Secondary	Proportion of subjects with seroconversion	Defined as a 4-fold or more rise in anti-Vi antibody titers	Baseline to Day 42