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

Phase 1

Completed

• Conditions: Typhoid Fever
• Interventions: Biological: Typhim Vi®; Biological: Typbar-TCV™; Biological: EuTCV

• Registration Number: NCT03956524
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-16
• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-20
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-06
• Last Update Posted: 2019-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparator group 2	Typhim Vi®	Single dose of Typhim Vi® will be administered intramuscularly
Comparator group 1	Typbar-TCV™	Single dose of Typbar-TCV™ will be administered intramuscularly
Test group	EuTCV	Single dose of EuTCV will be administered intramuscularly

Primary Outcome Measures

Name	Time	Method
Local and systemic solicited adverse events	Day 7
Serious adverse events	up to 6 weeks
Unsolicited adverse events	up to 6 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with seroconversion	Baseline to Day 42	Defined as a 4-fold or more rise in anti-Vi antibody titers

Trial Locations

Locations (1)

De La Salle Health Sciences Institute; 🇵🇭 Dasmariñas, Cavite, Philippines