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

NCT ID: NCT03956524

Last Updated: 2019-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-16

Study Completion Date

2019-08-31

Brief Summary

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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

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Conditions

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Typhoid Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Healthy adult volunteers will be randomized in a 1:1:1 ratio to receive single dose of test or the comparator vaccines.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test group

Single dose of EuTCV will be administered intramuscularly

Group Type EXPERIMENTAL

EuTCV

Intervention Type BIOLOGICAL

Single 0.5 mL dose of TCV of EuBiologics co., Ltd.

Comparator group 1

Single dose of Typbar-TCV™ will be administered intramuscularly

Group Type ACTIVE_COMPARATOR

Typbar-TCV™

Intervention Type BIOLOGICAL

Single 0.5 mL dose of TCV of Bharat Biotech

Comparator group 2

Single dose of Typhim Vi® will be administered intramuscularly

Group Type ACTIVE_COMPARATOR

Typhim Vi®

Intervention Type BIOLOGICAL

Single 0.5 mL dose of Vi capsular polysaccharide vaccine of Sanofi Pasteur

Interventions

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EuTCV

Single 0.5 mL dose of TCV of EuBiologics co., Ltd.

Intervention Type BIOLOGICAL

Typbar-TCV™

Single 0.5 mL dose of TCV of Bharat Biotech

Intervention Type BIOLOGICAL

Typhim Vi®

Single 0.5 mL dose of Vi capsular polysaccharide vaccine of Sanofi Pasteur

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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EuBiologics Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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De La Salle Health Sciences Institute

Dasmariñas, Cavite, Philippines

Site Status

Countries

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Philippines

References

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Choi SK, Baik YO, Kim CW, Kim SK, Oh IN, Yoon H, Yu D, Lee C. An open-label, comparative, single dose, clinical Phase Ⅰ study to assess the safety and immunogenicity of typhoid conjugate vaccine (Vi-CRM197) in healthy Filipino adults. Vaccine. 2021 May 6;39(19):2620-2627. doi: 10.1016/j.vaccine.2021.03.089. Epub 2021 Apr 10.

Reference Type DERIVED
PMID: 33849723 (View on PubMed)

Other Identifiers

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UTCV_101

Identifier Type: -

Identifier Source: org_study_id