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

EuBiologics

Status and phase: Completed; Phase 1

Conditions: Typhoid Fever

Treatments: Biological: Typhim Vi®; Biological: Typbar-TCV™; Biological: EuTCV

Study type: Interventional

Funder types: Industry

Identifiers

NCT03956524

UTCV_101

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Test group

Experimental group

Description:

Single dose of EuTCV will be administered intramuscularly

Treatment:

Biological: EuTCV

Comparator group 1

Active Comparator group

Description:

Single dose of Typbar-TCV™ will be administered intramuscularly

Treatment:

Biological: Typbar-TCV™

Comparator group 2

Active Comparator group

Description:

Single dose of Typhim Vi® will be administered intramuscularly

Treatment:

Biological: Typhim Vi®