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

Launched by EUBIOLOGICS CO.,LTD · May 16, 2019

Keywords

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Gender

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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