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OpenTrials
Completed

NCT Number: NCT03956524

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

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.

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Key information

Conditions

Typhoid Fever Bacterial Infections Bacterial Infections and Mycoses Enterobacteriaceae Infections Gram-Negative Bacterial Infections Infections Salmonella Infections

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

De La Salle Health Sciences Institute

Dasmariñas, Cavite, 4114, Philippines

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects aged between and including 18 and 45 years at time of Visit 1
  • Subjects willing to give written informed consent to participate in the trial
  • Subjects who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests

Exclusion criteria

  • Subjects unwilling to give his/her consent to participate in the trial
  • Subjects who have received Typhoid containing vaccines
  • Subjects who have past history of Typhoid
  • Subjects already immunized with any licensed vaccine within 4 weeks
  • Subjects with known hypersensitivity to any component of the study vaccine
  • Subjects who are pregnant, lactating or childbearing age not using a reliable method of contraception
  • Subjects with any abnormality or chronic disease
  • Subjects with evidence of acute illness within past 7 days requiring systemic antibiotic or antiviral therapy
  • Subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or typhoid
  • Subjects who have known history of immune function disorders
  • Subjects who have known history of administration of blood or blood-derived products
  • Subjects who have history of alcohol or substance abuse

Treatment and study plan

EuTCV

Biological

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

Typbar-TCV™

Biological

Single 0.5 mL dose of TCV of Bharat Biotech

Typhim Vi®

Biological

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

Primary outcomes

  1. Local and systemic solicited adverse events

    Time frame: Day 7

  2. Unsolicited adverse events

    Time frame: up to 6 weeks

  3. Serious adverse events

    Time frame: up to 6 weeks

Secondary outcomes

  1. Proportion of subjects with seroconversion

    Time frame: Baseline to Day 42

    Defined as a 4-fold or more rise in anti-Vi antibody titers

Sponsors and collaborators

Lead sponsor

EuBiologics Co.,Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 20, 2019
Registry last updated
Dec 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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