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OpenTrials
Completed

NCT Number: NCT04830371

Non-inferiority and Safety Study of EuTCV Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants

This is an observer-blinded, comparative, single dose, clinical phase II/III study to assess the immunogenicity and safety of EuTCV compared to Typhoid conjugate vaccine in healthy Filipino participants aged 6 months to 45 years.

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Key information

Age range

6 month–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

De La Salle Medical and Health Sciences Institute, Cavite, Philippines

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy participants ≥6 months and ≤45 years of age at enrolment
  • Participants/Parents/Legally Authorized Representative(LAR) willing to give written informed consent/assent to participate in the trial
  • Participants/Parents/LAR willing to follow the study procedures of the study and available for the entire duration of the study
  • Participants who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests
  • Female participants must have a negative serum (at Screening) and negative urinary (at Day 1) pregnancy test and agree to use 2 methods of contraception from dosing until 90 days after vaccination.

Exclusion criteria

  • Participants/Parents/LAR unwilling to give his/her consent/assent to participate in the trial
  • Participants concomitantly enrolled or scheduled to be enrolled in another trial
  • Children and infants with a congenital abnormality
  • Known history of immune function disorders including immunodeficiency disease, or chronic use of systemic steroids, cytotoxic or other immunosuppressive drugs
  • Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
  • History of uncontrolled coagulopathy or blood disorders
  • Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the trial objectives
  • History of alcohol or substance abuse

Treatment and study plan

EuTCV (Vi-CRM Typhoid conjugate vaccine)

Biological

Single dose, Intramuscular administration

Typbar-TCV

Biological

Single dose, Intramuscular administration

Primary outcomes

  1. Seroconversion rate

    Time frame: 4 weeks after vaccination of EuTCV (pooled of 3 batches)/Typbar-TCV compared to baseline

  2. Proportion of Solicited local and systemic AEs

    Time frame: 7 days after vaccination

  3. Proportion of unsolicited AEs

    Time frame: within 28 days after vaccination

Sponsors and collaborators

Lead sponsor

EuBiologics Co.,Ltd

Industry

Registry information

Official study title

A Phase II/III, Multicenter, Observer-Blinded, Randomized, Non-inferiority and Safety Study of Typhoid Conjugate Vaccine (EuTCV) Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 5, 2021
Registry last updated
Oct 7, 2021

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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