MedTrace Logo

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

NCT04830371 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 444

Last updated 2021-10-07

No results posted yet for this study

Summary

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.

Conditions

  • Typhoid Fever

Interventions

BIOLOGICAL

EuTCV (Vi-CRM Typhoid conjugate vaccine)

Single dose, Intramuscular administration

BIOLOGICAL

Typbar-TCV

Single dose, Intramuscular administration

Sponsors & Collaborators

  • EuBiologics Co.,Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-07
Primary Completion
2021-03-18
Completion
2021-08-01

Countries

  • Philippines

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04830371 on ClinicalTrials.gov