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Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)

NCT04051268 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3071

Last updated 2022-01-04

No results posted yet for this study

Summary

Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and Typhoid Vi polysaccharide vaccine.

Conditions

  • Safety Issues
  • Immunogenicity

Interventions

BIOLOGICAL

Vi-DT Typhoid Conjugate Vaccine

1 dose of Investigational Product

BIOLOGICAL

PQed Typhoid Conjugate Vaccine

1 dose of Active Comparator

BIOLOGICAL

Vi Polysaccharide Vaccine

1 dose of Active Comparator

Sponsors & Collaborators

  • PT Bio Farma

    lead INDUSTRY

Principal Investigators

  • Bernie E Medise, MD · Fakultas Kedokteran Universitas Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-03-02
Primary Completion
2021-11-24
Completion
2021-12-01

Countries

  • Indonesia

Study Locations

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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 NCT04051268 on ClinicalTrials.gov