NCT06921460

Brief Summary

Typhoid fever is a serious systemic infection caused by the enteric pathogen Salmonella enterica serovar typhi. S typhi is spread by the fecal-oral route. Although largely an endemic disease, S. typhi has epidemic potential. This research aims to determine the long-term immune response after administration of one dose of Bio TCV and PQed TCV vaccines in the population in Indonesia. Research participants will be taken from research participants who complete the Bio TCV (Typhoid 0319) Phase III clinical trial research included in the Main Study Group I.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
624

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 3, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

November 6, 2024

Last Update Submit

June 2, 2025

Conditions

Antibody Typhoid Vaccine

Outcome Measures

Primary Outcomes (1)

  • To evaluate antibody persistence 5 years after vaccination with one dose of Vi-DT vaccine (Bio TCV), compared to PQed TCV (Typbar)

    5 years since got vaccination

Study Arms (2)

Test

Bio-TCV group : Blood collection for long-term protection

Comparator

Typbar group : Blood collection for long-term protection

Eligibility Criteria

Age6 Months - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Subjects who previously enrolled in Phase 3 study Typhoid 0319 in Main Study I

You may qualify if:

  • Healthy
  • Subject/Parents/legal guardian(s) have been informed properly regarding the study and signed the informed consent form/and informed assent form.
  • Subject/parents/legal guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.

You may not qualify if:

  • History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Child Health Dr. Soetomo Hospital/School of Medicine, Airlangga University, Surabaya, East Java

Jakarta, DKI Jakarta, Indonesia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples.

Central Study Contacts

Bernie Medise, SpA(K), M

CONTACT

021-4894932bernie.medise@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2024

First Posted

April 10, 2025

Study Start

June 15, 2025

Primary Completion

August 31, 2025

Study Completion

December 31, 2025

Last Updated

June 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)