Long-Term Protection of Vi Antibodies Induced by Bio TCV in Indonesian Population Compared to PQed TCV

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-60
SponsorPT Bio Farma

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

624 Participants
are grouped into 2 trial groups
Group A: Test
Group B: Comparator

Trial outcomes

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)

Time frame
5 years since got vaccination

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: