Persistence and Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines in Indonesian

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-03

Study Completion Date

2024-12-30

Brief Summary

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Vi-DT Typhoid vaccine is a novel vaccine. This study will be done to know the long-term protection and persistent antibody by measured the antibody titer after 2,3,4 and 5 years after immunization.

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Detailed Description

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This study will be done to know the long-term protection and persistent antibody, by measured the antibody titer after 2,3,4 and 5 years after immunization.

Conditions

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Vaccine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

One dose Vi-DT vaccine in clinical trial subjects which is received primary dose at 6-23 months old.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Vi-DT Typhoid Conjugate Vaccine

Participants receive 1 dose (0.5ml) Vi-DT Typhoid Conjugate Vaccine, intramuscularly.

Group Type EXPERIMENTAL

Vi-DT Typhoid Conjugate Vaccine

Intervention Type DRUG

Typhoid Conjugate Vaccine

Interventions

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Vi-DT Typhoid Conjugate Vaccine

Typhoid Conjugate Vaccine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy.
* Subject who completed the phase II Vi-DT study (Typhoid 0218)
* Subjects/Parents have been informed properly regarding the study and signed the informed consent form.
* Subject/parents/legal guardians will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria

* Subject concomitantly enrolled or scheduled to be enrolled in another trial.
* Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5oC).
* Known history of allergy to any component of the vaccines.
* History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
* Any abnormality or chronic disease which according to the investigator might be compromised by the vaccination and/or interfere with the assessment of the trial objectives.

Minimum Eligible Age

6 Months

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes