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

PT Bio Farma

Status and phase

Completed

Phase 3

Phase 2

Conditions

Vaccine

Treatments

Drug: Vi-DT Typhoid Conjugate Vaccine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04741828

Typhoid 0220

Details and patient eligibility

About

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.

Full description

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.

Enrollment

188 patients

Sex

All

Ages

6 months to 40 years old

Volunteers

Accepts Healthy Volunteers

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.