Persistence and Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines in Indonesian Adults, Adolescent, Children and Infants

Typhoid 0220

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.

2021-05-03

2024-10-28

2024-12-30

Active (not recruiting)

Early phase I

188

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'One dose Vi-DT vaccine in clinical trial subjects which is received primary dose at 6-23 months old.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 188, 'type': 'ACTUAL'}}

2022-09-19