Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)

A Randomized, Observer Blinded, Comparative, Phase I Safety Study in Two Age De-escalating Cohorts to Assess the Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)

This study is to assess the safety of Vi-DT vaccine in adults and children.

To describe the safety of this vaccine following first and second dose immunization.

To assess preliminary information of immunogenicity following Vi-DT vaccine immunization.

Inclusion Criteria:

1. Healthy
2. Subjects/Parents have been informed properly regarding the study and signed the informed consent form
3. Subject/Parents will commit to comply with the instructions of the investigator and the schedule of the trial

Exclusion Criteria:

1. Subject concomitantly enrolled or scheduled to be enrolled in another trial
2. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C )
3. Known history of allergy to any component of the vaccines
4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
5. Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks).
6. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
7. Pregnancy & lactation (Adults)
8. Individuals who have previously received any vaccines against typhoid fever.
9. Subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose.
10. Individuals who have a previously ascertained typhoid fever.
11. History of alcohol or substance abuse.
12. Subject planning to move from the study area before the end of study period.