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

PT Bio Farma

Status and phase: Completed; Phase 1

Conditions: Safety Issues

Treatments: Biological: Vi polysaccharide vaccine; Biological: Pneumococcal conjugate vaccine; Biological: Vi-DT (Bio Farma); Biological: Influenzae vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03109600

Typhoid 0116

Details and patient eligibility

About

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

Full description

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

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

Enrollment: 100 patients

Sex: All

Ages: 2 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups

Vi-DT (Bio Farma)

Experimental group

Description:

2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine

Treatment:

Biological: Vi-DT (Bio Farma)

Vi polysaccharide vaccine

Active Comparator group

Description:

1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Influenzae Vaccine

Treatment:

Biological: Vi polysaccharide vaccine

Biological: Influenzae vaccine

Vi-DT (Bio Farma) ~ Children

Experimental group

Description:

2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine

Treatment:

Biological: Vi-DT (Bio Farma)

Vi polysaccharide vaccine ~ Children

Active Comparator group

Description:

1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Pneumococcal Conjugate Vaccine

Treatment:

Biological: Vi polysaccharide vaccine

Biological: Pneumococcal conjugate vaccine