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

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

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-18

Study Completion Date

2018-02-19

Brief Summary

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

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Detailed Description

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

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

Conditions

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Safety Issues

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Vi-DT (Bio Farma)

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

Group Type EXPERIMENTAL

Vi-DT (Bio Farma)

Intervention Type BIOLOGICAL

Typhoid Conjugate Vaccine

Vi polysaccharide vaccine

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

Group Type ACTIVE_COMPARATOR

Vi polysaccharide vaccine

Intervention Type BIOLOGICAL

Vi polysaccharide vaccine

Influenzae vaccine

Intervention Type BIOLOGICAL

1 dose of Influenzae vaccine

Vi-DT (Bio Farma) ~ Children

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

Group Type EXPERIMENTAL

Vi-DT (Bio Farma)

Intervention Type BIOLOGICAL

Typhoid Conjugate Vaccine

Vi polysaccharide vaccine ~ Children

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

Group Type ACTIVE_COMPARATOR

Vi polysaccharide vaccine

Intervention Type BIOLOGICAL

Vi polysaccharide vaccine

Pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

1 dose of Pneumococcal conjugate Vaccine

Interventions

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Vi-DT (Bio Farma)

Typhoid Conjugate Vaccine

Intervention Type BIOLOGICAL

Vi polysaccharide vaccine

Intervention Type BIOLOGICAL

Influenzae vaccine

1 dose of Influenzae vaccine

Intervention Type BIOLOGICAL

Pneumococcal conjugate vaccine

1 dose of Pneumococcal conjugate Vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes