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)

PT Bio Farma2 sites in 1 country100 target enrollmentApril 18, 2017

ConditionsSafety Issues

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Safety Issues
Sponsor: PT Bio Farma
Enrollment: 100
Locations: 2
Primary Endpoint: Local reaction and systemic event after vaccination
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed 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.

Registry

clinicaltrials.gov

Start Date

April 18, 2017

End Date

February 19, 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

PT Bio Farma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects/Parents have been informed properly regarding the study and signed the informed consent form
•Subject/Parents 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 ³ 37.5°C )
•Known history of allergy to any component of the vaccines
•History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
•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).
•Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
•Pregnancy \& lactation (Adults)
•Individuals who have previously received any vaccines against typhoid fever.
•Subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose.
•Individuals who have a previously ascertained typhoid fever.

Outcomes

Primary Outcomes

Local reaction and systemic event after vaccination

Time Frame: 28 days

Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination.

Secondary Outcomes

Adverse events after vaccination(28 days)
Serious adverse events after vaccination(28 days)
Routine laboratory evaluation that probably related to the vaccination.(7 days)
Preliminary assessment of immunogenicity of typhoid conjugated vaccine (Vi-DT)(28 days)
Geometric Mean Titers (GMT) following immunization(28 days)