Clinical trial NCT03109600: Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety Issues
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2017-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Local reaction and systemic event after vaccination
timeFrame: 28 days
Secondary outcomes:
measure: Adverse events after vaccination
timeFrame: 28 days
measure: Serious adverse events after vaccination
timeFrame: 28 days
measure: Routine laboratory evaluation that probably related to the vaccination.
timeFrame: 7 days
measure: Preliminary assessment of immunogenicity of typhoid conjugated vaccine (Vi-DT)
timeFrame: 28 days
measure: Geometric Mean Titers (GMT) following immunization
timeFrame: 28 days
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Puskesmas Jatinegara
state: DKI Jaya
city: Jakarta
country: Indonesia
facility: Jatinegara Primary Health Center
Study officials:
affiliation: Faculty of Medicine, University of Indonesia
name: Bernie Endyarni, MD
role: PRINCIPAL_INVESTIGATOR
References: