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

Phase 1

Completed

• Conditions: Safety Issues
• Interventions: Biological: Vi-DT (Bio Farma); Biological: Vi polysaccharide vaccine; Biological: Influenzae vaccine; Biological: Pneumococcal conjugate vaccine

• Registration Number: NCT03109600
• Lead Sponsor: PT Bio Farma

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.

Study Timeline

• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-12
• Study Start: 2017-04-18
• Status Verified: 2017-07
• Primary Completion: 2017-09-28
• Study Completion: 2018-02-19
• Last Update Submitted: 2018-03-04
• Last Update Posted: 2018-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vi-DT (Bio Farma)	Vi-DT (Bio Farma)	2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine
Vi-DT (Bio Farma) ~ Children	Vi-DT (Bio Farma)	2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine
Vi polysaccharide vaccine ~ Children	Vi polysaccharide vaccine	1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Pneumococcal Conjugate Vaccine
Vi polysaccharide vaccine	Influenzae vaccine	1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Influenzae Vaccine
Vi polysaccharide vaccine ~ Children	Pneumococcal conjugate vaccine	1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Pneumococcal Conjugate Vaccine
Vi polysaccharide vaccine	Vi polysaccharide vaccine	1 dose of 0.5 ml Vi polysaccharide vaccine + 1 dose of Influenzae Vaccine

Primary Outcome Measures

Name	Time	Method
Local reaction and systemic event after vaccination	28 days	Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination.

Secondary Outcome Measures

Name	Time	Method
Adverse events after vaccination	28 days	Percentage of subjects with at least one of these adverse events, solicited or not, within 24 h, 48h, 72h and 28 days after each vaccination.
Serious adverse events after vaccination	28 days	Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination and up to 6 months after the last vaccination.
Routine laboratory evaluation that probably related to the vaccination.	7 days	Deviation from routine blood laboratory, kidney and liver function laboratory evaluation that probably related to the vaccination.
Preliminary assessment of immunogenicity of typhoid conjugated vaccine (Vi-DT)	28 days	Percentage of subjects with \> 4 times increasing antibody
Geometric Mean Titers (GMT) following immunization	28 days	Geometric Mean Titers (GMT) 28 days following immunization

Trial Locations

Locations (2)

Jatinegara Primary Health Center; 🇮🇩 Jakarta, Indonesia

Puskesmas Jatinegara; 🇮🇩 Jakarta, DKI Jaya, Indonesia