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

Safety Issues Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03109600
• Other study ID #: Typhoid 0116
• Status: Completed
• Phase: Phase 1
• First received: November 1, 2016
• Last updated: March 4, 2018
• Start date: April 18, 2017
• Est. completion date: February 19, 2018

Study information

• Verified date: July 2017
• Source: PT Bio Farma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 19, 2018
• Est. primary completion date: September 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Safety Issues

Intervention

Biological:
• Vi-DT (Bio Farma)
Typhoid Conjugate Vaccine
• Vi polysaccharide vaccine
Vi polysaccharide vaccine
• Influenzae vaccine
1 dose of Influenzae vaccine
• Pneumococcal conjugate vaccine
1 dose of Pneumococcal conjugate Vaccine

Locations

Country	Name	City	State
Indonesia	Jatinegara Primary Health Center	Jakarta
Indonesia	Puskesmas Jatinegara	Jakarta	DKI Jaya

Sponsors (1)

Lead Sponsor	Collaborator
PT Bio Farma

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local reaction and systemic event after vaccination	Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination.	28 days
Secondary	Adverse events after vaccination	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.	28 days
Secondary	Serious adverse events after vaccination	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.	28 days
Secondary	Routine laboratory evaluation that probably related to the vaccination.	Deviation from routine blood laboratory, kidney and liver function laboratory evaluation that probably related to the vaccination.	7 days
Secondary	Preliminary assessment of immunogenicity of typhoid conjugated vaccine (Vi-DT)	Percentage of subjects with > 4 times increasing antibody	28 days
Secondary	Geometric Mean Titers (GMT) following immunization	Geometric Mean Titers (GMT) 28 days following immunization	28 days