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

Primary Purpose

Safety Issues

Status

Completed

Phase

Phase 1

Locations

Indonesia

Study Type

Interventional

Intervention

Vi-DT (Bio Farma)

Vi polysaccharide vaccine

Influenzae vaccine

Pneumococcal conjugate vaccine

About this trial

This is an interventional prevention trial for Safety Issues

Eligibility Criteria

2 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy
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.
History of alcohol or substance abuse.
Subject planning to move from the study area before the end of study period.

Sites / Locations

Puskesmas Jatinegara
Jatinegara Primary Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Vi-DT (Bio Farma)

Vi polysaccharide vaccine

Vi-DT (Bio Farma) ~ Children

Vi polysaccharide vaccine ~ Children

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Local reaction and systemic event after vaccination

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

Secondary Outcome Measures

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.

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.

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.

Preliminary assessment of immunogenicity of typhoid conjugated vaccine (Vi-DT)

Percentage of subjects with > 4 times increasing antibody

Geometric Mean Titers (GMT) following immunization

Geometric Mean Titers (GMT) 28 days following immunization

Full Information

NCT ID

NCT03109600

First Posted

November 1, 2016

Last Updated

March 4, 2018

Sponsor

PT Bio Farma

1. Study Identification

Unique Protocol Identification Number

NCT03109600

Brief Title

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

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

April 18, 2017 (Actual)

Primary Completion Date

September 28, 2017 (Actual)

Study Completion Date

February 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PT Bio Farma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Safety Issues

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vi-DT (Bio Farma)

Arm Type

Experimental

Arm Description

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

Arm Title

Vi polysaccharide vaccine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Vi-DT (Bio Farma) ~ Children

Arm Type

Experimental

Arm Description

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

Arm Title

Vi polysaccharide vaccine ~ Children

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Vi-DT (Bio Farma)

Intervention Description

Typhoid Conjugate Vaccine

Intervention Type

Biological

Intervention Name(s)

Vi polysaccharide vaccine

Intervention Description

Vi polysaccharide vaccine

Intervention Type

Biological

Intervention Name(s)

Influenzae vaccine

Intervention Description

1 dose of Influenzae vaccine

Intervention Type

Biological

Intervention Name(s)

Pneumococcal conjugate vaccine

Intervention Description

1 dose of Pneumococcal conjugate Vaccine

Primary Outcome Measure Information:

Title

Local reaction and systemic event after vaccination

Description

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

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Adverse events after vaccination

Description

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.

Time Frame

28 days

Title

Serious adverse events after vaccination

Description

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.

Time Frame

28 days

Title

Routine laboratory evaluation that probably related to the vaccination.

Description

Deviation from routine blood laboratory, kidney and liver function laboratory evaluation that probably related to the vaccination.

Time Frame

7 days

Title

Preliminary assessment of immunogenicity of typhoid conjugated vaccine (Vi-DT)

Description

Percentage of subjects with > 4 times increasing antibody

Time Frame

28 days

Title

Geometric Mean Titers (GMT) following immunization

Description

Geometric Mean Titers (GMT) 28 days following immunization

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy 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. History of alcohol or substance abuse. Subject planning to move from the study area before the end of study period.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bernie Endyarni, MD

Organizational Affiliation

Faculty of Medicine, University of Indonesia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Puskesmas Jatinegara

City

Jakarta

State/Province

DKI Jaya

Country

Indonesia

Facility Name

Jatinegara Primary Health Center

City

Jakarta

Country

Indonesia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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