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Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)

Primary Purpose

Safety Issues, Immunogenicity

Status

Completed

Phase

Phase 3

Locations

Indonesia

Study Type

Interventional

Intervention

Vi-DT Typhoid Conjugate Vaccine

PQed Typhoid Conjugate Vaccine

Vi Polysaccharide Vaccine

About this trial

This is an interventional prevention trial for Safety Issues focused on measuring Vaccine, Typhoid Conjugate Vaccine

Eligibility Criteria

6 Months - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy.
Subject/Parents/legal guardian(s) have been informed properly regarding the study and signed the informed consent form/and informed assent form.
Subject/parents/legal guardian(s) 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 (axilary 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, corticosteroid therapy and other immunosuppressants)
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 vaccinated with any vaccine within one month prior and expect to receive other vaccines within one month following vaccination except MR (Measles Rubella) vaccine.
Individuals who have a previously ascertained typhoid fever by laboratory confirmation (blood culture/new rapid test) at any time.
Subject planning to move from the study area before the end of study period.

Sites / Locations

Jatinegara Primary Health Care

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

Vi-DT TCV Batch 1

Vi-DT TCV Batch 2

Vi-DT TCV Batch 3

PQed Typhoid Conjugate Vaccine (subjects 6 mo-45 yo)

Vi Polysaccharide Vaccine (subjects 46-60 years old)

Arm Description

1 dose of 0.5 ml of Vi-DT TCV vaccine batch 1

1 dose of 0.5 ml of Vi-DT TCV vaccine batch 2

1 dose of 0.5 ml of Vi-DT TCV vaccine batch 3

1 dose of 0.5 ml of PQed TCV Vaccine

1 dose of 0.5 ml of Vi Polysaccharide Vaccine

Outcomes

Primary Outcome Measures

Immunogenicity

Seroconversion following vaccination with one dose of Vi-DT (Bio Farma) in adults, children and infants.

Secondary Outcome Measures

Describe antibody response following vaccination

Comparison of GMT, seroconversion between each lot number of Vi-DT (Bio Farma ) vaccine in each group.

Adverse event, solicited or unsolicited

Number and percentage with at least one adverse event, solicited or unsolicited, within 30 minutes, 72 hours, 7 days, and 28 days after vaccination.

Comparison the safety and immunogenicity

Comparison of adverse events occuring until 28 days after vaccination between each lot number of Vi-DT (Bio Farma ) vaccine and PQed typhoid conjugate vaccine

Full Information

NCT ID

NCT04051268

First Posted

August 6, 2019

Last Updated

December 30, 2021

Sponsor

PT Bio Farma

1. Study Identification

Unique Protocol Identification Number

NCT04051268

Brief Title

Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)

Official Title

Immunogenicity and Safety of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults, Children and Infants, Lot to Lot Consistency, Non-inferiority to PQed (Prequalified) TCV (Typhoid Conjugate Vaccine)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

March 2, 2020 (Actual)

Primary Completion Date

November 24, 2021 (Actual)

Study Completion Date

December 1, 2021 (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

Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and Typhoid Vi polysaccharide vaccine.

Detailed Description

Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and to Typhoid Vi polysaccharide vaccine. Involved participants aged 6 months old to 60 years old.

6. Conditions and Keywords

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

Safety Issues, Immunogenicity

Keywords

Vaccine, Typhoid Conjugate Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Subjects 6 months - 45 years of age: Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine Subjects 46 - 60 years of age: Randomized, observer blind, lot to lot consistency, superiority to Vi polysaccharide vaccine. Subjects 6 months - 60 years old: Randomized, observer blind, lot to lot consistency

Masking

ParticipantInvestigator

Masking Description

Investigational Product and Active Comparator was masking Number of lot was masking

Allocation

Randomized

Enrollment

3071 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vi-DT TCV Batch 1

Arm Type

Experimental

Arm Description

1 dose of 0.5 ml of Vi-DT TCV vaccine batch 1

Arm Title

Vi-DT TCV Batch 2

Arm Type

Experimental

Arm Description

1 dose of 0.5 ml of Vi-DT TCV vaccine batch 2

Arm Title

Vi-DT TCV Batch 3

Arm Type

Experimental

Arm Description

1 dose of 0.5 ml of Vi-DT TCV vaccine batch 3

Arm Title

PQed Typhoid Conjugate Vaccine (subjects 6 mo-45 yo)

Arm Type

Active Comparator

Arm Description

1 dose of 0.5 ml of PQed TCV Vaccine

Arm Title

Vi Polysaccharide Vaccine (subjects 46-60 years old)

Arm Type

Active Comparator

Arm Description

1 dose of 0.5 ml of Vi Polysaccharide Vaccine

Intervention Type

Biological

Intervention Name(s)

Vi-DT Typhoid Conjugate Vaccine

Intervention Description

1 dose of Investigational Product

Intervention Type

Biological

Intervention Name(s)

PQed Typhoid Conjugate Vaccine

Intervention Description

1 dose of Active Comparator

Intervention Type

Biological

Intervention Name(s)

Vi Polysaccharide Vaccine

Intervention Description

1 dose of Active Comparator

Primary Outcome Measure Information:

Title

Immunogenicity

Description

Seroconversion following vaccination with one dose of Vi-DT (Bio Farma) in adults, children and infants.

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Describe antibody response following vaccination

Description

Comparison of GMT, seroconversion between each lot number of Vi-DT (Bio Farma ) vaccine in each group.

Time Frame

28 days

Title

Adverse event, solicited or unsolicited

Description

Number and percentage with at least one adverse event, solicited or unsolicited, within 30 minutes, 72 hours, 7 days, and 28 days after vaccination.

Time Frame

28 days

Title

Comparison the safety and immunogenicity

Description

Comparison of adverse events occuring until 28 days after vaccination between each lot number of Vi-DT (Bio Farma ) vaccine and PQed typhoid conjugate vaccine

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy. Subject/Parents/legal guardian(s) have been informed properly regarding the study and signed the informed consent form/and informed assent form. Subject/parents/legal guardian(s) 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 (axilary 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, corticosteroid therapy and other immunosuppressants) 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 vaccinated with any vaccine within one month prior and expect to receive other vaccines within one month following vaccination except MR (Measles Rubella) vaccine. Individuals who have a previously ascertained typhoid fever by laboratory confirmation (blood culture/new rapid test) at any time. 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 E Medise, MD

Organizational Affiliation

Fakultas Kedokteran Universitas Indonesia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jatinegara Primary Health Care

City

Jakarta

State/Province

Jakart

Country

Indonesia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)

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