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

NCT04051268 | Completed Phase 3 DMC

• 1 other identifier: Typhoid 0319
• Study Type: interventional
• Target: 3,071
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety Issues; Immunogenicity

Keywords

Vaccine; Typhoid Conjugate Vaccine

Outcome Measures

Primary Outcomes (1)

• Immunogenicity

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

  28 days

Secondary Outcomes (3)

• Describe antibody response following vaccination

  28 days

• Adverse event, solicited or unsolicited

  28 days

• Comparison the safety and immunogenicity

  28 days

Study Arms (5)

Vi-DT TCV Batch 1

EXPERIMENTAL

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

Biological: Vi-DT Typhoid Conjugate Vaccine

Vi-DT TCV Batch 2

EXPERIMENTAL

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

Biological: Vi-DT Typhoid Conjugate Vaccine

Vi-DT TCV Batch 3

EXPERIMENTAL

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

Biological: Vi-DT Typhoid Conjugate Vaccine

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

ACTIVE COMPARATOR

1 dose of 0.5 ml of PQed TCV Vaccine

Biological: PQed Typhoid Conjugate Vaccine

Vi Polysaccharide Vaccine (subjects 46-60 years old)

ACTIVE COMPARATOR

1 dose of 0.5 ml of Vi Polysaccharide Vaccine

Biological: Vi Polysaccharide Vaccine

Interventions

Vi-DT Typhoid Conjugate Vaccine BIOLOGICAL

1 dose of Investigational Product

Vi-DT TCV Batch 1; Vi-DT TCV Batch 2; Vi-DT TCV Batch 3

PQed Typhoid Conjugate Vaccine BIOLOGICAL

1 dose of Active Comparator

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

Vi Polysaccharide Vaccine BIOLOGICAL

1 dose of Active Comparator

Vi Polysaccharide Vaccine (subjects 46-60 years old)

Eligibility Criteria

• Age: 6 Months - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PT Bio Farma: lead

Study Sites (1)

Jatinegara Primary Health Care

Jakarta, Jakart, Indonesia

Location

MeSH Terms

Interventions

Vi polysaccharide vaccine, typhoid

Study Officials

• Bernie E Medise, MD

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Investigational Product and Active Comparator was masking Number of lot was masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 9, 2019
• Study Start: March 2, 2020
• Primary Completion: November 24, 2021
• Study Completion: December 1, 2021
• Last Updated: January 4, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)