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

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)

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

Study Overview

• Status: Completed
• Conditions: Safety Issues; Immunogenicity
• Intervention / Treatment: Biological: Vi-DT Typhoid Conjugate Vaccine; Biological: PQed Typhoid Conjugate Vaccine; Biological: 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.

• Study Type: Interventional
• Enrollment (Actual): 3071
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Jakart
    • Jakarta, Jakart, Indonesia
      • Jatinegara Primary Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vi-DT TCV Batch 1; 1 dose of 0.5 ml of Vi-DT TCV vaccine batch 1	Biological: Vi-DT Typhoid Conjugate Vaccine; 1 dose of Investigational Product
Experimental: Vi-DT TCV Batch 2; 1 dose of 0.5 ml of Vi-DT TCV vaccine batch 2	Biological: Vi-DT Typhoid Conjugate Vaccine; 1 dose of Investigational Product
Experimental: Vi-DT TCV Batch 3; 1 dose of 0.5 ml of Vi-DT TCV vaccine batch 3	Biological: Vi-DT Typhoid Conjugate Vaccine; 1 dose of Investigational Product
Active Comparator: PQed Typhoid Conjugate Vaccine (subjects 6 mo-45 yo); 1 dose of 0.5 ml of PQed TCV Vaccine	Biological: PQed Typhoid Conjugate Vaccine; 1 dose of Active Comparator
Active Comparator: Vi Polysaccharide Vaccine (subjects 46-60 years old); 1 dose of 0.5 ml of Vi Polysaccharide Vaccine	Biological: Vi Polysaccharide Vaccine; 1 dose of Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity	Seroconversion following vaccination with one dose of Vi-DT (Bio Farma) in adults, children and infants.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe antibody response following vaccination	Comparison of GMT, seroconversion between each lot number of Vi-DT (Bio Farma ) vaccine in each group.	28 days
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.	28 days
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	28 days

Collaborators and Investigators

• Sponsor: PT Bio Farma
• Investigators: Principal Investigator: Bernie E Medise, MD, Fakultas Kedokteran Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Actual): November 24, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: December 30, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Vaccine; Typhoid Conjugate Vaccine
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Salmonella Infections; Typhoid Fever; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: Typhoid 0319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No