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

Phase 3

Completed

• Conditions: Safety Issues; Immunogenicity

• Registration Number: NCT04051268
• Lead Sponsor: PT Bio Farma

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.

Study Timeline

• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-07
• Study First Posted: 2019-08-09
• Study Start: 2020-03-02
• Primary Completion: 2021-11-24
• Status Verified: 2021-12
• Study Completion: 2021-12-01
• Last Update Submitted: 2021-12-30
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3071

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Describe antibody response following vaccination	28 days	Comparison of GMT, seroconversion between each lot number of Vi-DT (Bio Farma ) vaccine in each group.
Adverse event, solicited or unsolicited	28 days	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	28 days	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

Trial Locations

Locations (1)

Jatinegara Primary Health Care; 🇮🇩 Jakarta, Jakart, Indonesia