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

Safety Issues Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04051268
• Other study ID #: Typhoid 0319
• Status: Completed
• Phase: Phase 3
• Start date: March 2, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2021
• Source: PT Bio Farma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3071
• Est. completion date: December 1, 2021
• Est. primary completion date: November 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immunogenicity
• Safety Issues
• Typhoid Fever

Intervention

Biological:
• Vi-DT Typhoid Conjugate Vaccine
1 dose of Investigational Product
• PQed Typhoid Conjugate Vaccine
1 dose of Active Comparator
• Vi Polysaccharide Vaccine
1 dose of Active Comparator

Locations

Country	Name	City	State
Indonesia	Jatinegara Primary Health Care	Jakarta	Jakart

Sponsors (1)

Lead Sponsor	Collaborator
PT Bio Farma

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity	Seroconversion following vaccination with one dose of Vi-DT (Bio Farma) in adults, children and infants.	28 days
Secondary	Describe antibody response following vaccination	Comparison of GMT, seroconversion between each lot number of Vi-DT (Bio Farma ) vaccine in each group.	28 days
Secondary	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
Secondary	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