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

PT Bio Farma

Status and phase: Completed; Phase 3

Conditions: Safety Issues; Immunogenicity

Treatments: Biological: Vi-DT Typhoid Conjugate Vaccine; Biological: Vi Polysaccharide Vaccine; Biological: PQed Typhoid Conjugate Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04051268

Typhoid 0319

Details and patient eligibility

About

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

Full 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.

Enrollment: 3,071 patients

Sex: All

Ages: 6 months to 60 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,071 participants in 5 patient groups

Vi-DT TCV Batch 1

Experimental group

Description:

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

Treatment:

Biological: Vi-DT Typhoid Conjugate Vaccine

Vi-DT TCV Batch 2

Experimental group

Description:

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

Treatment:

Biological: Vi-DT Typhoid Conjugate Vaccine

Vi-DT TCV Batch 3

Experimental group

Description:

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

Treatment:

Biological: Vi-DT Typhoid Conjugate Vaccine

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

Active Comparator group

Description:

1 dose of 0.5 ml of PQed TCV Vaccine

Treatment:

Biological: PQed Typhoid Conjugate Vaccine

Vi Polysaccharide Vaccine (subjects 46-60 years old)

Active Comparator group

Description:

1 dose of 0.5 ml of Vi Polysaccharide Vaccine

Treatment:

Biological: Vi Polysaccharide Vaccine