Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)
NCT ID: NCT04051268
Last Updated: 2022-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
3071 participants
INTERVENTIONAL
2020-03-02
2021-12-01
Brief Summary
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Detailed Description
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Involved participants aged 6 months old to 60 years old.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Subjects 6 months - 60 years old: Randomized, observer blind, lot to lot consistency
PREVENTION
DOUBLE
Study Groups
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Vi-DT TCV Batch 1
1 dose of 0.5 ml of Vi-DT TCV vaccine batch 1
Vi-DT Typhoid Conjugate Vaccine
1 dose of Investigational Product
Vi-DT TCV Batch 2
1 dose of 0.5 ml of Vi-DT TCV vaccine batch 2
Vi-DT Typhoid Conjugate Vaccine
1 dose of Investigational Product
Vi-DT TCV Batch 3
1 dose of 0.5 ml of Vi-DT TCV vaccine batch 3
Vi-DT Typhoid Conjugate Vaccine
1 dose of Investigational Product
PQed Typhoid Conjugate Vaccine (subjects 6 mo-45 yo)
1 dose of 0.5 ml of PQed TCV Vaccine
PQed Typhoid Conjugate Vaccine
1 dose of Active Comparator
Vi Polysaccharide Vaccine (subjects 46-60 years old)
1 dose of 0.5 ml of Vi Polysaccharide Vaccine
Vi Polysaccharide Vaccine
1 dose of Active Comparator
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Months
60 Years
ALL
Yes
Sponsors
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PT Bio Farma
INDUSTRY
Responsible Party
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Principal Investigators
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Bernie E Medise, MD
Role: PRINCIPAL_INVESTIGATOR
Fakultas Kedokteran Universitas Indonesia
Locations
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Jatinegara Primary Health Care
Jakarta, Jakart, Indonesia
Countries
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Other Identifiers
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Typhoid 0319
Identifier Type: -
Identifier Source: org_study_id
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