Status:
COMPLETED
Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)
Lead Sponsor:
PT Bio Farma
Conditions:
Safety Issues
Immunogenicity
Eligibility:
All Genders
6-60 years
Phase:
PHASE3
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 ol...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
3071 Patients enrolled
Trial Details
Trial ID
NCT04051268
Start Date
March 2 2020
End Date
December 1 2021
Last Update
January 4 2022
Active Locations (1)
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1
Jatinegara Primary Health Care
Jakarta, Jakart, Indonesia