Status:
COMPLETED
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine in Indonesian Adults, Adolescents, Children and Infants
Lead Sponsor:
PT Bio Farma
Conditions:
Safety Issues
Immunogenicity
Eligibility:
All Genders
6-40 years
Phase:
PHASE2
Brief Summary
This study is to assess the safety and immunogenicity of Vi-DT vaccine in adults, adolescent, children and infants.
Detailed Description
To describe the safety of this vaccine following one dose immunization in adults, adolescent, children and infants. To assess immunogenicity following one dose of Vi-DT vaccine immunization. To compa...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Healthy
- Subjects/Parents have been informed properly regarding the study and signed the informed consent form
- Subject/parents/legal guardians will commit themselves to comply with the instructions of the investigator and the schedule of the trial.
- Exclusion Criteria For adults-adolescent-children:
- Subject concomitantly enrolled or scheduled to be enrolled in another trial
- Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary 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 immunosuppresant).
- 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 immunized with any vaccine within 1 month prior and expect to receive other vaccines within 1 month following immunization.
- Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization.
- History of substance abuse (Adults).
- Subject planning to move from the study area before the end of study period.
- Exclusion Criteria for infants:
- Subject concomitantly enrolled or scheduled to be enrolled in another trial
- Mother less than 18 years of age at the age of enrollment of the infant
- Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary 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 immunosuppresant).
- Any abnormality or chronic disease which according to the investigator might be compromised by the vaccination and/or interfere with the assessment of the trial objectives.
- Individuals who have previously received any vaccines against typhoid fever.
- Subjects already immunized with any vaccine within 1 month prior and expect to receive other vaccines within 1 month following immunization, except MR vaccine.
- Individuals who have a previously ascertained typhoid fever within 3 months prior to immunization.
- Subject planning to move from the study area before the end of study period.
Exclusion
Key Trial Info
Start Date :
July 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2020
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT03460405
Start Date
July 16 2018
End Date
January 30 2020
Last Update
February 20 2020
Active Locations (2)
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1
Puskesmas Jatinegara
Jakarta, Indonesia
2
Puskesmas Senen
Jakarta, Indonesia