Vi-DT (Bio Farma)
BiologicalTyphoid Conjugate Vaccine
NCT Number: NCT03109600
This study is to assess the safety of Vi-DT vaccine in adults and children.
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Notify Me2 year–40 year
All sexes
Interventional
Phase 1
Puskesmas Jatinegara, Jakarta, DKI Jaya, Indonesia
To describe the safety of this vaccine following first and second dose immunization.
To assess preliminary information of immunogenicity following Vi-DT vaccine immunization.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Typhoid Conjugate Vaccine
Vi polysaccharide vaccine
1 dose of Influenzae vaccine
1 dose of Pneumococcal conjugate Vaccine
Time frame: 28 days
Percentage of subjects with at least one immediate reaction (local reaction or systemic event) after vaccination.
Time frame: 28 days
Percentage of subjects with at least one of these adverse events, solicited or not, within 24 h, 48h, 72h and 28 days after each vaccination.
Time frame: 28 days
Number and percentage of subjects with serious adverse event from inclusion until 28 day after vaccination and up to 6 months after the last vaccination.
Time frame: 7 days
Deviation from routine blood laboratory, kidney and liver function laboratory evaluation that probably related to the vaccination.
Time frame: 28 days
Percentage of subjects with > 4 times increasing antibody
Time frame: 28 days
Geometric Mean Titers (GMT) 28 days following immunization
PT Bio Farma
Industry
A Randomized, Observer Blinded, Comparative, Phase I Safety Study in Two Age De-escalating Cohorts to Assess the Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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