Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine
A Randomized, Observer-Blinded, Phase I Study to Assess the Safety and Immunogenicity of Vi-DT Conjugate Vaccine Compared to Vi-Polysaccharide (Typhim Vi®, Sanofi Pasteur) Typhoid Vaccine in Healthy Filipino Adults and Children
Sponsor: International Vaccine Institute
A PHASE1 clinical study on Typhoid, this trial is completed. The trial is conducted by International Vaccine Institute and has accumulated 9 data snapshots since 2016. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)This study will be carried out in healthy adults and children at a single site. Subjects will be stratified according to age.
The study procedure is as follows:
Visit 1 (day-1 to -7): Screen participants by medical history, physical examination and lab investigations. Collect blood for safety and immunogenicity assessments.
Visit 2 (day 0): Enroll, randomize and administer first dose of vaccine to eligible participants
Visit 3 (day 3): Assess participant safety by medical history and physical examination
Visit 4 (day 7): Record solicited adverse reaction 7 days post vaccination, and collect blood for safety lab assessments.
Visit 5 (day 28): Assess participant safety, collect blood for immunogenicity assessments, and administer second vaccine dose
Visit 6 (day 31): Participants safety will be assessed by medical history and physical examination
Visit 7 (day 35): Record solicited adverse reaction 7 days post second vaccination.
Visit 8 (day 56): Collect blood for immunogenicity assessments, assess participant safety, and fill in study completion form in the absence of any safety concern.
This study is observer-blind: vaccine administrator and vaccine safety evaluator will be two distinct persons to avoid bias of safety assessment. Trial staff other than the vaccine administrator.
This study will be carried out in healthy adults and children at a single site. Subjects will be stratified according to age.
The study procedure is as follows:
Visit 1 (day-1 to -7): Screen participants by medical history, physical examination and lab investigations. Collect blood for safety and immunogenicity assessments.
Visit 2 (day 0): Enroll, randomize and administer first dose of vaccine to eligible participants
Visit 3 (day 3): Assess participant safety by medical history and physical examination
Visit 4 (day 7): Record solicited adverse reaction 7 days post vaccination, and collect blood for safety lab assessments.
Visit 5 (day 28): Assess participant safety, collect blood for immunogenicity assessments, and administer second vaccine dose
Visit 6 (day 31): Participants safety will be assessed by medical history and physical examination
Visit 7 (day 35): Record solicited adverse reaction 7 days post second vaccination.
Visit 8 (day 56): Collect blood for immunogenicity assessments, assess participant safety, and fill in study completion form in the absence of any safety concern.
This study is observer-blind: vaccine administrator and vaccine safety evaluator will be two distinct persons to avoid bias of safety assessment. Trial staff other than the vaccine administrator.
Status Flow
Change History
9 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE1
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE1
-
May 2020 — Jan 2021 [monthly]
Completed PHASE1
-
Feb 2019 — May 2020 [monthly]
Completed PHASE1
▶ Show 4 earlier versions
-
Jun 2018 — Feb 2019 [monthly]
Completed PHASE1
-
Mar 2018 — Jun 2018 [monthly]
Completed PHASE1
Status: Unknown Status → Completed
-
Feb 2018 — Mar 2018 [monthly]
Unknown Status PHASE1
Status: Not Yet Recruiting → Unknown Status
-
Jan 2017 — Feb 2018 [monthly]
Not Yet Recruiting PHASE1
First recorded
May 2016
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- International Vaccine Institute
- SK Chemicals Co., Ltd.
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
No location information available.