deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm NCT02645032

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

Conditions Typhoid
Updated 9 times since 2017 Last updated: Apr 26, 2020 Started: May 19, 2016 Primary completion: Feb 9, 2017 Completion: Feb 9, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Feb 2018 · 13 months · monthly snapshotNot Yet Recruiting~Feb 2018 – ~Mar 2018 · 28 days · monthly snapshotUnknown Status~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshotCompleted~Jun 2018 – ~Feb 2019 · 8 months · monthly snapshotCompleted~Feb 2019 – ~May 2020 · 15 months · monthly snapshotCompleted~May 2020 – ~Jan 2021 · 8 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

9 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  4. May 2020 — Jan 2021 [monthly]

    Completed PHASE1

  5. Feb 2019 — May 2020 [monthly]

    Completed PHASE1

Show 4 earlier versions
  1. Jun 2018 — Feb 2019 [monthly]

    Completed PHASE1

  2. Mar 2018 — Jun 2018 [monthly]

    Completed PHASE1

    Status: Unknown StatusCompleted

  3. Feb 2018 — Mar 2018 [monthly]

    Unknown Status PHASE1

    Status: Not Yet RecruitingUnknown Status

  4. 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

Sponsor contact:
  • International Vaccine Institute
  • SK Chemicals Co., Ltd.
Data source: International Vaccine Institute

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.