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NCT03981952 · ClinicalTrials.gov registry record · Phase 1
Salmonella Conjugates CVD 1000: Study of Responses to Vaccination With Trivalent Invasive Salmonella Disease Vaccine
A Phase 1 study of Risk Reduction, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
- 1
- Study location
NCT03981952: Completed Phase 1 study of Risk Reduction, sponsored by University of Maryland, Baltimore.
NCT03981952 is a Phase 1 study of Risk Reduction that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 96 participants, below the 3,691-participant average among 13 other Risk Reduction trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03981952, a Phase 1 study of Risk Reduction, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, placebo-controlled dose-escalation study. The main purpose of this research is to test the safety and measure the immune response of the trivalent vaccine against invasive Salmonella disease. The vaccine will be tested over a range of doses.
Primary Outcome
To assess the frequency and severity of solicited local (i.e., injective site) and systemic (such as fever) AEs during the first 7 days following each dose of vaccine.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Trivalent Invasive Salmonella Disease Vaccine (6.25 µg)
- BIOLOGICAL Trivalent Invasive Salmonella Disease Vaccine (12 µg)
- BIOLOGICAL Trivalent Invasive Salmonella Disease Vaccine (25 µg)
- BIOLOGICAL Trivalent Invasive Salmonella Disease Vaccine (highest, well-tolerated dose among Cohorts A-C)
Study Locations (1)
Maryland
- University of Maryland, Baltimore, Center for Vaccine Development and Global Health - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2019-10-28 |
| Est. Completion | 2021-05-07 |
| Phase | Phase 1 |
What the finished NCT03981952 record still lists
NCT03981952 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 3,691-participant average among 13 other Risk Reduction trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Risk Reduction appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT03981952 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03981952 about?
NCT03981952 is a clinical study titled "Salmonella Conjugates CVD 1000: Study of Responses to Vaccination With Trivalent Invasive Salmonella Disease Vaccine". This is a randomized, placebo-controlled dose-escalation study. The main purpose of this research is to test the safety and measure the immune response of the trivalent vaccine against invasive Salmonella disease. The vaccine will be tested over a range of doses.
What is the current status of trial NCT03981952?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2019-10-28. Estimated completion is 2021-05-07.
What conditions does trial NCT03981952 study?
This clinical trial studies the following conditions: Risk Reduction.
What interventions are being tested in trial NCT03981952?
The interventions under investigation include: Placebo (OTHER), Trivalent Invasive Salmonella Disease Vaccine (6.25 µg) (BIOLOGICAL), Trivalent Invasive Salmonella Disease Vaccine (12 µg) (BIOLOGICAL), Trivalent Invasive Salmonella Disease Vaccine (25 µg) (BIOLOGICAL), Trivalent Invasive Salmonella Disease Vaccine (highest, well-tolerated dose among Cohorts A-C) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03981952?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03981952 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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96 11th of 13 higher than 3 of 13 other Risk Reduction trials
participants (enrollment target), bucketed by value
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