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NCT03611946 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-naïve Adults
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT03611946 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 56 participants.
The verdict
NCT03611946, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
This is a phase 1 double-blind, placebo controlled trial designed to evaluate the safety, reactogenicity, and immunogenicity of a single dose of the live attenuated Zika vaccine rZIKV/D4Δ30-713 in adults with no history of previous flavivirus infection.
Interventions
- BIOLOGICAL Single dose of rZIKV/D4Δ30-713 (10^3 PFU) via subcutaneous injection (0.5ml)
- BIOLOGICAL Single dose of placebo via subcutaneous injection (0.5ml).
- BIOLOGICAL Single dose of rZIKV/D4Δ30-713 (10^4 PFU) via subcutaneous injection (0.5ml)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2018-07-06 |
| Est. Completion | 2022-03-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03611946
The ClinicalTrials.gov registry entry for NCT03611946 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Single dose of rZIKV/D4Δ30-713 (10^3 PFU) via subcutaneous injection (0.5ml) is the first listed.
NCT03611946 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03611946 about?
NCT03611946 is a clinical study titled "Safety and Immunogenicity of the Live Attenuated Zika Vaccine rZIKV/D4Δ30-713 in Flavivirus-naïve Adults". This is a phase 1 double-blind, placebo controlled trial designed to evaluate the safety, reactogenicity, and immunogenicity of a single dose of the live attenuated Zika vaccine rZIKV/D4Δ30-713 in adults with no history of previous flavivirus infection.
What is the current status of trial NCT03611946?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2018-07-06. Estimated completion is 2022-03-18.
What interventions are being tested in trial NCT03611946?
The interventions under investigation include: Single dose of rZIKV/D4Δ30-713 (10^3 PFU) via subcutaneous injection (0.5ml) (BIOLOGICAL), Single dose of placebo via subcutaneous injection (0.5ml). (BIOLOGICAL), Single dose of rZIKV/D4Δ30-713 (10^4 PFU) via subcutaneous injection (0.5ml) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03611946?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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