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NCT03343626 · ClinicalTrials.gov registry record · Phase 1
Safety, Immunogenicity, and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Participants
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 271
- Enrollment target
NCT03343626 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 271 participants.
The verdict
NCT03343626, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 271 participants
- Enrollment target
Study Summary
The purpose of this study is to describe the safety, tolerability and immunogenicity of two doses of purified inactivated Zika virus vaccine (PIZV) given 28 days apart. Three different vaccine doses containing different protein concentrations (2, 5 or 10 microgram \[mcg\]) each, will be given as 2 dose schedule to flavivirus naive and primed healthy adults. Participants will be followed for 7 days post each dose for tolerability and up to 6 months post dose 2 for safety. Immunogenicity assessment will be performed at 28 days post each dose and 6 months post dose 2. In addition, the selected dose group and control group will be followed till 24 months post dose 2 for safety and persistence of immunity.
Interventions
- DRUG Placebo
- BIOLOGICAL PIZV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 271 participants |
| Start Date | 2017-11-13 |
| Est. Completion | 2020-11-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03343626
The ClinicalTrials.gov registry entry for NCT03343626 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 271 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03343626 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03343626 about?
NCT03343626 is a clinical study titled "Safety, Immunogenicity, and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Participants". The purpose of this study is to describe the safety, tolerability and immunogenicity of two doses of purified inactivated Zika virus vaccine (PIZV) given 28 days apart. Three different vaccine doses containing different protein concentrations (2, 5 or 10 microgram \[mcg\]) each, will be given as 2 d...
What is the current status of trial NCT03343626?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 271 participants. The study started on 2017-11-13. Estimated completion is 2020-11-24.
What interventions are being tested in trial NCT03343626?
The interventions under investigation include: Placebo (DRUG), PIZV (BIOLOGICAL).
Who is sponsoring clinical trial NCT03343626?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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