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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: Completed Phase 1 study, sponsored by Takeda.
NCT03343626 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 271 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (352% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after first vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents daily activity with or without treatment), erythema (\<25 mm, mild: \>=25 to- \<=50 mm, moderate: \>50 to \<=100 mm, severe: \>100 mm), and swelling and induration (\<25 mm, mild: \>=25 to \<=-50 mm, moderate: \>50
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 |
What the finished NCT03343626 record still lists
NCT03343626 is an interventional study that assigns participants to a tested intervention. The registered 271 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (352% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03343626 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03343626's enrollment target sits among peer trials
271 150th of 2000 higher than 1,851 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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