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NCT03356561 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Ad26.ZIKV.001 in Healthy Adult Volunteers
A Phase 1 study of Healthy, sponsored by Janssen Vaccines & Prevention B.V..
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT03356561: Completed Phase 1 study of Healthy, sponsored by Janssen Vaccines & Prevention B.V..
NCT03356561 is a Phase 1 study of Healthy that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 100 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (85% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03356561, a Phase 1 study of Healthy, has completed, sponsored by Janssen Vaccines & Prevention B.V..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of Ad26.ZIKV.001 at 2 dose levels, 5\*10\^10 viral particles (vp) and 1\*10\^11 vp, administered intramuscularly as single dose and as 2-dose schedules in healthy adults.
Primary Outcome
Number of participants with solicited injection site (local) AEs will be evaluated. Solicited local AEs including pain, erythema, and induration at the study vaccine injection site, will be noted in the participant diary from Day 1 to Day 8. Local AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Ad26.ZIKV.001 5*10^10 vp
- BIOLOGICAL Ad26.ZIKV.001 1*10^11 vp
Study Locations (2)
Kansas
- Johnson County Clinical Trials - Lenexa
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2017-11-26 |
| Est. Completion | 2019-09-23 |
| Phase | Phase 1 |
What the finished NCT03356561 record still lists
NCT03356561 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03356561 reports a single indexed study location in Kansas, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03356561 about?
NCT03356561 is a clinical study titled "A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Ad26.ZIKV.001 in Healthy Adult Volunteers". The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of Ad26.ZIKV.001 at 2 dose levels, 5\*10\^10 viral particles (vp) and 1\*10\^11 vp, administered intramuscularly as single dose and as 2-dose schedules in healthy adults.
What is the current status of trial NCT03356561?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2017-11-26. Estimated completion is 2019-09-23.
What conditions does trial NCT03356561 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT03356561?
The interventions under investigation include: Placebo (BIOLOGICAL), Ad26.ZIKV.001 5*10^10 vp (BIOLOGICAL), Ad26.ZIKV.001 1*10^11 vp (BIOLOGICAL).
Who is sponsoring clinical trial NCT03356561?
This trial is sponsored by Janssen Vaccines & Prevention B.V., which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03356561 being conducted?
This trial has 2 study locations across Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03356561's enrollment target sits among peer trials
100 219th of 1090 higher than 851 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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