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NCT04917861 · ClinicalTrials.gov registry record · Phase 2
A Study of Zika Vaccine mRNA-1893 in Adult Participants Living in Endemic and Non-Endemic Flavivirus Areas
A Phase 2 study of Zika Virus, sponsored by ModernaTX.
- Completed
- Registry status
- Phase 2
- Development phase
- 808
- Enrollment target
- 11
- Study locations
NCT04917861: Completed Phase 2 study of Zika Virus, sponsored by ModernaTX.
NCT04917861 is a Phase 2 study of Zika Virus that has completed, run by ModernaTX. The registered enrollment target is 808 participants, above the 173-participant average among 3 other Zika Virus trials with a reported enrollment target (367% higher). The trial reports 11 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04917861, a Phase 2 study of Zika Virus, has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 808 participants
- Enrollment target
- 11
- Study locations
Study Summary
This clinical study will evaluate the safety, tolerability, and reactogenicity of 2 dose levels of messenger RNA (mRNA)-1893 Zika vaccine in comparison to a placebo control in healthy participants who are flavivirus-seronegative and in participants who are flavivirus-seropositive.
Primary Outcome
Solicited ARs (local and systemic) were collected in the electronic diary. Local ARs included: pain, erythema (redness), swelling/induration (hardness). Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, body temperature (potentially fever), and chills. A summary of all serious adverse events (SAEs) and all nonserious adverse events (AEs) ("Other"), regardless of causality, is in Reported "Adverse Events" se
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL mRNA-1893
Study Locations (11)
PR
- Clinical Research Puerto Rico, Inc. - Guayama
- Ponce Medical School Foundation, Inc. - Ponce
- Ponce Medical School Foundation, Inc. - Ponce
- Clinical Research Puerto Rico, Inc. - San Juan
- Latin Clinical Trial Center, Inc. - San Juan
- GCM Medical Group, PSC - San Juan
- Carribean Medical Research - San Juan
- University of Puerto Rico - San Juan
Iowa
- Meridian Clinical Research (Sioux City, IA) - Sioux City
Kansas
- Johnson County Clin-Trials - Lenexa
Texas
- Benchmark Research - Fort Worth - Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 808 participants |
| Start Date | 2021-06-07 |
| Est. Completion | 2024-07-26 |
| Phase | Phase 2 |
What the finished NCT04917861 record still lists
NCT04917861 is an interventional study that assigns participants to a tested intervention. The registered 808 participants enrollment target is mid-sized for trials with a published cap, above the 173-participant average among 3 other Zika Virus trials with a reported enrollment target (367% higher).
The record links to 1 condition, with Zika Virus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04917861 lists 11 locations in 4 states (PR, Iowa, Kansas).
Frequently Asked Questions
What is clinical trial NCT04917861 about?
NCT04917861 is a clinical study titled "A Study of Zika Vaccine mRNA-1893 in Adult Participants Living in Endemic and Non-Endemic Flavivirus Areas". This clinical study will evaluate the safety, tolerability, and reactogenicity of 2 dose levels of messenger RNA (mRNA)-1893 Zika vaccine in comparison to a placebo control in healthy participants who are flavivirus-seronegative and in participants who are flavivirus-seropositive.
What is the current status of trial NCT04917861?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 808 participants. The study started on 2021-06-07. Estimated completion is 2024-07-26.
What conditions does trial NCT04917861 study?
This clinical trial studies the following conditions: Zika Virus.
What interventions are being tested in trial NCT04917861?
The interventions under investigation include: Placebo (BIOLOGICAL), mRNA-1893 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04917861?
This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04917861 being conducted?
This trial has 11 study locations across Iowa, Kansas, Texas, PR. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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