CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 120 enrolled
Drug / intervention
mRNA-1893 +1 morebiological
Likely dose
mRNA-1893 Zika vaccine (dose not specified in document)AI-extracted
Key inclusion· 5
  • ✓Age 18 to 49 years
  • ✓Good general health per medical history, labs, vitals, and physical exam
  • ✓Flavivirus seronegative: negative flavivirus test (dengue, West Nile, Zika)
  • ✓Flavivirus seropositive: positive flavivirus test (dengue, West Nile, Zika)
Key exclusion· 15
  • ✕Acute or chronic clinically significant disease
  • ✕Prior vaccination with dengue, Japanese encephalitis, tick-borne encephalitis, West Nile, Yellow Fever, or Zika vaccine
  • ✕Neurologic disorder
  • ✕BMI ≤18 or ≥35 kg/m²

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04064905
NCT04064905Phase 1Completed
CompareCT.gov

A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of Zika Vaccine mRNA-1893 in Healthy Flavivirus Seropositive and Seronegative Adults

ModernaTX, Inc.·interventional·Posted Aug 22, 2019·Updated Aug 21, 2024

In Brief

A Phase 1 clinical trial evaluating mRNA-1893 and Placebo for Zika Virus. Completed, enrolled 120 participants across 4 sites in 2 countries.

Detailed Summary

This clinical study will evaluate the safety, tolerability and reactogenicity of mRNA-1893 Zika vaccines in flavivirus seronegative and flavivirus seropositive participants

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsZika Virus
CountriesPuerto Rico, United States
CollaboratorsBiomedical Advanced Research and Development Authority

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedAug 22, 2019
Enrollment StartJul 30, 2019
Primary CompletionMar 22, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.9 years ago

Interventions

mRNA-1893biological

Zika vaccine

Placeboother

0.9% sodium chloride