drugset / Trial / NCT04917861

A Study of Zika Vaccine mRNA-1893 in Adult Participants Living in Endemic and Non-Endemic Flavivirus Areas

NCT04917861 ↗

Phase 2 Completed 808 enrolled ModernaTX, Inc.
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2021-06-07
Primary completion
2024-07-26
Completion
2024-07-26

Outcome

Met primary endpoint

registry analysis (other test); Placebo vs mRNA-1893 Low Dose (2-Dose Regimen); Geometric Mean Ratio (GMR) 7.002 (95% CI 5.451 to 8.992) NCT04917861 ↗

registry analysis (other test); Placebo vs mRNA-1893 High Dose (2-Dose Regimen); GMR 7.123 (95% CI 5.467 to 9.279) NCT04917861 ↗

registry analysis (other test); Placebo vs mRNA-1893 Low Dose (2-Dose Regimen); percentage difference 76.69 (95% CI 69.10 to 82.68) NCT04917861 ↗

registry analysis (other test); Placebo vs mRNA-1893 Low Dose (2-Dose Regimen); percentage difference 75.46 (95% CI 68.12 to 81.49) NCT04917861 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject mRNA-1893 Messenger RNA (mRNA) — —