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A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Vaccine Formulations

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary endpoints revised (3)
    • Enrollment target: 1094 to 1144
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints revised (4)
    v6
  2. Primary and study completion dates: May 7, 2026 to Dec 31, 2026v5 Show 6 more changesShow less
    • Primary endpoints revised (3)
    • Enrollment target: 764 to 1094
    • Study sites: 5 to 6
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: 5 to 4
    • Study description expanded, about 22 words
  3. Trial status: Active, Not Recruiting to Recruitingv4 Show 8 more changesShow less
    • Enrollment target: 100 to 764
    • Primary and study completion dates: Oct 29, 2025 to May 7, 2026
    • Primary endpoints: 2 to 3
    • Study sites: 1 to 5
    • Eligibility criteria expanded, about 85 words
    • Secondary endpoints: 1 to 5
    • Study description expanded, about 56 words
    • Study title shortened, about 3 words
  4. Primary completion date: Oct 29, 2024 to Oct 29, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 6, 2024 to Sep 9, 2024
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Moderna
49 trials monitored
See 3 trials at risk
The purpose of this study is to investigate the immunogenicity and safety of mRNA COVID-19 variant-containing vaccine formulations against the vaccine-matched variants and newly emerged variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Trial Details
NCT Number NCT06585241
Lead Sponsor ModernaTX, Inc.
Conditions
(from sponsor)		 SARS-CoV-2
Related terms Coronavirus Infections, COVID-19, Virus Diseases
Enrollment 1,144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov