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A Phase 2/3, Three-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age

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Trial Profile

A Phase 2/3, Three-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 23 Jul 2025

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At a glance

  • Drugs Elasomeran (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms KidCOVE
  • Sponsors Moderna Therapeutics

Most Recent Events

  • 10 Jul 2025 According to a Moderna Therapeutics media release, the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Spikevax, the Company's COVID-19 vaccine, in children 6 months through 11 years of age who are at increased risk for COVID-19 disease.
  • 01 Apr 2024 Status changed from active, no longer recruiting to completed.
  • 25 Oct 2023 Planned End Date changed from 12 Nov 2023 to 5 Apr 2024.

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