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A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older

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A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Sep 2024

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At a glance

  • Drugs Ad26.COV2 S (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ENSEMBLE
  • Sponsors Janssen Vaccines and Prevention B.V

    • Most Recent Events

    • 23 Jun 2023 Results from four (NCT04470427, NCT04516746, NCT04505722, and NCT04611802) COVID-19 prevention network efficacy trials published in the Vaccine
    • 04 May 2023 Status changed from active, no longer recruiting to completed.
    • 18 May 2022 Data was used from this trial to stratify severity of disease using the mild, moderate and severe/critical disease signs for assessing costs of COVID-19 by US payer perspective presented at the 27th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research

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