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A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older and to Evaluate 2 Dose Levels of Ad26.COV2.S in Healthy Adolescents Aged 12 to 17 Years Inclusive

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Trial Profile

A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older and to Evaluate 2 Dose Levels of Ad26.COV2.S in Healthy Adolescents Aged 12 to 17 Years Inclusive

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 15 Sep 2023

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At a glance

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

    • Most Recent Events

    • 15 Nov 2022 Results of pooled analysis (of cohorts 1a and 3 from the phase 1/2a COV1001 study NCT04436276 and group 5 from the phase 2a COV2001 study NCT04535453) assessing Antibody Persistence After a Single Dose of COVID 19 Vaccine Ad26.COV2.S in Humans Using a Mechanistic Modeling and Simulation Approach published in the Clinical Pharmacology and Therapeutics.
    • 03 Jun 2022 Results of a pooled analysis (NCT04436276 and NCT04535453) assessed the durability of anti-SARS-CoV-2 antibodies elicited by single-dose Ad26.COV2.S and the impact of boostingpublished in the Vaccine
    • 12 Apr 2022 Status changed from active, no longer recruiting to completed.
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