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A Randomized, Double-blind, Placebo-controlled, First-in-Human, Phase 1/2a Study to Evaluate Safety, Reactogenicity and Immunogenicity of Monovalent HPV16 and HPV18 Ad26-vectored Vaccine Components and an MVA-vectored HPV16/18 Vaccine Component in Otherwise Healthy Women With HPV16 or 18 Infection of the Cervix

Trial Profile

A Randomized, Double-blind, Placebo-controlled, First-in-Human, Phase 1/2a Study to Evaluate Safety, Reactogenicity and Immunogenicity of Monovalent HPV16 and HPV18 Ad26-vectored Vaccine Components and an MVA-vectored HPV16/18 Vaccine Component in Otherwise Healthy Women With HPV16 or 18 Infection of the Cervix

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 11 Nov 2021

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At a glance

  • Drugs JNJ 63682918 (Primary) ; JNJ 63682931 (Primary) ; JNJ 65195208 (Primary)
  • Indications Human papillomavirus infections
  • Focus Adverse reactions; First in man
  • Sponsors Janssen Vaccines and Prevention B.V
  • Most Recent Events

    • 14 Dec 2020 Status changed from active, no longer recruiting to discontinued, due to low enrolment and increasing COVID restrictions, following an earlier enrolment pause in Aprilmade it clear that completion of the study would not be feasible
    • 21 Sep 2020 Planned primary completion date changed from 9 Aug 2020 to 15 Oct 2020.
    • 21 Sep 2020 Status changed from recruiting to active, no longer recruiting.
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