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Immunogenicity and Safety of Tetravalent Dengue Vaccine Given in 1-, 2-, or 3- Dose Schedules (STAGE I) Followed by a Single Booster Injection of the Same Vaccine (STAGE II) 1 or 2 Years After the Last Primary Dose in Healthy Subjects 9 to 50 Years of Age in Colombia and the Philippines

Trial Profile

Immunogenicity and Safety of Tetravalent Dengue Vaccine Given in 1-, 2-, or 3- Dose Schedules (STAGE I) Followed by a Single Booster Injection of the Same Vaccine (STAGE II) 1 or 2 Years After the Last Primary Dose in Healthy Subjects 9 to 50 Years of Age in Colombia and the Philippines

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 28 Apr 2021

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At a glance

  • Drugs CYD TDV (Primary)
  • Indications Dengue
  • Focus Pharmacodynamics
  • Sponsors Sanofi Pasteur
  • Most Recent Events

    • 01 Apr 2021 Protocol was amended; the original co-primary objectives of non-inferiority of the one-dose and two-dose groups to the three-dose group were altered to include non-inferiority of the two-dose group to the three-dose group only, to be assessed in individuals who were dengue seropositive at baseline.
    • 01 Apr 2021 Results published in The Lancet Infectious Diseases
    • 24 Aug 2020 Status changed from active, no longer recruiting to completed.
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