A Phase IV Open-Label, Non-Randomized, Multi-Cohort, Multicenter Study in Previously Unvaccinated Immunocompromised Adults to Determine the Immunogenicity and Safety of AZD1222 Vaccine for the Prevention of COVID-19. (VICTORIA)

Study identification

• EU PAS number:
  EUPAS44425
• Study ID:
  50526
• Official title and acronym:
  A Phase IV Open-Label, Non-Randomized, Multi-Cohort, Multicenter Study in Previously Unvaccinated Immunocompromised Adults to Determine the Immunogenicity and Safety of AZD1222 Vaccine for the Prevention of COVID-19. (VICTORIA)
• DARWIN EU® study:
  No
• Study countries:
  Thailand

  Ukraine
• Study description:
  This was a Phase IV trial and the aim of this study was to learn more about whether AZD1222 can prevent COVID-19 infection in people with a suppressed or compromised (weakened) immune system who had not been previously vaccinated. As a result of increased COVID-19 vaccination rates globally, and particularly in the immunocompromised population, the study could not recruit the required number of unvaccinated/naïve participants. Therefore, the European Medicines Agency removed the requirement for this study and the study was terminated early.
• Study status:
  Finalised

Research institutions and networks

Institutions

AstraZeneca

Justin Green

Faculty of Medicine Siriraj Hospital, Mahidol University 2 Wang lang Road, Bangkoknoi, Bangkok 10700, Thailand, Maharaj Nakorn Chiang Mai Hospital 110 Intavaroros Road, Muang 50200, Thailand, Srinagarind Hospital, Khon Kaen University 123 Mitraparp Road, Muang, Khon Kaen 40002, Thailand, Pratia Clinic Ukraine LLC 7, Poltavskyi Shlyach Str, Kharkiv 61052, Ukraine

Study timelines

Date when funding contract was signed

Actual:11/08/2021

Study start date

Planned:28/01/2022

Actual:31/01/2022

Data analysis start date

Planned:02/06/2023

Actual:02/06/2023

Date of final study report

Planned:18/08/2023

Actual:25/08/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)
• Regulatory procedure number:
  EMEA/H/C/005675/MEA/009

Other study registration identification numbers and links

D8111C00010