A Phase IV Non-Interventional Enhanced Active Surveillance Study of Adults Vaccinated with AZD1222

Study identification

• EU PAS number:
  EUPAS41335
• Study ID:
  46864
• Official title and acronym:
  A Phase IV Non-Interventional Enhanced Active Surveillance Study of Adults Vaccinated with AZD1222
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Spain

  Sweden
• Study description:
  * The AZ:CONNECTEU study will be stopped. Ongoing participants will be informed and off-boarded. Vaxzevria’s safety continues to be monitored through the implementation of other studies and through established safety reporting platforms across Europe. This is a Phase IV real-world, observational, non-interventional, prospective cohort study of adults vaccinated with AZD1222. The purpose of this study is to assess the safety and tolerability of AZD1222 among AZD1222 vaccinated adults in the real-world setting. The study will use an innovative digital platform (study app and web portal) as well as a traditional call centre to collect participant responses to a series of health and well-being questionnaires over an 18-month period (follow-up after both first and second AZD1222 vaccine doses). Investigators and study personnel will have real-time access to enrolment trends and reported adverse events (AEs) via an investigator dashboard within the digital platform. Research coordinators at vaccination sites will invite AZD1222 vaccinated adults to join the study. Participants can enrol at the vaccination site with assistance from a research coordinator or can take home the study information brochure and enrol within 28 days after the first dose of AZD1222. Participants will receive periodic reminders (either push notifications/e-mails or phone calls) to complete the questionnaires and the participants will also be able to input information into the questionnaires at any time throughout the study period.
• Study status:
  Finalised

Research institutions and networks

Institutions

Parexel International

United States

Centre Hospitalier D'Argenteuil - Hopital Victor Dupouy Argenteuil, France, Centre Hospitalier Universitaire (CHU) Amiens-Picardie Amiens, France, Medizentrum Essen Borbeck Essen, Germany, Complejo Hospitalario Universitario de Santiago Santiago de Compostela, Spain, H. de San Pedro Logroño, Spain, EAP Mataró 6 (Gatassa) CAP II El Maresme Mataró, Spain, Centro de Salud Monforte de Lemos Monforte de Lemos, Spain

Study timelines

Date when funding contract was signed

Planned: 04/02/2021

Actual: 04/02/2021

Study start date

Planned: 08/06/2021

Actual: 31/05/2021

Data analysis start date

Planned: 08/07/2021

Actual: 30/06/2021

Date of interim report, if expected

Actual: 15/09/2021

Date of final study report

Planned: 25/02/2022

Actual: 07/03/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca AB

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

D8111R00003