Effectiveness evaluation of the local additional risk minimisation measures for STAMARIL® in the United Kingdom: a survey for healthcare professionals and vaccinees

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105873
• EU PAS number:
  EUPAS50782
• Study ID:
  105873
• Official title and acronym:
  Effectiveness evaluation of the local additional risk minimisation measures for STAMARIL® in the United Kingdom: a survey for healthcare professionals and vaccinees
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This will be a national, multicentre, prospective, cross-sectional, and multi-channel survey based on primary data collection conducted separately among qualified HCPs (physicians, nurses and pharmacists) and STAMARIL® vaccinees (or their parents/guardians if vaccinees are younger than 18 years old) in the UK (England, Wales, Northern Ireland and Scotland). The survey will be conducted primarily through a web (and/or paper for vaccinees) questionnaire. The survey will be conducted within 12 to 18 months following the implementation of the local aRMM in the UK as per the European guideline on good pharmacovigilance practices (GVP) – Module XVI (Rev 3).
• Study status:
  Finalised

Research institutions and networks

Institutions

Sanofi

Study timelines

Date when funding contract was signed

Planned: 02/12/2021

Actual: 02/12/2021

Study start date

Planned: 01/03/2023

Actual: 01/03/2023

Date of final study report

Planned: 29/02/2024

Actual: 25/06/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi

Study protocol

Updated protocol

rdct-sta00059-protocol-amendment.pdf

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)