Pilot study: reactogenicity surveillance in Belgium following immunization with seasonal influenza vaccines

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28016
• EU PAS number:
  EUPAS15696
• Study ID:
  28016
• Official title and acronym:
  Pilot study: reactogenicity surveillance in Belgium following immunization with seasonal influenza vaccines
• DARWIN EU® study:
  No
• Study countries:
  Belgium
• Study description:
  Background: The EMA calls for a strategy for enhanced safety surveillance of seasonal influenza vaccines. In order to mitigate risks associated with potential new safety concerns within the first month after the start of immunisation, the strategy aims to detect a potential increase in reactogenicity and allergic events in near real-time in the earliest vaccinated cohort.Objective: In this pilot study, we will assess the feasibility of conducting a rapid assessment of reactogenicity of seasonal influenza vaccines in Belgium. The primary objective is to assess whether the required data can be collected in a timely manner. Methods: We aim to recruit subjects aged 18 to 65 years who will have received inactivated seasonal influenza vaccine through routine clinical practice in occupational setting. For seven days, subjects will receive a daily SMS with a link to a web-based questionnaire where reactogenicity events and their severity will be solicited.
• Study status:
  Finalised

Research institutions and networks

Institutions

P95 Clinical and Epidemiology Services

Belgium

Colombia

Netherlands

South Africa

Thailand

United States

Study timelines

Date when funding contract was signed

Planned: 14/09/2016

Actual: 14/09/2016

Study start date

Planned: 06/10/2016

Actual: 06/10/2016

Data analysis start date

Planned: 07/11/2016

Actual: 10/10/2016

Date of final study report

Planned: 31/12/2016

Actual: 01/12/2016

Sources of funding

Other

More details on funding

P95

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable