Surveillance of Adverse Event related to childhood vaccination reported by parents

Study identification

• EU PAS number:
  EUPAS5350
• Study ID:
  28000
• Official title and acronym:
  Surveillance of Adverse Event related to childhood vaccination reported by parents
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  Background: In recent years in Italy the trend of spontaneous reports of suspected adverse reactions from vaccine has been influenced by several factors. In 2009 there was an increase in reporting linked to the pandemic influenza vaccine, while in 2011-2012 many reports are linked to the active post licensure safety monitoring of HPV vaccine. The new Pharmacovigilance legislation came into force in Europe in July 2012 and one of the indication was to increase the involvement of patients in reporting systems. Objective: the surveillance of adverse event after immunization (AEFI) reported by patients. Methods: Every adverse event should be reported immediately to healthcare professional in the vaccination center. The safety of vaccines is linked to the constant surveillance of adverse events. In this study all vaccinated children until to 15 months age were involved. For each vaccination parents will receive a Vaccination Diary for surveillance of adverse events by the healthcare professional, accompanied by a letter describing this project and reminding the importance of reporting. First of all healthcare professional will complete the Vaccination Diary in the vaccine section and then the parents should complete the Vaccination Diary describing any adverse event occurred after administration of vaccine. This Vaccination Diary may be delivered to next vaccination or sent by fax or e-mail, even if parents don’t observe any adverse event. This pilot study lasts three months from 1th October/November 2013 until 31st December/January 2013. All Vaccination Diaries delivered by parents will be collected and sent to the Regional Centre of Pharmacovigilance. These diaries with an adverse events will be included in the Italian Pharmacovigilance database.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pharmacology Unit - Veneto Pharmacovigilance Centre (Pharmacol UNIVR), University Hospital Verona

Italy

Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina

Italy

One local health unit Veneto Region, One local health unit Liguria Region, One local health unit Emilia -Romagna Region, Three local health units Piemonte Region, Nine local health units Sicily Region, One local health unit Calabria Region, Three local macro-areas Autonomy Trento Region

Study timelines

Date when funding contract was signed

Planned: 01/01/2011

Actual: 01/01/2011

Study start date

Planned: 01/01/2012

Actual: 01/01/2012

Data analysis start date

Planned: 01/05/2014

Actual: 01/05/2014

Date of final study report

Planned: 01/10/2014

Actual: 09/02/2015

Sources of funding

Other

More details on funding

Italian Agency Medicines

Regulatory

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