Status: Finalised First registered on: 03/12/2013
Last updated on: 12/02/2019
1. Study identification
EU PAS Register NumberEUPAS5350
Official titleSurveillance of Adverse Event related to childhood vaccination reported by parents
Study title acronym
Study typeActive surveillance
Brief description of the studyBackground: 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsPharmacol UNIVR
Department/Research groupPharmacology Unit - Veneto Pharmacovigilance Centre
Organisation/affiliationUniversity Hospital Verona
Website/Homepagewww.sfm.univr.it
Details of (Primary) lead investigator
Title Professor
Last name Ugo
First name Moretti
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?6

University of Messina
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
Countries in which this study is being conducted
National study

Italy
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/01/201101/01/2011
Start date of data collection01/01/201201/01/2012
Start date of data analysis01/05/201401/05/2014
Date of interim report, if expected
Date of final study report01/10/201409/02/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyItalian Agency Medicines100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Ugo
First name Moretti
Address line 1Pharmacology Unit
Address line 2Policlinico GB Rossi 
Address line 3P.le L.A. Scuro 10 
CityVerona 
Postcode37134 
CountryItaly
Phone number (incl. country code)390458124245 
Alternative phone number390458027602 
Fax number (incl. country code)390458124876 
Email address ugo.moretti@univr.it
Public Enquiries
Title Professor 
Last name Ugo 
First name Moretti 
Address line 1Pharmacology Unit 
Address line 2Policlinico GB Rossi 
Address line 3P.le L.A. Scuro 10 
CityVerona 
Postcode37134 
CountryItaly 
Phone number (incl. country code)390458124245 
Alternative phone number390458027602 
Fax number (incl. country code)390458124876 
Email address ugo.moretti@univr.it 
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