Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: Incidence rates of pertussis and pertussis related outcomes of whole-cell pertussis and acellular pertussis vaccines in pre-school children (benefit study on pertussis vaccination)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/21757
• EU PAS number:
  EUPAS13766
• Study ID:
  21757
• Official title and acronym:
  Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: Incidence rates of pertussis and pertussis related outcomes of whole-cell pertussis and acellular pertussis vaccines in pre-school children (benefit study on pertussis vaccination)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Italy

  Netherlands

  Spain

  Sweden
• Study description:
  The overall proof-of-concept (POC) question is to test the system for benefit-risk monitoring of vaccines in Europe. This will first be done by using test cases. For this POC, the following research question is used: “Has the initial benefit-risk profile in children prior to school-entry booster been maintained after the switch from whole-cell pertussis vaccines to acellular pertussis vaccines”?There will we 3 different POCs carried out, the one presented here will test the benefits of pertussis vaccines in the population.
• Study status:
  Finalised

Research institution and networks

Institutions

P95 Epidemiology & Pharmacovigilance

Belgium

Colombia

Netherlands

South Africa

Thailand

United States

VACCINE.GRID

Switzerland

Pharmacoepidemiology and Pharmacovigilance department, Spanish Agency of medicines and medical devices (AEMPS)

Spain

University Medical Center Utrecht (UMCU)

Netherlands

Department of Medical Informatics - Health Data Science, Erasmus Medical Center (ErasmusMC)

Netherlands

P95 Epidemiology & Pharmacovigilance

Belgium

Colombia

Netherlands

South Africa

Thailand

United States

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

IMS Health

Networks

Accelerated development of vaccine benefit-risk collaboration in Europe (ADVANCE)

Contact details

Arnheim Dahlström Lisen

Study contact

[e-mail]

Miriam Sturkenboom

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 31/10/2013

Actual: 31/10/2013

Data collection

Planned: 02/04/2016

Actual: 01/10/2016

Date of final study report

Planned: 31/10/2016

Actual: 30/07/2017

Sources of funding

EU institutional research programme

Pharmaceutical company and other private sector 

More details on funding

Sanofi Pasteur, GSK, MSD Sanofi Pasteur, IMI

Study protocol

Initial protocol

pertussis_benefit_POC

Regulatory

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