ADVANCE POC I Risk pillar - Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: Incidence rates of safety outcomes of whole-cell pertussis and acellular pertussis vaccines in pre-school children

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/21721
• EU PAS number:
  EUPAS13779
• Study ID:
  21721
• Official title and acronym:
  ADVANCE POC I Risk pillar - Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: Incidence rates of safety outcomes of whole-cell pertussis and acellular pertussis vaccines in pre-school children
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Italy

  Spain

  United Kingdom
• Study description:
  RATIONALE: The ADVANCE proof-of-concept (POC) question is to test the system for benefit-risk monitoring of vaccines in Europe. For this POC feasibility study, the research question “Has the initial benefit-risk profile in children prior to school-entry booster been maintained after the switch from whole-cell pertussis (wP) vaccines to acellular pertussis (aP) vaccines?” is used.OBJECTIVES:1. To evaluate participating databases on quality criteria for inclusion in the study.2. To provide incidence rates of specific events (i.e. injection site reactions, fever, somnolence, persistent crying, irritability, febrile or afebrile seizure/convulsion, hypotonic-hyporesponsive episode HHE, extensive limb swelling) within risk periods after each dose of wP or aP vaccine and within the periods outside the risk windows (baseline) in pre-school children for a benefit/risk analysis model.3. To provide calendar time specific incidence data as test for methods development in ADVANCE WP4.STUDY DESIGN: is a retrospective dynamic cohort study.The study will be conducted utilizing electronic health care data from ADVANCE partners in different European countriesPOPULATION: The study population will comprise all children registered in any of the participating databases during the study period and for whom an adequate start and end of follow-up and date of birth can be defined.Children will be followed from start of the study period, one month after date of birth, or date of valid data in the database (whichever is the latest) until the end of study period (31-12-2015, the school-entry pertussis booster, transferring out of the database, death, reaching age 6 years: whichever is the earliest).Data Analysis: incidence rates (i.e. baseline and risk-window specific) of known adverse reactions following vaccination with pertussis-containing vaccines for use in a multi-criteria decision analysis (MCDA) model of benefits and risks of wP versus aP pertussis vaccines.
• Study status:
  Finalised

Research institutions and networks

Institutions

Erasmus Medical Centre Rotterdam

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

Spain

SSI Denmark, BIFAP Spain, FISABIO Spain, THIN UK

Networks

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

Study timelines

Date when funding contract was signed

Planned: 01/10/2013

Actual: 01/10/2013

Study start date

Planned: 01/06/2016

Actual: 01/06/2016

Date of final study report

Planned: 01/06/2016

Actual: 17/08/2017

Sources of funding

EU institutional research programme

More details on funding

IMI

Study protocol

Initial protocol

ADVANCE POC-Risk-Protocol

Regulatory

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