ADVANCE POC I Benefit-Risk pillar – testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: benefit-risk analysis of pertussis vaccines in pre-school children comparing whole-cell and acellular formulations in the post-marketing setting

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/31237
• EU PAS number:
  EUPAS13978
• Study ID:
  31237
• Official title and acronym:
  ADVANCE POC I Benefit-Risk pillar – testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: benefit-risk analysis of pertussis vaccines in pre-school children comparing whole-cell and acellular formulations in the post-marketing setting
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Italy

  Spain

  United Kingdom
• Study description:
  The overall ADVANCE 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?”The objectives of this specific benefit-risk modelling exercise, which focuses on testing methods for benefit-risk analysis with pertussis vaccines as test case, are the following:1. To analyze the benefit-risk balance of pertussis-containing vaccines in children comparing wP and aP formulations at the time of the switch from wP to aP adopting a public health perspective (historical benefit-risk)2. To investigate the impact of (1) statistical uncertainty in benefit and risk estimates as obtained from the literature, clinical trials, observational databases (uncertainty analyses), (2) differences in preferences and (3) subjective model choices (scenario analyses).3. To identify the benefit and risk criteria that would most likely modify the benefit-risk balance in case they would change over time (i.e. the pivotal parameters).4. To assess the feasibility of (retrospectively) monitoring the benefit-risk balance of pertussis-containing vaccines over time (this to mimic prospective monitoring)5. To re-analyze the benefit-risk balance of pertussis-containing vaccines in children comparing wP and aP formulations from a public health perspective using all currently available evidence (current assessment).
• Study status:
  Finalised

Research institutions and networks

Institutions

P95 Clinical and Epidemiology Services

Belgium

Colombia

Netherlands

South Africa

Thailand

United States

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

Data analysis start date

Planned: 01/09/2016

Actual: 01/09/2016

Date of interim report, if expected

Actual: 30/04/2017

Date of final study report

Planned: 01/02/2017

Actual: 30/07/2017

Sources of funding

EU institutional research programme

More details on funding

IMI

Study protocol

Initial protocol

ADVANCE_POCI_BRprotocol

Regulatory

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