Study identification

PURI

https://redirect.ema.europa.eu/resource/21742

EU PAS number

EUPAS13908

Study ID

21742

Official title and acronym

ADVANCE POC Study Protocol - Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case. Coverage rates of acellular and whole-cell pertussis-containing vaccines in preschool children (ADVANCE Coverage POC)

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”?

Study status

Finalised
Research institution and networks

Institutions

THIN UK, FISABIO Spain, BIFAP spain, SSI Denmark

Networks

Contact details

Hanne-Dorthe Emborg

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EU institutional research programme
Pharmaceutical company and other private sector 

More details on funding

GSK, SP, NOVARTIS, SP MSD, CRUCELL, PFIZER, TAKEDA, IMI
Study protocol
Initial protocol

ADVANCE POC-Coverage-Protocol

English (1.62 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable