Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000400

EU PAS number

EUPAS1000000400

Study ID

1000000400

Official title and acronym

A post-authorisation safety study of ABRYSVO in immunocompromised, or renally or hepatically impaired adults aged 60 years and older in a real world setting in Europe and UK

DARWIN EU® study

No

Study countries

France
Spain
United Kingdom

Study description

As immunocompromised, renally and hepatically impaired older adults were not included in clinical trials that supported regulatory approvals, the safety profile of ABRYSVO in these populations is unknown. This protocol describes a post-authorization safety study (PASS) to assess the safety of ABRYSVO in immunocompromised, or renally or hepatically impaired adults aged 60 and older in select European countries and in the UK, with data sources that can capture vaccine exposure in the target populations, and where outcomes and key covariates can be ascertained.

Study status

Planned
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution
Julius Clinical Research
Netherlands
First published:
06/03/2024
InstitutionNon-Pharmaceutical companyENCePP partner
Analysis Group, Inc.

Networks

Contact details

Cynthia De Luise

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer 100%
Study protocol
Initial protocol

C3671038_RSV VACCINE OLDER ADULT PROTOCOL V1.0_09JUL2024.pdf

English (1016.93 KB - PDF)View document
Updated protocol

C3671038_RSV VACCINE OLDER ADULT UPDATED PROTOCOL V2.0_07OCT2024.pdf

English (1 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)