Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000295

EU PAS number

EUPAS1000000295

Study ID

1000000295

Official title and acronym

Observational Cohort Study Evaluating Real-World ABRYSVO Vaccine Effectiveness and Impact Against Medically-Attended RSV-related and All-Cause Outcomes Among Infants Born to Individuals Vaccinated During Pregnancy

DARWIN EU® study

No

Study countries

United States

Study description

This study will be conducted in collaboration with an integrated delivery health care organization in the United States using electronic medical record (EMR) data, collected during routine standard of care clinical encounters. This study will use a retrospective cohort design to study the vaccine effectiveness (VE) and impact of ABRYSVO vaccination during pregnancy in a real-world population over multiple RSV seasons.

Study status

Planned
Research institutions and networks

Institutions

Kaiser Permanente Northern California (KPNC)

Networks

Kaiser Permanente Northern California

Contact details

Nicola Klein

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer INC
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable