Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000476

EU PAS number

EUPAS1000000476

Study ID

1000000476

Official title and acronym

Non-Interventional Postmarketing Safety Study to Evaluate the COMIRNATY 2024-2025 Formula (monovalent KP.2) in the United States

DARWIN EU® study

No

Study countries

United States

Study description

The study will be conducted in two phases, each with its own specific objectives.
In Phase 1, the primary objective is to estimate the incidence of pre-specified AESIs in a risk window following vaccination with the COMIRNATY 2024-2025 Formula compared to the incidence of these events during a post-vaccination control window (ie, expected rates of these events).
In Phase 2, the primary objective is to estimate the incidence of pre-specified AESIs among individuals who receive the COMIRNATY 2024-2025 Formula compared to the incidence among individuals with no recorded vaccination with the COMIRNATY 2024-2025 Formula.
The secondary objective is to estimate the incidence of pre-specified AESIs among individuals who receive the COMIRNATY 2024-2025 Formula compared to the incidence among individuals with no recorded vaccination with the COMIRNATY 2024-2025 Formula within subgroups of immunocompromised individuals, individuals with specific comorbidities, individuals with prior SARS-CoV-2 infection, individuals with prior COVID-19 vaccination, individuals with concomitant administration of non-COVID-19 vaccines, pregnant individuals, children, and the elderly, if sample size permits.
This is a non-interventional observational study utilizing an administrative claims database in the US.
Phase 1 will utilize a self-controlled risk interval (SCRI) design, and Phase 2 will utilize a matched comparative safety cohort design.

Study status

Ongoing
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution
Optum - United States

Contact details

Jenny Sun

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

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
Study protocol
Initial protocol

C4591070 PROTOCOL AND STATISTICAL ANALYSIS PLAN_28OCT2024.pdf

English (1.27 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable