Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000267

EU PAS number

EUPAS1000000267

Study ID

1000000267

Official title and acronym

A Post-Marketing Near Real-Time Safety Surveillance of Respiratory Syncytial Virus Vaccine for Guillain-Barre Syndrome (GBS) among Older Adults in the United States

DARWIN EU® study

No

Study countries

United States

Study description

The United States (U.S.) Food and Drug Administration (FDA) approved RSVpreF (Abrysvo) RSV vaccine on 31 May 2023 in individuals ≥60 years and on 21 August 2023 in pregnant individuals at 32 through 36 weeks gestational age. GBS is an important potential risk, which is mentioned in the Abrysvo Risk Management Plan. Across all RSVpreF clinical trials, inflammatory neurologic events were reported in 3 of 20,255 adults aged ≥60 years within 42-days after vaccination with RSVpreF (1 case of GBS, 1 case of Miller Fisher syndrome [a variant of GBS] and 1 case reported as undifferentiated motor-sensory axonal polyneuropathy). On 09 November 2023, FDA informed Pfizer of a few potential cases of GBS among older adults receiving ABRYSVO that were reported to the FDA’s Vaccine Adverse Event Reporting System (VAERS).

To rapidly monitor the risk of GBS, Pfizer proposes to conduct a near real-time surveillance of Abrysvo among older adults in the U.S. This study will utilize both Rapid Cycle Analysis (RCA) and Self-Controlled Risk Interval (SCRI) analyses to detect and evaluate the risk of GBS following Abrysvo vaccination. RCA is an established method of near real-time surveillance that periodically assesses data for safety signal as exposures accrue. The SCRI study design is a commonly used self-controlled method in vaccine safety studies, to evaluate the association between a transient exposure, such as vaccination, and an acute event, such as an adverse reaction. The complementary approaches of conducting an active surveillance study using an RCA for signal detection and a comparative SCRI analysis for signal evaluation is essential for a robust vaccine safety study, which combines the advantage of timely signal detection and the ability to perform an in-depth analysis that is hypothesis-driven and well-controlled for time-invariant confounders.

Study status

Planned
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution
IQVIA
United Kingdom
First published:
22/04/2024
InstitutionNon-Pharmaceutical companyENCePP partner

Contact details

Juan (Joanne) Wu

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

C3671054_PROTOCOL- RSV NEAR REAL TIME SURVEILLANCE CLEAN_V1.0_14AUG2024.pdf

English (1.04 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