Study identification

EU PAS number

EUPAS29472

Study ID

41943

Official title and acronym

A Prospective Observational Safety Study on Pregnancy Outcomes in Women Immunized With Seasonal Cell Culture Influenza Trivalent (TIVc) or Quadrivalent (QIVc) Vaccine During Pregnancy (Flucelvax (TIVc or QIVc) Pregnancy Registry)

DARWIN EU® study

No

Study countries

United States

Study description

The study is a population based prospective cohort study designed to collect data on pregnancy outcomes and events of interest among women immunized with the seasonal cell culture trivalent influenza virus (TIVc) or the seasonal cell culture quadrivalent influenza virus (QIVc) vaccine during pregnancy. The study population will include pregnant women within the US who were immunized with the TIVc or QIVc vaccine as part of routine care at any time during pregnancy. Eligible pregnant women may self-enroll or voluntarily be enrolled by their health care provider (HCP). Women under 18 can be included in the study as long as parental consent can be obtained. De-identified data on minors will be accepted into the study if permitted by laws and regulations.

Study status

Finalised
Research institutions and networks

Institutions

Syneos Health
United Kingdom
First published:
06/03/2024
InstitutionNon-Pharmaceutical companyENCePP partner
UWCR Winston-Salem, NC

Contact details

Head Epidemiology Study Director

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Seqirus Inc.
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)