Postmarketing commitment safety study of HZ/su to evaluate pregnancy exposures and outcomes in immunodeficient or immunosuppressed women between 18 and 49 years of age (EPI-ZOSTER-039 VS US DB 214420)

Study identification

• EU PAS number:
  EUPAS104070
• Study ID:
  105603
• Official title and acronym:
  Postmarketing commitment safety study of HZ/su to evaluate pregnancy exposures and outcomes in immunodeficient or immunosuppressed women between 18 and 49 years of age (EPI-ZOSTER-039 VS US DB 214420)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The study will examine the risk of selected infant and pregnancy outcomes in immunodeficient or immunosuppressed women exposed to herpes zoster subunit vaccine (HZ/su) during pregnancy.
• Study status:
  Ongoing

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

Optum

Germany

Harvard Pilgrim Health Care Institute

Carelon Research, United States
CVS Health Clinical Trial Services, United States

Study timelines

Date when funding contract was signed

Actual: 09/11/2022

Study start date

Planned: 03/04/2023

Actual: 09/05/2022

Date of final study report

Planned: 30/04/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GSK

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable