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

• PURI:
  https://redirect.ema.europa.eu/resource/105603
• 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)

Harvard Pilgrim Health Care Institute

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

Study protocol

Initial protocol

Protocol_Amendment_2_Anonymized

Regulatory

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