Protocol

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

March 31, 2023
Authors:

Harvard Pilgrim Health Care Institute, CVS Health, Carelon Research, Optum Epidemiology, GlaxoSmithKline

Capability:
Pregnancy & Mother-Infant Linked Studies
Multi-Site Methods & Coordination
Expertise:
Regulatory Research & Support
RWE Research & Consulting
View the public protocol

GlaxoSmithKline, Harvard Pilgrim Health Care Institute, CVS Health, Carelon Research, Optum Epidemiology. 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) (EUPAS104070; Study ID 105603). Amsterdam: European Medicines Agency (EMA); 2023 Mar 31. Available from: https://catalogues.ema.europa.eu/node/3755/administrative-details