Post-marketing observational surveillance study to evaluate pregnancy outcomes among women who receive Heplisav-B or Engerix-B (DV2-HBV-28)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000304
• EU PAS number:
  EUPAS1000000304
• Study ID:
  1000000304
• Official title and acronym:
  Post-marketing observational surveillance study to evaluate pregnancy outcomes among women who receive Heplisav-B or Engerix-B (DV2-HBV-28)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This observational retrospective cohort study, conducted by Kaiser Permanente Southern California (KPSC) was conducted to assess the risk of pregnancy outcomes among women who received Heplisav-B or Engerix-B during 28 days prior to conception or pregnancy.; ; • Pregnancy outcomes: spontaneous abortion, induced abortion, and stillbirth; ; • Outcomes among live births:; o Assessed at birth: preterm birth, low birth weight, and small for gestational age; o Assessed at birth through 6 months of age: major birth defects;
• Study status:
  Finalised

Research institutions and networks

Institutions

Kaiser Permanente Southern California (KPSC)

Dynavax Technologies

Study timelines

Date when funding contract was signed

Actual: 07/08/2018

Study start date

Actual: 11/08/2022

Date of final study report

Actual: 09/07/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Dynavax Technologies Corporation

Study protocol

Initial protocol

1611-prot-amend.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable