Prospective cohort study to describe the natural history of Epstein-Barr virus infection

Study identification

• EU PAS number:
  EUPAS1000000914
• Study ID:
  1000000914
• Official title and acronym:
  Prospective cohort study to describe the natural history of Epstein-Barr virus infection
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Canada

  Denmark

  Japan

  United States
• Study description:
  This is a prospective cohort study to describe the natural history of Epstein-Barr virus (EBV) infection (including outcomes up to 6 years). The primary objectives of the study are to estimate EBV seroprevalence by study site at screening and, among participants who are seronegative at screening, estimate the incidence of (1) EBV seroconversion and (2) infectious mononucleosis (IM) during follow-up by study site.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Merck Sharp & Dohme LLC

United States

Study timelines

Date when funding contract was signed

Actual:10/12/2024

Study start date

Actual:26/09/2025

Data analysis start date

Planned:31/05/2031

Date of final study report

Planned:31/12/2033

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme

Regulatory

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