Investigating the effect of the 13-valent pneumococcal conjugate vaccine on major adverse cardiovascular events among Medicare enrollees aged ≥65 years in the United States

Study identification

• EU PAS number:
  EUPAS1000000520
• Study ID:
  1000000520
• Official title and acronym:
  Investigating the effect of the 13-valent pneumococcal conjugate vaccine on major adverse cardiovascular events among Medicare enrollees aged ≥65 years in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This retrospective observational study was designed to evaluate the effect of PCV13 on major adverse cardiovascular events (MACE) outcomes among adults aged ≥65 years in the United States using a large claims database from the Medicare health insurance program.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned:21/05/2024

Actual:21/05/2024

Study start date

Planned:15/04/2025

Actual:04/08/2025

Date of final study report

Planned:01/04/2026

Regulatory

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

Other study registration identification numbers and links

B1851222