A Test-Negative Case-Control Study to Evaluate the Effectiveness of V116, CAPVAXIVETM Against Pneumococcal Pneumonia in Older Adults

Study identification

• EU PAS number:
  EUPAS1000000640
• Study ID:
  1000000640
• Official title and acronym:
  A Test-Negative Case-Control Study to Evaluate the Effectiveness of V116, CAPVAXIVETM Against Pneumococcal Pneumonia in Older Adults
• DARWIN EU® study:
  No
• Study countries:
  Canada

  United States
• Study description:
  The main objective of this study is to assess the effectiveness of CAPVAXIVE in preventing hospitalized, confirmed community acquired pneumonia (CAP) (invasive and noninvasive) caused by S pneumoniae serotypes contained in CAPVAXIVE and/or cross-reactive serotypes 6C and 15B among participants who received no other pneumococcal vaccines than CAPVAXIVE in the previous 5 years.
• Study status:
  Planned

Research institutions and networks

Institutions

Merck Sharpe & Dohme LLC

IQVIA, Inc

Study timelines

Date when funding contract was signed

Planned: 22/04/2022

Actual: 22/04/2022

Study start date

Planned: 31/08/2025

Data analysis start date

Planned: 30/04/2029

Date of final study report

Planned: 31/12/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme LLC

Regulatory

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