A Phase 4 Observational, Real-World Study of 20-valent Pneumococcal Conjugate Vaccine Effectiveness Against Vaccine-Type Invasive Pneumococcal Disease in Adults Aged 65 years and above

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000007
• EU PAS number:
  EUPAS1000000007
• Study ID:
  1000000007
• Official title and acronym:
  A Phase 4 Observational, Real-World Study of 20-valent Pneumococcal Conjugate Vaccine Effectiveness Against Vaccine-Type Invasive Pneumococcal Disease in Adults Aged 65 years and above
• DARWIN EU® study:
  No
• Study countries:
  Czechia

  Israel

  Spain
• Study status:
  Planned

Research institutions and networks

Institutions

P95 Clinical and Epidemiology Services

Belgium

Colombia

Netherlands

South Africa

Thailand

United States

Study timelines

Date when funding contract was signed

Planned: 01/06/2024

Study start date

Planned: 01/09/2024

Date of final study report

Planned: 31/12/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Updated protocol

Pfizer_PCV20_EMA Study protocol_v1.1_02JUL2024_clean (1).pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 2 (specific obligation of marketing authorisation)
• Regulatory procedure number:
  EMEA/H/C/005451