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

27/03/2024
04/05/2026
EU PAS number:
EUPAS1000000007
Study
Ongoing
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Study identification

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 description

Multicountry observational study assessing real‑world effectiveness of PCV20 against vaccine‑type invasive pneumococcal disease in adults ≥65 years, using surveillance data to inform interim and final regulatory decisions.

Study status

Ongoing
Research institutions and networks

Institutions

P95 Clinical and Epidemiology Services
Belgium
Colombia
Netherlands
South Africa
Thailand
United States
First published:
21/02/2025
Institution Laboratory/Research/Testing facility Non-Pharmaceutical company ENCePP partner

Networks

IPD-VEN

Contact details

Germaine Hanquet 0000-0002-3382-0211

Primary lead investigator
ORCID number:
0000-0002-3382-0211

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 1 (imposed as condition of marketing authorisation)

Regulatory procedure number

EMEA/H/C/005451