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 summary
No information provided.
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

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