Study identification

EU PAS number

EUPAS50387

Study ID

50697

Official title and acronym

Retrospective cohort study evaluating effectiveness of GARDASIL™ against adult-onset recurrent respiratory papillomatosis in Norway

DARWIN EU® study

No

Study countries

Norway

Study description

Study cancelled - It has been combined with study V503-088 (EUPAS48452). Recurrent respiratory papillomatosis (RRP) is a rare disease caused by human papillomavirus (HPV) infection in the airways, marked by recurrent papillomatous lesions in the respiratory tract. HPV types 6 and 11 account for over 90% of RRP cases. GARDASIL/GARDASIL 9 vaccines protect against HPV types 6, 11, 16 and 18, and were administered to 12 year old girls from 2009-2016 as part of the childhood vaccination program in Norway. The primary objective of the study is to use a population-based retrospective cohort study to assess whether vaccination with GARDASIL/GARDASIL 9 before 17 years of age reduces the risk of adult-onset RRP. The secondary objectives of the study are to use nationwide registry data to assess annual incidence rates of adult onset RRP and juvenile-onset RRP among males and females in Norway since 2008.

Study status

Cancelled
Research institutions and networks

Institutions

Merck Sharp & Dohme LLC
United States
First published:
08/07/2025
Institution Pharmaceutical company

Contact details

Clinical Trials Disclosure Merck Sharp & Dohme LLC

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
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?

No

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

Not applicable