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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50697
• 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:
  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:
  Ongoing

Research institution and networks

Institutions

Merck & Co.

Study timelines

Date when funding contract was signed

Actual: 23/11/2021

Study start date

Planned: 28/02/2023

Actual: 26/01/2023

Data analysis start date

Planned: 28/06/2024

Date of final study report

Planned: 31/03/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme LLC

Study protocol

Initial protocol

V503-090-00-v1-Protocol_final redaction

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable