Population-based retrospective nested case-control study evaluating effectiveness of GARDASIL™ /GARDASIL™9 against adult-onset recurrent respiratory papillomatosis (AoRRP) in Sweden, Denmark, and Norway (V503-088)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50312
• EU PAS number:
  EUPAS48452
• Study ID:
  50312
• Official title and acronym:
  Population-based retrospective nested case-control study evaluating effectiveness of GARDASIL™ /GARDASIL™9 against adult-onset recurrent respiratory papillomatosis (AoRRP) in Sweden, Denmark, and Norway (V503-088)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Norway

  Sweden
• Study description:
  Adult-onset Recurrent Respiratory Papillomatosis (AoRRP) and juvenile-onset Recurrent Respiratory Papillomatosis (JoRRP) are rare medical conditions where human papillomavirus (HPV) types 6 and 11 cause wart-like growths in the larynx. GARDASIL™ and GARDASIL™9 are vaccines that target HPV types 6 and 11. This study will utilize data from national registries in Sweden, Denmark, and Norway to determine if vaccination with GARDASIL™ or GARDASIL™9 reduces the incidence of AoRRP. The study has 2 parts: (1) a population-based nested case-control study that allows the selection of controls from the same underlying population at risk as the disease cases in females aged 15 to 29 years (2) an ecological study using registry data to assess annual age-standardized incidence rates of JoRRP and AoRRP separately for juveniles (0-14 years) and adults (15-29 years) and by gender (males and females). The primary objective of the study is to assess if the odds of AoRRP are lower among females fully vaccinated with GARDASIL/GARDASIL 9 before the age of 17 years versus those unvaccinated.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Merck & Co.

Karolinska Institutet

Sweden

Cancer Registry of Norway
Danish Cancer Research Society

Study timelines

Date when funding contract was signed

Actual: 15/01/2021

Study start date

Planned: 15/12/2022

Actual: 26/10/2021

Data analysis start date

Planned: 15/05/2025

Date of final study report

Planned: 15/10/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme LLC

Study protocol

Initial protocol

V503-088-00-v2.1-Protocol_final redaction

Updated protocol

V503-088-01-v1-final-redaction.pdf

Regulatory

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