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

• 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 Sharp & Dohme LLC

United States

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

Actual:15/05/2025

Date of final study report

Planned:30/06/2026

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