Nested case-control study evaluating effectiveness of immunization of girls and women of childbearing potential with GARDASIL(TM)/GARDASIL(TM) 9 against juvenile-onset recurrent respiratory papillomatosis (JoRRP) in Sweden, Denmark, and Norway (V503-095)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000286
• EU PAS number:
  EUPAS1000000286
• Study ID:
  1000000286
• Official title and acronym:
  Nested case-control study evaluating effectiveness of immunization of girls and women of childbearing potential with GARDASIL(TM)/GARDASIL(TM) 9 against juvenile-onset recurrent respiratory papillomatosis (JoRRP) in Sweden, Denmark, and Norway (V503-095)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Norway

  Sweden
• Study description:
  Recurrent respiratory papillomatosis (RRP) is a medical condition where HPV types 6 and 11 cause wart-like growths in the larynx. The condition is rarely fatal but associated with high morbidity. Current treatment only offers temporary symptomatic relief. There is an expectation that HPV vaccination of mothers, targeting types 6 and 11, will reduce incidence of RRP in their children.; The primary objective of this study is to assess if the odds of JoRRP are lower among children whose biologic mothers were fully vaccinated with GARDASIL/GARDASIL 9 at least one year prior to delivery versus unvaccinated mothers.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Merck & Co.

Karolinska Institutet

Sweden

Cancer Registry of Norway
Danish Cancer Society

Study timelines

Date when funding contract was signed

Actual: 23/11/2021

Study start date

Actual: 03/03/2023

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

V503-095-00-v3-Protocol_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