GARDASIL(TM) Vaccine Impact in Population (VIP) Study (V501-033)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20359
• EU PAS number:
  EUPAS17505
• Study ID:
  20359
• Official title and acronym:
  GARDASIL(TM) Vaccine Impact in Population (VIP) Study (V501-033)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Norway

  Sweden
• Study description:
  This study was conducted to assess the impact of GARDASIL(TM) human papillomavirus (HPV) vaccine on the epidemiology of HPV-related genital disease in the general female population (18- to 45-year old) in participating Nordic countries. The study was based on a combination of national registry data and primary data collection that took a series of cross-sectional snap shots at the general female population in Denmark, Norway and Sweden between 2004 (before the implementation of population-based HPV vaccination) and 2012 (after this implementation). There were four components in the study, including 1) surveillance of HPV-related disease incidence (cervical, vaginal, and vulvar cancers, and their precursors), 2) pregnancy safety (i.e., prevalence of congenital anomalies in infants born to mothers with inadvertent exposure to the vaccine during pregnancy or shortly before conception), 3) HPV typing in cervical samples (to measure HPV prevalence in cervical cancer and precursor lesions, and in the general female population), and 4) questionnaire surveys (to assess life style and risk-taking sexual behavior). The first two components utilized the existing nationwide registry data in the Nordic countries while the last two components were based on cross-sectional collections of cervical samples and questionnaire survey data in the general female population.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

Danish Cancer Society Denmark, The Cancer Registry of Norway Norway, Karolinska Institutet Sweden

Study timelines

Date when funding contract was signed

Actual: 29/05/2007

Study start date

Actual: 29/05/2007

Data analysis start date

Actual: 02/12/2014

Date of final study report

Actual: 19/12/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme Corp.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

NCT01077856V501-033