Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology
Drug utilisation

Data collection methods

Combined primary data collection and secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Cross-sectional
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(J07BM01) papillomavirus (human types 6, 11, 16, 18)
papillomavirus (human types 6, 11, 16, 18)

Medical condition to be studied

Genital infection female
Genital infection viral
Genital lesion
Genital neoplasm malignant female
Population studied

Short description of the study population

All female residents aged 18- to 45-year old in the participating Nordic countries.
Registry Data: All female residents in the participating Nordic countries who are/were alive on January 1 in the year the data will be used for analysis were included
Survey Data: All female residents alive in the participating countries on July 1, 2004 (baseline survey) and July 1, 2011 (post-vaccination survey) and subjects providing consent granting permission to use the questionnaire data and to linkage of the questionnaire data to other registry databases by using their NPIN were included.
Cervical Sample Collection:
For HPV data in general female population:
• Cervical samples from residents of the participating countries collected between 2006 and 2007, or in 2011-2012 under (including) age 45.
For HPV data in lesional samples
• Cervical samples from women with a diagnosis of CIN or cervical cancer between 2004-2006 and 2011-2012.

Age groups

Adults (18 to < 46 years)

Special population of interest

Women of childbearing potential not using contraception
Women of childbearing potential using contraception

Estimated number of subjects

470000
Study design details

Main study objective

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) by utilizing nationwide registry databases as well as primary data collection in the participating Nordic countries.

Outcomes

1. To describe the incidence of select HPV-related female genital disease before and after the introduction of GARDASIL(TM)2. To describe the prevalence of HPV infection before and after the introduction of GARDASIL(TM)3. To describe congenital anomalies in babies born to women who wereinadvertently exposed to GARDASIL(TM) during their pregnancies, 1. To describe the incidence of select HPV-related female genital disease, stratified by recipient vs. non-recipient of GARDASIL(TM)2. To examine the prevalence of HPV infection in the general female population after the introduction of GARDASIL(TM)3. To characterize HPV vaccination in 18-45 year old females in the participating Nordic countries before and after introduction of GARDASIL(TM)

Data analysis plan

This was a descriptive study where no formal comparisons were done between the two time points (before and after the introduction of GARDASILTM), only cross-sectional estimates of the incidence of HPV-related female genital diseases, prevalence of vaccine-type and non-vaccine type HPV infection, and pregnancy safety in women with exposure to GARDASIL(TM) during pregnancy were calculated. The study was conducted in Denmark, Norway, and Sweden. Iceland was initially included in the study but had minimal uptake of GARDASIL(TM) and was subsequently excluded from analyses of the impact of GARDASIL(TM). Iceland was included in pregnancy safety evaluation.
Documents
Study publications
Hansen BT, Kjær SK, Arnheim-Dahlström L, Liaw KL, Jensen KE, Thomsen LT, Munk C…
Kjaer SK, Tran TN, Sparen P, Tryggvadottir L, Munk C, Dasbach E, Liaw KL, Nygår…
Hansen BT, Hagerup-Jenssen M, Kjaer SK, Munk C, Tryggvadottir L, Sparén P, Liaw…
Nygård M, Hansen BT, Dillner J, Munk C, Oddsson K, Tryggvadottir L, HortlundM, …