Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

Gardasil
Gardasil 9

Name of medicine, other

- human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
- human papillomavirus 9-valent vaccine (recombinant, adsorbed)

Anatomical Therapeutic Chemical (ATC) code

(J07BM01) papillomavirus (human types 6, 11, 16, 18)
(J07BM03) papillomavirus (human types 6, 11, 16, 18, 31, 33, 45, 52, 58)

Medical condition to be studied

Respiratory papilloma

Additional medical condition(s)

Adult-onset recurrent respiratory papillomatosis, Juvenile-onset Recurrent respiratory papillomatosis
Population studied

Age groups

Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
Children (2 to < 12 years)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)

Estimated number of subjects

3000000
Study design details

Main study objective

The primary objective is to assess whether vaccination with GARDASIL/GARDASIL 9 before 17 years of age reduces the risk of adult-onset RRP.

Outcomes

Incidence of adult-onset RRP among females measured using ICD-10 code D14.1, 1) Incidence of adult-onset RRP among males and females measured using ICD-10 code D14.1 2) Incidence of juvenile-onset RRP among males and females measured using ICD-10 code D14.1.

Data analysis plan

The data will be analyzed for the primary objective using a Cox Proportional Hazards Model for the risk of first adult-onset RRP incidence, using age as running time. For the secondary objectives, age-standardized incidence rates of juvenile-onset RRP and adult-onset RRP will be calculated stratified by age group and calendar period.