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

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Self controlled case-series
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

TOZINAMERAN

Medical condition to be studied

Vulval ulceration
Population studied

Short description of the study population

The study focused on general population in UK and patients visiting general practices in Spain identified through IMRD and THIN databases to determine the incidence rates of vulval ulceration and vulval ulceration in the vaccine exposed population.

Age groups

  • Adolescents (12 to < 18 years)
  • Children (2 to < 12 years)
  • Infants and toddlers (28 days – 23 months)
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Patients with vulval ulceration

Estimated number of subjects

880000
Study design details

Main study objective

To describe - Comirnaty vaccine exposure stratified by age, no of doses, and year of vaccination. - Incidence rates of vulval ulceration (i) in the general population stratified by age and year, (ii) following exposure to Comirnaty vaccine stratified by age, no of doses and year, and (iii) following exposure to other COVID-19 vaccines stratified by age, no of doses and year

Outcomes

Vulval ulceration, Vaccine utilisation was stratified by age group and number of doses. Event rates for vulval ulceration in the general population were stratified by age group and year. Event rates among exposed patients were stratified by age, and number of doses. Age was categorised as: < 10; 10-19; 20-29; 30-39; 40-49; 50-59; 60-69; 70-79; ≥80 years.

Data analysis plan

This was a cohort study describing vaccine exposure, population incidence rates of vulval ulceration and incidence rates of vulval ulceration in the vaccine exposed population (incl an exploratory Self-controlled Case Series)