A Post-licensure Surveillance Program for the Safety of GARDASIL™ in a Managed Care Organization Setting (V501-031)

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:
  Observational surveillance

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:
  Human papilloma virus immunisation

Population studied

• Short description of the study population:
  Females who received GARDASIL™ vaccination.; Inclusion Criteria for the Primary Populations; For Monitoring Short-Term Safety; 1. a female between ages 9-26 years at the time of first dose of GARDASIL™; 2. completes the series of 3-dose regimen of GARDASIL™ within 12 months of time (between the first and third doses) with at least an interval of 28 days between dose 1 and dose 2 and 12 weeks between dose 2 and dose 3.; For Evaluation of Inadvertent Exposure to GARDASIL™ During Pregnancy; 1. receives at least one dose of GARDASIL™ either up to 30 days prior to the date of conception during the study period in which accrual of the primary population takes place or at any time between conception and the day the pregnancy is resolved.; For Evaluating Select Autoimmune Conditions; 1. a female who has received at least one dose of GARDASIL™; 2. has been a member within the same MCO for at least 12 months prior to the receipt of GARDASIL™ (for medical record review); Inclusion Criteria for the Reference Groups; For Monitoring Short-Term Safety; 1. females between ages 9-26 years at the time of first dose of GARDASIL™ Inclusion Criteria for the Secondary Short-term Safety Analysis Cohort; 1. receives one or two doses of GARDASIL™; or; 2. Off -label use of at least one dose of GARDASIL™; SUBJECT/PATIENT EXCLUSION CRITERIA; 2.3.1 Exclusion Criteria for the Primary Populations; For Monitoring Short-Term Safety; 1. males; 2. receives incomplete regimen of GARDASIL™; 3. completes the 3-dose regimen of GARDASIL™ in more than 12 months of time.; 4. Less than a 28 day interval between doses 1 and 2 or less than a 12-week interval between doses 2 and 3 of GARDASIL™.; 5. younger than 9 or older than 26 years of age at receipt of first dose; For Evaluation of Pregnancy Safety; 1. males; 2. no record of pregnancy at the MCO; For Evaluating Select Autoimmune Conditions; 1. have been member of the same MCO for less than 12 months prior to receiving the first dose of GARDASIL™ (for medical record review); 2. males; E
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Estimated number of subjects:
  189629

Study design details

• Main study objective:
  To assess the general safety of Gardasil™ when administered to females as part of routine healthcare.
• Outcomes:
  The primary outcome is incidence rates of health outcomes resulting in emergency room visits or hospitalizations following receipt of Gardasil™, compared to post-vaccination self-comparison. The secondary outcomes are:1. To provide the descriptive epidemiology of the outcomes of pregnancy exposures to Gardasil™2. To provide the descriptive epidemiology of the outcomes of 16 pre-specified new onset autoimmune conditions after receipt of Gardasil™
• Data analysis plan:
  For each health outcome that results in a hospitalization or emergency room visit during the risk and/or self-comparison periods, the incidence rates will be calculated and the relative risk of health outcomes as estimated by the odd ratios and 95% confidence intervals will be estimated with conditional logistic regression.