Clinical trial NCT01153906: Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination
Official title: Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination in Females Aged 9-25 Years in the US
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Papillomavirus
Keywords: autoimmune diseases
HPV vaccine
papillomavirus
human papillomavirus
HPV
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-06-30
Enrollment: 1516
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Females between the ages of 9-25 years

Brief summary: The purpose of this post-marketing study is to evaluate the incidence of autoimmune diseases (AIDs) following females who have received at the least the first dose of Cervarix® as part of their routine health care.


Eligibility criteria: Inclusion Criteria:

Both cohorts:

* Have complete medical insurance coverage and pharmacy benefits.
* Enrolled female health plan members for at least one year prior to study entry.
* Age between 9 and 25 years at study entry.

Exposed cohort:

• Subjects who have received at least one dose of Cervarix®, with or without any other US age-appropriate recommended vaccines.

Unexposed cohort:

• No further specific inclusion criteria

Exclusion Criteria:

Both cohorts:

• Subjects with a diagnostic code of any of the AID endpoints of interest during the one year prior to the index date.

Exposed cohort:

• Subjects who received any dose of Gardasil® prior to the first dose of Cervarix®.

Unexposed cohort:

• Subjects who receive any dose of Cervarix® prior to the index date.

Primary outcomes:
measure: Occurrence of new cases of confirmed neuroinflammatory autoimmune diseases and other autoimmune diseases.
timeFrame: During the 12-month period following administration of at least the first dose of Cervarix® among the exposed cohort and during an equivalent time period among the unexposed cohort.
Secondary outcomes:
measure: Occurrence of new cases of confirmed systemic autoimmune diseases, organ-specific T-cell mediated autoimmune disease and organ-specific antibody-mediated autoimmune diseases.
timeFrame: During the 12-month period following administration of at least the first dose of Cervarix® among the exposed cohort and during an equivalent time period among the unexposed cohort.
measure: Occurrence of new cases of fibromyalgia
timeFrame: During the 12-month period following administration of at least the first dose of Cervarix® among the exposed cohort and during an equivalent time period among the unexposed cohort.
measure: Occurrence of new cases of psoriasis
timeFrame: During the 12-month period following administration of at least the first dose of Cervarix® among the exposed cohort and during an equivalent time period among the unexposed cohort.
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: GSK Investigational Site
state: Delaware
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: