Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination

NCT01153906 | Completed

• 1 other identifier: 113522
• Study Type: observational
• Target: 1,516
• Locations: 1 country
• Sites: 1

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.

Conditions

Infections, Papillomavirus

Keywords

autoimmune diseases; HPV vaccine; papillomavirus; human papillomavirus; HPV

Outcome Measures

Primary Outcomes (1)

• Occurrence of new cases of confirmed neuroinflammatory autoimmune diseases and other autoimmune diseases.

  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 (3)

• Occurrence of new cases of confirmed systemic autoimmune diseases, organ-specific T-cell mediated autoimmune disease and organ-specific antibody-mediated autoimmune diseases.

  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.

• Occurrence of new cases of fibromyalgia

  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.

• Occurrence of new cases of psoriasis

  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.

Study Arms (2)

Exposed cohort

Females 9-25 years of age, who received at least one dose of Cervarix® as part of their routine health care.

Other: Data collection

Unexposed cohort

Females 9-25 years of age, who did not receive Cervarix®

Other: Data collection

Interventions

Data collection OTHER

New onset of cases for endpoints of interest in the targeted population will be identified from ambulatory and inpatient electronic administrative data and will be confirmed by blinded review of the medical record by an Endpoint Adjudication Committee (EAC) that will confirm the AID case and will assess whether the onset of disease falls within the observation period. Fibromyalgia and psoriasis, for which a high number of cases are expected, will be identified from the electronic administrative data only.

Exposed cohort; Unexposed cohort

Eligibility Criteria

• Age: 9 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Females between the ages of 9-25 years

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Wilmington, Delaware, 19801, United States

Location

MeSH Terms

Conditions

Papillomavirus Infections; Autoimmune Diseases

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: June 30, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 2, 2014

Record last verified: 2014-09

Locations

US (1)