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OpenTrials
Completed

NCT Number: NCT01153906

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

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.

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Key information

Conditions

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

Age range

9 year–25 year

Sex eligibility

Female

Study type

Observational

Primary location

GSK Investigational Site

Wilmington, Delaware, 19801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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.

  2. Occurrence of new cases of fibromyalgia

    Time frame: 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.

  3. Occurrence of new cases of psoriasis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination in Females Aged 9-25 Years in the US

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 30, 2010
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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