Last updated: 11/07/2018 04:57:51
Cervarix long-term safety surveillancePGRx
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Cervarix long-term safety surveillance using the PGRx information system (PGRx study)
Trial description: This study aims to assess whether the use of Cervarix® is associated with a modified risk of central demyelination, type 1 diabetes (DT1), Cutaneous Lupus, inflammatory arthritis, idiopathic thrombocytopenic purpura (ITP), Lupus erythematosus, myositis and dermatomyositis, Guillain-Barre syndrome and/or Autoimmune thyroiditis and Graves disease by using the PGRx information system.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
To assess whether the use of Cervarix® is associated with a modified risk of central demyelination.
Timeframe: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of type 1 diabetes.
Timeframe: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of cutaneous Lupus.
Timeframe: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of inflammatory arthritis.
Timeframe: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of idiopathic thrombocytopenic purpura.
Timeframe: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of systemic lupus erythematosus.
Timeframe: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of addendum for cutaneous lupus.
Timeframe: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of myositis.
Timeframe: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of dermatomyositis.
Timeframe: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of Guillain-Barrre syndrome.
Timeframe: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of autoimmune thyroiditis
Timeframe: At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of Graves disease.
Timeframe: At Month 36
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Cervarix
Other: Data collection
Enrollment:
2945
Observational study model:
Case-Control
Primary completion date:
2014-17-12
Time perspective:
Prospective
Clinical publications:
Grimaldi-Bensouda L et al. (2017) Risk of autoimmune diseases and human papilloma virus (HPV) vaccines: Six years of case-referent surveillance. J Autoimmun. pii: S0896-8411(16)30214-1. doi: 10.1016/j.jaut.2017.01.005.
Medical condition
Infections, Papillomavirus
Product
SB580299
Collaborators
Not applicable
Study date(s)
August 2008 to December 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
14 - 79 years
Accepts healthy volunteers
Yes
- Male and female
- Age 14 to 79 years-old (included)
- Prior reported history of the disease
- Patient or Patient’s parent cannot read the interview guide or answer a telephone interview questionnaire in French
Inclusion and exclusion criteria
Inclusion criteria:
- Age 14 to 79 years-old (included)
- Patient residing in France
- Patient accepting to participate in the study
- Patient can read and respond to a telephone interview
Male and female
Exclusion criteria:
- Patient or Patient’s parent cannot read the interview guide or answer a telephone interview questionnaire in French
- Refusal to participate
Prior reported history of the disease
Trial location(s)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2014-17-12
Actual study completion date
2014-17-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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