Infections, PapillomavirusNCT01953822
Study Assessing Risk of Autoimmune Diseases in Females (9 - 25 Years) Exposed to Cervarix® in United Kingdom
An observational study of Infections, Papillomavirus, run by GlaxoSmithKline.
Trial summary
This is an observational cohort study to assess the risk of autoimmune disease(s) within 12 months of receiving the first dose of Cervarix® in the exposed cohort and over a comparable period in the unexposed cohorts. Read more about this study
- Who is it for?
- Ages 9 to 25 years
- Conditions the study is for
- Infections, Papillomavirus
- What is being tested?
- Data collection
- Type of treatment
- Vaccines
- How many people
- 1,053 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Female population is composed of female subjects vaccinated with Cervarix® between the ages of 9 to 25 years and unexposed female subjects identified from historical data. Male population is composed of 9- to 25-year-old male subjects not vaccinated with Cervarix®.
Who may be able to join
- Note: Other vaccines are allowed in this study regardless of the time of administration and the time interval between subsequent doses.
- Female aged from 9 to 25 years at the reference date (01 September 2008 through 31 August 2010).
- Recorded in the CPRD GOLD for at least 12 months before the reference date.
- The first dose of Cervarix received between 01 September 2008 through 31 August 2010, Full date (day/month/year) of Cervarix vaccination(s) available.
- Subject defined as acceptable in CPRD GOLD.
- Inclusion criteria for the unexposed historical female cohort:
Show all 17Show fewer
- Female aged 9 to 25 years at the reference date (01 September 2005 through 31 August 2007).
- Recorded in the CPRD GOLD for at least 12 months before the reference date.
- Subject defined as acceptable in CPRD GOLD.
- Inclusion criteria for the unexposed concurrent male cohort:
- Male aged 9 to 25 years at the reference date (01 September 2008 through 31 August 2010).
- Recorded in the CPRD GOLD for at least 12 months before the reference date.
- Subject defined as acceptable in CPRD GOLD.
- Inclusion criteria for the unexposed historical male cohort:
- Male aged 9 to 25 years at the reference date (01 September 2005 through 31 August 2007).
- Recorded in the CPRD GOLD for at least 12 months before the reference date.
- Subject defined as acceptable in CPRD GOLD.
Who cannot join
- Subjects with a diagnostic code of any auto-immune disease during the year prior to the reference date.
- Subjects who received at least one dose of unspecified HPV vaccine or Gardasil at any time before the reference date.
- Subjects who have been included in the other cohort.
- Subjects who received any dose of Cervarix at any time before the reference date.
About this study
Official title: An Observational Cohort Study to Assess the Risk of Autoimmune Diseases in Adolescent and Young Adult Women Aged 9 to 25 Years Exposed to Cervarix® in the United Kingdom
This is an observational cohort study to assess the risk of autoimmune disease(s) within 12 months of receiving the first dose of Cervarix® in the exposed cohort and over a comparable period in the unexposed cohorts.
This is an alternative study by GSK using the CPRD database in the UK to fulfil the US FDA safety commitment. The UK has had sufficient Cervarix® vaccination coverage during the period mid-September 2008 to 2011 to allow suitable data to be collected.
Read the detailed description
GSK's vaccine Cervarix® protects against Human Papilloma Virus Types-16 and 18-related pre-cancerous lesions. GSK is committed by the US Food and Drug Administration (FDA) to conduct a safety study to evaluate the incidence of new neurological and eye-related autoimmune diseases and other pre-specified autoimmune diseases in subjects receiving Cervarix® in the US. Because of the very low Cervarix® uptake in the US, the observational GSK study to address this commitment is due to be stopped, as it will take too long to recruit the target subjects.
The unexposed male cohorts will be enrolled in order to assess a possible change over time in the incidence rate of new onset of autoimmune disease(s) (NOAD) in the UK Clinical Practice Research Datalink General Practitioner OnLine database (CPRD GOLD) independent of Cervarix® introduction. The cohorts will be frequency matched for the age (age class of one year) and practice region identifier at reference date (age at first dose of Cervarix).
Additionally, the reference date (time = 0) for the vaccinated (exposed) cohort will be the date of the first dose of Cervarix® recorded in CPRD GOLD. The reference date for the unexposed (unvaccinated) cohorts will be a date randomly selected among the reference dates of the exposed subjects and minus 3 years for the historical cohorts.
The other observational study model is a self-control case-series (SCCS) analysis for confirmed NOAD in the exposed female cohort, using a risk period of one year after the first Cervarix® dose, a control period of one year and a six month buffer period between risk and control periods.
Human Papillomavirus Bivalent (Types 16 and 18) vaccine (recombinant) exposed cohort was investigated between 1-SEP-2008 and 31-AUG-2010.
The unexposed concurrent male cohort was investigated between 1-SEP-2008 and 31-AUG-2010.
Unexposed historical female and male cohorts were investigated between 1-SEP-2005 and 31-AUG-2007.
- Conditions
- Infections, Papillomavirus
- Being tested
- Data collection
- Keywords
- Observational, Cohort, Autoimmune disease, Cervarix®, Women aged 9 to 25 years, United Kingdom
- Medical subject headings
- Papillomavirus Infections, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data collection from an existing electronic healthcare databases - Clinical Practice Research Datalink (CPRD) GOLD.
| Study group | Role | What they receive |
|---|---|---|
| Cervarix vaccinated (exposed) female cohort | Female subjects vaccinated with at least one dose of Cervarix® between the ages of 9 to 25 years. Receives: Other: Data collection | |
| Unexposed historical female cohort | Unexposed female subjects identified from historical data, will be frequency matched for age and practice region identifier to the subjects included in the vaccinated (exposed) cohort. Receives: Other: Data collection | |
| Unexposed concurrent male cohort | Male population is composed of 9- to 25-year-old male subjects not vaccinated with Cervarix®. Receives: Other: Data collection | |
| Unexposed historical male cohort | Male population is composed of 9- to 25-year-old male subjects not vaccinated with Cervarix®. Comparison of the unexposed concurrent male cohort with the unexposed historical male cohort will be used as an internal control for changes over time in Clinical Practice Research Datalink (CPRD) GOLD in reporting New Onset of Autoimmune Diseases (NOAD). The male subjects will be frequency matched for age and practice region identifier to the subjects included in the vaccinated (exposed) cohort. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of new onset of confirmed autoimmune disease for neuroinflammatory/ophthalmic autoimmune diseases
Neuroinflammatory/ophthalmic autoimmune diseases: -Multiple Sclerosis; -Transverse myelitis; -Optic neuritis; -Guillain-Barré syndrome, including Miller Fisher syndrome and other variants; -Other demyelinating diseases: -Acute disseminated encephalomyelitis, including site specific variants: e.g. non-infectious encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis; -AI peripheral neuropathies and plexopathies (including chronic inflammatory demyelinating polyneuropathy, multifocal motor neuropathy and polyneuropathies associated with monoclonalgammopathy); -Auto-immune uveitis;
Measured: During the period of 1 year following administration of the first dose of Cervarix® (risk period) among an exposed cohort and during an equivalent time period in the unexposed cohorts
Occurrence of new onset of confirmed autoimmune disease for other autoimmune diseases
Other autoimmune diseases: -Systemic lupus erythematous; -Autoimmune (AI) disease with rheumatologic conditions: -Rheumatoid arthritis (RA);-Juvenile rheumatoid arthritis (JRA); -Still's disease; -Psoriatic arthritis; -Ankylosing Spondylitis; -AI haematological conditions: -Idiopathic thrombocytopenic purpura (ITP); -AI haemolytic anaemia; -AI endocrine conditions: -Type 1 diabetes mellitus; -AI thyroiditis including Hashimoto's disease, Graves' /Basedows' disease; -Inflammatory bowel / hepatic diseases: -Crohn's diseases; -Ulcerative colitis; -Autoimmune hepatitis;
Measured: During the period of 1 year following administration of the first dose of Cervarix® (risk period) among an exposed cohort and during an equivalent time period in the unexposed cohorts
Secondary outcomes (3)
Occurrence of Guillain Barré syndrome (including Miller Fisher syndrome and other variants), and autoimmune haemolytic anaemia
Measured: Within 2 months following the administration of the first dose of Cervarix®
Occurrence of idiopathic thrombocytopenic purpura (ITP)
Measured: Within six months following the administration of the first dose of Cervarix®
Occurrence of new onset of individual confirmed autoimmune disease
Occurrence of multiple sclerosis, transverse myelitis, optic neuritis, other demyelinating diseases, auto-immune uveitis, systemic lupus erythematous (SLE), rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), Still's disease, psoriatic arthritis, ankylosing spondylitis, type 1 diabetes mellitus, auto-immune thyroiditis (including Hashimoto's disease, Graves'/Basedows' disease), and inflammatory bowel / hepatic disease (Crohn's disease, ulcerative colitis and autoimmune hepatitis)
Measured: Within 1 year following the administration of the first dose of Cervarix®
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, PapillomavirusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,053 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953822
- Sponsor's protocol ID
- 116239
- Status last verified
- Dec 2016
- First submitted
- 26 Sep 2013
- Last updated
- 26 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cohort Study to Assess the Risk of Autoimmune Diseases in Adolescent and Young Adult Women Aged 9 to 25 Years Exposed to Cervarix® in the United Kingdom
- ClinicalTrials.gov ID
- NCT01953822
- Acronym / sponsor ID
- 116239
- Conditions
- Infections, Papillomavirus
- Keywords
- Observational, Cohort, Autoimmune disease, Cervarix®, Women aged 9 to 25 years, United Kingdom
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,053 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 1 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational cohort study to assess the risk of autoimmune disease(s) within 12 months of receiving the first dose of Cervarix® in the exposed cohort and over a comparable period in the unexposed cohorts.
This is an alternative study by GSK using the CPRD database in the UK to fulfil the US FDA safety commitment. The UK has had sufficient Cervarix® vaccination coverage during the period mid-September 2008 to 2011 to allow suitable data to be collected.
Detailed description
GSK's vaccine Cervarix® protects against Human Papilloma Virus Types-16 and 18-related pre-cancerous lesions. GSK is committed by the US Food and Drug Administration (FDA) to conduct a safety study to evaluate the incidence of new neurological and eye-related autoimmune diseases and other pre-specified autoimmune diseases in subjects receiving Cervarix® in the US. Because of the very low Cervarix® uptake in the US, the observational GSK study to address this commitment is due to be stopped, as it will take too long to recruit the target subjects.
The unexposed male cohorts will be enrolled in order to assess a possible change over time in the incidence rate of new onset of autoimmune disease(s) (NOAD) in the UK Clinical Practice Research Datalink General Practitioner OnLine database (CPRD GOLD) independent of Cervarix® introduction. The cohorts will be frequency matched for the age (age class of one year) and practice region identifier at reference date (age at first dose of Cervarix).
Additionally, the reference date (time = 0) for the vaccinated (exposed) cohort will be the date of the first dose of Cervarix® recorded in CPRD GOLD. The reference date for the unexposed (unvaccinated) cohorts will be a date randomly selected among the reference dates of the exposed subjects and minus 3 years for the historical cohorts.
The other observational study model is a self-control case-series (SCCS) analysis for confirmed NOAD in the exposed female cohort, using a risk period of one year after the first Cervarix® dose, a control period of one year and a six month buffer period between risk and control periods.
Human Papillomavirus Bivalent (Types 16 and 18) vaccine (recombinant) exposed cohort was investigated between 1-SEP-2008 and 31-AUG-2010.
The unexposed concurrent male cohort was investigated between 1-SEP-2008 and 31-AUG-2010.
Unexposed historical female and male cohorts were investigated between 1-SEP-2005 and 31-AUG-2007.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cervarix vaccinated (exposed) female cohort | – | Other: Data collectionFemale subjects vaccinated with at least one dose of Cervarix® between the ages of 9 to 25 years. |
| Unexposed historical female cohort | – | Other: Data collectionUnexposed female subjects identified from historical data, will be frequency matched for age and practice region identifier to the subjects included in the vaccinated (exposed) cohort. |
| Unexposed concurrent male cohort | – | Other: Data collectionMale population is composed of 9- to 25-year-old male subjects not vaccinated with Cervarix®. |
| Unexposed historical male cohort | – | Other: Data collectionMale population is composed of 9- to 25-year-old male subjects not vaccinated with Cervarix®. Comparison of the unexposed concurrent male cohort with the unexposed historical male cohort will be used as an internal control for changes over time in Clinical Practice Research Datalink (CPRD) GOLD in reporting New Onset of Autoimmune Diseases (NOAD). The male subjects will be frequency matched for age and practice region identifier to the subjects included in the vaccinated (exposed) cohort. |
Who may qualify
- Ages
- 9 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Female population is composed of female subjects vaccinated with Cervarix® between the ages of 9 to 25 years and unexposed female subjects identified from historical data. Male population is composed of 9- to 25-year-old male subjects not vaccinated with Cervarix®.
Key inclusion criteria (17 listed)
- Note: Other vaccines are allowed in this study regardless of the time of administration and the time interval between subsequent doses.
- Female aged from 9 to 25 years at the reference date (01 September 2008 through 31 August 2010).
- Recorded in the CPRD GOLD for at least 12 months before the reference date.
- The first dose of Cervarix received between 01 September 2008 through 31 August 2010, Full date (day/month/year) of Cervarix vaccination(s) available.
- Subject defined as acceptable in CPRD GOLD.
Key exclusion criteria (4 listed)
- Subjects with a diagnostic code of any auto-immune disease during the year prior to the reference date.
- Subjects who received at least one dose of unspecified HPV vaccine or Gardasil at any time before the reference date.
- Subjects who have been included in the other cohort.
- Subjects who received any dose of Cervarix at any time before the reference date.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionData collection from an existing electronic healthcare databases - Clinical Practice Research Datalink (CPRD) GOLD. | Other | Cervarix vaccinated (exposed) female cohort, Unexposed concurrent male cohort, Unexposed historical female cohort, Unexposed historical male cohort |
Primary outcome
Occurrence of new onset of confirmed autoimmune disease for neuroinflammatory/ophthalmic autoimmune diseases
Time frame: During the period of 1 year following administration of the first dose of Cervarix® (risk period) among an exposed cohort and during an equivalent time period in the unexposed cohorts
Neuroinflammatory/ophthalmic autoimmune diseases: -Multiple Sclerosis; -Transverse myelitis; -Optic neuritis; -Guillain-Barré syndrome, including Miller Fisher syndrome and other variants; -Other demyelinating diseases: -Acute disseminated encephalomyelitis, including site specific variants: e.g. non-infectious encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis; -AI peripheral neuropathies and plexopathies (including chronic inflammatory demyelinating polyneuropathy, multifocal motor neuropathy and polyneuropathies associated with monoclonalgammopathy); -Auto-immune uveitis;
Occurrence of new onset of confirmed autoimmune disease for other autoimmune diseases
Time frame: During the period of 1 year following administration of the first dose of Cervarix® (risk period) among an exposed cohort and during an equivalent time period in the unexposed cohorts
Other autoimmune diseases: -Systemic lupus erythematous; -Autoimmune (AI) disease with rheumatologic conditions: -Rheumatoid arthritis (RA);-Juvenile rheumatoid arthritis (JRA); -Still's disease; -Psoriatic arthritis; -Ankylosing Spondylitis; -AI haematological conditions: -Idiopathic thrombocytopenic purpura (ITP); -AI haemolytic anaemia; -AI endocrine conditions: -Type 1 diabetes mellitus; -AI thyroiditis including Hashimoto's disease, Graves' /Basedows' disease; -Inflammatory bowel / hepatic diseases: -Crohn's diseases; -Ulcerative colitis; -Autoimmune hepatitis;
3 secondary outcomes
Occurrence of Guillain Barré syndrome (including Miller Fisher syndrome and other variants), and autoimmune haemolytic anaemia
Time frame: Within 2 months following the administration of the first dose of Cervarix®
Occurrence of idiopathic thrombocytopenic purpura (ITP)
Time frame: Within six months following the administration of the first dose of Cervarix®
Occurrence of new onset of individual confirmed autoimmune disease
Time frame: Within 1 year following the administration of the first dose of Cervarix®
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Papillomavirus, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of new onset of confirmed autoimmune disease for neuroinflammatory/ophthalmic autoimmune diseases (time frame: During the period of 1 year following administration of the first dose of Cervarix® (risk period) among an exposed cohort and during an equivalent time period in the unexposed cohorts). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2016.