Infections, PapillomavirusNCT01905462
Post-marketing Safety Study to Assess the Risk of Spontaneous Abortions in Women Exposed to Cervarix Residing in UK
An observational study of Infections, Papillomavirus, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This study will assess the risk of spontaneous abortion during weeks 1-23 and weeks 1-19 of gestation, respectively, and other pregnancy outcomes, in an exposed cohort, i.e. women with last menstrual period (LMP) between 30 days before and 45 days after, or 30 days before and 90 days after any dose of Cervarix, when… Read more about this study
- Who is it for?
- Ages 15 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infections, Papillomavirus
- What is being tested?
- Data Collection and Cervarix
- How many people
- 1,046 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2012to Aug 2013
- 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 15 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Pregnant women aged 15 to 25 years, residing in UK, exposed to Cervarix and whose data is recorded in the CPRD GOLD.
Who may be able to join
- For the exposed cohort:
- All subjects must satisfy all of the following criteria at entry into the exposed cohort:
- Full date of first day of LMP available in the database or calculated from Estimated date of delivery (EDD).
- Female, aged between, and including, 15 and 25 years of age at LMP.
- Recorded in the CPRD GOLD for at least 12 months at LMP.
- First day of LMP available in the database or calculated from EDD between September 1st 2008 and June 30th 2011.
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- At least one dose of Cervarix received between September 1st 2008 and June 30th 2011.
- Full date of Cervarix vaccination(s) available.
- First day of LMP available in the database or calculated from EDD between 30 days before and 90 days after any dose of Cervarix.
- Subject defined as acceptable in CPRD GOLD.
- For the non-exposed cohort:
- All subjects must satisfy all of the following criteria at entry into the non-exposed cohort:
- Full date of first day of LMP available in the database or calculated from EDD.
- Female, aged between, and including, 15 and 25 years of age at LMP.
- Recorded in the CPRD GOLD since at least 12 months at LMP.
- First day of LMP available in the database or calculated from EDD between September 1st 2008 and June 30th 2011.
- At least one dose of Cervarix received between September 1st 2008 and June 30th 2011.
- Full date of Cervarix vaccination(s) available.
- First day of LMP available in the database or calculated from EDD between 120 days and 18 months after the last dose of Cervarix.
- Subject defined as acceptable in CPRD GOLD.
Who cannot join
- For the exposed cohort:
- Female with the first day LMP between 30 days before and 90 days after at least one dose of unspecified Human Papillomavirus vaccine and/or Gardasil.
- For the non-exposed cohort:
- Female with the first day LMP between 30 days before and 90 days after at least one dose of unspecified Human Papillomavirus vaccine and/or Gardasil.
- Female included for a previous pregnancy in the exposed cohort.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-marketing Safety Study to Assess the Risk of Spontaneous Abortions in Women Exposed to Cervarix in the United Kingdom
This study will assess the risk of spontaneous abortion during weeks 1-23 and weeks 1-19 of gestation, respectively, and other pregnancy outcomes, in an exposed cohort, i.e. women with last menstrual period (LMP) between 30 days before and 45 days after, or 30 days before and 90 days after any dose of Cervarix, when compared to a non-exposed cohort, i.e. women with LMP between 120 days and 18 months after the last Cervarix dose. The data collected in the Clinical Practice Research Datalink General Practitioner OnLine Database (CPRD GOLD) in the UK, will be analysed in this study.
Read the detailed description
Convenience sampling will be used in this study. It is planned to include all eligible pregnant women (included in CPRD GOLD and who fulfil to the inclusion/exclusion criteria) in each of the two cohorts.
- Conditions
- Infections, Papillomavirus
- Being tested
- Data Collection, Cervarix
- Keywords
- Cervarix, Spontaneous abortion, Vaccine, Human Papillomavirus
- Medical subject headings
- Papillomavirus Infections, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data CollectionOther
Analyses of data collected within the CPRD GOLD database.
CervarixBiological
Women with last menstrual period (LMP) between 30 days before and 45 days after, or 30 days before and 90 days after any dose of Cervarix and women with LMP between 120 days and 18 months after the last Cervarix dose.
| Study group | Role | What they receive |
|---|---|---|
| Exposed cohort | Women with the first day of LMP between 30 days before and 45 days after any Cervarix dose and between 30 days before and 90 days after any Cervarix dose. Receives: Other: Data Collection; Biological: Cervarix | |
| Non-exposed cohort | Women with the first day of LMP between 120 days and 18 months after their last Cervarix dose (and no further Cervarix dose before the outcome). Receives: Other: Data Collection; Biological: Cervarix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of spontaneous abortion
Measured: Weeks 1-23 of gestation
Secondary outcomes (3)
Occurrence of spontaneous abortion
Measured: Weeks 1-19 of gestation
Occurrence of other pregnancy outcomes
Induced/therapeutic and other abortions; Stillbirth; Birth defects identified among all pregnancies with known outcome classified as live births, stillbirths and abortions. For live births, birth defects identified within the first 12 weeks of life will be included; Small/large for gestational age at birth; Pre-term and post-term delivery.
Measured: 12 months after last menstrual period
Baby's death
Measured: First 12 weeks of baby's life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startNov 2012
- Primary completionAug 2013
- Study completionAug 2013
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
- 1,046 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Practice Research Datalink
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905462
- Sponsor's protocol ID
- 114101
- Status last verified
- Sep 2013
- First submitted
- 18 Jul 2013
- Last updated
- 30 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Safety Study to Assess the Risk of Spontaneous Abortions in Women Exposed to Cervarix in the United Kingdom
- ClinicalTrials.gov ID
- NCT01905462
- Acronym / sponsor ID
- 114101
- Conditions
- Infections, Papillomavirus
- Keywords
- Cervarix, Spontaneous abortion, Vaccine, Human Papillomavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,046 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Clinical Practice Research Datalink
- Study start
- Nov 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 23 Jul 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 study will assess the risk of spontaneous abortion during weeks 1-23 and weeks 1-19 of gestation, respectively, and other pregnancy outcomes, in an exposed cohort, i.e. women with last menstrual period (LMP) between 30 days before and 45 days after, or 30 days before and 90 days after any dose of Cervarix, when compared to a non-exposed cohort, i.e. women with LMP between 120 days and 18 months after the last Cervarix dose. The data collected in the Clinical Practice Research Datalink General Practitioner OnLine Database (CPRD GOLD) in the UK, will be analysed in this study.
Detailed description
Convenience sampling will be used in this study. It is planned to include all eligible pregnant women (included in CPRD GOLD and who fulfil to the inclusion/exclusion criteria) in each of the two cohorts.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed cohort | – | Other: Data Collection, Biological: CervarixWomen with the first day of LMP between 30 days before and 45 days after any Cervarix dose and between 30 days before and 90 days after any Cervarix dose. |
| Non-exposed cohort | – | Other: Data Collection, Biological: CervarixWomen with the first day of LMP between 120 days and 18 months after their last Cervarix dose (and no further Cervarix dose before the outcome). |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pregnant women aged 15 to 25 years, residing in UK, exposed to Cervarix and whose data is recorded in the CPRD GOLD.
Key inclusion criteria (20 listed)
- Full date of first day of LMP available in the database or calculated from Estimated date of delivery (EDD).
- Female, aged between, and including, 15 and 25 years of age at LMP.
- Recorded in the CPRD GOLD for at least 12 months at LMP.
- First day of LMP available in the database or calculated from EDD between September 1st 2008 and June 30th 2011.
- At least one dose of Cervarix received between September 1st 2008 and June 30th 2011.
Key exclusion criteria (5 listed)
- Female with the first day LMP between 30 days before and 90 days after at least one dose of unspecified Human Papillomavirus vaccine and/or Gardasil.
- Female with the first day LMP between 30 days before and 90 days after at least one dose of unspecified Human Papillomavirus vaccine and/or Gardasil.
- Female included for a previous pregnancy in the exposed cohort.
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 CollectionAnalyses of data collected within the CPRD GOLD database. | Other | Exposed cohort, Non-exposed cohort |
| CervarixWomen with last menstrual period (LMP) between 30 days before and 45 days after, or 30 days before and 90 days after any dose of Cervarix and women with LMP between 120 days and 18 months after the last Cervarix dose. | Biological | Exposed cohort, Non-exposed cohort |
Primary outcome
Occurrence of spontaneous abortion
Time frame: Weeks 1-23 of gestation
3 secondary outcomes
Occurrence of spontaneous abortion
Time frame: Weeks 1-19 of gestation
Occurrence of other pregnancy outcomes
Time frame: 12 months after last menstrual period
Baby's death
Time frame: First 12 weeks of baby's life
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 30 Sep 2013.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Papillomavirus, run by GlaxoSmithKline at 1 site in United Kingdom.
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 20 inclusion and 5 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 30 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 spontaneous abortion (time frame: Weeks 1-23 of gestation). 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 30 Sep 2013.