Infections, PapillomavirusNCT01290393
Post-marketing Study to Assess the Safety of CERVARIX When Used in the United States and in Canada
An observational study of Infections, Papillomavirus, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study will assess the risk of spontaneous abortion during weeks 1-19 of gestation, and other pregnancy outcomes, in an Exposed vaccinated cohort, i.e. women with last menstrual period between 30 days before and 90 days after any dose of CERVARIX, when compared to a Non-exposed vaccinated cohort, i.e. 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
- Type of treatment
- Vaccines
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2011to 20 Dec 2012
- 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: Women aged 15 to 25 years and residing in the United States or in Canada
Who may be able to join
- For Exposed vaccinated cohort:
- Written informed consent, and assent in case of minors, obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
- Aged between, and including, 15 and 25 years of age.
- Residing within the US or Canada.
- Subjects who received at least one dose of CERVARIX.
- Gestational age at inclusion should be 19 completed weeks (i.e. 133 days of gestation) or less.
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- Last menstrual period between 30 days before and 90 days after any dose of CERVARIX with a maximum of 20% of subjects with last menstrual period between 46 and 90 days after any dose of CERVARIX.
- Subjects who the Investigator believes can and will comply with the requirements of the protocol (e.g. available for phone interviews). Or subjects who the Investigator believes that parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol.
- For Non-exposed vaccinated cohort:
- Written informed consent, and assent in case of minors, obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
- Aged between, and including, 15 and 25 years of age.
- Residing within the US or Canada.
- Subjects who received at least one dose of CERVARIX or at least one dose of GARDASIL.
- Gestational age at inclusion should be 19 completed weeks (i.e. 133 days of gestation) or less.
- Last menstrual period between 120 days and 18 months after the last dose of CERVARIX/ GARDASIL.
- Subjects who the Investigator believes can and will comply with the requirements of the protocol (e.g. available for phone interviews). Or subjects who the Investigator believes that parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol.
Who cannot join
- For Exposed vaccinated cohort:
- Last menstrual period between 30 days before and 90 days after any GARDASIL dose.
- Ongoing pregnancy with foetus known to be non-viable.
- Ongoing pregnancy with pre-enrolment knowledge by prenatal diagnosis of a major structural defect.
- Use of any investigational or non-registered product (drug or vaccine) during the study period.
- For Non-exposed vaccinated cohort:
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- Ongoing pregnancy with foetus known to be non-viable.
- Ongoing pregnancy with pre-enrolment knowledge by prenatal diagnosis of a major structural defect.
- Use of any investigational or non-registered product (drug or vaccine) during the study period.
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
San Diego, California, 92123
About this study
Official title: Post-marketing Safety Study to Assess the Risk of Spontaneous Abortion Following Administration of CERVARIX in the United States and Canada
This study will assess the risk of spontaneous abortion during weeks 1-19 of gestation, and other pregnancy outcomes, in an Exposed vaccinated cohort, i.e. women with last menstrual period between 30 days before and 90 days after any dose of CERVARIX, when compared to a Non-exposed vaccinated cohort, i.e. women with last menstrual period between 120 days and 18 months after the last CERVARIX or GARDASIL dose.
Read the detailed description
The present study will be conducted by the OTIS (Organization of Teratology Information Specialists) network. OTIS is a non-profit organization specialised to assess exposures during pregnancy and dedicated to providing accurate evidence-based, clinical information to patients and health care professionals about exposures during pregnancy and lactation. OTIS is based on voluntary phone calls. Women call when they have questions and concerns about risks potentially associated with any kind of exposure during pregnancy or breastfeeding, including medications, chemicals, pesticides, diseases, infections, and vaccinations.
- Conditions
- Infections, Papillomavirus
- Being tested
- Data collection
- Keywords
- vaccine, Spontaneous abortions, Human papillomavirus, HPV, Cervarix, pregnancy
- 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
Data collection from hard copy interview forms routinely used by the Organization of Teratology Information Specialists (OTIS).
| Study group | Role | What they receive |
|---|---|---|
| Exposed vaccinated cohort | Women with last menstrual period between 30 days before and 90 days after any CERVARIX dose. The target sample size of the Exposed vaccinated cohort is 150 subjects. Receives: Other: Data collection | |
| Non-exposed vaccinated cohort | Women with last menstrual period between 120 days and 18 months after the last CERVARIX or GARDASIL dose. The target sample size of the Non-exposed vaccinated cohort is 300 subjects. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of spontaneous abortion during weeks 1-19 of gestation
Measured: This outcome measure will be recorded between zero and six weeks after end of pregnancy
Secondary outcomes (1)
Occurrence of other adverse pregnancy outcomes
Measured: This outcome measure will be recorded between zero and six weeks after end of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study start26 Sep 2011
- Primary completion20 Dec 2012
- Study completion20 Dec 2012
Why it stopped: Low accrual of subjects primarily attributable to the low uptake of Cervarix in the US and Canada in women aged 15 to 25 years of age.
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
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Organization of Teratology Information Specialists
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290393
- Sponsor's protocol ID
- 114176
- Status last verified
- Jul 2018
- First submitted
- 3 Feb 2011
- Last updated
- 26 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. 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 Abortion Following Administration of CERVARIX in the United States and Canada
- ClinicalTrials.gov ID
- NCT01290393
- Acronym / sponsor ID
- 114176
- Conditions
- Infections, Papillomavirus
- Keywords
- vaccine, Spontaneous abortions, Human papillomavirus, HPV, Cervarix, pregnancy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low accrual of subjects primarily attributable to the low uptake of Cervarix in the US and Canada in women aged 15 to 25 years of age.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- The Organization of Teratology Information Specialists
- Study start
- 26 Sep 2011 (actual)
- Primary completion
- 20 Dec 2012 (actual)
- Study completion
- 20 Dec 2012 (actual)
- First posted
- 7 Feb 2011 (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 1-19 of gestation, and other pregnancy outcomes, in an Exposed vaccinated cohort, i.e. women with last menstrual period between 30 days before and 90 days after any dose of CERVARIX, when compared to a Non-exposed vaccinated cohort, i.e. women with last menstrual period between 120 days and 18 months after the last CERVARIX or GARDASIL dose.
Detailed description
The present study will be conducted by the OTIS (Organization of Teratology Information Specialists) network. OTIS is a non-profit organization specialised to assess exposures during pregnancy and dedicated to providing accurate evidence-based, clinical information to patients and health care professionals about exposures during pregnancy and lactation. OTIS is based on voluntary phone calls. Women call when they have questions and concerns about risks potentially associated with any kind of exposure during pregnancy or breastfeeding, including medications, chemicals, pesticides, diseases, infections, and vaccinations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed vaccinated cohort | – | Other: Data collectionWomen with last menstrual period between 30 days before and 90 days after any CERVARIX dose. The target sample size of the Exposed vaccinated cohort is 150 subjects. |
| Non-exposed vaccinated cohort | – | Other: Data collectionWomen with last menstrual period between 120 days and 18 months after the last CERVARIX or GARDASIL dose. The target sample size of the Non-exposed vaccinated cohort is 300 subjects. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women aged 15 to 25 years and residing in the United States or in Canada
Key inclusion criteria (16 listed)
- Written informed consent, and assent in case of minors, obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
- Aged between, and including, 15 and 25 years of age.
- Residing within the US or Canada.
- Subjects who received at least one dose of CERVARIX.
- Gestational age at inclusion should be 19 completed weeks (i.e. 133 days of gestation) or less.
Key exclusion criteria (9 listed)
- Last menstrual period between 30 days before and 90 days after any GARDASIL dose.
- Ongoing pregnancy with foetus known to be non-viable.
- Ongoing pregnancy with pre-enrolment knowledge by prenatal diagnosis of a major structural defect.
- Use of any investigational or non-registered product (drug or vaccine) during the study period.
- Ongoing pregnancy with foetus known to be non-viable.
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 hard copy interview forms routinely used by the Organization of Teratology Information Specialists (OTIS). | Other | Exposed vaccinated cohort, Non-exposed vaccinated cohort |
Primary outcome
Occurrence of spontaneous abortion during weeks 1-19 of gestation
Time frame: This outcome measure will be recorded between zero and six weeks after end of pregnancy
1 secondary outcome
Occurrence of other adverse pregnancy outcomes
Time frame: This outcome measure will be recorded between zero and six weeks after end of pregnancy
Results and safety
The study was stopped early (reason given: Low accrual of subjects primarily attributable to the low uptake of Cervarix in the US and Canada in women aged 15 to 25 years of age.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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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 States.
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 16 inclusion and 9 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: stopped early, as of the sponsor's last update on 26 Jul 2018. 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 States. 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 was stopped early (reason given: Low accrual of subjects primarily attributable to the low uptake of Cervarix in the US and Canada in women aged 15 to 25 years of age.). Results are not available in the source record.
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 during weeks 1-19 of gestation (time frame: This outcome measure will be recorded between zero and six weeks after end of pregnancy). 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 Jul 2018.