Human Papillomavirus InfectionNCT01078220
Observational Surveillance Study to Detect Potential Safety Signals in Patients Who Have Had at Least One Dose of GARDASIL™ (V501-031)
An observational study of Human Papillomavirus Infection, run by Merck Sharp & Dohme LLC.
Trial summary
This is a post-licensure safety surveillance program to detect potential safety signals in subjects, from the managed care organizations database, who have used GARDASIL™. Read more about this study
- Who is it for?
- Ages 9 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- Type of treatment
- Vaccines
- How many people
- 189,629 participants
- Where
- No sites listed yet
- Study dates
- 6 Feb 2007to 13 Dec 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Managed Care Organizations (MCO) databases
Who may be able to join
- 3-Dose Safety Population
- Female 9-26 years at the time of first dose of GARDASIL™
- Completed the 3-dose regimen of GARDASIL™ per protocol
- Pregnancy Safety Population
- Received at least one dose of GARDASIL™ up to 30 days prior to the date of conception or any time between conception and the day of pregnancy resolution
- Autoimmune Safety Population
Show all 10Show fewer
- Female who has received at least one dose of GARDASIL™
- Has been a member of same Managed Care Organization (MCO) for at least 12 months prior to the receipt of GARDASIL™
- Any Dose Safety Population
- Female who has received at least one dose of GARDASIL™
Who cannot join
- 3-Dose Safety Population
- Male
- Receives incomplete regimen of GARDASIL™
- Completes the three dose regimen of GARDASIL™ in more than 12 months
- Less than 28 day interval between doses 1 and 2 or less than a 12 week interval between doses 2 and 3
- Younger than 9 or older than 26 years of age at receipt of first dose
Show all 12Show fewer
- Pregnancy Safety Population
- Males
- No record of pregnancy at the Managed Care Organization (MCO)
- Autoimmune Safety Population
- Member of the same MCO for less than 12 months prior to receiving the first dose
- Male
About this study
Official title: A Post-licensure Surveillance Program for the Safety of GARDASIL™ in a Managed Care Organization Setting
This is a post-licensure safety surveillance program to detect potential safety signals in subjects, from the managed care organizations database, who have used GARDASIL™.
- Conditions
- Human Papillomavirus Infection
- Keywords
- Human Papillomavirus (HPV)
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 3-Dose Safety Population (Primary) | Females between ages 9 to 26 at receipt of the first dose of GARDASIL who are members of the participating MCOs and have completed the 3-dose regimen of GARDSIL vaccination with 12 months. | |
| Pregnancy Safety Population | Females who received at least one dose of GARDASIL during pregnancy. | |
| Autoimmune Safety Population | Females who have received at least one dose of GARDASIL and have been members in the same MCO for at least 12 months prior to receiving their first dose of GARDASIL. | |
| Any Dose Safety Population (Secondary) | Females who have received at least one dose of GARDASIL and have been members in the same MCO for at least 12 months prior to receiving their first dose of GARDASIL. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate of Syncope
Syncope was defined as the presence of a syncope diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a "rule out" diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study.
Measured: On day of each vaccination
Incidence Rate of Cellulitis
Cellulitis was defined as the presence of a cellulitis or abscess diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a "rule out" diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study.
Measured: Within 14 days and within 60 days immediately after each vaccination
Secondary outcomes (3)
Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy
Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.
Measured: First dose of Gardasil in pregnancy up to 6 months after birth
Number of Miscarriages Among Females Who Received Gardasil During Pregnancy
Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.
Measured: First dose of Gardasil in pregnancy up to pregnancy resolution
Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil
Autoimmune cases were defined as newly diagnosed cases within 6 months after any
dose of Gardasil, as confirmed by medical record review by panels of physicians specializing in the 16 autoimmune conditions of interest.
Measured: within 6 months immediately after each vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study start6 Feb 2007
- Primary completion13 Dec 2010
- Study completion13 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- 189,629 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078220
- Sponsor's protocol ID
- V501-031
- Other IDs
- 2010_019, EP08014.031
- Status last verified
- Jun 2017
- First submitted
- 26 Feb 2010
- Last updated
- 11 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chao C, Klein NP, Velicer CM, Sy LS, Slezak JM, Takhar H, Ackerson B, Cheetham TC, Hansen J, Deosaransingh K, Emery M, Liaw KL, Jacobsen SJ. Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine. J Intern Med. 2012 Feb;271(2):193-203. doi: 10.1111/j.1365-2796.2011.02467.x. Epub 2011 Nov 15.
PubMed 21973261Klein NP, Hansen J, Chao C, Velicer C, Emery M, Slezak J, Lewis N, Deosaransingh K, Sy L, Ackerson B, Cheetham TC, Liaw KL, Takhar H, Jacobsen SJ. Safety of quadrivalent human papillomavirus vaccine administered routinely to females. Arch Pediatr Adolesc Med. 2012 Dec;166(12):1140-8. doi: 10.1001/archpediatrics.2012.1451.
PubMed 23027469
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-licensure Surveillance Program for the Safety of GARDASIL™ in a Managed Care Organization Setting
- ClinicalTrials.gov ID
- NCT01078220
- Acronym / sponsor ID
- V501-031
- Conditions
- Human Papillomavirus Infection
- Keywords
- Human Papillomavirus (HPV)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189,629 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente
- Study start
- 6 Feb 2007 (actual)
- Primary completion
- 13 Dec 2010 (actual)
- Study completion
- 13 Dec 2010 (actual)
- First posted
- 2 Mar 2010 (estimated)
- Results
- Posted 9 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a post-licensure safety surveillance program to detect potential safety signals in subjects, from the managed care organizations database, who have used GARDASIL™.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 3-Dose Safety Population (Primary) | – | –Females between ages 9 to 26 at receipt of the first dose of GARDASIL who are members of the participating MCOs and have completed the 3-dose regimen of GARDSIL vaccination with 12 months. |
| Pregnancy Safety Population | – | –Females who received at least one dose of GARDASIL during pregnancy. |
| Autoimmune Safety Population | – | –Females who have received at least one dose of GARDASIL and have been members in the same MCO for at least 12 months prior to receiving their first dose of GARDASIL. |
| Any Dose Safety Population (Secondary) | – | –Females who have received at least one dose of GARDASIL and have been members in the same MCO for at least 12 months prior to receiving their first dose of GARDASIL. |
Who may qualify
- Ages
- 9 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Managed Care Organizations (MCO) databases
Key inclusion criteria (10 listed)
- 3-Dose Safety Population
- Female 9-26 years at the time of first dose of GARDASIL™
- Completed the 3-dose regimen of GARDASIL™ per protocol
- Pregnancy Safety Population
- Received at least one dose of GARDASIL™ up to 30 days prior to the date of conception or any time between conception and the day of pregnancy resolution
Key exclusion criteria (12 listed)
- 3-Dose Safety Population
- Male
- Receives incomplete regimen of GARDASIL™
- Completes the three dose regimen of GARDASIL™ in more than 12 months
- Less than 28 day interval between doses 1 and 2 or less than a 12 week interval between doses 2 and 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence Rate of Syncope
Time frame: On day of each vaccination
Syncope was defined as the presence of a syncope diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a "rule out" diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study.
Incidence Rate of Cellulitis
Time frame: Within 14 days and within 60 days immediately after each vaccination
Cellulitis was defined as the presence of a cellulitis or abscess diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a "rule out" diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study.
3 secondary outcomes
Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy
Time frame: First dose of Gardasil in pregnancy up to 6 months after birth
Number of Miscarriages Among Females Who Received Gardasil During Pregnancy
Time frame: First dose of Gardasil in pregnancy up to pregnancy resolution
Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil
Time frame: within 6 months immediately after each vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21973261Chao C, Klein NP, Velicer CM, Sy LS, Slezak JM, Takhar H, Ackerson B, Cheetham TC, Hansen J, Deosaransingh K, Emery M, Liaw KL, Jacobsen SJ. Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine. J Intern Med. 2012 Feb;271(2):193-203. doi: 10.1111/j.1365-2796.2011.02467.x. Epub 2011 Nov 15.
- Results publication: PubMed 23027469Klein NP, Hansen J, Chao C, Velicer C, Emery M, Slezak J, Lewis N, Deosaransingh K, Sy L, Ackerson B, Cheetham TC, Liaw KL, Takhar H, Jacobsen SJ. Safety of quadrivalent human papillomavirus vaccine administered routinely to females. Arch Pediatr Adolesc Med. 2012 Dec;166(12):1140-8. doi: 10.1001/archpediatrics.2012.1451.
- EUPAS Register (EUPAS17730)Link provided by the sponsor.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus Infection, run by Merck Sharp & Dohme LLC.
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 10 inclusion and 12 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 11 Jul 2017. 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?
Yes. Results are posted in the registry (first posted 9 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence Rate of Syncope (time frame: On day of each vaccination). 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?
On the ClinicalTrials.gov record for NCT01078220, which also lists 2 linked publications.
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 11 Jul 2017.