Human Papilloma Virus InfectionNCT01567813
Post-Licensure Study of the Safety of GARDASIL™ in Males (V501-070)
An observational study of Human Papilloma Virus Infection, run by Merck Sharp & Dohme LLC.
Trial summary
This is a post-licensure safety observation cohort study to describe the general safety of GARDASIL™ (a quadrivalent human papillomavirus vaccine) in males. Read more about this study
- Who is it for?
- Ages 9 to 26 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus Infection
- Type of treatment
- Vaccines
- How many people
- 114,035 participants
- Where
- No sites listed yet
- Study dates
- 23 Jun 2011to 1 Jun 2019
- 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 26 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: Males who are members of a large geographically diverse US health plan.
Who may be able to join
- Male vaccinated with at least one dose of GARDASIL™ after the October 2009 FDA date of first licensure of GARDASIL™ for males
Who cannot join
- Female
- Male vaccinated prior to the October 2009 FDA date of first licensure of GARDASIL™ for males
- Male who received all doses of GARDASIL™ outside of the health plan
- Male < 9 and > 26 years of age at first dose
- Male not part of health plan at each dose
- 3-dose vaccination regimen given over a period > 12 months
Show all 10Show fewer
- Less than 28-day interval between first and second dose
- Less than 12 weeks between the second and third dose
- Less than 24 weeks between first and third dose
- Male with less than 12 months of health plan membership prior to first dose of GARDASIL™
About this study
Official title: Post-Licensure Observational Study of the Safety of GARDASIL™ in Males
This is a post-licensure safety observation cohort study to describe the general safety of GARDASIL™ (a quadrivalent human papillomavirus vaccine) in males.
- Conditions
- Human Papilloma Virus Infection
- Keywords
- Warts, Papillomavirus infections, DNA virus infections, Virus diseases, Skin diseases, viral, Tumor virus infections, Skin diseases, infectious, Skin diseases
- Medical subject headings
- Papillomavirus Infections, Warts, DNA Virus Infections, Virus Diseases, Skin Diseases, Viral, Tumor Virus Infections, Skin Diseases, Infectious, Skin Diseases
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 |
|---|---|---|
| Regimen Initiators | Any male health plan member who receives at least one dose of GARDASIL™ | |
| Regimen Completers | Regimen Initiators who complete the 3-dose vaccination regimen within 12 months | |
| Autoimmune cohort | Regimen Initiators who were members of the health plan during the 12-month period prior to their first dose of GARDASIL™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of health outcomes resulting in emergency room visits or hospitalizations in 60-day risk periods after each dose of GARDASIL™ compared to post-vaccination self-comparison periods
Measured: Within 60 days after each dose
Secondary outcomes (3)
Incidence of health outcomes resulting in emergency room visits or hospitalizations in the 60-day risk period following the first dose of GARDASIL™ compared to post-vaccination self-comparison periods
Measured: Within 60 days after the first dose
Incidence of syncope, convulsive syncope, epilepsy, convulsions, head trauma, and allergic reactions on the day of vaccination
Measured: Day of vaccination for each dose received (1 day for each dose, up to 3 total days)
Incidence of pre-specified new-onset conditions identified from the hospital, outpatient, and emergency room setting for 6 months after each dose of GARDASIL™ compared to the incidence of these conditions in an un-vaccinated population of males
Measured: Within 6 months after each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study start23 Jun 2011
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human Papilloma Virus 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
- Retrospective
- Enrolment
- 114,035 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567813
- Sponsor's protocol ID
- V501-070
- Other IDs
- EP08014.070
- Status last verified
- Jul 2022
- First submitted
- 28 Mar 2012
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Amend KL, Turnbull B, Zhou L, Marks MA, Velicer C, Saddier P, Seeger JD. Safety of 4-valent human papillomavirus vaccine in males: a large observational post-marketing study. Hum Vaccin Immunother. 2022 Nov 30;18(5):2073750. doi: 10.1080/21645515.2022.2073750. Epub 2022 Jun 17.
PubMed 35714277Seeger JD, Amend KL, Turnbull BR, Zhou L, Marks MA, Velicer C, Saddier P. Incident autoimmune conditions among males receiving quadrivalent human papillomavirus vaccine in the United States. Vaccine. 2023 Mar 10;41(11):1826-1833. doi: 10.1016/j.vaccine.2022.10.050. Epub 2022 Nov 21.
PubMed 36424257
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Licensure Observational Study of the Safety of GARDASIL™ in Males
- ClinicalTrials.gov ID
- NCT01567813
- Acronym / sponsor ID
- V501-070
- Conditions
- Human Papilloma Virus Infection
- Keywords
- Warts, Papillomavirus infections, DNA virus infections, Virus diseases, Skin diseases, viral, Tumor virus infections, Skin diseases, infectious, Skin diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114,035 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2011 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 30 Mar 2012 (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 a post-licensure safety observation cohort study to describe the general safety of GARDASIL™ (a quadrivalent human papillomavirus vaccine) in males.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regimen Initiators | – | –Any male health plan member who receives at least one dose of GARDASIL™ |
| Regimen Completers | – | –Regimen Initiators who complete the 3-dose vaccination regimen within 12 months |
| Autoimmune cohort | – | –Regimen Initiators who were members of the health plan during the 12-month period prior to their first dose of GARDASIL™ |
Who may qualify
- Ages
- 9 to 26 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Males who are members of a large geographically diverse US health plan.
Key inclusion criteria (1 listed)
- Male vaccinated with at least one dose of GARDASIL™ after the October 2009 FDA date of first licensure of GARDASIL™ for males
Key exclusion criteria (10 listed)
- Female
- Male vaccinated prior to the October 2009 FDA date of first licensure of GARDASIL™ for males
- Male who received all doses of GARDASIL™ outside of the health plan
- Male < 9 and > 26 years of age at first dose
- Male not part of health plan at each dose
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 of health outcomes resulting in emergency room visits or hospitalizations in 60-day risk periods after each dose of GARDASIL™ compared to post-vaccination self-comparison periods
Time frame: Within 60 days after each dose
3 secondary outcomes
Incidence of health outcomes resulting in emergency room visits or hospitalizations in the 60-day risk period following the first dose of GARDASIL™ compared to post-vaccination self-comparison periods
Time frame: Within 60 days after the first dose
Incidence of syncope, convulsive syncope, epilepsy, convulsions, head trauma, and allergic reactions on the day of vaccination
Time frame: Day of vaccination for each dose received (1 day for each dose, up to 3 total days)
Incidence of pre-specified new-onset conditions identified from the hospital, outpatient, and emergency room setting for 6 months after each dose of GARDASIL™ compared to the incidence of these conditions in an un-vaccinated population of males
Time frame: Within 6 months after each dose
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 22 Jul 2022.
- Results publication: PubMed 35714277Amend KL, Turnbull B, Zhou L, Marks MA, Velicer C, Saddier P, Seeger JD. Safety of 4-valent human papillomavirus vaccine in males: a large observational post-marketing study. Hum Vaccin Immunother. 2022 Nov 30;18(5):2073750. doi: 10.1080/21645515.2022.2073750. Epub 2022 Jun 17.
- Derived from this study: PubMed 36424257Seeger JD, Amend KL, Turnbull BR, Zhou L, Marks MA, Velicer C, Saddier P. Incident autoimmune conditions among males receiving quadrivalent human papillomavirus vaccine in the United States. Vaccine. 2023 Mar 10;41(11):1826-1833. doi: 10.1016/j.vaccine.2022.10.050. Epub 2022 Nov 21.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papilloma Virus 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 1 inclusion and 10 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 22 Jul 2022. 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?
Incidence of health outcomes resulting in emergency room visits or hospitalizations in 60-day risk periods after each dose of GARDASIL™ compared to post-vaccination self-comparison periods (time frame: Within 60 days after each dose). 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 NCT01567813, 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 22 Jul 2022.