Papillomavirus InfectionsNCT01355003
GARDASIL™ Post Marketing Surveillance in the Philippines (V501-077)
An observational study of Papillomavirus Infections, run by Merck Sharp & Dohme LLC.
Trial summary
This study will collect safety information on the use of GARDASIL™ in the Philippines. Read more about this study
- Who is it for?
- Ages 9 to 46 yearsHealthy volunteers can take part
- Conditions the study is for
- Papillomavirus Infections
- Type of treatment
- Vaccines
- How many people
- 1,080 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Jun 2010
- 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 46 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Data will be collected from physicians who prescribed GARDASIL™ and who voluntarily agree to provide information on their patients. Each physician can provide up to five reports corresponding to five patients.
Who may be able to join
- Received GARDASIL™
Who cannot join
None listed.
About this study
Official title: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) Post Marketing Surveillance Protocol
This study will collect safety information on the use of GARDASIL™ in the Philippines.
- Conditions
- Papillomavirus Infections
- 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 |
|---|---|---|
| All Participants | Participants who were vaccinated with GARDASIL™ by their physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events following any dose of vaccine
Measured: At least 30 days following any vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startFeb 2008
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Merck Sharp \& Dohme Corp (MSD) received exemption from PFDA on conduct of post-marketing surveillance (PMS) study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillomavirus InfectionsStudies 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
- Cross-sectional
- Enrolment
- 1,080 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
- NCT01355003
- Sponsor's protocol ID
- V501-077
- Status last verified
- Aug 2015
- First submitted
- 16 May 2011
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) Post Marketing Surveillance Protocol
- ClinicalTrials.gov ID
- NCT01355003
- Acronym / sponsor ID
- V501-077
- Conditions
- Papillomavirus Infections
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Merck Sharp \& Dohme Corp (MSD) received exemption from PFDA on conduct of post-marketing surveillance (PMS) study
- Enrolment
- 1,080 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 17 May 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 collect safety information on the use of GARDASIL™ in the Philippines.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | –Participants who were vaccinated with GARDASIL™ by their physician |
Who may qualify
- Ages
- 9 to 46 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Data will be collected from physicians who prescribed GARDASIL™ and who voluntarily agree to provide information on their patients. Each physician can provide up to five reports corresponding to five patients.
Key inclusion criteria (1 listed)
- Received GARDASIL™
Key exclusion criteria (0 listed)
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
Number of participants with adverse events following any dose of vaccine
Time frame: At least 30 days following any vaccine dose
Results and safety
The study was stopped early (reason given: Merck Sharp \& Dohme Corp (MSD) received exemption from PFDA on conduct of post-marketing surveillance (PMS) study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
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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 Papillomavirus Infections, 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 0 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 13 Aug 2015. 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 was stopped early (reason given: Merck Sharp \& Dohme Corp (MSD) received exemption from PFDA on conduct of post-marketing surveillance (PMS) study). 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?
Number of participants with adverse events following any dose of vaccine (time frame: At least 30 days following any vaccine dose). 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 13 Aug 2015.