HPV InfectionsPhase 1NCT00635830
An Open-Label, Single Dose Safety Study of Quadrivalent HPV Vaccine in Chinese Female Subjects (V501-035)
A Phase 1 study testing Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine in people with HPV Infections, run by Merck Sharp & Dohme LLC.
Trial summary
To prove that quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine is generally safe and well tolerated in the Chinese population. Read more about this study
- Who is it for?
- Ages 9 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infections
- What is being tested?
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Apr 2008
- Phase
- Phase 1
- 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 to 26 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subject Is Female, Between The Ages Of 9 Years And 0 Days And 26 Years And 364 Days On The Day Of Enrollment
- Subject (Or, For Minor Subjects, Parent/Legal Guardian And Subject) Fully Understands Study Procedures, Alternative Treatments Available, The Risks Involved With The Study, And Voluntarily Agrees To Participate By Giving Written Informed Consent
- Subject Is Able To Read, Understand, And Complete The Vaccination Report Card
Who cannot join
- Subject Is, At The Time Of Signing Informed Consent, A User Of Recreational Or Illicit Drugs Or Has Had A Recent History (Within The Last Year) Of Drug Or Alcohol Abuse Or Dependence. Alcohol Abusers Are Defined As Those Who Drink Despite Recurrent Social, Interpersonal, And/Or Legal Problems As A Result Of Alcohol Use
- Subject Has A History Of Severe Allergic Reaction (E.G., Swelling Of The Mouth And Throat, Difficulty Breathing, Hypotension Or Shock) That Required Medical Intervention
- Subject Has Known Allergy To Any Vaccine Component, Including Aluminum, Yeast, Or Benzonase (Nuclease, Nycomed [Used To Remove Residual Nucleic Acids From This And Other Vaccines])
About this study
Official title: An Open-Label, Single-Dose, Safety and Tolerability Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Chinese Female Subjects Aged 9 to 26 Years
To prove that quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine is generally safe and well tolerated in the Chinese population.
- Conditions
- HPV Infections
- Being tested
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant VaccineBiological
Also called V501
HPV 6,11,16,18 VLP, 0.5 mL 1 dose injection.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Open Label Receives: Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Serious Adverse Experiences, Systemic Adverse Experiences Occurring Within 14 Days After Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Vaccination
All adverse experiences were collected from the time the consent form was signed through 14 days following the vaccination. All subjects were requested to record injection-site adverse experiences and monitor temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after injection
Measured: For serious adverse experiences and systemic adverse experiences: 14 days follow-up after one dose of vaccination; For injection-site adverse experiences: 5 days follow-up after one dose of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionApr 2008
- Study completionApr 2008
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.
- Other trials for HPV 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635830
- Sponsor's protocol ID
- V501-035
- Other IDs
- 2008_003
- Status last verified
- Oct 2015
- First submitted
- 3 Mar 2008
- Last updated
- 9 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose, Safety and Tolerability Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Chinese Female Subjects Aged 9 to 26 Years
- ClinicalTrials.gov ID
- NCT00635830
- Acronym / sponsor ID
- V501-035
- Conditions
- HPV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Posted 20 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To prove that quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine is generally safe and well tolerated in the Chinese population.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant VaccineOpen Label |
Who may qualify
- Ages
- 9 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Subject Is Female, Between The Ages Of 9 Years And 0 Days And 26 Years And 364 Days On The Day Of Enrollment
- Subject (Or, For Minor Subjects, Parent/Legal Guardian And Subject) Fully Understands Study Procedures, Alternative Treatments Available, The Risks Involved With The Study, And Voluntarily Agrees To Participate By Giving Written Informed Consent
- Subject Is Able To Read, Understand, And Complete The Vaccination Report Card
Key exclusion criteria (3 listed)
- Subject Is, At The Time Of Signing Informed Consent, A User Of Recreational Or Illicit Drugs Or Has Had A Recent History (Within The Last Year) Of Drug Or Alcohol Abuse Or Dependence. Alcohol Abusers Are Defined As Those Who Drink Despite Recurrent Social, Interpersonal, And/Or Legal Problems As A Result Of Alcohol Use
- Subject Has A History Of Severe Allergic Reaction (E.G., Swelling Of The Mouth And Throat, Difficulty Breathing, Hypotension Or Shock) That Required Medical Intervention
- Subject Has Known Allergy To Any Vaccine Component, Including Aluminum, Yeast, Or Benzonase (Nuclease, Nycomed [Used To Remove Residual Nucleic Acids From This And Other Vaccines])
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 |
|---|---|---|
| Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant VaccineAlso: V501HPV 6,11,16,18 VLP, 0.5 mL 1 dose injection. | Biological | 1 |
Primary outcome
Measure Serious Adverse Experiences, Systemic Adverse Experiences Occurring Within 14 Days After Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Vaccination
Time frame: For serious adverse experiences and systemic adverse experiences: 14 days follow-up after one dose of vaccination; For injection-site adverse experiences: 5 days follow-up after one dose of vaccination
All adverse experiences were collected from the time the consent form was signed through 14 days following the vaccination. All subjects were requested to record injection-site adverse experiences and monitor temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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?
A Phase 1 study testing Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine in people with HPV 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 3 inclusion and 3 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 9 Oct 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2009). 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?
Measure Serious Adverse Experiences, Systemic Adverse Experiences Occurring Within 14 Days After Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Vaccination (time frame: For serious adverse experiences and systemic adverse experiences: 14 days follow-up after one dose of vaccination; For injection-site adverse experiences: 5 days follow-up after one dose of vaccination). 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 9 Oct 2015.