Cervical CancerPhase 3FUTURENCT00517309
Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED)
A Phase 3 study testing V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years in people with Cervical Cancer and Genital Warts, run by Merck Sharp & Dohme LLC.
Trial summary
The primary purpose of the study is to test the safety of HPV Vaccine in Women Read more about this study
- Who is it for?
- Ages 16 to 23 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Genital Warts
- What is being tested?
- V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,877 participants
- Where
- No sites listed yet
- Study dates
- 28 Dec 2001to 11 Jun 2004
- Phase
- Phase 3
- 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 16 to 23 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Females age 16 to 23 years old
- Must agree to refrain from sexual activity (vaginal or anal) for 48 hours prior to any scheduled visit
Who cannot join
- History of vaccination with an HPV vaccine
- History of hepatitis B infection
- History of vaccination with hepatitis B vaccine
- History of genital warts or treatment for genital warts
About this study
Official title: Immunogenicity and Safety of Quadrivalent HPV L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women When Administered Alone or Concomitantly With Hepatitis B Vaccine (Recombinant)--the F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease
The primary purpose of the study is to test the safety of HPV Vaccine in Women
- Conditions
- Cervical Cancer, Genital Warts
- Being tested
- V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years, Comparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 Years
- Medical subject headings
- Uterine Cervical Neoplasms, Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 YearsBiological
Comparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 YearsBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadrivalent HPV vaccine is generally well tolerated when administered alone or concomitantly with hepatitis B vaccine.
Secondary outcomes (1)
HPV vaccine is well tolerated in 16-23 year old females.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2007 (estimated)
- Study start28 Dec 2001
- Primary completion8 Jun 2004
- Study completion11 Jun 2004
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 Cervical CancerStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,877 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
- NCT00517309
- Sponsor's protocol ID
- V501-011
- Other IDs
- 2007_576
- Acronym
- FUTURE
- Status last verified
- Mar 2017
- First submitted
- 15 Aug 2007
- Last updated
- 22 Mar 2017
- Results posted
- No
Publications
Wheeler CM, Bautista OM, Tomassini JE, Nelson M, Sattler CA, Barr E; Protocol 11 study Investigators. Safety and immunogenicity of co-administered quadrivalent human papillomavirus (HPV)-6/11/16/18 L1 virus-like particle (VLP) and hepatitis B (HBV) vaccines. Vaccine. 2008 Jan 30;26(5):686-96. doi: 10.1016/j.vaccine.2007.11.043. Epub 2007 Dec 5.
PubMed 18164106Giuliano AR, Lazcano-Ponce E, Villa L, Nolan T, Marchant C, Radley D, Golm G, McCarroll K, Yu J, Esser MT, Vuocolo SC, Barr E. Impact of baseline covariates on the immunogenicity of a quadrivalent (types 6, 11, 16, and 18) human papillomavirus virus-like-particle vaccine. J Infect Dis. 2007 Oct 15;196(8):1153-62. doi: 10.1086/521679. Epub 2007 Sep 17.
PubMed 17955433
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Quadrivalent HPV L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women When Administered Alone or Concomitantly With Hepatitis B Vaccine (Recombinant)--the F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease
- ClinicalTrials.gov ID
- NCT00517309
- Acronym / sponsor ID
- FUTURE / V501-011
- Conditions
- Cervical Cancer, Genital Warts
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,877 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2001 (actual)
- Primary completion
- 8 Jun 2004 (actual)
- Study completion
- 11 Jun 2004 (actual)
- First posted
- 16 Aug 2007 (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.
The primary purpose of the study is to test the safety of HPV Vaccine in Women
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 16 to 23 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Females age 16 to 23 years old
- Must agree to refrain from sexual activity (vaginal or anal) for 48 hours prior to any scheduled visit
Key exclusion criteria (4 listed)
- History of vaccination with an HPV vaccine
- History of hepatitis B infection
- History of vaccination with hepatitis B vaccine
- History of genital warts or treatment for genital warts
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 |
|---|---|---|
| V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years | Biological | – |
| Comparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 Years | Biological | – |
Primary outcome
Quadrivalent HPV vaccine is generally well tolerated when administered alone or concomitantly with hepatitis B vaccine.
1 secondary outcome
HPV vaccine is well tolerated in 16-23 year old females.
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 Mar 2017.
- Background: PubMed 18164106Wheeler CM, Bautista OM, Tomassini JE, Nelson M, Sattler CA, Barr E; Protocol 11 study Investigators. Safety and immunogenicity of co-administered quadrivalent human papillomavirus (HPV)-6/11/16/18 L1 virus-like particle (VLP) and hepatitis B (HBV) vaccines. Vaccine. 2008 Jan 30;26(5):686-96. doi: 10.1016/j.vaccine.2007.11.043. Epub 2007 Dec 5.
- Background: PubMed 17955433Giuliano AR, Lazcano-Ponce E, Villa L, Nolan T, Marchant C, Radley D, Golm G, McCarroll K, Yu J, Esser MT, Vuocolo SC, Barr E. Impact of baseline covariates on the immunogenicity of a quadrivalent (types 6, 11, 16, and 18) human papillomavirus virus-like-particle vaccine. J Infect Dis. 2007 Oct 15;196(8):1153-62. doi: 10.1086/521679. Epub 2007 Sep 17.
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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 3 study testing V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years in people with Cervical Cancer and Genital Warts, 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 2 inclusion and 4 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 Mar 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quadrivalent HPV vaccine is generally well tolerated when administered alone or concomitantly with hepatitis B vaccine.. 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 NCT00517309, 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 Mar 2017.