Cervical CancerPhase 3NCT00092495

Study of an Investigational Vaccine in Pre-Adolescents and Adolescents (Gardasil)(V501-016)

A Phase 3 study testing V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine in people with Cervical Cancer and Genital Warts, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The primary purpose of the study is to determine if an investigational vaccine Gardasil (V501) with 4 components will provide an immune response and will be well tolerated in pre-adolescents and adolescents. Read more about this study

Who is it for?: Ages 10 to 23 yearsHealthy volunteers can take part
Conditions the study is for: Cervical Cancer, Genital Warts
What is being tested?: V501, Gardasil, human papillomavirus (type 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: 3,055 participants
Where: No sites listed yet
Study dates: Dec 2002to Feb 2009
Phase: Phase 3
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 10 to 23 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Healthy adolescents and pre-adolescents with no prior sexual history
Healthy women who have an intact uterus with lifetime history of 0-4 sexual partners

Who cannot join

Prior Human Papillomavirus (HPV) vaccination
Prior abnormal Paps
Prior history of genital warts

About this study

Official title: A Study to Demonstrate Immunogenicity and Tolerability of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents, and To Determine End-Expiry Specifications for the Vaccine

Conditions: Cervical Cancer, Genital Warts
Being tested: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
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, human papillomavirus (type 6, 11, 16, 18) recombinant vaccineBiological
Also called V501, Gardasil
qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.

Study groups in NCT00092495
Study group	Role	What they receive
1	Experimental	100% Formulation qHPV Vaccine Receives: Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
2	Experimental	60% Formulation qHPV Vaccine Receives: Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
3	Experimental	40% Formulation qHPV Vaccine Receives: Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
4	Experimental	20% Formulation qHPV Vaccine Receives: Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3
Seroconversion is defined as going from seronegative to seropositive.
Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL).
Measured: Week 4 Postdose 3 (Month 7)
Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3
Measured: Week 4 Postdose 3 (Month 7)
Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3
Seroconversion is defined as going from seronegative to seropositive.
Seropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL).
Measured: Week 4 Postdose 3 (Month 7)
Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3
Measured: Week 4 Postdose 3 (Month 7)
Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3
Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL). Seroconversion is defined as going from seronegative to seropositive.
Measured: Week 4 Postdose 3 (Month 7)
Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3
Measured: Week 4 Postdose 3 (Month 7)
Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3
Seroconversion is defined as going from seronegative to seropositive.
Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL).
Measured: Week 4 Postdose 3 (Month 7)
Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3
Seroconversion is defined as going from seronegative to seropositive.
Seropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL).
Measured: Week 4 Postdose 3 (Month 7)
Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3
Measured: Week 4 Postdose 3 (Month 7)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2002Feb 2009

First posted27 Sep 2004 (estimated)
Study startDec 2002
Primary completionSep 2004
Study completionFeb 2009

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 (6)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: 3,055 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00092495
Sponsor's protocol ID: V501-016
Other IDs: 2004_083
Status last verified: Dec 2014
First submitted: 22 Sep 2004
Last updated: 13 Jan 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Block SL, Nolan T, Sattler C, Barr E, Giacoletti KE, Marchant CD, Castellsague X, Rusche SA, Lukac S, Bryan JT, Cavanaugh PF Jr, Reisinger KS; Protocol 016 Study Group. Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women. Pediatrics. 2006 Nov;118(5):2135-45. doi: 10.1542/peds.2006-0461.
PubMed 17079588
Barr E, Gause CK, Bautista OM, Railkar RA, Lupinacci LC, Insinga RP, Sings HL, Haupt RM. Impact of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine in a sexually active population of North American women. Am J Obstet Gynecol. 2008 Mar;198(3):261.e1-11. doi: 10.1016/j.ajog.2007.09.001.
PubMed 18313445
Perez G, Lazcano-Ponce E, Hernandez-Avila M, Garcia PJ, Munoz N, Villa LL, Bryan J, Taddeo FJ, Lu S, Esser MT, Vuocolo S, Sattler C, Barr E. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like-particle vaccine in Latin American women. Int J Cancer. 2008 Mar 15;122(6):1311-8. doi: 10.1002/ijc.23260.
PubMed 18000825
Giuliano 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
Garland SM, Ault KA, Gall SA, Paavonen J, Sings HL, Ciprero KL, Saah A, Marino D, Ryan D, Radley D, Zhou H, Haupt RM, Garner EIO; Quadrivalent Human Papillomavirus Vaccine Phase III Investigators. Pregnancy and infant outcomes in the clinical trials of a human papillomavirus type 6/11/16/18 vaccine: a combined analysis of five randomized controlled trials. Obstet Gynecol. 2009 Dec;114(6):1179-1188. doi: 10.1097/AOG.0b013e3181c2ca21.
PubMed 19935017
Majewski S, Bosch FX, Dillner J, Iversen OE, Kjaer SK, Munoz N, Olsson SE, Paavonen J, Sigurdsson K, Bryan J, Esser MT, Giacoletti K, James M, Taddeo F, Vuocolo S, Barr E. The impact of a quadrivalent human papillomavirus (types 6, 11, 16, 18) virus-like particle vaccine in European women aged 16 to 24. J Eur Acad Dermatol Venereol. 2009 Oct;23(10):1147-55. doi: 10.1111/j.1468-3083.2009.03266.x. Epub 2009 Apr 23.
PubMed 19453788

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
Locally Advanced Cervical Adenocarcinoma, Locally Advanced Cervical Adenosquamous Carcinoma
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
RecruitingObservational study
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Endometrial Cancer, Cervical Cancer

All Cervical Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Demonstrate Immunogenicity and Tolerability of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents, and To Determine End-Expiry Specifications for the Vaccine
ClinicalTrials.gov ID: NCT00092495
Acronym / sponsor ID: V501-016
Conditions: Cervical Cancer, Genital Warts
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,055 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Dec 2002
Primary completion: Sep 2004 (actual)
Study completion: Feb 2009 (actual)
First posted: 27 Sep 2004 (estimated)
Results: Posted 8 Mar 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine100% Formulation qHPV Vaccine
2	Experimental	Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine60% Formulation qHPV Vaccine
3	Experimental	Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine40% Formulation qHPV Vaccine
4	Experimental	Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine20% Formulation qHPV Vaccine

Who may qualify

Ages: 10 to 23 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

Healthy adolescents and pre-adolescents with no prior sexual history
Healthy women who have an intact uterus with lifetime history of 0-4 sexual partners

Key exclusion criteria (3 listed)

Prior Human Papillomavirus (HPV) vaccination
Prior abnormal Paps
Prior history of 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, human papillomavirus (type 6, 11, 16, 18) recombinant vaccineAlso: V501, GardasilqHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.	Biological	1, 2, 3, 4

Primary outcome

Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3
Time frame: Week 4 Postdose 3 (Month 7)
Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL).
Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3
Time frame: Week 4 Postdose 3 (Month 7)
Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3
Time frame: Week 4 Postdose 3 (Month 7)
Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL).
Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3
Time frame: Week 4 Postdose 3 (Month 7)
Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3
Time frame: Week 4 Postdose 3 (Month 7)
Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL). Seroconversion is defined as going from seronegative to seropositive.
Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3
Time frame: Week 4 Postdose 3 (Month 7)
Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3
Time frame: Week 4 Postdose 3 (Month 7)
Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL).
Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3
Time frame: Week 4 Postdose 3 (Month 7)
Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL).
Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3
Time frame: Week 4 Postdose 3 (Month 7)

Results and safety

Results posted to the registry on 8 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
20% Formulation qHPV Vaccine	504	467
40% Formulation qHPV Vaccine	514	492
60% Formulation qHPV Vaccine	508	474
100% Formulation qHPV Vaccine	1,529	1,441
Extension Study	0	0

Primary outcome: Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3

Time frame: Week 4 Postdose 3 (Month 7). Number. Unit: Subjects

Measure	Girls 10-15 Years n = 423	Boys 10-15 Years n = 428	Women 16-23 Years n = 320
HPV 6 ≥ 20 mMU/mL	423	428	320
HPV 6 < 20 mMU/mL	0	0	0

Girls 10-15 Years vs Women 16-23 Years: p <0.001, Miettinen and Nurminen
Boys 10-15 Years vs Women 16-23 Years: p <0.001, Miettinen and Nurminen

Population analysed: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.

Primary outcome: Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3

Time frame: Week 4 Postdose 3 (Month 7). Geometric mean (95% Confidence Interval). Unit: mMU/mL

Measure	Girls 10-15 Years n = 423	Boys 10-15 Years n = 428	Women 16-23 Years n = 320
Value	987.3 (905.0 to 1077.0)	1116.1 (1022.7 to 1218.1)	603.0 (548.5 to 662.9)

Girls 10-15 Years vs Women 16-23 Years: p <0.001, ANOVA
Boys 10-15 Years vs Women 16-23 Years: p <0.001, ANOVA

Population analysed: : Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.

Primary outcome: Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3

Time frame: Week 4 Postdose 3 (Month 7). Number. Unit: Subjects

Measure	20% Formulation qHPV Vaccine n = 372	40% Formulation qHPV Vaccine n = 391	60% Formulation qHPV Vaccine n = 364	100% Formulation qHPV Vaccine n = 743
HPV 6 ≥ 20 mMU/mL	372	391	363	743
HPV 6 < 20 mMU/mL	0	0	1	0

20% Formulation qHPV Vaccine vs 100% Formulation qHPV Vaccine: p <0.001, Miettinen and Nurminen
40% Formulation qHPV Vaccine vs 100% Formulation qHPV Vaccine: p <0.001, Miettinen and Nurminen
60% Formulation qHPV Vaccine vs 100% Formulation qHPV Vaccine: p <0.001, Miettinen and Nurminen

Primary outcome: Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3

Time frame: Week 4 Postdose 3 (Month 7). Geometric mean (95% Confidence Interval). Unit: mMU/mL

Measure	20% Formulation qHPV Vaccine n = 372	40% Formulation qHPV Vaccine n = 391	60% Formulation qHPV Vaccine n = 364	100% Formulation qHPV Vaccine n = 743
Value	584.2 (526.7 to 647.9)	704.5 (636.6 to 779.7)	707.5 (632.5 to 791.2)	798.4 (747.1 to 853.2)

20% Formulation qHPV Vaccine vs 100% Formulation qHPV Vaccine: p <0.001, ANOVA
40% Formulation qHPV Vaccine vs 100% Formulation qHPV Vaccine: p <0.001, ANOVA
60% Formulation qHPV Vaccine vs 100% Formulation qHPV Vaccine: p <0.001, ANOVA

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
20% Formulation	5 of 496 (1%)	434 of 496 (87.5%)	Not reported
40% Formulation	2 of 509 (0.4%)	426 of 509 (83.7%)	Not reported
60% Formulation	1 of 500 (0.2%)	431 of 500 (86.2%)	Not reported
100% Formulation	4 of 1,498 (0.3%)	1,276 of 1,498 (85.2%)	Not reported

Limitations and caveats (from the sponsor): Of note, the number of subjects who completed the Vaccination Period (N=1441) is slightly higher than that specified in the publication by Block, et al (2006; N=1430). The data provided here is based on final data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17079588Block SL, Nolan T, Sattler C, Barr E, Giacoletti KE, Marchant CD, Castellsague X, Rusche SA, Lukac S, Bryan JT, Cavanaugh PF Jr, Reisinger KS; Protocol 016 Study Group. Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women. Pediatrics. 2006 Nov;118(5):2135-45. doi: 10.1542/peds.2006-0461.
Background: PubMed 18313445Barr E, Gause CK, Bautista OM, Railkar RA, Lupinacci LC, Insinga RP, Sings HL, Haupt RM. Impact of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine in a sexually active population of North American women. Am J Obstet Gynecol. 2008 Mar;198(3):261.e1-11. doi: 10.1016/j.ajog.2007.09.001.
Background: PubMed 18000825Perez G, Lazcano-Ponce E, Hernandez-Avila M, Garcia PJ, Munoz N, Villa LL, Bryan J, Taddeo FJ, Lu S, Esser MT, Vuocolo S, Sattler C, Barr E. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like-particle vaccine in Latin American women. Int J Cancer. 2008 Mar 15;122(6):1311-8. doi: 10.1002/ijc.23260.
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.
Derived from this study: PubMed 19935017Garland SM, Ault KA, Gall SA, Paavonen J, Sings HL, Ciprero KL, Saah A, Marino D, Ryan D, Radley D, Zhou H, Haupt RM, Garner EIO; Quadrivalent Human Papillomavirus Vaccine Phase III Investigators. Pregnancy and infant outcomes in the clinical trials of a human papillomavirus type 6/11/16/18 vaccine: a combined analysis of five randomized controlled trials. Obstet Gynecol. 2009 Dec;114(6):1179-1188. doi: 10.1097/AOG.0b013e3181c2ca21.
Derived from this study: PubMed 19453788Majewski S, Bosch FX, Dillner J, Iversen OE, Kjaer SK, Munoz N, Olsson SE, Paavonen J, Sigurdsson K, Bryan J, Esser MT, Giacoletti K, James M, Taddeo F, Vuocolo S, Barr E. The impact of a quadrivalent human papillomavirus (types 6, 11, 16, 18) virus-like particle vaccine in European women aged 16 to 24. J Eur Acad Dermatol Venereol. 2009 Oct;23(10):1147-55. doi: 10.1111/j.1468-3083.2009.03266.x. Epub 2009 Apr 23.

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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, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine 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 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 13 Jan 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 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?

Yes. Results are posted in the registry (first posted 8 Mar 2010). 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?

Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3 (time frame: Week 4 Postdose 3 (Month 7)). The study lists 9 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 NCT00092495, which also lists 6 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 13 Jan 2015.