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AzTrials

Cervical CancerPhase 3NCT00092482

Immunogenicity Bridge Between an Investigational Monovalent Vaccine and the Equivalent Component of Gardasil (V501) a Quadrivalent Vaccine (V501-012)(COMPLETED)

A Phase 3 study testing V501, Gardasil, human papillomavirus (type 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.

Completed

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

Official record
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Trial summary

The purpose of the study is to determine if an investigational vaccine with a single component develops an immune response that is similar to the equivalent investigational vaccine with four components to reduce cervical disease. 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, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years
Type of treatment
Vaccines
How many people
3,882 participants
Where
No sites listed yet
Study dates
28 Jun 2002to 15 Aug 2008
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

  • Female with an intact uterus with lifetime history of 0-4 sexual partners

Who cannot join

  • Prior Human Papillomavirus Vaccine (HPV) vaccination;
  • Prior abnormal paps;
  • Prior history of genital warts

About this study

Official title: Immunogenicity and Safety of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Consistency Lots for 16- to 23-Year-Old Women With and Additional Immunogenicity Bridge to the Monovalent HPV 16 Vaccine Pilot Manufacturing Lot Study-The F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)

The purpose of the study is to determine if an investigational vaccine with a single component develops an immune response that is similar to the equivalent investigational vaccine with four components to reduce cervical disease.

Being tested
V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / 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, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 yearsBiological

What is being measured

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

  1. Tolerability and immune responses at week 4 post dose 3.

Timeline

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

  1. First posted27 Sep 2004 (estimated)
  2. Study start28 Jun 2002
  3. Primary completion30 Jun 2004
  4. Study completion15 Aug 2008

Resources

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
3,882 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00092482
Sponsor's protocol ID
V501-012
Other IDs
2004_080
Status last verified
Mar 2017
First submitted
22 Sep 2004
Last updated
22 Mar 2017
Results posted
No

Publications

  • Garland SM, Steben M, Hernandez-Avila M, Koutsky LA, Wheeler CM, Perez G, Harper DM, Leodolter S, Tang GW, Ferris DG, Esser MT, Vuocolo SC, Nelson M, Railkar R, Sattler C, Barr E; 012 Study Investigators. Noninferiority of antibody response to human papillomavirus type 16 in subjects vaccinated with monovalent and quadrivalent L1 virus-like particle vaccines. Clin Vaccine Immunol. 2007 Jun;14(6):792-5. doi: 10.1128/CVI.00478-06. Epub 2007 Apr 11.

    PubMed 17428949

  • 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

  • Brown DR, Garland SM, Ferris DG, Joura E, Steben M, James M, Radley D, Vuocolo S, Garner EI, Haupt RM, Bryan JT. The humoral response to Gardasil over four years as defined by total IgG and competitive Luminex immunoassay. Hum Vaccin. 2011 Feb;7(2):230-8. doi: 10.4161/hv.7.2.13948. Epub 2011 Feb 1.

    PubMed 21307649

  • Brown DR, Castellsague X, Ferris D, Garland SM, Huh W, Steben M, Wheeler CM, Saah A, Luxembourg A, Li S, Velicer C. Human papillomavirus seroprevalence and seroconversion following baseline detection of nine human papillomavirus types in young women. Tumour Virus Res. 2022 Jun;13:200236. doi: 10.1016/j.tvr.2022.200236. Epub 2022 May 4.

    PubMed 35525430

  • Doshi P, Bourgeois F, Hong K, Jones M, Lee H, Shamseer L, Spence O, Jefferson T. Adjuvant-containing control arms in pivotal quadrivalent human papillomavirus vaccine trials: restoration of previously unpublished methodology. BMJ Evid Based Med. 2020 Dec;25(6):213-219. doi: 10.1136/bmjebm-2019-111331. Epub 2020 Mar 17.

    PubMed 32184277

  • Insinga RP, Perez G, Wheeler CM, Koutsky LA, Garland SM, Leodolter S, Joura EA, Ferris DG, Steben M, Hernandez-Avila M, Brown DR, Elbasha E, Munoz N, Paavonen J, Haupt RM; FUTURE I Investigators. Incident cervical HPV infections in young women: transition probabilities for CIN and infection clearance. Cancer Epidemiol Biomarkers Prev. 2011 Feb;20(2):287-96. doi: 10.1158/1055-9965.EPI-10-0791.

    PubMed 21300618

  • Garland SM, Insinga RP, Sings HL, Haupt RM, Joura EA. Human papillomavirus infections and vulvar disease development. Cancer Epidemiol Biomarkers Prev. 2009 Jun;18(6):1777-84. doi: 10.1158/1055-9965.EPI-09-0067.

    PubMed 19505910

  • Brown DR, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Wheeler CM, Perez G, Koutsky LA, Tay EH, Garcia P, Ault KA, Garland SM, Leodolter S, Olsson SE, Tang GW, Ferris DG, Paavonen J, Steben M, Bosch FX, Dillner J, Joura EA, Kurman RJ, Majewski S, Munoz N, Myers ER, Villa LL, Taddeo FJ, Roberts C, Tadesse A, Bryan J, Lupinacci LC, Giacoletti KE, Sings HL, James M, Hesley TM, Barr E. The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in generally HPV-naive women aged 16-26 years. J Infect Dis. 2009 Apr 1;199(7):926-35. doi: 10.1086/597307.

    PubMed 19236279

  • Wheeler CM, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Perez G, Brown DR, Koutsky LA, Tay EH, Garcia P, Ault KA, Garland SM, Leodolter S, Olsson SE, Tang GW, Ferris DG, Paavonen J, Steben M, Bosch FX, Dillner J, Joura EA, Kurman RJ, Majewski S, Munoz N, Myers ER, Villa LL, Taddeo FJ, Roberts C, Tadesse A, Bryan J, Lupinacci LC, Giacoletti KE, James M, Vuocolo S, Hesley TM, Barr E. The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in sexually active women aged 16-26 years. J Infect Dis. 2009 Apr 1;199(7):936-44. doi: 10.1086/597309.

    PubMed 19236277

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 / 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 1 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 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?

Tolerability and immune responses at week 4 post dose 3.. 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 NCT00092482, which also lists 9 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.

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