NCT00092482

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,882

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2002

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2002

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2004

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2008

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

September 22, 2004

Last Update Submit

March 20, 2017

Conditions

Cervical CancerGenital Warts

Outcome Measures

Primary Outcomes (1)

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

Interventions

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

Eligibility Criteria

Age16 Years - 23 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 17428949BACKGROUND

  • 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.

    PMID: 17955433BACKGROUND

  • 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.

    PMID: 21307649RESULT

  • 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.

    PMID: 35525430DERIVED

  • 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.

    PMID: 32184277DERIVED

  • 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.

    PMID: 21300618DERIVED

  • 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.

    PMID: 19505910DERIVED

  • 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.

    PMID: 19236279DERIVED

  • 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.

    PMID: 19236277DERIVED

MeSH Terms

Conditions

Uterine Cervical NeoplasmsCondylomata Acuminata

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18Vaccines, SyntheticDuration of Therapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPapillomavirus InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesWartsSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vaccines, CombinedVaccinesBiological ProductsComplex MixturesPapillomavirus VaccinesViral VaccinesRecombinant ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigensBiological FactorsPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2004

First Posted

September 27, 2004

Study Start

June 28, 2002

Primary Completion

June 30, 2004

Study Completion

August 15, 2008

Last Updated

March 22, 2017

Record last verified: 2017-03