NCT00517309

Brief Summary

The primary purpose of the study is to test the safety of HPV Vaccine in Women

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,877

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2001

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

December 28, 2001

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2004

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2004

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2007

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

2.4 years

First QC Date

August 15, 2007

Last Update Submit

March 20, 2017

Conditions

Cervical CancerGenital Warts

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

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

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 18164106BACKGROUND

  • 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

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

August 15, 2007

First Posted

August 16, 2007

Study Start

December 28, 2001

Primary Completion

June 8, 2004

Study Completion

June 11, 2004

Last Updated

March 22, 2017

Record last verified: 2017-03