NCT00092495

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
3,055

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 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

December 1, 2002

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
21 days 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
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 8, 2010

Completed
Last Updated

January 13, 2015

Status Verified

December 1, 2014

Enrollment Period

1.8 years

First QC Date

September 22, 2004

Results QC Date

February 15, 2010

Last Update Submit

December 29, 2014

Conditions

Cervical CancerGenital Warts

Outcome Measures

Primary Outcomes (9)

  • 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).

    Week 4 Postdose 3 (Month 7)

  • Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3

    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).

    Week 4 Postdose 3 (Month 7)

  • Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3

    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.

    Week 4 Postdose 3 (Month 7)

  • Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3

    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).

    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).

    Week 4 Postdose 3 (Month 7)

  • Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3

    Week 4 Postdose 3 (Month 7)

Study Arms (4)

1

EXPERIMENTAL

100% Formulation qHPV Vaccine

Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine

2

EXPERIMENTAL

60% Formulation qHPV Vaccine

Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine

3

EXPERIMENTAL

40% Formulation qHPV Vaccine

Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine

4

EXPERIMENTAL

20% Formulation qHPV Vaccine

Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine

Interventions

V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccineBIOLOGICAL

qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.

Also known as: V501, Gardasil
1234

Eligibility Criteria

Age10 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 17079588BACKGROUND

  • 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.

    PMID: 18313445BACKGROUND

  • 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.

    PMID: 18000825BACKGROUND

  • 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

  • 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.

    PMID: 19935017DERIVED

  • 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.

    PMID: 19453788DERIVED

MeSH Terms

Conditions

Uterine Cervical NeoplasmsCondylomata Acuminata

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18Vaccines, Synthetic

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 Factors

Limitations and Caveats

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.

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
ClinicalTrialsDisclosure@merck.com

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

December 1, 2002

Primary Completion

September 1, 2004

Study Completion

February 1, 2009

Last Updated

January 13, 2015

Results First Posted

March 8, 2010

Record last verified: 2014-12