NCT00378560

Brief Summary

A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,021

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2006

Typical duration for phase_2

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 12, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2009

Completed
10 months until next milestone

Results Posted

Study results publicly available

June 29, 2010

Completed
Last Updated

April 17, 2017

Status Verified

March 1, 2017

Enrollment Period

3.3 years

First QC Date

September 18, 2006

Results QC Date

April 21, 2010

Last Update Submit

March 20, 2017

Conditions

HPV Infections

Outcome Measures

Primary Outcomes (1)

  • Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype

    Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up.

    Over 30 months

Secondary Outcomes (4)

  • Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6)

    At one month after completed vaccination series (Month 7)

  • Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11)

    At one month after completed vaccination series (Month 7)

  • Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16)

    At one month after completed vaccination series (Month 7)

  • Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18)

    At one month after completed vaccination series (Month 7)

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo

Biological: Comparator: Placebo

2

EXPERIMENTAL

Vaccine

Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

Interventions

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant VaccineBIOLOGICAL

V501; Gardasil, 0.5 ml injection in 3 dosing regimen

Also known as: V501, Gardasil
2
Comparator: PlaceboBIOLOGICAL

Placebo 0.5 ml injection in 3 dosing regimen

1

Eligibility Criteria

Age18 Years - 26 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female Subject Aged 18 To 26 Years
  • With 1-4 Lifetime Sexual Partners

You may not qualify if:

  • Male Subject

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Yoshikawa H, Ebihara K, Tanaka Y, Noda K. Efficacy of quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine (GARDASIL) in Japanese women aged 18-26 years. Cancer Sci. 2013 Apr;104(4):465-72. doi: 10.1111/cas.12106. Epub 2013 Mar 7.

    PMID: 23331518RESULT

  • Murata S, Shirakawa M, Sugawara Y, Shuto M, Sawata M, Tanaka Y. Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants. Papillomavirus Res. 2020 Dec;10:100205. doi: 10.1016/j.pvr.2020.100205. Epub 2020 Aug 19.

    PMID: 32827835DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

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

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vaccines, CombinedVaccinesBiological ProductsComplex MixturesPapillomavirus VaccinesViral Vaccines

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
1-800-672-6372

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 2
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 18, 2006

First Posted

September 20, 2006

Study Start

June 12, 2006

Primary Completion

September 16, 2009

Study Completion

September 16, 2009

Last Updated

April 17, 2017

Results First Posted

June 29, 2010

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php