V501 Efficacy Study in Women Aged 18 to 26 (V501-027)

March 20, 2017 updated by: Merck Sharp & Dohme LLC

V501 Phase II Efficacy Study in Women Aged 18 to 26

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1021

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 26 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Male Subject

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Placebo
Biological: Comparator: Placebo
Placebo 0.5 ml injection in 3 dosing regimen
Experimental: 2
Vaccine
Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
V501; Gardasil, 0.5 ml injection in 3 dosing regimen
Other Names:
  • Gardasil
  • V501

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Over 30 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6)
Time Frame: At one month after completed vaccination series (Month 7)

Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) by vaccine group.

The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "7.0".
At one month after completed vaccination series (Month 7)
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11)
Time Frame: At one month after completed vaccination series (Month 7)

Month 7 HPV cLIA Geometric Mean Titers by vaccine group.

The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "8.0".
At one month after completed vaccination series (Month 7)
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16)
Time Frame: At one month after completed vaccination series (Month 7)

Month 7 HPV cLIA Geometric Mean Titers by vaccine group.

The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "11.0".
At one month after completed vaccination series (Month 7)
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18)
Time Frame: At one month after completed vaccination series (Month 7)

Month 7 HPV cLIA Geometric Mean Titers by vaccine group.

The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "10.0".
At one month after completed vaccination series (Month 7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2006

Primary Completion (Actual)

September 16, 2009

Study Completion (Actual)

September 16, 2009

Study Registration Dates

First Submitted

September 18, 2006

First Submitted That Met QC Criteria

September 19, 2006

First Posted (Estimate)

September 20, 2006

Study Record Updates

Last Update Posted (Actual)

April 17, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V501-027
  • 2006_032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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