Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)

November 25, 2015 updated by: Merck Sharp & Dohme LLC

A Phase IIa Randomized, Double-Blind Controlled With Gardasil, Clinical Trial to Study theTolerability and Immunogenicity of V505 (a Multivalent Human Papilloma Virus [HPV] L1 Virus Like Particle [VLP] Vaccine) in Healthy 16 to 26 Year Old Women

The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

511

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

16 years to 26 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female between 16 to 26 years old
  • Has never had Pap testing or have only had normal Pap test results
  • Lifetime history of 0 to 4 sexual partners

Exclusion Criteria:

  • History of an abnormal cervical biopsy result; History of a positive test for HPV; History of external genital/vaginal warts; Currently a user of any illegal drugs or an alcohol abuser
  • History of severe allergic reaction that required medical attention
  • Are pregnant
  • Received a marketed HPV vaccine
  • Currently enrolled in a clinical trial
  • Currently has (or has a history of) certain medical conditions or is currently taking or has taken certain medications (details will be discussed at time of consent)

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Arm 1: 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen.
Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant
0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen at Day 1, Month 2 and Month 6.
EXPERIMENTAL: 2
Arm 2: 0.5 ml injection of V505 formulation 1 as 3 dose regimen.
Biological: Comparator: V505 formulation 1
0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6.
EXPERIMENTAL: 3
Arm 3: 0.5 ml injection of V505 formulation 2 as 3 dose regimen
Drug: Comparator: V505 formulation 2
0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6.
Drug: Comparator: V505 formulation 2
0.5 ml injection of V505 formulation 2 as 2 dose regimen at Day 1 and Month 6.
EXPERIMENTAL: 4
Arm 4: 0.5 ml injection of V505 formulation 2 as 2 dose regimen and 1 Pbo injection
Drug: Comparator: V505 formulation 2
0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6.
Drug: Comparator: V505 formulation 2
0.5 ml injection of V505 formulation 2 as 2 dose regimen at Day 1 and Month 6.
Biological: Comparator: Placebo (unspecified)
0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.
EXPERIMENTAL: 5
Arm 5: 0.5 ml injection of V505 formulation 3 as 2 dose regimen and 1 Pbo injection
Biological: Comparator: Placebo (unspecified)
0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.
Biological: Comparator: V505 formulation 3
0.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen
Time Frame: 4 weeks post dose 3
4 weeks post dose 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen
Time Frame: 4 weeks post dose 2
4 weeks post dose 2

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

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

October 1, 2007

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

August 22, 2007

First Submitted That Met QC Criteria

August 22, 2007

First Posted (ESTIMATE)

August 24, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

November 26, 2015

Last Update Submitted That Met QC Criteria

November 25, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V505-001
  • 2007_567

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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