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

NCT ID: NCT00520598

Last Updated: 2015-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

511 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-05-31

Brief Summary

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

Detailed Description

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Conditions

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Cervical Cancer Vulvar Cancer Vaginal Cancer Genital Warts Human Papillomavirus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Arm 1: 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen.

Group Type ACTIVE_COMPARATOR

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

Intervention Type BIOLOGICAL

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.

2

Arm 2: 0.5 ml injection of V505 formulation 1 as 3 dose regimen.

Group Type EXPERIMENTAL

Comparator: V505 formulation 1

Intervention Type BIOLOGICAL

0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6.

3

Arm 3: 0.5 ml injection of V505 formulation 2 as 3 dose regimen

Group Type EXPERIMENTAL

Comparator: V505 formulation 2

Intervention Type DRUG

0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6.

4

Arm 4: 0.5 ml injection of V505 formulation 2 as 2 dose regimen and 1 Pbo injection

Group Type EXPERIMENTAL

Comparator: V505 formulation 2

Intervention Type DRUG

0.5 ml injection of V505 formulation 2 as 2 dose regimen at Day 1 and Month 6.

Comparator: Placebo (unspecified)

Intervention Type BIOLOGICAL

0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.

5

Arm 5: 0.5 ml injection of V505 formulation 3 as 2 dose regimen and 1 Pbo injection

Group Type EXPERIMENTAL

Comparator: V505 formulation 3

Intervention Type BIOLOGICAL

0.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6.

Comparator: Placebo (unspecified)

Intervention Type BIOLOGICAL

0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.

Interventions

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Comparator: V505 formulation 1

0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6.

Intervention Type BIOLOGICAL

Comparator: V505 formulation 2

0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6.

Intervention Type DRUG

Comparator: V505 formulation 2

0.5 ml injection of V505 formulation 2 as 2 dose regimen at Day 1 and Month 6.

Intervention Type DRUG

Comparator: V505 formulation 3

0.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6.

Intervention Type 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.

Intervention Type BIOLOGICAL

Comparator: Placebo (unspecified)

0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

16 Years

Maximum Eligible Age

26 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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2007_567

Identifier Type: -

Identifier Source: secondary_id

V505-001

Identifier Type: -

Identifier Source: org_study_id