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

NCT00520598 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 511

Last updated 2015-11-26

No results posted yet for this study

Summary

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

Conditions

  • Cervical Cancer
  • Vulvar Cancer
  • Vaginal Cancer
  • Genital Warts
  • Human Papillomavirus Infection

Interventions

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.

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: V505 formulation 3

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

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.

BIOLOGICAL

Comparator: Placebo (unspecified)

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

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
26 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2011-05-31
Completion
2011-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00520598 on ClinicalTrials.gov