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

NCT00378560 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1021

Last updated 2017-04-17

Study results available
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Summary

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

Conditions

  • HPV Infections

Interventions

BIOLOGICAL

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

V501; Gardasil, 0.5 ml injection in 3 dosing regimen

BIOLOGICAL

Comparator: Placebo

Placebo 0.5 ml injection in 3 dosing regimen

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-06-12
Primary Completion
2009-09-16
Completion
2009-09-16

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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 NCT00378560 on ClinicalTrials.gov