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Broad Spectrum HPV Vaccine Dose Ranging Study (V502-001)

NCT00260039 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2015-06-08

No results posted yet for this study

Summary

This dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate immune responses in women who are between 16 and 23 years of age at enrollment.

Conditions

Interventions

BIOLOGICAL

Comparator: Gardasil

0.5 mL intramuscular injection administered at Day 1, Month 2 and Month 6

BIOLOGICAL

Comparator: octavalent HPV Vaccine - dose formulation 1

0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6

BIOLOGICAL

Comparator: octavalent HPV Vaccine - dose formulation 2

0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6

BIOLOGICAL

Comparator: octavalent HPV Vaccine - dose formulation 3

0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6

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
23 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-08-31
Completion
2007-08-31

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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 NCT00260039 on ClinicalTrials.gov