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Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)

NCT00851643 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2016-02-03

Study results available
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Summary

This study will examine the safety and tolerability of octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine formulated with amorphous aluminum hydroxysulfate (AAHS) and ISCOMATRIX™ (IMX). Reviews of safety and tolerability will be used to select the dose(s) of IMX for further studies of the octavalent HPV L1 VLP vaccine.

Conditions

Interventions

BIOLOGICAL

Octavalent HPV with 15 mcg IMX / AAHS

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

BIOLOGICAL

Octavalent HPV with 30 mcg IMX / AAHS

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

BIOLOGICAL

Octavalent HPV with 60 mcg IMX / AAHS

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

BIOLOGICAL

Octavalent HPV with 120 mcg IMX / AAHS

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

BIOLOGICAL

Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)

0.5-mL 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
18 Years
Max Age
24 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2007-12-31
Completion
2009-11-30

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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 NCT00851643 on ClinicalTrials.gov