At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Multicenter, Biphasic, Controlled With GARDASIL™ Dose-Escalation Study of Octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and ISCOMATRIX™ (IMX)
In Brief
A Phase 1 clinical trial evaluating Octavalent HPV with 15 mcg IMX / AAHS, Octavalent HPV with 30 mcg IMX / AAHS, and 3 other interventions for Human Papilloma Virus and 4 related conditions. Completed, enrolled 158 participants.
Detailed 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.
Study Details
Timeline
Interventions
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6