CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 206 enrolled
Drug / intervention
Comparator: Placebo (PBO) +5 morebiological
Likely dose
V710 Comparator: Placebo (PBO) 90 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00572910
NCT00572910Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of Merck Staphylococcus Aureus Vaccine (V710) in Adult Patients With End-Stage Renal Disease on Chronic Hemodialysis

Merck Sharp & Dohme LLC·interventional·Posted Dec 13, 2007·Updated Apr 3, 2015

In Brief

A Phase 2 clinical trial evaluating Comparator: Placebo (PBO) and V710 Comparator: Placebo (PBO) for Staphylococcus Aureus Infection. Completed, enrolled 206 participants.

Detailed Summary

This is a study to evaluate the safety and immunogenicity of V710 with and without Merck Aluminum Adjuvant (MAA) in adult participants with end-stage kidney disease who are on hemodialysis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStaphylococcus Aureus Infection
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 13, 2007
Enrollment StartAug 1, 2008
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.6 years ago

Interventions

Comparator: Placebo (PBO)biological

Group 6: Placebo (PBO / PBO / PBO)

V710 Comparator: Placebo (PBO)biological

Group 5A: V710 (90 mcg / 90 mcg / 90 mcg) with MAA Group 5B: V710 (90 mcg / 90 mcg / PBO) with MAA

V710 Comparator: Placebo (PBO)biological

Group 4A: V710 (60 mcg / PBO / 60 mcg) with MAA Group 4B: V710 (60 mcg / PBO / PBO) with MAA

V710 Comparator: Placebo (PBO)biological

Group 3A: V710 (60 mcg / 60 mcg / 60 mcg) with MAA Group 3B: V710 (60 mcg / 60 mcg / PBO) with MAA

V710 Comparator: Placebo (PBO)biological

Group 2A: V710 (60 mcg / PBO / 60 mcg) without MAA Group 2B: V710 (60 mcg / PBO / PBO) without MAA

V710 Comparator: Placebo (PBO)biological

Group 1A: V710 (60 mcg / 60 mcg / 60 mcg) without MAA Group 1B: V710 (60 mcg / 60 mcg / PBO) without MAA