At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 51 enrolled
Drug / intervention
Comparator: V710 +1 morebiological
Likely dose
Comparator: V710 60 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.
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Single Dose of the Lyophilized Formulation of Merck Staphylococcus Aureus Vaccine (V710) in Healthy Adults
In Brief
A Phase 1 clinical trial evaluating Comparator: V710 and Comparator: placebo for Healthy. Completed, enrolled 51 participants.
Detailed Summary
This study is being performed to evaluate a single 60 Mcg dose of lyophilized formulation of Merck Staphylococcus aureus vaccine (V710) in healthy subjects. This study is intended to provide necessary safety and immunogenicity data for the lyophilized formulation of V710 prior to its subsequent evaluation in patients at risk for developing serious S. aureus infections.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
Primary CompletionOct 2007
Study CompletionDec 2007
First PostedJan 2009
TodayJul 2026
First PostedJan 14, 2009
Enrollment StartAug 1, 2007
Primary CompletionOct 1, 2007
Study CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.5 years ago
Interventions
Comparator: V710biological
Single dose V710 (60 Mcg/0.5 mL) by intramuscular injection.
Comparator: placebobiological
Single dose of buffered saline placebo (0.5 mL) by intramuscular injection.