At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 136 enrolled
Drug / intervention
Staphylococcus aureus 4-antigen vaccine +1 morebiological
Likely dose
Staphylococcus aureus 4-antigen vaccine 0.5 mLfrom 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 Phase 1/2a Placebo-controlled, Randomized, Double-blind, Sponsor-unblinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of Staphylococcus Aureus 4-antigen Vaccine (sa4ag) In Japanese Adults
In Brief
A Phase 2 clinical trial evaluating Staphylococcus aureus 4-antigen vaccine and Placebo for Staphylococcal Infections. Completed, enrolled 136 participants across 2 sites.
Detailed Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of a single dose of Staphylococcus aureus 4 antigen vaccine in Japanese adults aged 20 to \<86 years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStaphylococcal Infections
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJun 2015
First PostedJul 2015
Primary CompletionSep 2016
TodayJul 2026
First PostedJul 9, 2015
Enrollment StartJun 1, 2015
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.0 years ago
Interventions
Staphylococcus aureus 4-antigen vaccinebiological
a single 0.5 mL dose of investigational product into the deltoid muscle in the upper arm
Placebobiological
a single 0.5 mL dose of investigational product into the deltoid muscle in the upper arm