At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 122 enrolled
Drug / intervention
Fluzone High Dose Vaccine +1 morebiological
Likely dose
Not stated in 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.
Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients (SHIVERING 2)
In Brief
A Phase 2 clinical trial evaluating Fluzone High Dose Vaccine and Standard of care/Placebo for Influenza and 4 related conditions. Completed, enrolled 122 participants across 1 site.
Detailed Summary
The investigators' hypothesis is that the administration of Fluzone® High-Dose with booster to all patients with monoclonal gammopathies (irrespective of age) will lead to seroconversion rates exceeding 50% and more importantly, will reduce influenza-related morbidity, reduce interruptions in cancer therapy and may reduce disease progression at the end of the flu season
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartSep 2015
First PostedOct 2015
Primary CompletionOct 2017
Study CompletionJun 2018
TodayJul 2026
First PostedOct 2, 2015
Enrollment StartSep 1, 2015
Primary CompletionOct 1, 2017
Study CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.8 years ago
Interventions
Fluzone High Dose Vaccinebiological
Standard of care/Placebobiological