Phase 2
Completed N=122
Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients
Source: ClinicalTrials.gov NCT02566265 ↗Enrolled (actual)
122
Serious AEs
7.4%
Results posted
Jan 2019
Primary outcomePrimary: Number of Participants With Treatment Failure by Primary Endpoint — 26; 13 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Failure by Primary Endpoint |
26; 13 | — |
Eligibility Criteria
Inclusion Criteria
- Understand and voluntarily sign an informed consent form.
- Age ≥18 years at the time of signing the informed consent form.
- Diagnosis of any monoclonal gammopathy: Monoclonal Gammopathy of Undetermined Significance (MGUS), asymptomatic / active multiple myeloma, asymptomatic / active Waldenstrӧm Macroglobulinemia (WM).
Exclusion Criteria
- Any serious egg allergy or prior serious adverse reaction to an influenza vaccine.
- Use of any other influenza vaccine for the 2015 to 2016 flu season.
- Women who are pregnant or plan to become pregnant in the study period.
Data sourced from ClinicalTrials.gov (NCT02566265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.