CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 105 enrolled
Drug / intervention
Standard Trivalent Influenza Vaccine +1 morebiological
Likely dose
Standard Trivalent Influenza 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.

Search/NCT01666782
NCT01666782Phase 2Completed
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A Randomized Pilot Study Comparing High-Dose Influenza Vaccine to Standard-Dose Influenza Vaccine in Adult Oncology Patients Less Than 65 Years Receiving Chemotherapy

Saad Jamshed MD·interventional·Posted Aug 16, 2012·Updated Jun 24, 2016

In Brief

A Phase 2 clinical trial evaluating Standard Trivalent Influenza Vaccine and High-Dose Influenza Vaccine for Cancer and Influenza Viral Infections. Completed, enrolled 105 participants across 2 sites.

Detailed Summary

The safety and immunogenicity of high dose influenza vaccine has not been studied in young patients receiving chemotherapy. This study will evaluate and compare the immunogenicity and safety of high dose influenza to standard dose influenza vaccine in adult oncology patients who are younger than 65 years old receiving chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer, Influenza Viral Infections
CountriesUnited States
CollaboratorsSanofi

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 16, 2012
Enrollment StartAug 1, 2012
Primary CompletionJun 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.9 years ago

Interventions

Standard Trivalent Influenza Vaccinebiological

Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.

High-Dose Influenza Vaccinebiological

Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.