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NCT02566265 · OUTCOME

Number of Participants With Treatment Failure by Primary Endpoint

Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients · Source last updated 2019-01-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
1 year

What was measured

Any documented flu infection during the 2015-2016 flu season or evidence of disease progression.

Groups in this outcome

Fluzone High Dose Vaccine Then Fluzone High Dose Booster

Fluzone High dose vaccine administered at Day 0. Fluzone High dose vaccine administered as a booster after 30 days from the initial vaccine. Fluzone High Dose Vaccine

Standard of Care

Fluzone High-Dose if age greater than or equal to 65 or Standard dose influenza vaccine if age less than 65 at day 0. Placebo administered 30 days after the initial vaccine. Standard of care/Placebo

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Fluzone High Dose Vaccine Then Fluzone High Dose Booster81
Standard of Care41

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fluzone High Dose Vaccine Then Fluzone High Dose Booster26Not reportedNot reportedNot reportedNot reported
Standard of Care13Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        13
denoms
  1. counts
    1. group Id
      OG000
      value
      81
    2. group Id
      OG001
      value
      41
    units
    Participants
description
Any documented flu infection during the 2015-2016 flu season or evidence of disease progression.
groups
  1. description
    Fluzone High dose vaccine administered at Day 0. Fluzone High dose vaccine administered as a booster after 30 days from the initial vaccine. Fluzone High Dose Vaccine
    id
    OG000
    title
    Fluzone High Dose Vaccine Then Fluzone High Dose Booster
  2. description
    Fluzone High-Dose if age greater than or equal to 65 or Standard dose influenza vaccine if age less than 65 at day 0. Placebo administered 30 days after the initial vaccine. Standard of care/Placebo
    id
    OG001
    title
    Standard of Care
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
1 year
title
Number of Participants With Treatment Failure by Primary Endpoint
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice