ID

35180

Descripción

Study ID: 107022 Clinical Study ID: 107022 Study Title: A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with Fluarix (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00321373 Study Link: https://clinicaltrials.gov/ct2/show/NCT00321373 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A - 2 different formulations Trade Name: FluarixTM Study Indication: Influenza The following AEs constitute contraindications to administration of vaccine at that point in time; if this AE occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE. Visit 1: Day 0, Pre vaccination Visit 2: Day 21, Post vaccination 1 Phone contact: Day 30, post vaccination 1 Visit 3: Day 180, post vaccination 1

Link

https://clinicaltrials.gov/ct2/show/NCT00321373

Palabras clave

  1. 22/2/19 22/2/19 -
  2. 25/2/19 25/2/19 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

22 de febrero de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0

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Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373

Contraindications to Vaccination

Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of Visit
Descripción

Date of Visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Descripción

Subject Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Contraindications to Vaccination
Descripción

Contraindications to Vaccination

Alias
UMLS CUI-1
C0522473
UMLS CUI-2
C0042196
Acute disease at the time of vaccination.
Descripción

Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without lowgrade febrile illness, i.e. Oral temperature <37.5°C (99.5°F) / Axillary temperature <37.5°C (99.5°F).

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001314

Similar models

Contraindications to Vaccination

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Contraindications to Vaccination
C0522473 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Acute Disease
Item
Acute disease at the time of vaccination.
boolean
C0001314 (UMLS CUI [1])

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