ID
35250
Beschrijving
Study ID: 107191 Clinical Study ID: 107191 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 FluarixTM (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years. Patient Level Data: NA Clinicaltrials.gov Identifier: NA EudraCT Number: 2006-000939-97 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A Trade Name: FluarixTM Study Indication: Influenza The purpose of this form is to document any concimtant medication, the subject has received during the study. It should be filled out at each visit/contact. At each study visit/contact, the investigator should question the subject about any medication(s) taken. - All concomitant medication, with the exception of vitamins and/or dietary supplements, administered at ANY time during the period starting with administration of the study vaccines/ comparator and ending 30 days after administration of the study vaccines/ comparator are to be recorded with generic name of the medication (trade names are allowed for combination drugs, i.e. multi-component drugs), medical indication, total daily dose, route of administration, start and end dates of treatment. - Any treatments and/or medications specifically contraindicated, e.g., any immunoglobulins, other blood products and any immune modifying drugs administered within 3 months or at any time during the study period are to be recorded with generic n-me of the medication (trade names are allowed for combination drugs only), medical indication, total daily dose, route of administration, start and end dates of treatment. - A prophylactic medication is a medication administered in the absence of ANY symptom and in anticipation of a reaction to the vaccination (e.g. an anti-pyretic is considered to be prophylactic when it is given in the absence of fever [rectal temperature < 38°C] and any other symptom, to prevent fever from occurring). Any concomitant medication administered prophylactically in anticipation of reaction to the vaccination must be recorded in the CRF with generic name of the medication (trade names are allowed for combination drugs only), total daily dose, route of administration, start and end dates of treatment and coded as ‘Prophylactic’. - Concomitant medication administered for the treatment of an AE or SAE within the follow-up period for adverse events must be recorded in the CRF with generic name of the medication (trade names are allowed for combination drugs only), medical indication (including which AE/SAE), total daily dose, route of administration, start and end dates of treatment. Similarly, concomitant medication administered for the treatment of an SAE, at any time, must be recorded on the SAE Report Form. 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 Visit 1 and 2 are part of the study: "Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373"
Trefwoorden
Versies (3)
- 13-02-19 13-02-19 -
- 25-02-19 25-02-19 - Sarah Riepenhausen
- 25-02-19 25-02-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
25 februari 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix EudraCT Number 2006-000939-97
Concomitant Medication
- StudyEvent: ODM
Beschrijving
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Drug name
Datatype
text
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Medical Indication
Datatype
text
Alias
- UMLS CUI [1]
- C3146298
Beschrijving
Medical Indication Prophylactic
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0199176
- UMLS CUI [1,2]
- C3146298
- UMLS CUI [1,3]
- C0013227
Beschrijving
Total Daily Dose
Datatype
text
Alias
- UMLS CUI [1]
- C2348070
Beschrijving
Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
start date of medication
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
If ongoing at the end of study, no entry is needed. Please fill out the following item instead.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschrijving
Ongoing Medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
For GSK
Datatype
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0457083
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Concomitant Medication
- StudyEvent: ODM
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C0013227 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0457083 (UMLS CUI [1,2])