ID
34991
Description
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 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
Link
https://clinicaltrials.gov/ct2/show/NCT00321373
Keywords
Versions (2)
- 2/5/19 2/5/19 -
- 2/7/19 2/7/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 7, 2019
DOI
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License
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
Concomitant Medication
- StudyEvent: ODM
Description
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Description
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Description
Drug name
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Medical Indication
Data type
text
Alias
- UMLS CUI [1]
- C3146298
Description
Medical Indication Prophylactic
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0199176
- UMLS CUI [1,2]
- C3146298
- UMLS CUI [1,3]
- C0013227
Description
Total Daily Dose
Data type
text
Alias
- UMLS CUI [1]
- C2348070
Description
Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
start date of medication
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
End Date of medication
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
Ongoing Medication
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
For GSK
Data type
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0457083
Similar models
Concomitant Medication
- StudyEvent: ODM
C3146298 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0457083 (UMLS CUI [1,2])