ID
34869
Descrição
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 the subjects general medical history and the physical examination performed at visit 1. Please report medication(s) as specified in the protocol and fill in the Medication section. 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
Palavras-chave
Versões (2)
- 31/01/2019 31/01/2019 -
- 01/02/2019 01/02/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
1 de fevereiro de 2019
DOI
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Licença
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
General Medical History/Physical Examination
- StudyEvent: ODM
Descrição
General Medical History, Phyiscal Examination
Alias
- UMLS CUI-1
- C0262926 (Medical History)
- SNOMED
- 392521001
- LOINC
- LP6817-3
- UMLS CUI-2
- C0031809 (Physical Examination)
- SNOMED
- 5880005
- LOINC
- MTHU028014
Descrição
If yes, please give diagnosis and tick appropriate Past/Current box(es).
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0521987 (Pre-existing condition)
- SNOMED
- 102478008
- UMLS CUI [2]
- C1457887 (Symptoms)
- LOINC
- MTHU021540
Descrição
General Medical History, Phyiscal Examination Record
Alias
- UMLS CUI-1
- C0262926 (Medical History)
- SNOMED
- 392521001
- LOINC
- LP6817-3
- UMLS CUI-2
- C0031809 (Physical Examination)
- SNOMED
- 5880005
- LOINC
- MTHU028014
Descrição
Diagnosis
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0011900 (Diagnosis)
- SNOMED
- 439401001
- LOINC
- LP30831-9
Descrição
Past
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0455458 (PMH - past medical history)
- SNOMED
- 417662000
- LOINC
- MTHU027722
Descrição
Current
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C0521116 (Current (present time))
- SNOMED
- 15240007
- UMLS CUI [1,2]
- C0011900 (Diagnosis)
- SNOMED
- 439401001
- LOINC
- LP30831-9
Descrição
MedDRA System Organ Class
Tipo de dados
integer
Alias
- UMLS CUI [1]
- C2347091 (MedDRA System Organ Class)
Similar models
General Medical History/Physical Examination
- StudyEvent: ODM
C0031809 (UMLS CUI-2)
C1457887 (UMLS CUI [2])
C0031809 (UMLS CUI-2)
C0011900 (UMLS CUI [1,2])
Sem comentários