ID
36620
Descripción
Study ID: 105910 Clinical Study ID: 105910 Study Title: Compare Immunogenicity & Reactogenicity of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (New vs Current) Given in Healthy Infants. The DTPa-HBV-IPV Vaccine (New Formulation) Will Also be Assessed in a 3rd Group of Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00320463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: DTPa-HBV-IPV/Hib vaccine Trade Name: N/A Study Indication: Diphtheria, Hepatitis B, Poliomyelitis, Tetanus, Whooping Cough
Palabras clave
Versiones (1)
- 26/5/19 26/5/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
26 de mayo de 2019
DOI
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Licencia
Creative Commons BY-NC 3.0
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DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants; NCT00320463
Visit 2 - Dose 2
- StudyEvent: ODM
Descripción
Check for Study Continuation
Alias
- UMLS CUI-1
- C0805733
- UMLS CUI-2
- C0008976
Descripción
Continuation status, Clinical Trials
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0805733
- UMLS CUI [1,2]
- C0008976
Descripción
Continuation status, Clinical Trials, Reason
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0805733
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C0566251
Descripción
Continuation status, Clinical Trials, Reason
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0805733
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C0566251
Descripción
Continuation status, Clinical Trials, Decision
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0805733
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C0679006
Descripción
Vaccine Administration
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2368628
Descripción
Vaccination, Administration of Vaccine, Date in time
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0011008
Descripción
Vaccination, Body Temperature, Vaccination, Before
Tipo de datos
float
Unidades de medida
- °C
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0005903
- UMLS CUI [1,3]
- C0042196
- UMLS CUI [1,4]
- C0332152
Descripción
Vaccination, Administration of vaccine, Body Temperature, Measurement site
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0005903
- UMLS CUI [1,4]
- C0449687
Descripción
Vaccination, Administration of Vaccine
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2368628
Descripción
Vaccination, Administration of Vaccine, Vial Device, Replacement, Numbers
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0184301
- UMLS CUI [1,4]
- C0559956
- UMLS CUI [1,5]
- C0600091
Descripción
Vaccination, Administration of Vaccine, Vial Device, Wrong, Numbers
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0184301
- UMLS CUI [1,4]
- C3827420
- UMLS CUI [1,5]
- C0600091
Descripción
Vaccination, Administration of Vaccine, Anatomic Site, Drug Administration Routes
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C1515974
- UMLS CUI [1,4]
- C0013153
Descripción
Vaccination, Administration of Vaccine, Protocol Compliance
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0525058
Descripción
Vaccination, Administration of Vaccine, Side
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0441987
Descripción
Vaccination, Administration of Vaccine, Anatomic site
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C1515974
Descripción
Vaccination, Administration of Vaccine, Drug Administration Routes
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0013153
Descripción
Vaccination, Administration of Vaccine, Not done
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C1272696
Descripción
Vaccination, Administration of Vaccine, Decision
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0679006
Descripción
Solicited Adverse Events - Local Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
- UMLS CUI-4
- C0545082
- UMLS CUI-5
- C0332307
Descripción
Adverse Event, Symptoms, Local
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Descripción
Adverse Event, Symptoms, Local
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Descripción
Adverse Event, Symptoms, Local
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Descripción
Adverse Event, Symptoms, Local
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Descripción
Adverse Event, Symptoms, Local
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Descripción
Adverse Event, Symptoms, Local
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Descripción
Adverse Event, Symptoms, Local, Continuous
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C0549178
Descripción
Adverse Event, Symptoms, Local, End Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C0806020
Descripción
Adverse Event, Symptoms, Local, Visit/Advice
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C0545082
Descripción
Adverse Event, Symptoms, Local, Visit/Advice, Type
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C0545082
- UMLS CUI [1,5]
- C0332307
Descripción
Solicited Adverse Events - General Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0159028
Descripción
Adverse Event, General symptom
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0159028
Descripción
Adverse Event, General symptom
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0159028
Descripción
Adverse Event, General symptom
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0159028
Descripción
Adverse Event, General symptom
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0159028
Descripción
Adverse Event, General symptom
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0159028
Descripción
Adverse Event, General symptom
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0159028
Descripción
Adverse Event, General symptom, Continuous
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C0549178
Descripción
Adverse Event, General symptom, End Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C0806020
Descripción
Adverse Event, General symptom, Etiology aspects
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C0015127
Descripción
Adverse Event, General symptom, Visit/Advice
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C0545082
Descripción
Adverse Event, General symptom, Visit/Advice, Type
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C0545082
- UMLS CUI [1,4]
- C0332307
Descripción
Unsolicited Adverse Event
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0042196
Similar models
Visit 2 - Dose 2
- StudyEvent: ODM
C0008976 (UMLS CUI-2)
C0008976 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
C2368628 (UMLS CUI-2)
C2368628 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0005903 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C2368628 (UMLS CUI [1,2])
C0005903 (UMLS CUI [1,3])
C0449687 (UMLS CUI [1,4])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
C0184301 (UMLS CUI [1,3])
C0559956 (UMLS CUI [1,4])
C0600091 (UMLS CUI [1,5])
C2368628 (UMLS CUI [1,2])
C0184301 (UMLS CUI [1,3])
C3827420 (UMLS CUI [1,4])
C0600091 (UMLS CUI [1,5])
C2368628 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,4])
C2368628 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C0545082 (UMLS CUI-4)
C0332307 (UMLS CUI-5)
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
C0332307 (UMLS CUI [1,5])
C0159028 (UMLS CUI-2)
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
C0042196 (UMLS CUI-2)
C0042196 (UMLS CUI [1,2])