ID
36612
Description
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
Keywords
Versions (1)
- 5/26/19 5/26/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 26, 2019
DOI
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License
Creative Commons BY-NC 3.0
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DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants; NCT00320463
Diary Card - Dose 3
- StudyEvent: ODM
Description
Solicited Adverse Events - Local Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
Description
Adverse Event, Symptoms, Local
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Description
Adverse Event, Symptoms, Local
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Description
Adverse Event, Symptoms, Local
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Description
Adverse Event, Symptoms, Local
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Description
Adverse Event, Symptoms, Local
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Description
Adverse Event, Symptoms, Local, Continuous
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C0549178
Description
Adverse Event, Symptoms, Local, End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C0806020
Description
Adverse Event, Symptoms, Local, Visit/Advice
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C0545082
Description
Other Local Symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C0205394
Description
Symptoms, Local, Other
Data type
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
Description
Symptoms, Local, Other, Symptom Intensity
Data type
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0518690
Description
Symptoms, Local, Other, Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0808070
Description
Symptoms, Local, Other, End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0806020
Description
Symptoms, Local, Other, Continuous
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0549178
Description
Symptoms, Local, Other, Visit
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C020539
- UMLS CUI [1,4]
- C0545082
Description
Solicited Adverse Events - General Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0159028
Description
Adverse Event, General symptom
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0159028
Description
Adverse Event, General symptom
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0159028
Description
Adverse Event, General symptom
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0159028
Description
Adverse Event, General symptom
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0159028
Description
Adverse Event, General symptom
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0159028
Description
Adverse Event, General symptom, Continuous
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C0549178
Description
Adverse Event, General symptom, End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C0806020
Description
Adverse Event, General symptom, Visit/Advice
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C0545082
Description
Other General Symptoms
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0205394
Description
General symptom, Other
Data type
text
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
Description
General symptom, Other, Symptom Intensity
Data type
text
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0518690
Description
General symptom, Other, Start date
Data type
date
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0808070
Description
General symptom, Other, End date
Data type
date
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0806020
Description
General symptom, Other, Continuous
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0549178
Description
General symptom, Other, Visit
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0545082
Description
Medication
Alias
- UMLS CUI-1
- C0013227
Description
Pharmaceutical Preparations, Medication name
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2360065
Description
Pharmaceutical Preparations, Indication
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C3146298
Description
Pharmaceutical Preparations, Daily Dose, Total
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C2348070
- UMLS CUI [1,3]
- C0439810
Description
Pharmaceutical Preparations, Start date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Description
Pharmaceutical Preparations, End date
Data type
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Description
Pharmaceutical Preparations, Continuous
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Similar models
Diary Card - Dose 3
- StudyEvent: ODM
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-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])
C0205276 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,4])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,4])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
C0205276 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
C0205276 (UMLS CUI [1,2])
C020539 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
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])
C0549178 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0205394 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C2360065 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])