ID
35694
Beschrijving
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B
Trefwoorden
Versies (2)
- 12-03-19 12-03-19 -
- 15-03-19 15-03-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
15 maart 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565)
Visit 1 - Demographics; General Medical History; Laboratory Tests; Baseline Assessment; General Symptoms Observed Just Before Injection
Beschrijving
Demographics
Alias
- UMLS CUI-1
- C1704791
Beschrijving
Subject initials - First name
Datatype
text
Alias
- UMLS CUI [1,1]
- C1997894
- UMLS CUI [1,2]
- C2986440
- UMLS CUI [2]
- C1443235
Beschrijving
Subject initials - Family Name
Datatype
text
Alias
- UMLS CUI [1,1]
- C1997894
- UMLS CUI [1,2]
- C2986440
- UMLS CUI [2]
- C1301584
Beschrijving
Date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Gender
Datatype
text
Beschrijving
Race
Datatype
text
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
If other race, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Eligibility
Alias
- UMLS CUI-1
- C0013893
Beschrijving
If no, please give the corresponding criterion number(s)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013893
Beschrijving
Corresponding criterion number(s)
Datatype
text
Alias
- UMLS CUI [1,1]
- C1516637
- UMLS CUI [1,2]
- C0237753
Beschrijving
Investigator Signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
General Medical History / Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Beschrijving
Medical Condition
Alias
- UMLS CUI-1
- C0012634
Beschrijving
Diagnosis
Datatype
integer
Alias
- UMLS CUI [1]
- C0011900
Beschrijving
Status
Datatype
integer
Alias
- UMLS CUI [1]
- C0449438
Beschrijving
Medical Condition
Datatype
text
Alias
- UMLS CUI [1]
- C0012634
Beschrijving
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Beschrijving
Baseline Temperature
Alias
- UMLS CUI-1
- C0005903
- UMLS CUI-2
- C1442488
Beschrijving
Baseline Assessment - General Symptoms
Alias
- UMLS CUI-1
- C1442488
- UMLS CUI-2
- C1516048
- UMLS CUI-3
- C0159028
Beschrijving
Does the subject experience any of the following general solicited signs or symptoms just before injection
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C1533685
- UMLS CUI [1,3]
- C0332152
Beschrijving
General Symptoms Observed Just Before Injection
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C1533685
- UMLS CUI-3
- C0332152
Beschrijving
General Symptoms Observed Just Before Injection
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C1533685
- UMLS CUI-3
- C0332152
Similar models
Visit 1 - Demographics; General Medical History; Laboratory Tests; Baseline Assessment; General Symptoms Observed Just Before Injection
C0019994 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
C1443235 (UMLS CUI [2])
C2986440 (UMLS CUI [1,2])
C1301584 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0031809 (UMLS CUI-2)
C0012634 (UMLS CUI [1,2])
C1516048 (UMLS CUI-2)
C0159028 (UMLS CUI-3)
C1533685 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C1533685 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
C1533685 (UMLS CUI-2)
C0332152 (UMLS CUI-3)