ID

32064

Beskrivning

Study ID: 103992 Clinical Study ID: 103992 Study Title: Evaluate immunogenicity, reactogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated HRV vaccine (RIX4414 at 106.5 CCID50) when given concomitantly with OPV versus given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00139334 https://clinicaltrials.gov/ct2/show/NCT00139334 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis This form is for documentation of medical history and results of the physical examination. To be assessed at visit 1. Timing: Day 0 Age: 6 weeks +/- 1 week

Länk

https://clinicaltrials.gov/ct2/show/NCT00139334

Nyckelord

Versioner (2)
  1. 2018-10-16 2018-10-16 - Sarah Riepenhausen
  2. 2018-10-16 2018-10-16 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

16 oktober 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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GSK Biologicals' oral HRV vaccine given with OPV in infants NCT00139334

Engelsk

Medical history and Physical examination

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
General medical history and physical examination
Beskrivning

General medical history and physical examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
Beskrivning

If yes: please tick appropriate boxe(s) below and give diagnosis. Please report medication(s) as specified in the protocol and fill in the Medication section

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0262926
Organ system
Beskrivning

Organ system

Datatyp

integer

Alias
UMLS CUI [1]
C0678852
If other Organ system, specify
Beskrivning

Other Organ system

Datatyp

text

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0205394
Diagnoses
Beskrivning

Diagnoses

Datatyp

text

Alias
UMLS CUI [1]
C0011900
Was the diagnosis in the past?
Beskrivning

past diagnosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0679831
Is the diagnosis current?
Beskrivning

Current diagnosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0521116
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Similar models

Medical history and Physical examination

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
General medical history and physical examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Medical history
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
boolean
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
Item
Organ system
integer
C0678852 (UMLS CUI [1])
Disease category
Code List
Organ system
CL Item
cutaneous (10)
CL Item
eyes (5)
CL Item
ears-nose-throat (6)
CL Item
cardiovascular (2)
CL Item
respiratory (3)
CL Item
gastrointestinal (1)
CL Item
muskuloskeletal (7)
CL Item
neurological (8)
CL Item
genitourinary (12)
CL Item
haematology (11)
CL Item
allergies (4)
CL Item
endocrine (9)
CL Item
other (99)
Other Organ system
Item
If other Organ system, specify
text
C0678852 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Diagnoses
Item
Diagnoses
text
C0011900 (UMLS CUI [1])
past diagnosis
Item
Was the diagnosis in the past?
boolean
C0011900 (UMLS CUI [1,1])
C0679831 (UMLS CUI [1,2])
Current diagnosis
Item
Is the diagnosis current?
boolean
C0011900 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Tillbaka till toppen 

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