ID

32064

Description

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

Link

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

Keywords

Versions (2)
  1. 10/16/18 10/16/18 - Sarah Riepenhausen
  2. 10/16/18 10/16/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

October 16, 2018

DOI

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License

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

English

Medical history and Physical examination

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

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

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?
Description

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

Data type

boolean

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

Organ system

Data type

integer

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

Other Organ system

Data type

text

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

Diagnoses

Data type

text

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

past diagnosis

Data type

boolean

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

Current diagnosis

Data type

boolean

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

Medical history and Physical examination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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