ID

32071

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?term=NCT00139334&rank=1 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 demographics, informed consent and randomization/treatment number. To be filled in at Visit 1. Timing: Day 0 Age: 6 weeks +/- 1 week

Länk

https://clinicaltrials.gov/ct2/show/NCT00139334?term=NCT00139334&rank=1

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

Demographics and Administrative Data

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
Informed Consent
Beskrivning

Informed Consent

Alias
UMLS CUI-1
C0021430
I certify that Informed Consent has been obtained prior to any study procedure. Informed Consent Date
Beskrivning

Informed Consent Date

Datatyp

date

Alias
UMLS CUI [1]
C2985782
Demographics
Beskrivning

Demographics

Alias
UMLS CUI-1
C1704791
Center number
Beskrivning

Center number

Datatyp

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of birth
Beskrivning

Date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Race
Beskrivning

Race

Datatyp

integer

Alias
UMLS CUI [1]
C0034510
If other Race, please specify
Beskrivning

Other Race

Datatyp

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0205394
Height
Beskrivning

Height

Datatyp

integer

Måttenheter
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Randomisation/Treatment Allocation
Beskrivning

Randomisation/Treatment Allocation

Alias
UMLS CUI-1
C0034656
Record treatment number
Beskrivning

Treatment number

Datatyp

text

Alias
UMLS CUI [1]
C1522541
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Similar models

Demographics and Administrative Data

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
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
I certify that Informed Consent has been obtained prior to any study procedure. Informed Consent Date
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
Black (1)
CL Item
Arabic/North African (4)
CL Item
White/Caucasian (2)
CL Item
East and South East Asian (5)
CL Item
South Asian (6)
CL Item
American Hispanic (7)
CL Item
Japanese (8)
CL Item
Bangladeshi (97)
CL Item
other (9)
Other Race
Item
If other Race, please specify
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Randomisation/Treatment Allocation
C0034656 (UMLS CUI-1)
Treatment number
Item
Record treatment number
text
C1522541 (UMLS CUI [1])
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