ID

32070

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 height and weight (Visits 3, 5 and 6) and blood sample information (visits 3 and 6). Visit 3 -> Timing: day 45, Age: 12 weeks +/- 1 week. Visit 5 -> Timing: day 75, Age: 16 weeks +/- 1 week. Visit 6 -> Timing: day 105, Age: 20 weeks +/- 1 week.

Länk

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

Nyckelord

  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

Height, weight and blood sample

Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Beskrivning

Date of visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Visit number
Beskrivning

Visit number

Datatyp

integer

Alias
UMLS CUI [1]
C1549755
Height and Weight
Beskrivning

Height and Weight

Alias
UMLS CUI-1
C0005890
UMLS CUI-2
C0005910
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
Laboratory tests: Blood Sample
Beskrivning

Laboratory tests: Blood Sample

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0005834
Has a blood sample been taken? (2 mL)
Beskrivning

Only necessary for Visits 3 and 6 (no protocol demanded blood sample for visit 5).

Datatyp

boolean

Alias
UMLS CUI [1]
C0005834
If yes, Blood sample date
Beskrivning

Please complete only if different from visit date.

Datatyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008

Similar models

Height, weight and blood sample

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])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Visit number
integer
C1549755 (UMLS CUI [1])
Code List
Visit number
CL Item
Visit 3 (3)
CL Item
Visit 5 (no blood sample necessary) (5)
CL Item
Visit 6 (6)
Item Group
Height and Weight
C0005890 (UMLS CUI-1)
C0005910 (UMLS CUI-2)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
weight
Item
weight
float
C0005910 (UMLS CUI [1])
Item Group
Laboratory tests: Blood Sample
C0022885 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
Blood sample
Item
Has a blood sample been taken? (2 mL)
boolean
C0005834 (UMLS CUI [1])
Blood sample date
Item
If yes, Blood sample date
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

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