ID

32069

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 planned stool samples for the "stool subset". To be filled in at visit 3 (prior to and after first dose of study vaccine) and at visit 5 (prior and after second dose of study vaccine). Visit 3, Vaccination 1 -> Timing: Day 45, Age: 12 weeks +/- 1 week Visit 5, Vaccination 2 -> Timing: Day 75, Age: 16 weeks +/- 1 week This is not for documentation of stool samples in case of a gastroenteritis episode. Please use the Stool Collection form in that case.

Link

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

Keywords

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

GlaxoSmithKline

Uploaded on

October 16, 2018

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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

Planned stool samples

1 forms  
  1. StudyEvent: ODM
    1. Planned stool samples
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit number
Description

Visit number

Data type

text

Alias
UMLS CUI [1]
C1549755
Laboratory tests: Planned stool samples (only for a subset of subjects)
Description

Laboratory tests: Planned stool samples (only for a subset of subjects)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C1550661
UMLS CUI-3
C1301732
Was a stool sample collected for the stool subset at day of or 1 day prior to study vaccination?
Description

Stool sample prior to vaccination

Data type

text

Alias
UMLS CUI [1,1]
C1550661
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0597418
If yes, specify date of stool collection prior to study vaccination
Description

Date of Stool sample prior to vaccination

Data type

date

Alias
UMLS CUI [1,1]
C1550661
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0597418
UMLS CUI [1,4]
C1302413
Was a stool sample collected for the stool subset at day 4 +/- 1 after study vaccination?
Description

Stool sample 3-5 days after vaccination

Data type

text

Alias
UMLS CUI [1,1]
C1550661
UMLS CUI [1,2]
C0231290
UMLS CUI [1,3]
C0597418
If yes, specify date of stool collection 3-5 days after study vaccination
Description

Date of Stool sample 3-5 days after vaccination

Data type

date

Alias
UMLS CUI [1,1]
C1550661
UMLS CUI [1,2]
C0231290
UMLS CUI [1,3]
C0597418
UMLS CUI [1,4]
C1302413
Was a stool sample collected for the stool subset at day 7 +/- 1 after study vaccination?
Description

Stool sample 6-8 days after vaccination

Data type

text

Alias
UMLS CUI [1,1]
C1550661
UMLS CUI [1,2]
C0231290
UMLS CUI [1,3]
C0597418
If yes, specify date of stool collection 6-8 days after study vaccination
Description

Date of Stool sample 6-8 days after vaccination

Data type

date

Alias
UMLS CUI [1,1]
C1550661
UMLS CUI [1,2]
C0231290
UMLS CUI [1,3]
C0597418
UMLS CUI [1,4]
C1302413
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Similar models

Planned stool samples

1 forms
  1. StudyEvent: ODM
    1. Planned stool samples
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])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Visit number
text
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
Visit 3 (Vaccination 1) (3)
(Comment:en)
CL Item
Visit 5 (Vaccination 2) (5)
(Comment:en)
Item Group
Laboratory tests: Planned stool samples (only for a subset of subjects)
C0022885 (UMLS CUI-1)
C1550661 (UMLS CUI-2)
C1301732 (UMLS CUI-3)
Item
Was a stool sample collected for the stool subset at day of or 1 day prior to study vaccination?
text
C1550661 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0597418 (UMLS CUI [1,3])
Stool sample <= 1 day from vaccination
Code List
Was a stool sample collected for the stool subset at day of or 1 day prior to study vaccination?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
NA (NA)
Date of Stool sample prior to vaccination
Item
If yes, specify date of stool collection prior to study vaccination
date
C1550661 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0597418 (UMLS CUI [1,3])
C1302413 (UMLS CUI [1,4])
Item
Was a stool sample collected for the stool subset at day 4 +/- 1 after study vaccination?
text
C1550661 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
C0597418 (UMLS CUI [1,3])
Stool sample <= 1 day from vaccination
Code List
Was a stool sample collected for the stool subset at day 4 +/- 1 after study vaccination?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
NA (NA)
Date of Stool sample 3-5 days after vaccination
Item
If yes, specify date of stool collection 3-5 days after study vaccination
date
C1550661 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
C0597418 (UMLS CUI [1,3])
C1302413 (UMLS CUI [1,4])
Item
Was a stool sample collected for the stool subset at day 7 +/- 1 after study vaccination?
text
C1550661 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
C0597418 (UMLS CUI [1,3])
Stool sample <= 1 day from vaccination
Code List
Was a stool sample collected for the stool subset at day 7 +/- 1 after study vaccination?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
NA (NA)
Date of Stool sample 6-8 days after vaccination
Item
If yes, specify date of stool collection 6-8 days after study vaccination
date
C1550661 (UMLS CUI [1,1])
C0231290 (UMLS CUI [1,2])
C0597418 (UMLS CUI [1,3])
C1302413 (UMLS CUI [1,4])
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