ID

32436

Description

Study ID: 102248 Clinical Study ID: 102248 Study Title: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00241644 Study Link: https://clinicaltrials.gov/ct2/show/NCT00241644 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Infections, Rotavirus The visits are defined as follows: Visit 1: (Study/Participation) Day 0, Age: 5-10 weeks, Dose 1 Visit 2: (Study/Participation) Month 1, 30-48 days after Visit 1, Dose 2 Visit 3: (Study/Participation) Month 2, 30-48 days after Visit 2, Dose 3 Visit 4: (Study/Participation) Month 3, 30-48 days after Visit 3, Visit 5: (Study/Participation) 1 year of age, 343-391 days of age For amendment 5: Visit 5: (Study/Participation) 21-48 days after Visit 4 Visit 6: (Study/Participation) 1 year of age, 343-391 days of age This form contains information about testing the subject for HIV. It should be checked at Visit 3 and is part of study amendment 1.

Link

https://clinicaltrials.gov/ct2/show/NCT00241644

Keywords

Versions (1)
  1. 11/1/18 11/1/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 1, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644

English

HIV Testing

1 forms  
  1. StudyEvent: ODM
    1. HIV Testing
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
HIV Testing
Description

HIV Testing

Alias
UMLS CUI-1
C1321876
Has the subject been exposed to HIV?
Description

Medical History for HIV exposure

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0019682
UMLS CUI [1,3]
C0332157
Has the Informed Consent Addendum for HIV testing been signed at visit 3 or previously due to hospitalization or symptoms indicative of AIDS ?
Description

Informed Consent Addendum for HIV Testing

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0459958
Informed Consent Date
Description

If the subject has previously signed informed consent

Data type

date

Alias
UMLS CUI [1]
C2985782
Was a blood sample taken for the HIV testing at visit 3 or previously due to hospitalization or symptoms indicative of AIDS ?
Description

If bloodsample had been taken

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Blood sample date
Description

If bloodsample had been taken

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Elisa testing result
Description

If bloodsample had been taken

Data type

text

Alias
UMLS CUI [1]
C0014441
PCR testing result
Description

Subjects testet positive need a confirmatory test at visit 4, if HIV asymptomatic up to visit 4.

Data type

text

Alias
UMLS CUI [1,1]
C0032520
UMLS CUI [1,2]
C1274040
Back to the top of the page

Similar models

HIV Testing

1 forms
  1. StudyEvent: ODM
    1. HIV Testing
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
HIV Testing
C1321876 (UMLS CUI-1)
Item
Has the subject been exposed to HIV?
text
C0262926 (UMLS CUI [1,1])
C0019682 (UMLS CUI [1,2])
C0332157 (UMLS CUI [1,3])
Medical History for HIV
Code List
Has the subject been exposed to HIV?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Unknown (Unknown)
Informed Consent Addendum for HIV Testing
Item
Has the Informed Consent Addendum for HIV testing been signed at visit 3 or previously due to hospitalization or symptoms indicative of AIDS ?
boolean
C0021430 (UMLS CUI [1,1])
C0459958 (UMLS CUI [1,2])
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Blood Sample for HIV Testing
Item
Was a blood sample taken for the HIV testing at visit 3 or previously due to hospitalization or symptoms indicative of AIDS ?
boolean
C0005834 (UMLS CUI [1])
Blood sample date
Item
Blood sample date
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Elisa testing result
text
C0014441 (UMLS CUI [1])
Elisa testing result
Code List
Elisa testing result
CL Item
Negative (Negative)
CL Item
Positive (Positive)
CL Item
Unknown (Unknown)
CL Item
Not applicable (subjects exposed to HIV) (Not applicable (subjects exposed to HIV))
Item
PCR testing result
text
C0032520 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
PCR testing result
Code List
PCR testing result
CL Item
Negative (Negative)
CL Item
Positive (Positive)
CL Item
Unknown (Unknown)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial