ID

32454

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 the confirmation testing of the subject for HIV. It should be checked at Visit 4 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

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License

Creative Commons BY-NC 3.0
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Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644

English

HIV Confirmation Testing

1 forms  
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 Confirmatory Test
Description

HIV Confirmatory Test

Alias
UMLS CUI-1
C1321876
Was a blood sample taken for the confirmatory HIV testing ?
Description

Blood Sample for HIV Testing

Data type

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1321876
Blood sample date
Description

If blood sample was taken

Data type

date

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

PCR testing result

Data type

integer

Alias
UMLS CUI [1,1]
C0032520
UMLS CUI [1,2]
C1274040
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Similar models

HIV Confirmation Testing

1 forms
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 Confirmatory Test
C1321876 (UMLS CUI-1)
Item
Was a blood sample taken for the confirmatory HIV testing ?
integer
C0005834 (UMLS CUI [1,1])
C1321876 (UMLS CUI [1,2])
Blood Sample for HIV Testing
Code List
Was a blood sample taken for the confirmatory HIV testing ?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Blood sample date
Item
Blood sample date
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
PCR testing result
integer
C0032520 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
PCR testing result
Code List
PCR testing result
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Unknown (3)
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