ID

32629

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 asks if the patient had any episodes of gastroenteritis between visits. It should be checked on visit 2-5. The HIV-Test itemgroup is part of amendment 4.

Link

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

Keywords

Versions (2)
  1. 11/1/18 11/1/18 -
  2. 11/9/18 11/9/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

November 9, 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

Gastroenteritis Episodes, HIV Testing

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit number
Description

Visit number

Data type

integer

Alias
UMLS CUI [1]
C1549755
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
Gastroenteritis Episodes
Description

Gastroenteritis Episodes

Alias
UMLS CUI-1
C0017160
Did the subject present any gastroenteritis episode between visits?
Description

If yes, please collect a stool sample and fill in the Gastroenteritis episodes section.

Data type

boolean

Alias
UMLS CUI [1]
C0017160
HIV Test
Description

HIV Test

Alias
UMLS CUI-1
C1321876
Was a HIV test performed on the subject since last visit?
Description

HIV testing should be proposed if a child develops symptoms indicative of AIDS (WHO interim stage III or IV) or has to be hospitalized with SAE, and HIV testing has not yet been performed.

Data type

boolean

Alias
UMLS CUI [1]
C1321876
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Similar models

Gastroenteritis Episodes, HIV Testing

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1320722 (UMLS CUI-1)
Item
Visit number
integer
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Gastroenteritis Episodes
C0017160 (UMLS CUI-1)
Gastroenteritis episodes
Item
Did the subject present any gastroenteritis episode between visits?
boolean
C0017160 (UMLS CUI [1])
Item Group
HIV Test
C1321876 (UMLS CUI-1)
HIV Test
Item
Was a HIV test performed on the subject since last visit?
boolean
C1321876 (UMLS CUI [1])
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