ID

32436

Descripción

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

Palabras clave

Versiones (1)
  1. 1/11/18 1/11/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

1 de noviembre de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

HIV Testing

1 formularios  
  1. StudyEvent: ODM
    1. HIV Testing
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Descripción

Date of visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
HIV Testing
Descripción

HIV Testing

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

Medical History for HIV exposure

Tipo de datos

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 ?
Descripción

Informed Consent Addendum for HIV Testing

Tipo de datos

boolean

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

If the subject has previously signed informed consent

Tipo de datos

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 ?
Descripción

If bloodsample had been taken

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005834
Blood sample date
Descripción

If bloodsample had been taken

Tipo de datos

date

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

If bloodsample had been taken

Tipo de datos

text

Alias
UMLS CUI [1]
C0014441
PCR testing result
Descripción

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

Tipo de datos

text

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

HIV Testing

1 formularios
  1. StudyEvent: ODM
    1. HIV Testing
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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)
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