ID

32437

Descrição

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 a blood sample has been taken from the patient and should be checked at visit 1.

Link

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

Palavras-chave

Versões (1)
  1. 01/11/2018 01/11/2018 -
Titular dos direitos

GlaxoSmithKline

Transferido a

1 de novembro de 2018

DOI

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Licença

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

Inglês

Laboratory Tests Visit 1

1 Formulários  
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Descrição

Date of visit

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Subject number
Descrição

Subject number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Laboratory Tests
Descrição

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken?
Descrição

2 ml in South Africa and 1 ml in Malawi for subset only (Amendment 4)

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005834
Date of Blood Sample
Descrição

Please complete only if different from visit date:

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Medical History for HIV
Descrição

Medical History for HIV

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0019682
Has the subject been exposed to HIV?
Descrição

Subject exposed to HIV

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0332157
Was a HIV test performed at Visit 1?
Descrição

If yes, complete the specific HIV section.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1321876
UMLS CUI [1,2]
C0262926
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Similar models

Laboratory Tests Visit 1

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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
Laboratory Tests
C0022885 (UMLS CUI-1)
Blood Sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Blood Sample Date
Item
Date of Blood Sample
text
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Medical History for HIV
C0262926 (UMLS CUI-1)
C0019682 (UMLS CUI-2)
Subject exposed to HIV
Item
Has the subject been exposed to HIV?
boolean
C0019682 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
HIV Test
Item
Was a HIV test performed at Visit 1?
boolean
C1321876 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
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