ID

33970

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 the HIV repeat test, that should be performed at visit 6 and is part of amendment 1

Link

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

Palabras clave

Versiones (3)
  1. 31/10/18 31/10/18 -
  2. 17/11/18 17/11/18 -
  3. 9/1/19 9/1/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

9 de enero de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644

Inglés

HIV Repeat Test

1 formularios  
  1. StudyEvent: ODM
    1. HIV Repeat Test
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 repeat test
Descripción

HIV repeat test

Alias
UMLS CUI-1
C1321876
Was a blood sample taken after breast feeding cessation (subject HIV exposed but PCR negative at visit 3) ?
Descripción

This item is only applicable in visit 6 of amendment 1

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0019682
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0006147
UMLS CUI [3,1]
C0854048
UMLS CUI [3,2]
C0032520
UMLS CUI [3,3]
C1512346
Blood sample date
Descripción

Please fill in only if different from visit date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
HIV Testing Results (PCR)
Descripción

HIV Testing Results (PCR)

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1321876
UMLS CUI [1,2]
C0032520
UMLS CUI [1,3]
C1274040
Volver a la parte superior de la página

Similar models

HIV Repeat Test

1 formularios
  1. StudyEvent: ODM
    1. HIV Repeat Test
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 repeat test
C1321876 (UMLS CUI-1)
Item
Was a blood sample taken after breast feeding cessation (subject HIV exposed but PCR negative at visit 3) ?
integer
C0332157 (UMLS CUI [1,1])
C0019682 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0006147 (UMLS CUI [2,3])
C0854048 (UMLS CUI [3,1])
C0032520 (UMLS CUI [3,2])
C1512346 (UMLS CUI [3,3])
HIV repeat test
Code List
Was a blood sample taken after breast feeding cessation (subject HIV exposed but PCR negative at visit 3) ?
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
HIV Testing Results (PCR)
integer
C1321876 (UMLS CUI [1,1])
C0032520 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
HIV Testing Results (PCR)
Code List
HIV Testing Results (PCR)
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Unknown (3)
CL Item
NA (4)
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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