ID

32630

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 asks, if and when routine vaccine administrations have taken place and should be checked at visits 1-3.

Link

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

Palabras clave

Versiones (2)
  1. 1/11/18 1/11/18 -
  2. 9/11/18 9/11/18 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

9 de noviembre de 2018

DOI

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Licencia

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

Inglés

Routine Vaccine Administration

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit number
Descripción

Visit number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1549755
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
Routine Vaccine Administrations
Descripción

Routine Vaccine Administrations

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0205547
OPV Vaccination
Descripción

If Yes is ticked, the above vaccines are not to be reported again in the Concomitant Vaccination section at the end of the CRF. Any other vaccines administered during the study period are to be recorded in the Concomitant Vaccination section at the end of the CRF.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032375
OPV Vaccination administration date if different from visit date:
Descripción

OPV Vaccination Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0032375
UMLS CUI [1,2]
C0011008
DTPw-HB/Hib vaccination
Descripción

If Yes is ticked, the above vaccines are not to be reported again in the Concomitant Vaccination section at the end of the CRF. Any other vaccines administered during the study period are to be recorded in the Concomitant Vaccination section at the end of the CRF.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2240392
UMLS CUI [1,2]
C3653328
UMLS CUI [1,3]
C0012559
DTPw-HB/Hib vaccination administration date if different from visit date:
Descripción

DTPw-HB/Hib vaccination Date

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2240392
UMLS CUI [1,2]
C3653328
UMLS CUI [1,3]
C0012559
UMLS CUI [1,4]
C1115436
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Similar models

Routine Vaccine Administration

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1320722 (UMLS CUI-1)
Item
Visit number
integer
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
Visit 1 (1)
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Routine Vaccine Administrations
C2368628 (UMLS CUI-1)
C0205547 (UMLS CUI-2)
OPV Vaccination
Item
OPV Vaccination
boolean
C0032375 (UMLS CUI [1])
OPV Vaccination Date
Item
OPV Vaccination administration date if different from visit date:
date
C0032375 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
DTPw-HB/Hib vaccination
Item
DTPw-HB/Hib vaccination
boolean
C2240392 (UMLS CUI [1,1])
C3653328 (UMLS CUI [1,2])
C0012559 (UMLS CUI [1,3])
DTPw-HB/Hib vaccination Date
Item
DTPw-HB/Hib vaccination administration date if different from visit date:
text
C2240392 (UMLS CUI [1,1])
C3653328 (UMLS CUI [1,2])
C0012559 (UMLS CUI [1,3])
C1115436 (UMLS CUI [1,4])
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