ID

32630

Beschreibung

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

Stichworte

Versionen (2)
  1. 01.11.18 01.11.18 -
  2. 09.11.18 09.11.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

9. November 2018

DOI

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

Englisch

Routine Vaccine Administration

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit number
Beschreibung

Visit number

Datentyp

integer

Alias
UMLS CUI [1]
C1549755
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Routine Vaccine Administrations
Beschreibung

Routine Vaccine Administrations

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

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.

Datentyp

boolean

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

OPV Vaccination Date

Datentyp

date

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

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.

Datentyp

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:
Beschreibung

DTPw-HB/Hib vaccination Date

Datentyp

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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Ähnliche Modelle

Routine Vaccine Administration

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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