ID

32449

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 for concomitant vaccinations of the subject. It should be filled out at Visit 1 and re-checked at each subsequent visit.

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

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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

Concomitant Vaccination

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Concomitant Vaccination
Descripción

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Has any vaccine other than the study vaccine(s) been administered since birth (except OPV and DTPw- HB/Hib given at visit 1,2 and 3)?
Descripción

If yes, please record concomitant vaccination with trade name and / or generic name, route and vaccine administration date.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0262926
Vaccination Data
Descripción

Vaccination Data

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0680532
Trade/Name of Vaccination
Descripción

Trade/Name of Vaccination

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0042210
Vaccination Route
Descripción

Vaccination Route

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Vaccine Administration Date
Descripción

Vaccine Administration Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2368628
Comment for GSK
Descripción

Comment for GSK

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0008961
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Similar models

Concomitant Vaccination

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Vaccine administered since birth
Item
Has any vaccine other than the study vaccine(s) been administered since birth (except OPV and DTPw- HB/Hib given at visit 1,2 and 3)?
boolean
C2368628 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Item Group
Vaccination Data
C0042196 (UMLS CUI-1)
C0680532 (UMLS CUI-2)
Trade/Name of Vaccination
Item
Trade/Name of Vaccination
text
C0027365 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Item
Vaccination Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Vaccination Route
Code List
Vaccination Route
CL Item
Intradermal  (ID)
CL Item
Parenteral (PE)
CL Item
Inhalation  (IH)
CL Item
Oral (PO)
CL Item
Intramuscular  (IM)
CL Item
Subcutaneous (SC)
CL Item
Intravenous  (IV)
CL Item
Sublingual (SL)
CL Item
Intranasal  (NA)
CL Item
Transdermal (TD)
CL Item
Other  (OTH)
CL Item
Unknown (UNK)
Vaccine Administration Date
Item
Vaccine Administration Date
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Comment for GSK
Item
Comment for GSK
text
C0947611 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
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