ID

32449

Description

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

Keywords

Versions (1)
  1. 11/1/18 11/1/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 1, 2018

DOI

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License

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

English

Concomitant Vaccination

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Concomitant Vaccination
Description

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)?
Description

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

Data type

boolean

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

Vaccination Data

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

Trade/Name of Vaccination

Data type

text

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

Vaccination Route

Data type

text

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

Vaccine Administration Date

Data type

date

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

Comment for GSK

Data type

text

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

Concomitant Vaccination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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