ID

32451

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 defines when a subject should be excluded from the study or when a vaccination should be postponed. The form should be checked at each visit subsequent to the first 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

Elimination Criteria

1 forms  
  1. StudyEvent: ODM
    1. Elimination Criteria
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Number
Description

Visit Number

Data type

integer

Alias
UMLS CUI [1]
C1549755
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Elimination Criteria During the Study
Description

Elimination Criteria During the Study

Alias
UMLS CUI-1
C0680251
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
Description

Use of investigational or non-registered product other than study vaccine

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C1521826
UMLS CUI [2,3]
C0042210
Chronic administration (defined as more than 14 days) of immunosuppressants during the study period. (Topical steroids are allowed.)
Description

Chronic administration of immunosuppressants except topic

Data type

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C1522168
UMLS CUI [2,3]
C0038317
Administration of a vaccine not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after.
Description

Administration of other vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0205394
Administration of immunoglobulins and/or any blood products during the study period.
Description

Administration of immunoglobulins or blood products

Data type

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0371802
Contraindication to Subsequent Vaccination
Description

Contraindication to Subsequent Vaccination

Alias
UMLS CUI-1
C1301624
UMLS CUI-2
C0042196
Hypersensitivity reaction due to the vaccine.
Description

Hypersensitivity to vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1521826
UMLS CUI [1,3]
C0042210
IS
Description

Intussusception

Data type

boolean

Alias
UMLS CUI [1]
C0021933
Axillary temperature > 37.5°C or rectal temperature > 38.0°C.
Description

The following AEs constitute contraindications to administration of HRV vaccine or placebo at that point in time; if any one of these AEs occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0489749
UMLS CUI [2]
C1531924
°C
GE within 7 days preceding the study vaccine administration
Description

The following AEs constitute contraindications to administration of HRV vaccine or placebo at that point in time; if any one of these AEs occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE

Data type

boolean

Alias
UMLS CUI [1]
C0017160
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Similar models

Elimination Criteria

1 forms
  1. StudyEvent: ODM
    1. Elimination Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
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)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI-1)
Use of investigational or non-registered product other than study vaccine
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
boolean
C0013230 (UMLS CUI [1])
C0332300 (UMLS CUI [2,1])
C1521826 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
Chronic administration of immunosuppressants except topic
Item
Chronic administration (defined as more than 14 days) of immunosuppressants during the study period. (Topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0332300 (UMLS CUI [2,1])
C1522168 (UMLS CUI [2,2])
C0038317 (UMLS CUI [2,3])
Administration of other vaccine
Item
Administration of a vaccine not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after.
boolean
C2368628 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Administration of immunoglobulins or blood products
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1])
C0371802 (UMLS CUI [2])
Item Group
Contraindication to Subsequent Vaccination
C1301624 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Hypersensitivity to vaccine
Item
Hypersensitivity reaction due to the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C1521826 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Intussusception
Item
IS
boolean
C0021933 (UMLS CUI [1])
Axillary or rectal temperature
Item
Axillary temperature > 37.5°C or rectal temperature > 38.0°C.
float
C0489749 (UMLS CUI [1])
C1531924 (UMLS CUI [2])
Gastroenteritis
Item
GE within 7 days preceding the study vaccine administration
boolean
C0017160 (UMLS CUI [1])
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