ID

32072

Description

Study ID: 103992 Clinical Study ID: 103992 Study Title: Evaluate immunogenicity, reactogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated HRV vaccine (RIX4414 at 106.5 CCID50) when given concomitantly with OPV versus given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00139334 https://clinicaltrials.gov/ct2/show/NCT00139334?term=NCT00139334&rank=1 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis This form contains the trial's Eligibility Criteria. To be filled in at visit 1, prior to any study procedures. Timing: Day 0 Age: 6 weeks +/- 1 day

Link

https://clinicaltrials.gov/ct2/show/NCT00139334?term=NCT00139334&rank=1

Keywords

  1. 10/16/18 10/16/18 - Sarah Riepenhausen
  2. 10/16/18 10/16/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

October 16, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

GSK Biologicals' oral HRV vaccine given with OPV in infants NCT00139334

Eligibility Criteria

  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Eligibility Check
Description

Eligibility Check

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Description

If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.

Data type

boolean

Alias
UMLS CUI [1]
C1302261
Inclusion criteria
Description

Inclusion criteria

Alias
UMLS CUI-1
C1512693
Compliance of parents
Description

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study. (1)

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0030551
Specific age
Description

A male or female between, and including, 6 weeks +/- 1 week of age at the tiem of Visit 1. (2)

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Written Informed Consent
Description

Written informed consent obtained from the parent or guardian of the subject. (3)

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Health problems
Description

Free of obvious health problems as established by medical history and clinical examination before entering into the study. (4)

Data type

boolean

Alias
UMLS CUI [1]
C1446390
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Investigational drug/vaccine
Description

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. (5)

Data type

boolean

Alias
UMLS CUI [1]
C0013230
Vaccination 14 days before or after study vaccination
Description

Planned administration of a vaccine not foreseen by the study protocol within 14 days before each dose of study vaccine(s) and ending 14 days after. (6)

Data type

boolean

Alias
UMLS CUI [1]
C0042196
Concomitant major immunosuppressants
Description

Chronic administration (defined as more than 14 days) of major immunosuppressants (equivalent to prednisone 1mg/kg/day) since birth. (Topical steroids are allowed.) (7)

Data type

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C2347852
Malnutrition, weight for age Z-score
Description

Malnutrition (< 3Z score weight for age). (8)

Data type

boolean

Alias
UMLS CUI [1]
C0162429
Polio
Description

History of/or intercurrent polio disease. (9)

Data type

boolean

Alias
UMLS CUI [1]
C0032371
Confirmed RV GE
Description

Previous confirmed occurrence of RV GE. (10)

Data type

boolean

Alias
UMLS CUI [1,1]
C0017160
UMLS CUI [1,2]
C0035870
Experimental RV vaccine
Description

History of use of experimental RV vaccine. (11)

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0597418
Previous vaccinations
Description

Previous routine vaccination except BCG, HBV and OPV vaccination at birth (should be documented in the CRF). (12)

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0679831
Chronic gastrointestinal disease including uncorrected congenital malformation of the gastrointestinal tract, intussusception or other serious medical condition
Description

Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator. (13)

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2,1]
C4023588
UMLS CUI [2,2]
C4072785
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0205404
Immunosuppressive or immunodeficient condition, including HIV infection
Description

Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. (14)

Data type

boolean

Alias
UMLS CUI [1]
C3829792
UMLS CUI [2]
C4048329
UMLS CUI [3]
C0019693
Allergic disease/reaction, likely exacerbated by study vaccine
Description

History of allergic disease or reaction likely to be exacerbated by any component of the vaccine. (15)

Data type

boolean

Alias
UMLS CUI [1]
C2106654
Acute disease, moderate or severe
Description

Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as mild upper respiratory infection with or without low- grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F) / Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F).) (16)

Data type

boolean

Alias
UMLS CUI [1]
C0001314
family history of congenital or hereditary immunodeficiency
Description

A family history of congenital or hereditary immunodeficiency. (17)

Data type

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0853602
UMLS CUI [2,1]
C0241889
UMLS CUI [2,2]
C0439660
UMLS CUI [2,3]
C0021051
Administration of immunoglobulins and/or blood products
Description

Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. (18)

Data type

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
Neurologic disorders or seizures
Description

History of any neurologic disorders or seizures. (19)

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0036572
pulmonary, cardiovascular, hepatic or renal functional abnormality
Description

Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. (20)

Data type

boolean

Alias
UMLS CUI [1]
C0231921
UMLS CUI [2]
C0678859
UMLS CUI [3]
C0232804
UMLS CUI [4]
C0232741

Similar models

Eligibility Criteria

  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Eligibility Check
C0013893 (UMLS CUI-1)
Eligibility Check
Item
Did the subject meet all the entry criteria?
boolean
C1302261 (UMLS CUI [1])
Item Group
Inclusion criteria
C1512693 (UMLS CUI-1)
Compliance of parents
Item
Compliance of parents
boolean
C1321605 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
Specific age
Item
Specific age
boolean
C0001779 (UMLS CUI [1])
Written Informed Consent
Item
Written Informed Consent
boolean
C0021430 (UMLS CUI [1])
Health problems
Item
Health problems
boolean
C1446390 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Investigational drug/vaccine
Item
Investigational drug/vaccine
boolean
C0013230 (UMLS CUI [1])
Vaccination 14 days before or after study vaccination
Item
Vaccination 14 days before or after study vaccination
boolean
C0042196 (UMLS CUI [1])
Concomitant major immunosuppressants
Item
Concomitant major immunosuppressants
boolean
C0021081 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Malnutrition, weight for age z-score
Item
Malnutrition, weight for age Z-score
boolean
C0162429 (UMLS CUI [1])
Polio
Item
Polio
boolean
C0032371 (UMLS CUI [1])
Confirmed RV GE
Item
Confirmed RV GE
boolean
C0017160 (UMLS CUI [1,1])
C0035870 (UMLS CUI [1,2])
Experimental RV vaccine
Item
Experimental RV vaccine
boolean
C0304229 (UMLS CUI [1,1])
C0597418 (UMLS CUI [1,2])
Previous vaccinations
Item
Previous vaccinations
boolean
C0042196 (UMLS CUI [1,1])
C0679831 (UMLS CUI [1,2])
Chronic gastrointestinal disease including uncorrected congenital malformation of the gastrointestinal tract, intussusception or other serious medical condition
Item
Chronic gastrointestinal disease including uncorrected congenital malformation of the gastrointestinal tract, intussusception or other serious medical condition
boolean
C0017178 (UMLS CUI [1])
C4023588 (UMLS CUI [2,1])
C4072785 (UMLS CUI [2,2])
C3843040 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
Immunosuppressive or immunodeficient condition, including HIV infection
Item
Immunosuppressive or immunodeficient condition, including HIV infection
boolean
C3829792 (UMLS CUI [1])
C4048329 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Allergic disease/reaction, likely exacerbated by study vaccine
Item
Allergic disease/reaction, likely exacerbated by study vaccine
boolean
C2106654 (UMLS CUI [1])
Acute disease, moderate or severe
Item
Acute disease, moderate or severe
boolean
C0001314 (UMLS CUI [1])
family history of congenital or hereditary immunodeficiency
Item
family history of congenital or hereditary immunodeficiency
boolean
C0241889 (UMLS CUI [1,1])
C0853602 (UMLS CUI [1,2])
C0241889 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
C0021051 (UMLS CUI [2,3])
Administration of immunoglobulins and/or blood products
Item
Administration of immunoglobulins and/or blood products
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
Neurologic disorders or seizures
Item
Neurologic disorders or seizures
boolean
C0027765 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
pulmonary, cardiovascular, hepatic or renal functional abnormality
Item
pulmonary, cardiovascular, hepatic or renal functional abnormality
boolean
C0231921 (UMLS CUI [1])
C0678859 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C0232741 (UMLS CUI [4])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial