ID

32446

Descrizione

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 Eligibility criteria for study. To be checked at first visit

collegamento

https://clinicaltrials.gov/ct2/show/NCT00241644

Keywords

versioni (1)
  1. 01/11/18 01/11/18 -
Titolare del copyright

GlaxoSmithKline

Caricato su

1 novembre 2018

DOI

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Licenza

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

Inglese

Eligibility Criteria

1 moduli  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative Data
Descrizione

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Descrizione

Date of visit

Tipo di dati

date

Alias
UMLS CUI [1]
C1320303
Subject number
Descrizione

Subject number

Tipo di dati

integer

Alias
UMLS CUI [1]
C2348585
Eligibility Check
Descrizione

Eligibility Check

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

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.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
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.
Descrizione

Parents Protocol Compliance

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0030551
A male or female child between, and including, 5 and 10 weeks of age at the time of the first study vaccination.
Descrizione

Gender, Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C0021270
Written informed consent obtained from the parent or guardian of the subject
Descrizione

Informed Consent Guardian or parents

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1274041
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030551
Healthy subjects as established by medical history and clinical examination before entering into the study.
Descrizione

Subject Healthy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
Birth weight > 2000 g.
Descrizione

Birth weight

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0005612
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
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.
Descrizione

Use of investigational drug or vaccine

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0042210
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C1521826
UMLS CUI [3,3]
C0042210
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Descrizione

Concurrently participating in another clinical study with exposure to investigational drug

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0013227
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.
Descrizione

Planned administration of other vaccine

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0205394
Chronic administration (defined as more than 14 days) of immunosuppressants since birth. (Topical steroids are allowed.)
Descrizione

Chronic administration of immunosuppressants except topical steroids

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C1515119
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C0038317
UMLS CUI [2,3]
C1522168
History of use of experimental rotavirus vaccine.
Descrizione

History of use of experimental rotavirus vaccine

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1517586
UMLS CUI [1,3]
C0597418
Previous routine vaccination except BCG, HBV and OPV vaccination at birth (should be documented in the eCRF).
Descrizione

Previous routine vaccination except BCG, HBV and OPV

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C0004886
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C0474232
UMLS CUI [4,1]
C0332300
UMLS CUI [4,2]
C0032375
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
Descrizione

History of gastrointestinal disease

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C0017189
UMLS CUI [2,2]
C0000768
UMLS CUI [3]
C0021933
UMLS CUI [4,1]
C0009488
UMLS CUI [4,2]
C0205082
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
Descrizione

Immunodeficient condition based on medical history or physical examination

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C4048329
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C4048329
UMLS CUI [2,2]
C0031809
History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
Descrizione

History of allergic disease

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2106654
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
Acute disease at the time of enrolment.
Descrizione

(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).) (warrants deferral of vaccination).

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0001314
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0001314
UMLS CUI [2,2]
C0205082
Gastroenteritis within 7 days preceding the first study vaccine administration (warrants deferral of the vaccination).
Descrizione

Recent Gastroenteritis

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0017160
UMLS CUI [1,2]
C0332185
Previous confirmed occurrence of RV GE.
Descrizione

Recent Rotavirus Gastroenteritis

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0035870
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0017160
A family history of congenital or hereditary immunodeficiency.
Descrizione

Family history of congenital or hereditary immunodeficiency

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0853602
UMLS CUI [2,1]
C0241889
UMLS CUI [2,2]
C0021051
UMLS CUI [2,3]
C0439660
Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
Descrizione

History of or planned administration of immunoglobulins or blood products

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0021027
UMLS CUI [2,1]
C1301732
UMLS CUI [2,2]
C0021027
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0456388
UMLS CUI [4,1]
C1301732
UMLS CUI [4,2]
C0456388
History of any neurologic disorders or seizures.
Descrizione

History of neurologic disorders or seizures

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0027765
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0036572
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Descrizione

pulmonary, cardiovascular, hepatic or renal dysfunction

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C3279454
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0024115
UMLS CUI [5]
C0031809
UMLS CUI [6]
C0587081
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Similar models

Eligibility Criteria

1 moduli
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Eligibility Check
C0013893 (UMLS CUI-1)
Subject met all entry criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
C1512693 (UMLS CUI-1)
Parents Protocol Compliance
Item
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.
boolean
C0525058 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
Gender, Age
Item
A male or female child between, and including, 5 and 10 weeks of age at the time of the first study vaccination.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C0021270 (UMLS CUI [2,2])
Informed Consent Guardian or parents
Item
Written informed consent obtained from the parent or guardian of the subject
boolean
C0021430 (UMLS CUI [1,1])
C1274041 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
Subject Healthy
Item
Healthy subjects as established by medical history and clinical examination before entering into the study.
boolean
C3898900 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
Birth weight
Item
Birth weight > 2000 g.
boolean
C0005612 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI-1)
Use of investigational drug or vaccine
Item
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.
boolean
C0013230 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C0332300 (UMLS CUI [3,1])
C1521826 (UMLS CUI [3,2])
C0042210 (UMLS CUI [3,3])
Concurrently participating in another clinical study with exposure to investigational drug
Item
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
Planned administration of other vaccine
Item
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.
boolean
C2368628 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Chronic administration of immunosuppressants except topical steroids
Item
Chronic administration (defined as more than 14 days) of immunosuppressants since birth. (Topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C0332300 (UMLS CUI [2,1])
C0038317 (UMLS CUI [2,2])
C1522168 (UMLS CUI [2,3])
History of use of experimental rotavirus vaccine
Item
History of use of experimental rotavirus vaccine.
boolean
C0262926 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C0597418 (UMLS CUI [1,3])
Previous routine vaccination except BCG, HBV and OPV
Item
Previous routine vaccination except BCG, HBV and OPV vaccination at birth (should be documented in the eCRF).
boolean
C0042210 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0332300 (UMLS CUI [2,1])
C0004886 (UMLS CUI [2,2])
C0332300 (UMLS CUI [3,1])
C0474232 (UMLS CUI [3,2])
C0332300 (UMLS CUI [4,1])
C0032375 (UMLS CUI [4,2])
History of gastrointestinal disease
Item
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
boolean
C0017178 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0017189 (UMLS CUI [2,1])
C0000768 (UMLS CUI [2,2])
C0021933 (UMLS CUI [3])
C0009488 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Immunodeficient condition based on medical history or physical examination
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
boolean
C4048329 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C4048329 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
History of allergic disease
Item
History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
boolean
C2106654 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Acute disease moderate or severe
Item
Acute disease at the time of enrolment.
boolean
C0001314 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0001314 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Recent Gastroenteritis
Item
Gastroenteritis within 7 days preceding the first study vaccine administration (warrants deferral of the vaccination).
boolean
C0017160 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Recent Rotavirus Gastroenteritis
Item
Previous confirmed occurrence of RV GE.
boolean
C0262926 (UMLS CUI [1,1])
C0035870 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0017160 (UMLS CUI [2,2])
Family history of congenital or hereditary immunodeficiency
Item
A family history of congenital or hereditary immunodeficiency.
boolean
C0241889 (UMLS CUI [1,1])
C0853602 (UMLS CUI [1,2])
C0241889 (UMLS CUI [2,1])
C0021051 (UMLS CUI [2,2])
C0439660 (UMLS CUI [2,3])
History of or planned administration of immunoglobulins or blood products
Item
Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
boolean
C0262926 (UMLS CUI [1,1])
C0021027 (UMLS CUI [1,2])
C1301732 (UMLS CUI [2,1])
C0021027 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C0456388 (UMLS CUI [3,2])
C1301732 (UMLS CUI [4,1])
C0456388 (UMLS CUI [4,2])
History of neurologic disorders or seizures
Item
History of any neurologic disorders or seizures.
boolean
C0262926 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0036572 (UMLS CUI [2,2])
pulmonary, cardiovascular, hepatic or renal dysfunction
Item
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
boolean
C0086565 (UMLS CUI [1])
C3279454 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0031809 (UMLS CUI [5])
C0587081 (UMLS CUI [6])
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