Informações:
Falhas:
ID
29490
Descrição
A multicenter study of the immunogenicity & safety of 2 doses of GSK Biologicals’oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants in India aged approximately 8 wks at the time of the first dose Study ID:103792 Clinical Study ID:103792 Study Title: A multicenter study of the immunogenicity & safety of 2 doses of GSK Biologicals’oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants in India aged approximately 8 wks at the time of the first dose Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:NCT00289172 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: BIO ROTA; Rotarix Study Indication: Infections, Rotavirus CRF Seiten: 375-430
Palavras-chave
Versões (2)
- 24/03/2018 24/03/2018 -
- 04/04/2018 04/04/2018 -
Titular dos direitos
GlaxoSmithKline
Transferido a
4 de abril de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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Rotavirus Vaccine RIX4414 Study NCT00289172
Similar models
Visit 1
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Subject No.
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Center number
Item
Center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (M)
(Comment:en)
CL Item
Female (F)
(Comment:en)
CL Item
Indian (93)
CL Item
Other (99)
Race: Specification
Item
If other race, please specify
text
C0034510 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Eligibility Check
Item
Did the subject meet all the entry criteria ? 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.
boolean
C0013893 (UMLS CUI [1])
Compliance
Item
Only subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
boolean
C1321605 (UMLS CUI [1])
age
Item
A male or female between, and including, 8 and 10 weeks of age at the time of the first vaccination.
boolean
C0001779 (UMLS CUI [1])
Written consent of guardian
Item
Written informed consent obtained from the parent or guardian of the subject.
boolean
C0021430 (UMLS CUI [1,1])
C0023226 (UMLS CUI [1,2])
C0023226 (UMLS CUI [1,2])
medical history
Item
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
C0262926 (UMLS CUI [1])
dtp opv hep b vacicnation
Item
The subjects should have been administered the first dose of DTP/ OPV/ hepatitis B vaccines as per the local universal immunization program (UIP) at 6 weeks of age.
boolean
C0012559 (UMLS CUI [1])
C0032375 (UMLS CUI [2])
C0474232 (UMLS CUI [3])
C0032375 (UMLS CUI [2])
C0474232 (UMLS CUI [3])
experimental drug
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine or the routine UIP vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
boolean
C0304229 (UMLS CUI [1])
immune modifying drugs
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1])
C0205191 (UMLS CUI [2,1])
C0005525 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,1])
C0005525 (UMLS CUI [2,2])
chronic drug therapy
Item
Any chronic drug therapy to be continued during the study period.
boolean
C0013216 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,2])
vaccination
Item
Administration of a vaccine not foreseen by the study protocol within 6 weeks of the first dose of vaccine or planned administration during the study of a vaccine not foreseen by the study protocol, with the exception of diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib), OPV and vaccination against tuberculosis, which can be given with at least two weeks separation from the first and subsequent dose of the study vaccine.
boolean
C0042196 (UMLS CUI [1])
rotavirus gastroenteritis
Item
History of confirmed rotavirus gastroenteritis.
boolean
C0035870 (UMLS CUI [1])
C0017160 (UMLS CUI [2])
C0017160 (UMLS CUI [2])
concomitant rotavirus vaccination
Item
Prior administration of experimental rotavirus vaccine.
boolean
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0035870 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0035870 (UMLS CUI [1,3])
medical history of gi tract disease | gi tract malformation
Item
Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
boolean
C0017178 (UMLS CUI [1])
C0017189 (UMLS CUI [2,1])
C0302142 (UMLS CUI [2,2])
C0000768 (UMLS CUI [2,3])
C0017189 (UMLS CUI [2,1])
C0302142 (UMLS CUI [2,2])
C0000768 (UMLS CUI [2,3])
immunosuppressive condition
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection based on physical examination (no laboratory testing is required).
boolean
C0021051 (UMLS CUI [1])
family history | congenital immunodeficiency
Item
A family history of congenital or hereditary immunodeficiency
boolean
C0853602 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0021051 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
C0241889 (UMLS CUI [1,2])
C0021051 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
medical history allergies
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0262926 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,2])
Major congenital defects | serious chronic disease
Item
Major congenital defects or serious chronic illness.
boolean
C0000768 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Seizures | nervous system disorder
Item
history of seizures or any neurologic disorders.
boolean
C0036572 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
C0027765 (UMLS CUI [2])
Acute disease
Item
Acute disease at the time of enrolment.
boolean
C0001314 (UMLS CUI [1])
gastroenteritis
Item
Gastroenteritis (diarrhea) within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
boolean
C0017160 (UMLS CUI [1])
comorbidity
Item
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or medical history.
boolean
C0009488 (UMLS CUI [1])
Immunoglobulins | Blood product
Item
administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
C0456388 (UMLS CUI [2])
Item Group
Randomisation/ Treatment Allocation
C0034656 (UMLS CUI-1)
Treatment Number
Item
Record treatment number
integer
C1522541 (UMLS CUI [1])
Item Group
General Medical History / Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C0031809 (UMLS CUI-2)
Medical History
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
boolean
C0262926 (UMLS CUI [1])
Item Group
General medical history / physical examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C0031809 (UMLS CUI-2)
Item
Diagnosis body systems
integer
C0682591 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
CL Item
Cutaneous (1)
CL Item
Eyes (2)
CL Item
Ears-nose-throat (3)
CL Item
Cardiovascular (4)
CL Item
Respiratory (5)
CL Item
Gastrointestinal (6)
CL Item
Muskuloskeletal (7)
CL Item
Neurological (8)
CL Item
Genitourinary (9)
CL Item
Haematology (10)
CL Item
Allergies (11)
CL Item
Endocrine (12)
CL Item
Other (specify) (13)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Past or current diagnosis
integer
C0011900 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
C1444637 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2,1])
C0521116 (UMLS CUI [2,2])
CL Item
past (1)
CL Item
current (2)
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Date blood sample taken
Item
Date blood sample taken
boolean
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Breast Milk (1)
CL Item
Infant Formula (2)
CL Item
Both (3)
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1])
CL Item
Study Vaccine (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (N)
Replacement vial
Item
Replacement vial
text
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Wrong vial number
Item
Wrong vial number
text
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
Comments on vaccine administration
Item
Comments (on vaccine administration)
text
C2368628 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
Date of vaccination
Item
Date of vaccination
date
C4301990 (UMLS CUI [1])
Item
Why was the vaccine not administered?
text
C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
CL Item
Other, please specify (e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...) (OTH)
Number of serious adverse event
Item
SAE No
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
number of unsolicited adverse event
Item
Please specify unsolicited AE No
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
specify other reason
Item
Please specify 'other' most appropriate category for non administration.
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
Item
Regurgitation with in 30 minutes after HRV vaccine or placebo?
text
C0175795 (UMLS CUI [1,1])
C2004489 (UMLS CUI [1,2])
C2004489 (UMLS CUI [1,2])
Code List
Regurgitation with in 30 minutes after HRV vaccine or placebo?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not administered only (NA)
Item
Please tick who took decision:
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
Item Group
Unsolicited Adverse Events
C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0042196 (UMLS CUI-2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
text
C0877248 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
C0042196 (UMLS CUI [2])
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
CL Item
Information not available (U)
CL Item
No vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, Fill in the Non-Serious Adverse Event section or Serious Adverse Event report as necessary. (Y)