ID

29490

Beschreibung

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

Stichworte

Versionen (2)
  1. 24.03.18 24.03.18 -
  2. 04.04.18 04.04.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

4. April 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Rotavirus Vaccine RIX4414 Study NCT00289172

Englisch

Visit 1

1 Formulare  
  1. StudyEvent: ODM
    1. Visit 1
Header
Beschreibung

Header

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject No.

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Beschreibung

DD/MON/YY

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Informed consent
Beschreibung

Informed consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Beschreibung

I certify that Informed Consent has been obtained prior to any study procedure.

Datentyp

date

Alias
UMLS CUI [1]
C2985782
Demographics
Beschreibung

Demographics

Alias
UMLS CUI-1
C1704791
Center number
Beschreibung

Center number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beschreibung

Race

Datentyp

text

Alias
UMLS CUI [1]
C0034510
If other race, please specify
Beschreibung

Race: Specification

Datentyp

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C2348235
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Eligibility Check
Beschreibung

Eligibility Check

Alias
UMLS CUI-1
C0013893
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.
Beschreibung

Eligibility Check

Datentyp

boolean

Alias
UMLS CUI [1]
C0013893
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C1516637
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.
Beschreibung

Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
A male or female between, and including, 8 and 10 weeks of age at the time of the first vaccination.
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Written informed consent obtained from the parent or guardian of the subject.
Beschreibung

Written consent of guardian

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0023226
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Beschreibung

medical history

Datentyp

boolean

Alias
UMLS CUI [1]
C0262926
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.
Beschreibung

dtp opv hep b vacicnation

Datentyp

boolean

Alias
UMLS CUI [1]
C0012559
UMLS CUI [2]
C0032375
UMLS CUI [3]
C0474232
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
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.
Beschreibung

experimental drug

Datentyp

boolean

Alias
UMLS CUI [1]
C0304229
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.)
Beschreibung

immune modifying drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2,1]
C0205191
UMLS CUI [2,2]
C0005525
Any chronic drug therapy to be continued during the study period.
Beschreibung

chronic drug therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0205191
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.
Beschreibung

vaccination

Datentyp

boolean

Alias
UMLS CUI [1]
C0042196
History of confirmed rotavirus gastroenteritis.
Beschreibung

rotavirus gastroenteritis

Datentyp

boolean

Alias
UMLS CUI [1]
C0035870
UMLS CUI [2]
C0017160
Prior administration of experimental rotavirus vaccine.
Beschreibung

concomitant rotavirus vaccination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0035870
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.
Beschreibung

medical history of gi tract disease | gi tract malformation

Datentyp

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2,1]
C0017189
UMLS CUI [2,2]
C0302142
UMLS CUI [2,3]
C0000768
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection based on physical examination (no laboratory testing is required).
Beschreibung

immunosuppressive condition

Datentyp

boolean

Alias
UMLS CUI [1]
C0021051
A family history of congenital or hereditary immunodeficiency
Beschreibung

family history | congenital immunodeficiency

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0853602
UMLS CUI [1,2]
C0241889
UMLS CUI [2,1]
C0021051
UMLS CUI [2,2]
C0439660
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Beschreibung

medical history allergies

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0020517
Major congenital defects or serious chronic illness.
Beschreibung

Major congenital defects | serious chronic disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0205404
history of seizures or any neurologic disorders.
Beschreibung

Seizures | nervous system disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2]
C0027765
Acute disease at the time of enrolment.
Beschreibung

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 diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., Oral/ axillary temperature <37.5°C

Datentyp

boolean

Alias
UMLS CUI [1]
C0001314
Gastroenteritis (diarrhea) within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
Beschreibung

gastroenteritis

Datentyp

boolean

Alias
UMLS CUI [1]
C0017160
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or medical history.
Beschreibung

comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Beschreibung

Immunoglobulins | Blood product

Datentyp

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
Randomisation/ Treatment Allocation
Beschreibung

Randomisation/ Treatment Allocation

Alias
UMLS CUI-1
C0034656
Record treatment number
Beschreibung

Treatment Number

Datentyp

integer

Alias
UMLS CUI [1]
C1522541
General Medical History / Physical Examination
Beschreibung

General Medical History / Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
Beschreibung

Medical History

Datentyp

boolean

Alias
UMLS CUI [1]
C0262926
General medical history / physical examination
Beschreibung

General medical history / physical examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Diagnosis body systems
Beschreibung

Diagnosis body systems

Datentyp

integer

Alias
UMLS CUI [1,1]
C0682591
UMLS CUI [1,2]
C0011900
Diagnosis
Beschreibung

Diagnosis

Datentyp

text

Alias
UMLS CUI [1]
C0011900
Past or current diagnosis
Beschreibung

Past or current diagnosis

Datentyp

integer

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C1444637
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C0521116
Laboratory tests
Beschreibung

Laboratory tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken?
Beschreibung

Blood sample

Datentyp

integer

Alias
UMLS CUI [1]
C0005834
Date blood sample taken
Beschreibung

Please complete only if different from visit date

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
Is the child fed with:
Beschreibung

child feeding

Datentyp

text

Alias
UMLS CUI [1]
C0420979
Vaccine administration
Beschreibung

Vaccine administration

Alias
UMLS CUI-1
C2368628
Pre-Vaccination temperature
Beschreibung

Pre-Vaccination temperature

Datentyp

float

Maßeinheiten
  • degree Celsius
Alias
UMLS CUI [1]
C0005903
degree Celsius
Vaccine administration
Beschreibung

Vaccine administration

Datentyp

text

Alias
UMLS CUI [1]
C2368628
Replacement vial
Beschreibung

Replacement vial

Datentyp

text

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0559956
UMLS CUI [1,3]
C0600091
Wrong vial number
Beschreibung

Wrong vial number

Datentyp

text

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C3827420
Comments (on vaccine administration)
Beschreibung

Comments on vaccine administration

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0947611
Date of vaccination
Beschreibung

fill in only if different from visit date

Datentyp

date

Alias
UMLS CUI [1]
C4301990
Why was the vaccine not administered?
Beschreibung

Please tick the ONE most appropriate category for non administration

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0392360
SAE No
Beschreibung

Please specify number of SAE if that is the reason, why vaccine wasn't administered.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Please specify unsolicited AE No
Beschreibung

number of unsolicited adverse event

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449788
Please specify 'other' most appropriate category for non administration.
Beschreibung

e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...

Datentyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1521902
UMLS CUI [1,3]
C2368628
Regurgitation with in 30 minutes after HRV vaccine or placebo?
Beschreibung

regurgitation after oral medication

Datentyp

text

Alias
UMLS CUI [1,1]
C0175795
UMLS CUI [1,2]
C2004489
Please tick who took decision:
Beschreibung

Decision

Datentyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
Unsolicited Adverse Events
Beschreibung

Unsolicited Adverse Events

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0042196
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
Beschreibung

Unsolicited Adverse Events

Datentyp

text

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C0042196
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Ähnliche Modelle

Visit 1

1 Formulare
  1. StudyEvent: ODM
    1. Visit 1
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Subject No.
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Informed consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Center number
Item
Center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
(Comment:en)
CL Item
Female (F)
(Comment:en)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
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])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Eligibility Check
C0013893 (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])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
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])
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])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
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])
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])
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])
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])
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])
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])
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])
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])
Seizures | nervous system disorder
Item
history of seizures or any neurologic disorders.
boolean
C0036572 (UMLS CUI [1])
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])
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)
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)
Item
Diagnosis body systems
integer
C0682591 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Diagnosis body systems
Code List
Diagnosis body systems
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])
Past or current
Code List
Past or current diagnosis
CL Item
past (1)
CL Item
current (2)
Item Group
Laboratory tests
C0022885 (UMLS CUI-1)
Item
Has a blood sample been taken?
integer
C0005834 (UMLS CUI [1])
Blood sample
Code List
Has a blood sample been taken?
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])
Item
Is the child fed with:
text
C0420979 (UMLS CUI [1])
child feeding
Code List
Is the child fed with:
CL Item
Breast Milk (1)
CL Item
Infant Formula (2)
CL Item
Both (3)
Item Group
Vaccine administration
C2368628 (UMLS CUI-1)
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1])
Item
Vaccine administration
text
C2368628 (UMLS CUI [1])
Vaccine administration
Code List
Vaccine administration
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])
Wrong vial number
Item
Wrong vial number
text
C0184301 (UMLS CUI [1,1])
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])
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])
Why was the vaccine not administered?
Code List
Why was the vaccine not administered?
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])
number of unsolicited adverse event
Item
Please specify unsolicited AE No
integer
C0877248 (UMLS CUI [1,1])
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])
Item
Regurgitation with in 30 minutes after HRV vaccine or placebo?
text
C0175795 (UMLS CUI [1,1])
C2004489 (UMLS CUI [1,2])
regurgitation after oral medication
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])
Decision
Code List
Please tick who took decision:
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
Item Group
Unsolicited Adverse Events
C0877248 (UMLS CUI-1)
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])
Unsolicited Adverse Events
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)
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