ID
41663
Description
Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00307021 https://clinicaltrials.gov/ct2/show/NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). This form is to be used in case of a Serious Adverse Event (SAE), which is here defined as: A serious adverse event (SAE) is any untoward medical occurrence that: a. results in death, b. is life-threatening, NOTE: The term 'life-threatening' in the definition of 'serious' refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe. c. requires hospitalization or prolongation of existing hospitalization, NOTE: In general, hospitalization signifies that the subject has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician’s office or out-patient setting. Complications that occur during hospitalization are AEs. If a complication prolongs hospitalization or fulfils any other serious criteria, the event is serious. When in doubt as to whether “hospitalization” occurred or was necessary, the AE should be considered serious. Hospitalization for elective treatment of a pre-existing condition that did not worsen from baseline is not considered an AE. d. results in disability/incapacity, or NOTE: The term disability means a substantial disruption of a person’s ability to conduct normal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhoea, influenza, and accidental trauma (e.g. sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption. e. is a congenital anomaly/birth defect in the offspring of a study subject. f. Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately lifethreatening or result in death or hospitalization but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization. Serious Adverse Events (SAEs) related to study participation (e.g. procedures, invasive tests, change from existing therapy) or SAEs related to GSK concurrent medication will be collected and recorded from the time the subject consents to participate in the study. For all other SAEs, the standard time period for collecting and recording SAEs will begin from the administration of the first dose of vaccine / placebo / comparator and will end minimum 30 days (see protocol) following administration of the last dose of vaccine / placebo / comparator for each subject.
Link
https://clinicaltrials.gov/ct2/show/NCT00307021
Keywords
Versions (1)
- 12/5/20 12/5/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
December 5, 2020
DOI
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License
Creative Commons BY-NC 4.0
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Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021
Serious Adverse Event Report
- StudyEvent: ODM
Description
SAE
Alias
- UMLS CUI-1
- C1519255
Description
Diagnosis only (if known), otherwise sign/symptom. A separate form should be used for each SAE however if multiple SAEs which are temporarily or clinically related are apparent at the time of initial reporting then these may be reported on the same page.
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
The start date should document the first occurrence of the SAE. This is generally the start date of the signs/symptoms and not necessarily the date that the event met the definition of serious.
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C1519255
Description
All SAEs must be followed until the events are resolved, the condition stabilises, the events are otherwise explained, or the subject is lost to follow-up. (rest of the paragraph not readable)
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Description
If fatal, record date of death Record the date of resolution or the date of death as applicable. (rest of paragraph not readable)
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
Description
Record the maximum intensity that occurred over the duration of the event (see protocol for definition of intensity). Amend the intensity if it increases.
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Description
If administration of the investigational product was stopped permanently and not restarted enter 1-Investigational product(s) withdrawn and enter the date that investigational product was discontinued in section 9. If administration of the investigational product was not modified and all scheduled doses were given enter 2-Dose not changed. If administration of investigational product was temporarily interrupted but then restarted enter 3-Dose Interrupted. If the subject did not receive investigational product dose at the time of the event or if the subject has received all his doses or if the subject died and there was no prior decision to discontinue investigational product enter X-Not applicable.
Data type
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Description
Withdrawal due to SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Description
This box is mandatory and has to be completed before faxing the form. It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. (...) Confounding factors, such as concomitant medication, a concurrent illness, or relevant medical history, should also be considered. (Rest of paragraph not readable)
Data type
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1519255
Description
Medically attended visit because of SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C1386497
- UMLS CUI [1,3]
- C1519255
Description
Outcome fatal, autopsy performed
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1302234
- UMLS CUI [1,3]
- C0004398
Description
Seriousness
Alias
- UMLS CUI-1
- C1710056
Description
SAE Results in death
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1705232
- UMLS CUI [1,2]
- C1519255
Description
SAE is life threatening
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1517874
- UMLS CUI [1,2]
- C1519255
Description
SAE requires or prolongs hospitalization
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2826664
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0745041
Description
Hospitalisation: Date of admission
Data type
date
Alias
- UMLS CUI [1,1]
- C0806429
- UMLS CUI [1,2]
- C1519255
Description
Hospitalisation: Date of discharge
Data type
date
Alias
- UMLS CUI [1,1]
- C2710998
- UMLS CUI [1,2]
- C1519255
Description
SAE results in disability / incapacity
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
Description
SAE causes Congenital anomaly / birth defect in the offspring
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C1519255
Description
Other Reason for SAE
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3840932
Description
Other Reason for SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3840932
Description
Demography Data
Alias
- UMLS CUI-1
- C0011298
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Weight
Data type
integer
Measurement units
- Pounds
Alias
- UMLS CUI [1]
- C0005910
Description
Weight
Data type
integer
Measurement units
- Ounces
Alias
- UMLS CUI [1]
- C0005910
Description
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Description
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C1517331
- UMLS CUI [1,4]
- C0304229
Description
Possible causes of SAE
Alias
- UMLS CUI-1
- C3828190
Description
Possible cause of SAE other than investigational product: Disease under study
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C0012634
- UMLS CUI [1,6]
- C0347984
- UMLS CUI [1,7]
- C0008976
Description
Possible cause of SAE other than investigational product: Medical condition
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C4745084
Description
Possible cause of SAE other than investigational product: Lack of efficacy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C0235828
Description
Possible cause of SAE other than investigational product: Withdrawal of investigational product
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C2349954
- UMLS CUI [1,6]
- C0304229
Description
Possible cause of SAE other than investigational product: Concomitant medication
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C2347852
Description
Possible cause of SAE other than investigational product: Activity related to study participation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C2348568
Description
Possible cause of SAE other than investigational product: Other
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C0205394
Description
Possible cause of SAE other than investigational product: Other
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0304229
- UMLS CUI [1,5]
- C0205394
Description
Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0262926
Description
Give any concomitant medication(s) which may have contributed to the event. There is no need to list medications which are definitely not linked to the event.
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1519255
Description
Date of onset of medical condition
Data type
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0574845
Description
Condition present at time of SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C1519255
Description
Date of last occurrence of medical condition
Data type
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
Description
Other relevant risk factors
Alias
- UMLS CUI-1
- C0035648
Description
Family or social history relevant to SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C0241889
- UMLS CUI [1,2]
- C2347946
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [2,1]
- C3714536
- UMLS CUI [2,2]
- C2347946
- UMLS CUI [2,3]
- C1519255
- UMLS CUI [3]
- C1519384
- UMLS CUI [4]
- C0013146
- UMLS CUI [5]
- C0337074
Description
Relevant Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Description
Drug name Concomitant Medication
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Description
Concomitant Medication Dose
Data type
text
Alias
- UMLS CUI [1]
- C2826811
Description
Concomitant Medication Unit
Data type
text
Alias
- UMLS CUI [1]
- C2826646
Description
Concomitant Medication Frequency
Data type
text
Alias
- UMLS CUI [1]
- C2826654
Description
Concomitant Medication Route
Data type
text
Alias
- UMLS CUI [1]
- C2826730
Description
Concomitant Medication taken prior to study
Data type
text
Alias
- UMLS CUI [1]
- C2826667
Description
Concomitant Medication Date started
Data type
date
Alias
- UMLS CUI [1]
- C2826734
Description
Concomitant Medication Date stopped
Data type
date
Alias
- UMLS CUI [1]
- C2826744
Description
Concomitant Medication Reason for medication
Data type
text
Alias
- UMLS CUI [1]
- C2826696
Description
Details of investigational product(s)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C1522508
Description
Vaccine should be given as described on the CRF vaccination page (or protocol). In case of multiple vaccinations on the same day, it is important to also mention if the vaccines were administered mixed or separetely.
Data type
text
Alias
- UMLS CUI [1,1]
- C0042210
- UMLS CUI [1,2]
- C2360065
Description
Vaccine Dose Number
Data type
text
Alias
- UMLS CUI [1,1]
- C0042210
- UMLS CUI [1,2]
- C1115464
Description
Vaccine Lot Number
Data type
text
Alias
- UMLS CUI [1,1]
- C0042210
- UMLS CUI [1,2]
- C1115660
Description
Vaccine Route / site
Data type
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
- UMLS CUI [2,1]
- C1515974
- UMLS CUI [2,2]
- C0042210
Description
Vaccine Date of administration
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2368628
Description
Treatment blind broken at investigational site
Data type
text
Alias
- UMLS CUI [1]
- C3897431
Description
Details of relevant assessments
Alias
- UMLS CUI-1
- C1261322
- UMLS CUI-2
- C1519255
Description
Details of tests/procedures to diagnose/confirm SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0011900
- UMLS CUI [2,2]
- C1519255
Description
Narrative remarks
Alias
- UMLS CUI-1
- C0947611
Description
Narrative remarks: description of signs/symptoms and details of TREATMENT given for SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0037088
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C2981656
Description
SAE additional / Follow-up information
Alias
- UMLS CUI-1
- C1524062
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C1519255
- UMLS CUI-4
- C1522577
Description
SAE additional / follow-up information
Data type
text
Alias
- UMLS CUI [1,1]
- C1524062
- UMLS CUI [1,2]
- C1533716
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [2,1]
- C1522577
- UMLS CUI [2,2]
- C1533716
- UMLS CUI [2,3]
- C1519255
Description
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Description
Report Type
Data type
integer
Alias
- UMLS CUI [1]
- C0585733
Description
Investigator's signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Date of signature
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Investigator's name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Serious Adverse Event Report
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C2985846 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0745041 (UMLS CUI [2,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0231170 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0012634 (UMLS CUI [1,5])
C0347984 (UMLS CUI [1,6])
C0008976 (UMLS CUI [1,7])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C4745084 (UMLS CUI [1,5])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0235828 (UMLS CUI [1,5])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2349954 (UMLS CUI [1,5])
C0304229 (UMLS CUI [1,6])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2347852 (UMLS CUI [1,5])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2348568 (UMLS CUI [1,5])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C2347946 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C3714536 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])
C1519384 (UMLS CUI [3])
C0013146 (UMLS CUI [4])
C0337074 (UMLS CUI [5])
C2360065 (UMLS CUI [1,2])
C1522508 (UMLS CUI-2)
C2360065 (UMLS CUI [1,2])
C1115464 (UMLS CUI [1,2])
C1115660 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C2368628 (UMLS CUI [1,2])
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C0037088 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C2981656 (UMLS CUI [2,2])
C1533716 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
C1533716 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522577 (UMLS CUI [2,1])
C1533716 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])
C0011008 (UMLS CUI [1,2])