Information:
Fel:
ID
29749
Beskrivning
https://clinicaltrials.gov/show/NCT00197028 Visit 1 Case Report Form Study ID: 103967 Clinical Study ID: 103967 Study Title: A Phase I/IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197028 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: BIO MALARIA; SB257049 Study Indication: Malaria
Länk
https://clinicaltrials.gov/show/NCT00197028
Nyckelord
Versioner (1)
- 2018-04-18 2018-04-18 -
Rättsinnehavare
GlaxoSmithKline (GSK)
Uppladdad den
18 april 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region, Study ID: 103967, NCT00197028
Case Report Form, Screening, Visit 1
- StudyEvent: ODM
Similar models
Case Report Form, Screening, Visit 1
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Elimination Criteria during the Study
C0680251 (UMLS CUI-1)
Item
The following criteria should be checked at each visit subsequent to the first visit. If any become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject’s evaluability in the according-to-protocol (ATP) analysis.
integer
C0680251 (UMLS CUI [1])
Code List
The following criteria should be checked at each visit subsequent to the first visit. If any become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject’s evaluability in the according-to-protocol (ATP) analysis.
CL Item
[ A ] Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period. (1)
(Comment:en)
CL Item
[ B ] Chronic administration (defined as more than 14 days) of immunosuppressants or other immunemodifying drugs during the study period (for corticosteroids, this will mean prednisone, or equivalent, < 0.5 mg/kg/day. Inhaled and topical steroids are allowed). (2)
(Comment:en)
CL Item
[ E ] Administration of either TETRActHib or study vaccines in the incorrect limb. (4)
(Comment:en)
CL Item
[ F ] Failure to thrive (5)
(Comment:en)
CL Item
[ C ] Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each vaccination of vaccine(s) and ending 30 days after. (6)
(Comment:en)
CL Item
[ D ] Administration of immunoglobulins and/or any blood products during the study period. (3)
(Comment:en)
Item Group
Informed Consent and Demographics
C0021430 (UMLS CUI-1)
C0011298 (UMLS CUI-2)
C0011298 (UMLS CUI-2)
Informed Consent Date
Item
I certify that Informed Consent has been obtained prior to any study procedure. Informed Consent Date:
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
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])
CL Item
Female ([F])
CL Item
[1] Black (1)
CL Item
[4] Arabic/North African (2)
CL Item
[2] White/Caucasian (3)
CL Item
[5] East & South East Asian (4)
CL Item
[6] South Asian (5)
CL Item
[7] American Hispanic (6)
CL Item
[8] Japanese (7)
CL Item
[9] Other, please specify: ___________________________________ (8)
Geographical area
Item
Geographical area: (Barrios, local government areas)
integer
C0681784 (UMLS CUI [1])
CL Item
Yes (1)
CL Item
No → If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria. (2)
Item
Inclusion criteria Tick the boxes corresponding to any of the inclusion criteria the subject failed.
integer
Code List
Inclusion criteria Tick the boxes corresponding to any of the inclusion criteria the subject failed.
CL Item
[ 1 ] A male or female infant of between 6 and 12 weeks of age at the time of first vaccination. (1)
CL Item
[ 2 ] Written informed consent obtained from the parent(s) or guardian(s) of the subject (2)
CL Item
[ 3 ] Free of obvious health problems as established by medical history and clinical examination before entering into the study. (3)
CL Item
[ 4 ] Born to a mother who is HBsAg negative (4)
CL Item
[ 5 ] Born to a mother who is HIV negative. (5)
CL Item
[ 6 ] Born after a normal gestation period (between 36 and 42 weeks). (6)
CL Item
[ 7 ] Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. (7)
Item
Exclusion criteria Tick the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
integer
Code List
Exclusion criteria Tick the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
CL Item
[ 8 ] BCG administration within one week of proposed administration of a study vaccine. (1)
(Comment:en)
CL Item
[ 9 ] Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first vaccination of study vaccine, or planned use during the study period. (2)
(Comment:en)
CL Item
[ 10 ] Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. (3)
(Comment:en)
CL Item
[ 11 ] 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). (4)
(Comment:en)
CL Item
[ 12 ] Any chronic drug therapy to be continued during the study period. (5)
(Comment:en)
CL Item
[ 13 ] Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular), Hemophilus influenzae type b or hepatitis B vaccines. (6)
(Comment:en)
CL Item
[ 14 ] Major congenital abnormality. (7)
(Comment:en)
CL Item
[ 15 ] Serious acute or chronic illness determined by clinical, physical examination and laboratory screening tests (8)
(Comment:en)
CL Item
[ 16 ] Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination (no laboratory testing required) (9)
(Comment:en)
CL Item
[ 17 ] A family history of congenital or hereditary immunodeficiency. (10)
(Comment:en)
CL Item
[ 18 ] History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. (11)
CL Item
[ 19 ] History of any neurological disorders or seizures. (12)
CL Item
[ 20 ] Maternal death. (13)
CL Item
[ 21 ] >Moderate malnutrition at screening defined as weight for age Z-score less than -2; this corresponds to a weight of x 3.9 kg for 2 month old boys and x 3.6 kg for 2 month old girls. (14)
CL Item
[ 22 ] Hemoglobin < 80 g/L (15)
CL Item
[ 23 ] Simultaneous participation in any other clinical trial. (16)
CL Item
[ 24 ] Same sex twin (17)
CL Item
[ 25 ] Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial. (18)
Item Group
Screening conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Item
Did the subject experience any Serious Adverse Event during screening? (only SAEs related to study participation or to a concurrent medication need to be considered and reported)
integer
C1519255 (UMLS CUI [1])
Code List
Did the subject experience any Serious Adverse Event during screening? (only SAEs related to study participation or to a concurrent medication need to be considered and reported)
CL Item
No (1)
CL Item
Yes → Specify total number of SAE's (2)
Number of SAEs
Item
Number of SAEs
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Screening failure
Item
Is the subject a screening failure? (Was the subject withdrawn prior to randomisation or first vaccination?)
boolean
C1710477 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
Item
Major reason for failure. (Tick 1 box only)
integer
C1710477 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
CL Item
[ELI] Eligibility criteria not fulfilled (inclusion and exclusion criteria) → Please tick failing criteria on Eligibility form (1)
CL Item
[PTV] Protocol violation, please specify:_________________________________________ (2)
CL Item
[SAE] Serious adverse event → Please complete and submit SAE report → Please specify SAE No.: |__|__| (3)
CL Item
[CWS] Consent withdrawal / not willing to participate, not due to a serious adverse event. (4)
CL Item
[MIG] Migrated / moved from the study area (5)
CL Item
[LFU] Lost to follow-up. (6)
CL Item
[OTH] Other → Please specify:__________________________________________________ (7)
Item
Who made the decision:
integer
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])
CL Item
[I] Investigator (1)
CL Item
[P] Parents/Guardians (2)
Investigator’s signature
Item
Investigator’s signature
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Printed name
Item
Printed Investigator's name:
text
C2826892 (UMLS CUI [1])