ID

29749

Description

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

Link

https://clinicaltrials.gov/show/NCT00197028

Keywords

Versions (1)
  1. 4/18/18 4/18/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

April 18, 2018

DOI

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License

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

English

Case Report Form, Screening, Visit 1

1 forms  
Elimination Criteria during the Study
Description

Elimination Criteria during the Study

Alias
UMLS CUI-1
C0680251
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.
Description

Elimination Criteria during the Study

Data type

integer

Alias
UMLS CUI [1]
C0680251
Informed Consent and Demographics
Description

Informed Consent and Demographics

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C0011298
I certify that Informed Consent has been obtained prior to any study procedure. Informed Consent Date:
Description

Informed Consent Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
Center Number
Description

Center Number

Data type

integer

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

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

integer

Alias
UMLS CUI [1]
C0034510
Geographical area: (Barrios, local government areas)
Description

Geographical area

Data type

integer

Alias
UMLS CUI [1]
C0681784
Eligibility Check
Description

Eligibility Check

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

Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.

Data type

integer

Alias
UMLS CUI [1]
C0013893
Inclusion criteria Tick the boxes corresponding to any of the inclusion criteria the subject failed.
Description

Inclusion criteria

Data type

integer

Exclusion criteria Tick the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
Description

Exclusion Criteria

Data type

integer

Screening conclusion
Description

Screening conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
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)
Description

Serious Adverse Event

Data type

integer

Alias
UMLS CUI [1]
C1519255
Number of SAEs
Description

Number of SAEs

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
Is the subject a screening failure? (Was the subject withdrawn prior to randomisation or first vaccination?)
Description

Screening failure

Data type

boolean

Alias
UMLS CUI [1,1]
C1710477
UMLS CUI [1,2]
C0231175
Major reason for failure. (Tick 1 box only)
Description

Screening failure

Data type

integer

Alias
UMLS CUI [1,1]
C1710477
UMLS CUI [1,2]
C0231175
Who made the decision:
Description

Decision maker

Data type

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
Administative data
Description

Administative data

Alias
UMLS CUI-1
C1320722
Investigator’s signature
Description

I confirm that I have reviewed the data in these screening forms for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Printed Investigator's name:
Description

Printed name

Data type

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Case Report Form, Screening, Visit 1

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Elimination Criteria during the Study
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)
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])
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])
CL Item
Female ([F])
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
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])
Item Group
Eligibility Check
C0013893 (UMLS CUI-1)
Item
Did the subject meet all the entry criteria?
integer
C0013893 (UMLS CUI [1])
Eligibility check
Code List
Did the subject meet all the entry criteria?
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
Inclusion criteria
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
Exclusion Criteria
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)
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])
Serious Adverse Event
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])
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])
Item
Major reason for failure. (Tick 1 box only)
integer
C1710477 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Screening failure
Code List
Major reason for failure. (Tick 1 box only)
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])
Decision maker
Code List
Who made the decision:
CL Item
[I] Investigator (1)
CL Item
[P] Parents/Guardians (2)
Item Group
Administative data
C1320722 (UMLS CUI-1)
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])
Printed name
Item
Printed Investigator's name:
text
C2826892 (UMLS CUI [1])
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