Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item
Cohort
integer
C0599755 (UMLS CUI [1])
CL Item
HIV-neg. exposed (2)
CL Item
HIV-neg. unexposed, 3+1 schedule (3)
CL Item
HIV-neg. unexposed, 3+0 schedule (4)
CL Item
HIV-neg. unexposed, 2+1 schedule (5)
Item
Visit Type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Returned for this visit?
Item
Did the subject return for this visit?
boolean
C0805733 (UMLS CUI [1])
Item
reason for study non-continuation
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
reason for study non-continuation
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
Same study discontinuation reason and decision as previous visit
Item
Same reason and decision as previous visit
boolean
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C2127115 (UMLS CUI [1,4])
C0457454 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0679006 (UMLS CUI [2,3])
C2127115 (UMLS CUI [2,4])
Specify SAE Number
Item
Specify SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Specify AE Number
Item
Specify AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Specify solicited AE Code
Item
Specify solicited AE Code
integer
C1517001 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Specify other reason for study discontinuation
Item
Specify other reason for non-continuation
text
C3840932 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
Item
Please select who made the decision
text
C0457454 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Code List
Please select who made the decision
CL Item
Parents/Guardians (P)
Recent other investigational or non-registered drug/vaccine
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines.
boolean
C0332185 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0332185 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C1875384 (UMLS CUI [2,3])
Administration of a pneumococcal vaccine not foreseen by the study protocol
Item
Administration of a pneumococcal vaccine not foreseen by the study protocol
boolean
C2368628 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0358314 (UMLS CUI [1,4])
positive HIV DNA-PCR test during study
Item
A positive HIV DNA-PCR test during the study
boolean
C1294177 (UMLS CUI [1,1])
C1335447 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
Administration of immunoglobulins and/or any blood products since birth or administration during the study period
Item
Administration of immunoglobulins and/or any blood products since birth or administration during the study period.
boolean
C0205156 (UMLS CUI [1,1])
C0021027 (UMLS CUI [1,2])
C1533734 (UMLS CUI [1,3])
C0205156 (UMLS CUI [2,1])
C0371802 (UMLS CUI [2,2])
C0021027 (UMLS CUI [3,1])
C1533734 (UMLS CUI [3,2])
C0347984 (UMLS CUI [3,3])
C2347804 (UMLS CUI [3,4])
C0371802 (UMLS CUI [4,1])
C0347984 (UMLS CUI [4,2])
C2347804 (UMLS CUI [4,3])
confirmed or suspected immunosuppressive or immunodeficient condition
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
boolean
C0750484 (UMLS CUI [1,1])
C0021051 (UMLS CUI [1,2])
C0750484 (UMLS CUI [2,1])
C4048329 (UMLS CUI [2,2])
C0242114 (UMLS CUI [3,1])
C0021051 (UMLS CUI [3,2])
C0242114 (UMLS CUI [4,1])
C4048329 (UMLS CUI [4,2])
Informed Consent Amendment 1/ 2
Item
Has the informed consent following the Amendment 1/ Amendment 2 approval been signed before or the day of this visit, or between the previous performed visit and this visit?
boolean
C0021430 (UMLS CUI [1,1])
C0680532 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Date of ICF Amendment signed
Item
Date of ICF Amendment signed
date
C0021430 (UMLS CUI [1,1])
C0680532 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Breastfeeding continuing?
Item
Is the mother still breastfeeding since last visit?
boolean
C0006147 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Breastfeeding Cessation Date
Item
Breastfeeding Cessation Date
date
C0006147 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])