ID

37861

Beschreibung

Study ID: 111634 Clinical Study ID: 111634 Study Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00829010 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK1024850A Trade Name: Tritanrix-HepB/Hib, Rotarix Study Indication: Infections, Streptococcal This phase III trial studies the immunogenicity, safety and reactogenicity of a 10-valent pneumococcal conjugate vaccine in three groups of infants that differ by HIV status: HIV-positive infants, HIV-negative infants who are exposed to the virus (by their HIV-positive mother), and HIV-negative infants who are not exposed. The study consists of Screening at 4-8 weeks of age (only for HIV-positive and HIV-exposed infants without HIV-DNA test) and 10 subsequent Visits over a period of 23 months. There are five study cohorts: HIV-positive and HIV-exposed participants receive the vaccine at Visits 1, 2, 3 (i.e. 6, 10 and 14 weeks of life; primary course) and 5 (9-10 months of age; booster), whereas HIV-negative, unexposed infants are randomly assigned to one of three vaccination schedules: the aforementioned schedule consisting of the primary course and the booster, or the 3-dose primary course only without the booster vaccination, or a different primary course consisting of only two vaccinations at Visits 1 and 3 (6 and 14 weeks of age) followed by a booster at Visit 5 (9-10 months). Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old. This form contains the Study Continuation Check and (if applicable) information on why the subject was withdrawn from the study, the Elimination Criteria Check, information on whether the ICF Amendment has been signed, and the subject's weight, and is to be filled in at Visits 2 to 10, for all cohorts. Additionally, this form records whether the infant is still breastfed, which is only applicable to HIV-negative subjects with HIV-positive mothers (=HIV-exposed cohort).

Stichworte

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  5. 17.10.19 17.10.19 - Sarah Riepenhausen
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GlaxoSmithKline

Hochgeladen am

28. August 2019

DOI

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Creative Commons BY-NC 3.0
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10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010

Englisch

Study Continuation, Elimination Criteria, ICF Amendment, Weight, Breastfeeding Continuation

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Cohort
Beschreibung

Please note that while the rest of this form is applicable to all cohorts, the itemgroup regarding breastfeeding is only applicable to Cohort 2 (= HIV-neg. exposed infants).

Datentyp

integer

Alias
UMLS CUI [1]
C0599755
Visit Type
Beschreibung

This form is to be used at each Visit (Visits 2 to 10).

Datentyp

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Date of Visit
Beschreibung

Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old.

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Study Continuation
Beschreibung

Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the subject return for this visit?
Beschreibung

If yes, complete the approriate forms. If no, please select the ONE most appropriate reason and skip the following forms of this visit, or select "Same reason and decision as previous visit" (option available from Visit 2 (HIV-pos. and HIV-exposed cohorts) or 3 (all HIV-negative, unexposed cohorts) onwards).

Datentyp

boolean

Alias
UMLS CUI [1]
C0805733
reason for study non-continuation
Beschreibung

If SAE, please complete and submit SAE report, and specify SAE No. If AE, please complete Non-serious Adverse Event form, and specify AE No. or solicited AE code. If Other Reason, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Same reason and decision as previous visit
Beschreibung

This option is not applicable to the HIV-negative, unexposed cohorts at Visit 2, but is available to all cohorts from Visit 3 onwards.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C2127115
UMLS CUI [2,1]
C0457454
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0679006
UMLS CUI [2,4]
C2127115
Specify SAE Number
Beschreibung

if SAE major reason for non-continuation

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Specify AE Number
Beschreibung

if AE major reason for non-continuation

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Specify solicited AE Code
Beschreibung

if AE major reason for discontinuation

Datentyp

integer

Alias
UMLS CUI [1,1]
C1517001
UMLS CUI [1,2]
C1518404
UMLS CUI [1,3]
C0600091
Specify other reason for non-continuation
Beschreibung

e.g.: consent withdrawal, Protocol violation, …

Datentyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C2348235
UMLS CUI [1,3]
C0457454
UMLS CUI [1,4]
C0008976
Please select who made the decision
Beschreibung

Who made discontinuation decision

Datentyp

text

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0679006
Elimination Criteria during Study
Beschreibung

Elimination Criteria during Study

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C0347984
UMLS CUI-3
C0008976
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.
Beschreibung

leads to elimination from safety and immunogenicity ATP analyses

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0013230
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C1875384
Administration of a pneumococcal vaccine not foreseen by the study protocol
Beschreibung

leads to elimination from safety and immunogenicity ATP analyses

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1444655
UMLS CUI [1,3]
C2348563
UMLS CUI [1,4]
C0358314
A positive HIV DNA-PCR test during the study
Beschreibung

leads to elimination from safety and immunogenicity ATP analyses only applicable to HIV unexposed uninfected infants and HIV exposed uninfected infants (i.e. Cohorts 2-5)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1294177
UMLS CUI [1,2]
C1335447
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C2347804
Administration of immunoglobulins and/or any blood products since birth or administration during the study period.
Beschreibung

leads to elimination from immunogenicity ATP analysis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0021027
UMLS CUI [1,3]
C1533734
UMLS CUI [2,1]
C0205156
UMLS CUI [2,2]
C0371802
UMLS CUI [3,1]
C0021027
UMLS CUI [3,2]
C1533734
UMLS CUI [3,3]
C0347984
UMLS CUI [3,4]
C2347804
UMLS CUI [4,1]
C0371802
UMLS CUI [4,2]
C0347984
UMLS CUI [4,3]
C2347804
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
Beschreibung

leads to elimination from immunogenicity ATP analysis applicable to HIV unexposed uninfected infants only (i.e. Cohorts 3, 4, 5)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0021051
UMLS CUI [2,1]
C0750484
UMLS CUI [2,2]
C4048329
UMLS CUI [3,1]
C0242114
UMLS CUI [3,2]
C0021051
UMLS CUI [4,1]
C0242114
UMLS CUI [4,2]
C4048329
Informed Consent Amendment 1 / 2
Beschreibung

Informed Consent Amendment 1 / 2

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C0680532
UMLS CUI-3
C2348563
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?
Beschreibung

(applicable only if ICF Amendment 1 / Amendment 2 has not been signed at previous performed visit)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0680532
UMLS CUI [1,3]
C2348563
Date of ICF Amendment signed
Beschreibung

(this item is not applicable for Visit 1, i.e. a date is not recorded if the Amendment has been signed at/before Visit 1)

Datentyp

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0680532
UMLS CUI [1,3]
C0011008
Weight
Beschreibung

Weight

Alias
UMLS CUI-1
C0005910
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Breastfeeding
Beschreibung

Breastfeeding

Alias
UMLS CUI-1
C0006147
Is the mother still breastfeeding since last visit?
Beschreibung

If no, record date of cessation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006147
UMLS CUI [1,2]
C0549178
Breastfeeding Cessation Date
Beschreibung

if applicable

Datentyp

date

Alias
UMLS CUI [1,1]
C0006147
UMLS CUI [1,2]
C0806020
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Ähnliche Modelle

Study Continuation, Elimination Criteria, ICF Amendment, Weight, Breastfeeding Continuation

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
HIV-pos. (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])
Visit Type
Code List
Visit Type
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
CL Item
Visit 6 (6)
CL Item
Visit 7 (7)
CL Item
Visit 8 (8)
CL Item
Visit 9 (9)
CL Item
Visit 10 (10)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
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])
major reason for vaccine non-administration
Code List
reason for study non-continuation
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Other (OTH)
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])
Who made non-administration decision
Code List
Please select who made the decision
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
Item Group
Elimination Criteria during Study
C0680251 (UMLS CUI-1)
C0347984 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
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])
Item Group
Informed Consent Amendment 1 / 2
C0021430 (UMLS CUI-1)
C0680532 (UMLS CUI-2)
C2348563 (UMLS CUI-3)
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])
Item Group
Weight
C0005910 (UMLS CUI-1)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Breastfeeding
C0006147 (UMLS CUI-1)
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])
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