ID

37969

Description

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. In addition to the use of samples for the tests described in the protocol, the sponsor might use samples for additional research; therefore, this form records what is also covered by the subject Informed Consent form of each center.

Keywords

Versions (1)
  1. 9/3/19 9/3/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 3, 2019

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License

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

English

Use of Human Samples

1 forms  
  1. StudyEvent: ODM
    1. Use of Human Samples
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Center Number
Description

Center Number

Data type

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Use of human samples by GSK
Description

Use of human samples by GSK

Alias
UMLS CUI-1
C2347026
UMLS CUI-2
C0086418
UMLS CUI-3
C0457083
UMLS CUI-4
C2347796
Quality Assurance of tests described in the protocol
Description

This may include the management of the quality of these current tests, the maintenance or improvement of these current tests, the development of new test methods for the markers described in the protocol as well as making sure that new tests are comparable to previous methods and work reliably.

Data type

boolean

Alias
UMLS CUI [1,1]
C0178932
UMLS CUI [1,2]
C0039593
UMLS CUI [1,3]
C1507394
Further investigation by GSK Biologicals into the ability of the vaccines to protect people if any findings from related studies require it and further research in the diseases under study. These investigations exclude genetics testing.
Description

Vaccine research and research in diseases under study, excludig genetic testing

Data type

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0035168
UMLS CUI [1,3]
C1705847
UMLS CUI [1,4]
C0243064
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0035168
UMLS CUI [2,3]
C1705847
UMLS CUI [2,4]
C0243064
Further investigation by GSK Biologicals into the ability of the vaccines to protect people if any findings from related studies require it and further research in the diseases under study. These investigations exclude genetic testing. Investigator will always ask in advance the permission of the independent Ethics Committee/Institutional Review Board linked to the institution where this research is performed.
Description

{adapt to local naming}

Data type

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0035168
UMLS CUI [1,3]
C2346499
UMLS CUI [1,4]
C0086911
UMLS CUI [1,5]
C1705847
UMLS CUI [1,6]
C0243064
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0035168
UMLS CUI [2,3]
C2346499
UMLS CUI [2,4]
C0086911
UMLS CUI [2,5]
C1705847
UMLS CUI [2,6]
C0243064
Further research by GSK Biologicals that is NOT RELATED to the vaccines or the diseases under study done on an anonymous basis (meaning that any identification linking the subject to the sample is destroyed). This research excludes genetic testing and does not affect subject participation in the study.
Description

Anonymous research unrelated to this study, excluding genetic testing

Data type

boolean

Alias
UMLS CUI [1,1]
C0035168
UMLS CUI [1,2]
C2346787
UMLS CUI [1,3]
C0445356
UMLS CUI [1,4]
C0008976
UMLS CUI [1,5]
C1705847
UMLS CUI [1,6]
C0243064
HIV Testing
Description

HIV Testing

Data type

boolean

Alias
UMLS CUI [1]
C1321876
Please tick if a 15 years GSK storage period is covered by the subject's Informed Consent form of your center.
Description

Storage period in informed consent form

Data type

integer

Alias
UMLS CUI [1,1]
C1698986
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0370003
UMLS CUI [1,4]
C0021430
If other GSK storage period, please specify
Description

Specify other storage period

Data type

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1698986
UMLS CUI [1,4]
C0449238
UMLS CUI [1,5]
C0370003
ICF Effective date
Description

Complete and submit a new form for each change during the study

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0009797
Investigator's signature
Description

Investigator's signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Description

Investigator's signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Printed Investigator's name
Description

Printed Investigator's name

Data type

text

Alias
UMLS CUI [1]
C2826892
Date of investigator's signature
Description

Date of investigator's signature

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Use of Human Samples

1 forms
  1. StudyEvent: ODM
    1. Use of Human Samples
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Center Number
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
Use of human samples by GSK
C2347026 (UMLS CUI-1)
C0086418 (UMLS CUI-2)
C0457083 (UMLS CUI-3)
C2347796 (UMLS CUI-4)
Quality Assurance of tests described in the protocol
Item
Quality Assurance of tests described in the protocol
boolean
C0178932 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C1507394 (UMLS CUI [1,3])
Vaccine research and research in diseases under study, excludig genetic testing
Item
Further investigation by GSK Biologicals into the ability of the vaccines to protect people if any findings from related studies require it and further research in the diseases under study. These investigations exclude genetics testing.
boolean
C0042210 (UMLS CUI [1,1])
C0035168 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0243064 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0035168 (UMLS CUI [2,2])
C1705847 (UMLS CUI [2,3])
C0243064 (UMLS CUI [2,4])
Vaccine research and research in diseases under study, excluding genetic testing, with ethics review
Item
Further investigation by GSK Biologicals into the ability of the vaccines to protect people if any findings from related studies require it and further research in the diseases under study. These investigations exclude genetic testing. Investigator will always ask in advance the permission of the independent Ethics Committee/Institutional Review Board linked to the institution where this research is performed.
boolean
C0042210 (UMLS CUI [1,1])
C0035168 (UMLS CUI [1,2])
C2346499 (UMLS CUI [1,3])
C0086911 (UMLS CUI [1,4])
C1705847 (UMLS CUI [1,5])
C0243064 (UMLS CUI [1,6])
C0012634 (UMLS CUI [2,1])
C0035168 (UMLS CUI [2,2])
C2346499 (UMLS CUI [2,3])
C0086911 (UMLS CUI [2,4])
C1705847 (UMLS CUI [2,5])
C0243064 (UMLS CUI [2,6])
Anonymous research unrelated to this study, excluding genetic testing
Item
Further research by GSK Biologicals that is NOT RELATED to the vaccines or the diseases under study done on an anonymous basis (meaning that any identification linking the subject to the sample is destroyed). This research excludes genetic testing and does not affect subject participation in the study.
boolean
C0035168 (UMLS CUI [1,1])
C2346787 (UMLS CUI [1,2])
C0445356 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C1705847 (UMLS CUI [1,5])
C0243064 (UMLS CUI [1,6])
HIV Testing
Item
HIV Testing
boolean
C1321876 (UMLS CUI [1])
Item
Please tick if a 15 years GSK storage period is covered by the subject's Informed Consent form of your center.
integer
C1698986 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,4])
GSK storage period, informed consent form
Code List
Please tick if a 15 years GSK storage period is covered by the subject's Informed Consent form of your center.
CL Item
At least 15 years storage period by GSK Biologicals (1)
CL Item
Other (2)
Specify other storage period
Item
If other GSK storage period, please specify
text
C1521902 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1698986 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
C0370003 (UMLS CUI [1,5])
ICF Effective date
Item
ICF Effective date
date
C0011008 (UMLS CUI [1,1])
C0009797 (UMLS CUI [1,2])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Date of investigator's signature
Item
Date of investigator's signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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