ID

37968

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. This form contains the Study Conclusion and is to be used twice - at the interim analysis at/after Visit 6 and at the final analysis at the end of the study (or if the subject has been withdrawn).

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

Study Conclusion

1 forms  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Cohort
Description

Cohort

Data type

integer

Alias
UMLS CUI [1]
C0599755
Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Type of Visit
Description

Type of Visit

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject experience any Serious Adverse Event during the study period ?
Description

If yes, please give the total number of SAE's in next item

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Total number of SAE's:
Description

if applicable

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
Did any elimination criteria become applicable during the study?
Description

If Yes, please specify in next item

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2347804
UMLS CUI [1,3]
C0347984
Specify elimination criteria that became applicable during the study
Description

Specify elimination criteria during study

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C2347804
Was the subject withdrawn from study?
Description

If yes, fill in the remaining items in this itemgroup. If no, skip the rest of this itemgroup. Note for the interim analysis timepoint: A subject is withdrawn from the interim analysis if he/she did not come for the interim analysis timepoint visit.

Data type

boolean

Alias
UMLS CUI [1]
C0422727
Major reason for withdrawal
Description

select one For SAE, Please complete and submit SAE report, and specify SAE No. For AEX/NSAE: Please complete Non-serious Adverse Event section, and please specify AE No. or solicited AE code for Protocol Violation, please specify For other, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205164
SAE Number
Description

also complete and submit SAE report

Data type

integer

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

also complete Non-serious Adverse Event form provide AE Number or solicited AE code (next item)

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Solicited AE Code
Description

also complete Non-serious Adverse Event form provide AE Number or solicited AE code

Data type

text

Alias
UMLS CUI [1,1]
C1517001
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0600091
Specify protocol violation
Description

Specify protocol violation

Data type

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C1521902
Specify other reason for withdrawal
Description

Specify other reason for withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205164
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C1521902
Who made withdrawal decision?
Description

Who made withdrawal decision?

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
Date of last contact
Description

Date of last contact

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1705415
Was the subject in good condition at date of last contact?
Description

If no, please give details within the Adverse Events section

Data type

boolean

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0805839
Investigator's Signature
Description

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigators signature
Description

"I confirm that I have reviewed the data in this Case Report Form 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
Investigators signature Date
Description

Investigators signature Date

Data type

date

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

Investigator's name

Data type

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Study Conclusion

1 forms
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Type of Visit
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of Visit
Code List
Type of Visit
CL Item
Interim Study Conclusion (at/after Visit 6) (1)
CL Item
Final Study Conclusion (at/after Visit 10) (2)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Serious Adverse Event
Item
Did the subject experience any Serious Adverse Event during the study period ?
boolean
C1519255 (UMLS CUI [1])
Number of SAEs
Item
Total number of SAE's:
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Elimination criteria during the study
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
Specify elimination criteria during study
Item
Specify elimination criteria that became applicable during the study
text
C2348235 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
Was subject withdrawn from study?
Item
Was the subject withdrawn from study?
boolean
C0422727 (UMLS CUI [1])
Item
Major reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
reason for withdrawal
Code List
Major reason for withdrawal
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Protocol violation (PTV)
CL Item
Consent withdrawal, not due to an adverse event (CWS)
CL Item
Migrated / moved from the study area (MIG)
CL Item
Lost to follow-up. (LFU)
CL Item
Other (OTH)
SAE Number
Item
SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number
Item
AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Solicited AE Code
Item
Solicited AE Code
text
C1517001 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Specify protocol violation
Item
Specify protocol violation
text
C1709750 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Specify other reason for withdrawal
Item
Specify other reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
Item
Who made withdrawal decision?
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
reason for withdrawal
Code List
Who made withdrawal decision?
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
Date of last contact
Item
Date of last contact
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1705415 (UMLS CUI [1,3])
Subject condition at last contact
Item
Was the subject in good condition at date of last contact?
boolean
C1142435 (UMLS CUI [1,1])
C0805839 (UMLS CUI [1,2])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigators signature
Item
Investigators signature
text
C2346576 (UMLS CUI [1])
Investigators signature Date
Item
Investigators signature Date
date
C0011008 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
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