ID
37947
Beskrivning
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 This form contains the Study Continuation Check and (if applicable) information on why the subject was withdrawn from the study, the Elimination Criteria Check, information on whether the ICF Amendment has been signed, the subject's weight, and whether the child experienced a meningitis, 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).
Nyckelord
Versioner (5)
- 2019-08-26 2019-08-26 -
- 2019-08-28 2019-08-28 -
- 2019-09-02 2019-09-02 -
- 2019-09-02 2019-09-02 -
- 2019-10-17 2019-10-17 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
2 september 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010
Study Continuation, Elimination Criteria, ICF Amendment, Weight, Meningitis, Breastfeeding Continuation
Beskrivning
Study Continuation
Alias
- UMLS CUI-1
- C0805733
- UMLS CUI-2
- C0008976
Beskrivning
If yes, complete the appropriate 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).
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0805733
Beskrivning
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
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [1,3]
- C0008976
Beskrivning
This option is not applicable to the HIV-negative, unexposed cohorts at Visit 2, but is available to all cohorts from Visit 3 onwards.
Datatyp
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
Beskrivning
if SAE major reason for non-continuation
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beskrivning
if AE major reason for non-continuation
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Beskrivning
if AE major reason for discontinuation
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1517001
- UMLS CUI [1,2]
- C1518404
- UMLS CUI [1,3]
- C0600091
Beskrivning
e.g.: consent withdrawal, Protocol violation, …
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [1,3]
- C0457454
- UMLS CUI [1,4]
- C0008976
Beskrivning
Who made discontinuation decision
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C0679006
Beskrivning
Elimination Criteria during Study
Alias
- UMLS CUI-1
- C0680251
- UMLS CUI-2
- C0347984
- UMLS CUI-3
- C0008976
Beskrivning
leads to elimination from safety and immunogenicity ATP analyses
Datatyp
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
Beskrivning
leads to elimination from safety and immunogenicity ATP analyses
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1444655
- UMLS CUI [1,3]
- C2348563
- UMLS CUI [1,4]
- C0358314
Beskrivning
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)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1294177
- UMLS CUI [1,2]
- C1335447
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C2347804
Beskrivning
leads to elimination from immunogenicity ATP analysis
Datatyp
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
Beskrivning
leads to elimination from immunogenicity ATP analysis applicable to HIV unexposed uninfected infants only (i.e. Cohorts 3, 4, 5)
Datatyp
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
Beskrivning
Informed Consent Amendment 1 / 2
Alias
- UMLS CUI-1
- C0021430
- UMLS CUI-2
- C0680532
- UMLS CUI-3
- C2348563
Beskrivning
(applicable only if ICF Amendment 1 / Amendment 2 has not been signed at previous performed visit)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0680532
- UMLS CUI [1,3]
- C2348563
Beskrivning
(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)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0680532
- UMLS CUI [1,3]
- C0011008
Beskrivning
Weight
Alias
- UMLS CUI-1
- C0005910
Beskrivning
Meningitis
Alias
- UMLS CUI-1
- C0025289
Beskrivning
Breastfeeding
Alias
- UMLS CUI-1
- C0006147
Similar models
Study Continuation, Elimination Criteria, ICF Amendment, Weight, Meningitis, Breastfeeding Continuation
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
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])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
C0347984 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
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])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0358314 (UMLS CUI [1,4])
C1335447 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
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])
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])
C0680532 (UMLS CUI-2)
C2348563 (UMLS CUI-3)
C0680532 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0680532 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1711239 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
C0549178 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])