ID
44707
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 is used for recording clinical symptoms of HIV as well as staging the disease, is only applicable to HIV-positive infants and is to be filled in at Visits 1, 5, 8 and 10.
Stichworte
Versionen (2)
- 28.08.19 28.08.19 -
- 27.09.21 27.09.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
27. September 2021
DOI
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Lizenz
Creative Commons BY-NC 3.0
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10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010
WHO Clinical Staging of HIV
- StudyEvent: ODM
Beschreibung
Clinical HIV staging
Alias
- UMLS CUI-1
- C1976611
- UMLS CUI-2
- C0205210
Beschreibung
HIV infection WHO clinical stage 1
Alias
- UMLS CUI-1
- C1536038
Beschreibung
HIV infection WHO clinical stage 2
Alias
- UMLS CUI-1
- C1536039
Beschreibung
under 10 per cent of presumed or measured body weight. Unexplained refers to where the condition is not explained by other conditions
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1828173
- UMLS CUI [1,2]
- C1319166
Beschreibung
Recurrent upper respiratory tract infections (sinusitis, tonsillitis, otitis media, pharyngitis)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0041912
- UMLS CUI [1,2]
- C2945760
- UMLS CUI [2]
- C0029882
- UMLS CUI [3]
- C0037199
- UMLS CUI [4]
- C0040425
- UMLS CUI [5]
- C0031350
Beschreibung
Herpes zoster
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0019360
Beschreibung
Angular cheilitis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0221237
Beschreibung
Recurrent oral ulceration
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2945760
- UMLS CUI [1,2]
- C0149745
Beschreibung
Papular pruritic eruptions
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519353
- UMLS CUI [1,2]
- C0033774
- UMLS CUI [1,3]
- C0037274
Beschreibung
Seborrhoeic dermatitis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0036508
Beschreibung
Fungal nail infection
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0026946
- UMLS CUI [1,2]
- C0343026
Beschreibung
HIV infection WHO clinical stage 3
Alias
- UMLS CUI-1
- C1536040
Beschreibung
over 10 per cent of presumed or measured body weight Unexplained refers to where the condition is not explained by other conditions
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1828173
- UMLS CUI [1,2]
- C1319166
Beschreibung
for longer than one month Unexplained refers to where the condition is not explained by other conditions
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0011991
- UMLS CUI [1,2]
- C4288071
- UMLS CUI [1,3]
- C0008679
Beschreibung
intermittent or constant for longer than one month. Unexplained refers to where the condition is not explained by other conditions
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C4288071
- UMLS CUI [1,2]
- C0476474
Beschreibung
Persistent oral candidiasis
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0006849
- UMLS CUI [1,2]
- C0205322
Beschreibung
changed from "leukopenia" (in the original file) to "leukoplakia" (in this electronic document) due to context
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1304455
Beschreibung
Pulmonary tuberculosis (current)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0041327
- UMLS CUI [1,2]
- C0521116
Beschreibung
Severe bacterial infections (e.g. pneumonia, empyema, pyomyositis, bone or joint infection, meningitis, bacteraemia, severe pelvic inflammatory disease)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0004623
- UMLS CUI [1,2]
- C1292730
- UMLS CUI [2]
- C0032285
- UMLS CUI [3]
- C0014009
- UMLS CUI [4]
- C1704275
- UMLS CUI [5]
- C0029443
- UMLS CUI [6]
- C0157749
- UMLS CUI [7]
- C0025289
- UMLS CUI [8]
- C0004610
- UMLS CUI [9,1]
- C0242172
- UMLS CUI [9,2]
- C1292730
Beschreibung
Acute necrotizing ulcerative stomatitis, gingivitis or periodontitis
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0017575
- UMLS CUI [1,2]
- C0205178
- UMLS CUI [2,1]
- C0205178
- UMLS CUI [2,2]
- C0392103
- UMLS CUI [3]
- C0472840
Beschreibung
Unexplained refers to where the condition is not explained by other conditions. Cut-offs: anaemia: below 8 g/dl neutropenia: below 0.5 x 10^9/l thrombocytopenia: below 50 x 10^9/l
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C4288071
- UMLS CUI [1,2]
- C0027947
- UMLS CUI [2,1]
- C4288071
- UMLS CUI [2,2]
- C0205191
- UMLS CUI [2,3]
- C0040034
- UMLS CUI [3,1]
- C4288071
- UMLS CUI [3,2]
- C0002871
Beschreibung
HIV infection WHO clinical stage 4
Alias
- UMLS CUI-1
- C1536041
Beschreibung
HIV wasting syndrome
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0343755
Beschreibung
Pneumocystis pneumonia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1535939
Beschreibung
Recurrent bacterial pneumonia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1844383
- UMLS CUI [1,2]
- C0032285
Beschreibung
orolabial, genital or anorectal of more than one month’s duration or visceral at any site
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0019348
- UMLS CUI [1,2]
- C0008679
Beschreibung
Oesophageal candidiasis (or candidiasis of trachea, bronchi or lungs)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0239295
- UMLS CUI [2]
- C0343862
- UMLS CUI [3]
- C1536274
- UMLS CUI [4]
- C0153251
Beschreibung
Extrapulmonary tuberculosis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0679362
Beschreibung
Kaposi sarcoma
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0036220
Beschreibung
retinitis or infection of other organs
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0010823
Beschreibung
Central nervous system toxoplasmosis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0751629
Beschreibung
HIV encephalopathy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0206019
Beschreibung
Extrapulmonary cryptococcosis including meningitis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0343890
- UMLS CUI [2]
- C1394255
Beschreibung
Disseminated non-tuberculous mycobacteria infection
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205221
- UMLS CUI [1,2]
- C1265234
- UMLS CUI [1,3]
- C0009450
Beschreibung
Progressive multifocal leukoencephalopathy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0023524
Beschreibung
Chronic cryptosporidiosis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0239055
Beschreibung
Chronic isosporiasis
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0311386
- UMLS CUI [1,2]
- C0205191
Beschreibung
Disseminated mycosis (coccidiomycosis or histoplasmosis)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0553576
- UMLS CUI [2,1]
- C0262426
- UMLS CUI [2,2]
- C0205221
- UMLS CUI [3,1]
- C0019655
- UMLS CUI [3,2]
- C0205221
Beschreibung
Recurrent septicemia (including non-typhoidal Salmonella)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0349437
- UMLS CUI [1,2]
- C2945607
- UMLS CUI [2,1]
- C0036690
- UMLS CUI [2,2]
- C2945760
Beschreibung
Lymphoma (cerebral or B cell non-Hodgkin)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0240803
- UMLS CUI [2,1]
- C0024305
- UMLS CUI [2,2]
- C0079731
Beschreibung
Invasive cervical carcinoma
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1334177
Beschreibung
Atypical disseminated leishmaniasis
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0860236
- UMLS CUI [1,2]
- C0205182
Beschreibung
Symptomatic HIV-associated nephropathy or HIV-associated cardiomyopathy
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0078911
- UMLS CUI [1,2]
- C0231220
- UMLS CUI [2]
- C2721728
Ähnliche Modelle
WHO Clinical Staging of HIV
- StudyEvent: ODM
C0205210 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
C0205210 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,2])
C0205246 (UMLS CUI [1,3])
C1319166 (UMLS CUI [1,2])
C2945760 (UMLS CUI [1,2])
C0029882 (UMLS CUI [2])
C0037199 (UMLS CUI [3])
C0040425 (UMLS CUI [4])
C0031350 (UMLS CUI [5])
C0149745 (UMLS CUI [1,2])
C0033774 (UMLS CUI [1,2])
C0037274 (UMLS CUI [1,3])
C0343026 (UMLS CUI [1,2])
C1319166 (UMLS CUI [1,2])
C4288071 (UMLS CUI [1,2])
C0008679 (UMLS CUI [1,3])
C0476474 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
C1292730 (UMLS CUI [1,2])
C0032285 (UMLS CUI [2])
C0014009 (UMLS CUI [3])
C1704275 (UMLS CUI [4])
C0029443 (UMLS CUI [5])
C0157749 (UMLS CUI [6])
C0025289 (UMLS CUI [7])
C0004610 (UMLS CUI [8])
C0242172 (UMLS CUI [9,1])
C1292730 (UMLS CUI [9,2])
C0205178 (UMLS CUI [1,2])
C0205178 (UMLS CUI [2,1])
C0392103 (UMLS CUI [2,2])
C0472840 (UMLS CUI [3])
C0027947 (UMLS CUI [1,2])
C4288071 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0040034 (UMLS CUI [2,3])
C4288071 (UMLS CUI [3,1])
C0002871 (UMLS CUI [3,2])
C0032285 (UMLS CUI [1,2])
C0008679 (UMLS CUI [1,2])
C0343862 (UMLS CUI [2])
C1536274 (UMLS CUI [3])
C0153251 (UMLS CUI [4])
C1394255 (UMLS CUI [2])
C1265234 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
C0205191 (UMLS CUI [1,2])
C0262426 (UMLS CUI [2,1])
C0205221 (UMLS CUI [2,2])
C0019655 (UMLS CUI [3,1])
C0205221 (UMLS CUI [3,2])
C2945607 (UMLS CUI [1,2])
C0036690 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0024305 (UMLS CUI [2,1])
C0079731 (UMLS CUI [2,2])
C0205182 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,2])
C2721728 (UMLS CUI [2])