ID
38431
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 information on a large swelling reaction and is to be filled in at the Interim Analysis at/after Visit 6 and at the End of Study Analysis at/after Visit 10. Please complete this form for: (a) any local swelling with diameter > 50 mm, and/or (b) any noticeable diffuse injection site swelling (diameter not measurable), and/or (c) any noticeable increased circumference of the injected limb. If hospitalization is required, a Serious Adverse Event (SAE) form is to be completed as well and send to the sponsor (GlaxoSmithKline Biologicals) within 24 hours after becoming aware of the SAE.
Nyckelord
Versioner (2)
- 2019-08-28 2019-08-28 -
- 2019-10-17 2019-10-17 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
17 oktober 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
Large Swelling Reaction
- StudyEvent: ODM
Beskrivning
Large Swelling Reaction - Report of physical examination
Alias
- UMLS CUI-1
- C0038999
- UMLS CUI-2
- C0443286
- UMLS CUI-3
- C0031809
Beskrivning
Date of physical examination
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0011008
Beskrivning
Examination performed by study member during large swelling reaction period
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0035173
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C0038999
- UMLS CUI [1,5]
- C0443286
- UMLS CUI [1,6]
- C1948053
Beskrivning
Date when swelling first considered a large swelling
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C0456389
- UMLS CUI [1,4]
- C0205435
- UMLS CUI [1,5]
- C1698059
- UMLS CUI [1,6]
- C0549177
Beskrivning
Time after vaccination
Datatyp
integer
Måttenheter
- h
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C1948053
- UMLS CUI [1,3]
- C0687676
- UMLS CUI [1,4]
- C0042196
Beskrivning
Measurement of the greatest diameter
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Beskrivning
Please specify in "Case description" section
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0332307
Beskrivning
at the site of maximum swelling
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0424682
- UMLS CUI [1,2]
- C0015385
- UMLS CUI [1,3]
- C0038999
Beskrivning
at the same level
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0424682
- UMLS CUI [1,2]
- C0015385
- UMLS CUI [1,3]
- C1521805
Beskrivning
Please record the temperature. If temperature has been taken more than once a day please report the highest value. Please check a Yes/No item for each symptom occurring during the extensive swelling period. If other symptoms are associated with the large swelling reaction: please specify in "Case Description" section
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0886414
Beskrivning
Route of temperature measurement
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C0449444
Beskrivning
if yes, fill in size in next item
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0332575
Beskrivning
largest diameter
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
Beskrivning
if yes, fill in size in next item
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0332534
Beskrivning
largest diameter
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0332534
- UMLS CUI [1,2]
- C0456389
Beskrivning
if yes, record intensity in next item
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0030193
Beskrivning
Intensity of pain at administration site
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0521491
- UMLS CUI [1,2]
- C0518690
Beskrivning
if yes, record intensity in next item
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C4062321
Beskrivning
Intensity of functional impairment
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C4062321
- UMLS CUI [1,2]
- C0518690
Beskrivning
Large swelling reaction - Clinical case desciption and outcome of the adverse event
Alias
- UMLS CUI-1
- C0038999
- UMLS CUI-2
- C0443286
- UMLS CUI-3
- C0678257
- UMLS CUI-4
- C0205210
- UMLS CUI-5
- C1705586
Beskrivning
Please give a clinical description of the observed large swelling reaction, including a description of the joint involved and specific associated symptoms. Please mention also eventual dignostic(s) procedures and therapeutic interventions. The original Case Report PDF includes schematic frontal sketches of a baby and a child.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C0868928
Beskrivning
Last date when the swelling was still considered to be a large swelling reaction
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C1698059
- UMLS CUI [1,3]
- C0549177
- UMLS CUI [1,4]
- C1698059
- UMLS CUI [1,5]
- C0806020
Beskrivning
If swelling lasting for less than 24 hours, please specify duration
Datatyp
integer
Måttenheter
- h
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0449238
Beskrivning
Outcome of the large swellling reaction
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0085565
- UMLS CUI [1,2]
- C0038999
Beskrivning
If yes, specify in following item
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0681841
- UMLS CUI [2]
- C0020517
- UMLS CUI [3]
- C0009450
- UMLS CUI [4]
- C3714660
- UMLS CUI [5]
- C0009488
Beskrivning
if applicable
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0681841
- UMLS CUI [1,4]
- C2348235
Similar models
Large Swelling Reaction
- StudyEvent: ODM
C0443286 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0035173 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0443286 (UMLS CUI [1,5])
C1948053 (UMLS CUI [1,6])
C0038999 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C0205435 (UMLS CUI [1,4])
C1698059 (UMLS CUI [1,5])
C0549177 (UMLS CUI [1,6])
C1948053 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
C0456389 (UMLS CUI [1,2])
C0015385 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
C0015385 (UMLS CUI [1,2])
C1521805 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0332534 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C4062321 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0443286 (UMLS CUI-2)
C0678257 (UMLS CUI-3)
C0205210 (UMLS CUI-4)
C1705586 (UMLS CUI-5)
C0868928 (UMLS CUI [1,2])
C1698059 (UMLS CUI [1,2])
C0549177 (UMLS CUI [1,3])
C1698059 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
C0449238 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0681841 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
C3714660 (UMLS CUI [4])
C0009488 (UMLS CUI [5])
C0205394 (UMLS CUI [1,2])
C0681841 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])