ID
37887
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 to be used in case of a meningitis, and e.g. includes information on symptoms and lumbar puncture. This form shall be filled in in addition to a regular SAE form.
Stichworte
Versionen (1)
- 28.08.19 28.08.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
28. August 2019
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010
Meningitis Report
- StudyEvent: ODM
Beschreibung
Section 1: Clinical Symptoms
Alias
- UMLS CUI-1
- C1457887
Beschreibung
Please complete itemgroup repeatedly for each symptom/sign
Datentyp
integer
Alias
- UMLS CUI [1]
- C0037088
Beschreibung
Signs and Symptoms, Assesment
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1441672
- UMLS CUI [1,2]
- C0037088
Beschreibung
Section 2: Blood Test
Alias
- UMLS CUI-1
- C0005834
Beschreibung
Date of blood test
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beschreibung
Antibiotic treatment initiated prior to blood culture
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0338237
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0200949
Beschreibung
Species in blood culture
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0200949
- UMLS CUI [1,2]
- C1705920
Beschreibung
Serology results
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0036743
- UMLS CUI [1,2]
- C1274040
Beschreibung
Other blood tests
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0022885
Beschreibung
Section 3: Lumbar Puncture
Alias
- UMLS CUI-1
- C0553794
Beschreibung
Date of lumbar puncture
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0553794
- UMLS CUI [1,2]
- C0011008
Beschreibung
Antibiotic treatment prior lumbar puncture
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0338237
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0553794
Beschreibung
Select all appearance items that apply
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0007806
- UMLS CUI [1,2]
- C2963144
Beschreibung
Select all appearance items that apply
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0007806
- UMLS CUI [1,2]
- C0311420
Beschreibung
Select all appearance items that apply
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0007806
- UMLS CUI [1,2]
- C0439665
Beschreibung
Select all appearance items that apply
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0007806
- UMLS CUI [1,2]
- C0333275
Beschreibung
CSF: Total WBC count
Datentyp
float
Maßeinheiten
- x 10^6/L
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C0007806
Beschreibung
give one of the two Polymorphonuclears (PMNs) units (percentage/absolute)
Datentyp
float
Maßeinheiten
- % of total WBC
Alias
- UMLS CUI [1,1]
- C1168338
- UMLS CUI [1,2]
- C1549488
- UMLS CUI [1,3]
- C0007806
Beschreibung
give one of the two Polymorphonuclears (PMNs) units (percentage/absolute)
Datentyp
float
Maßeinheiten
- x 10^6/L
Alias
- UMLS CUI [1,1]
- C1168338
- UMLS CUI [1,2]
- C0007806
Beschreibung
record one of the two Mononuclear lymphocyte units (percentage/absolute)
Datentyp
float
Maßeinheiten
- % of total WBC
Alias
- UMLS CUI [1,1]
- C1513475
- UMLS CUI [1,2]
- C0200635
- UMLS CUI [1,3]
- C1549488
- UMLS CUI [1,4]
- C0007806
Beschreibung
record one of the two Mononuclear lymphocyte units (percentage/absolute)
Datentyp
float
Maßeinheiten
- x 10^6/L
Alias
- UMLS CUI [1,1]
- C1513475
- UMLS CUI [1,2]
- C0200635
- UMLS CUI [1,3]
- C0007806
Beschreibung
CSF: Total RBC count
Datentyp
float
Maßeinheiten
- x 10^6/L
Alias
- UMLS CUI [1,1]
- C0014772
- UMLS CUI [1,2]
- C0007806
Beschreibung
CSF: Protein content
Datentyp
float
Maßeinheiten
- g/L
Alias
- UMLS CUI [1,1]
- C0555903
- UMLS CUI [1,2]
- C0007806
Beschreibung
Record in mmol/L, g/L or percentage
Datentyp
float
Maßeinheiten
- mmol/L
Alias
- UMLS CUI [1,1]
- C0337438
- UMLS CUI [1,2]
- C0007806
Beschreibung
Record in mmol/L, g/L or percentage
Datentyp
float
Maßeinheiten
- g/L
Alias
- UMLS CUI [1,1]
- C0337438
- UMLS CUI [1,2]
- C0007806
Beschreibung
Record in mmol/L, g/L or percentage
Datentyp
float
Maßeinheiten
- % plasma glucose concentration
Alias
- UMLS CUI [1,1]
- C0337438
- UMLS CUI [1,2]
- C0007806
Beschreibung
Record in g/L or mmol/L
Datentyp
float
Maßeinheiten
- g/L
Alias
- UMLS CUI [1]
- C0202042
Beschreibung
Record in g/L or mmol/L
Datentyp
float
Maßeinheiten
- mmol/L
Alias
- UMLS CUI [1]
- C0202042
Beschreibung
Gram stain result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0061856
- UMLS CUI [1,2]
- C1274040
Beschreibung
CSF Culture: Species 1
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0007806
- UMLS CUI [1,2]
- C0430400
- UMLS CUI [1,3]
- C1705920
Beschreibung
CSF Culture: Serotype/group 1
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0007806
- UMLS CUI [1,2]
- C0430400
- UMLS CUI [1,3]
- C0449943
Beschreibung
CSF Culture: Species 2
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0007806
- UMLS CUI [1,2]
- C0430400
- UMLS CUI [1,3]
- C1705920
Beschreibung
CSF Culture: Serotype/group 2
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0007806
- UMLS CUI [1,2]
- C0430400
- UMLS CUI [1,3]
- C0449943
Beschreibung
CSF Latex agglutination test (LAT)
Datentyp
text
Alias
- UMLS CUI [1]
- C2026623
Beschreibung
(e.g. Binax Now)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0729856
- UMLS CUI [1,3]
- C0007806
Beschreibung
Other CSF antigen detection test result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0729856
- UMLS CUI [1,3]
- C0007806
- UMLS CUI [1,4]
- C1274040
Beschreibung
CSF PCR Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2026647
- UMLS CUI [1,2]
- C1274040
Beschreibung
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Beschreibung
Type of report
Datentyp
integer
Alias
- UMLS CUI [1]
- C0585733
Beschreibung
Please do not forget to complete a Serious Adverse Event Form
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Printed Investigator's name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Date of investigator's signature
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Ähnliche Modelle
Meningitis Report
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0684224 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0025289 (UMLS CUI [1,3])
C2347796 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,2])
C0200949 (UMLS CUI [1,3])
C1705920 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,2])
C0553794 (UMLS CUI [1,3])
C2963144 (UMLS CUI [1,2])
C0311420 (UMLS CUI [1,2])
C0439665 (UMLS CUI [1,2])
C0333275 (UMLS CUI [1,2])
C0007806 (UMLS CUI [1,2])
C1549488 (UMLS CUI [1,2])
C0007806 (UMLS CUI [1,3])
C0007806 (UMLS CUI [1,2])
C0200635 (UMLS CUI [1,2])
C1549488 (UMLS CUI [1,3])
C0007806 (UMLS CUI [1,4])
C0200635 (UMLS CUI [1,2])
C0007806 (UMLS CUI [1,3])
C0007806 (UMLS CUI [1,2])
C0007806 (UMLS CUI [1,2])
C0007806 (UMLS CUI [1,2])
C0007806 (UMLS CUI [1,2])
C0007806 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0430400 (UMLS CUI [1,2])
C1705920 (UMLS CUI [1,3])
C0430400 (UMLS CUI [1,2])
C0449943 (UMLS CUI [1,3])
C0430400 (UMLS CUI [1,2])
C1705920 (UMLS CUI [1,3])
C0430400 (UMLS CUI [1,2])
C0449943 (UMLS CUI [1,3])
C0729856 (UMLS CUI [1,2])
C0007806 (UMLS CUI [1,3])
C0729856 (UMLS CUI [1,2])
C0007806 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
C1274040 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Keine Kommentare