ID

37887

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 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.

Keywords

Versions (1)
  1. 8/28/19 8/28/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 28, 2019

DOI

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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

Meningitis Report

1 forms  
  1. StudyEvent: ODM
    1. Meningitis Report
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
Country
Description

Country

Data type

text

Alias
UMLS CUI [1]
C0454664
Center Number
Description

Center Number

Data type

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Treatment Number
Description

Treatment Number

Data type

integer

Alias
UMLS CUI [1,1]
C1522541
UMLS CUI [1,2]
C0600091
Attached to SAE Report No
Description

Attached to SAE Report No

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0684224
UMLS CUI [1,3]
C0237753
Meningitis Report No
Description

Meningitis Report No

Data type

integer

Alias
UMLS CUI [1,1]
C0684224
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0025289
Sponsor receipt date
Description

(for GSK use)

Data type

date

Alias
UMLS CUI [1,1]
C2985846
UMLS CUI [1,2]
C2347796
Type of report
Description

Type of report

Data type

integer

Alias
UMLS CUI [1]
C0585733
Date of first symptoms
Description

Date of first symptoms

Data type

date

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0011008
Section 1: Clinical Symptoms
Description

Section 1: Clinical Symptoms

Alias
UMLS CUI-1
C1457887
Signs and Symptoms
Description

Please complete itemgroup repeatedly for each symptom/sign

Data type

integer

Alias
UMLS CUI [1]
C0037088
Was the symptom observed/present?
Description

Signs and Symptoms, Assesment

Data type

integer

Alias
UMLS CUI [1,1]
C1441672
UMLS CUI [1,2]
C0037088
Section 2: Blood Test
Description

Section 2: Blood Test

Alias
UMLS CUI-1
C0005834
Date of blood test
Description

Date of blood test

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Was antibiotic treatment initiated prior to the blood culture?
Description

Antibiotic treatment initiated prior to blood culture

Data type

integer

Alias
UMLS CUI [1,1]
C0338237
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0200949
Species in blood culture
Description

Species in blood culture

Data type

text

Alias
UMLS CUI [1,1]
C0200949
UMLS CUI [1,2]
C1705920
Serology results
Description

Serology results

Data type

text

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C1274040
Other blood tests
Description

Other blood tests

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0022885
Section 3: Lumbar Puncture
Description

Section 3: Lumbar Puncture

Alias
UMLS CUI-1
C0553794
Date of lumbar puncture
Description

Date of lumbar puncture

Data type

date

Alias
UMLS CUI [1,1]
C0553794
UMLS CUI [1,2]
C0011008
Was antibiotic treatment initiated prior to the lumbar puncture?
Description

Antibiotic treatment prior lumbar puncture

Data type

integer

Alias
UMLS CUI [1,1]
C0338237
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0553794
CSF appearance: Clear
Description

Select all appearance items that apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0007806
UMLS CUI [1,2]
C2963144
CSF appearance: Turbid
Description

Select all appearance items that apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0007806
UMLS CUI [1,2]
C0311420
CSF appearance: purulent
Description

Select all appearance items that apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0007806
UMLS CUI [1,2]
C0439665
CSF appearance: Hematic
Description

Select all appearance items that apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0007806
UMLS CUI [1,2]
C0333275
CSF: Total WBC count
Description

CSF: Total WBC count

Data type

float

Measurement units
  • x 10^6/L
Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C0007806
x 10^6/L
CSF: Polymorphonuclears (PMNs) percentage
Description

give one of the two Polymorphonuclears (PMNs) units (percentage/absolute)

Data type

float

Measurement units
  • % of total WBC
Alias
UMLS CUI [1,1]
C1168338
UMLS CUI [1,2]
C1549488
UMLS CUI [1,3]
C0007806
% of total WBC
CSF: Polymorphonuclears (PMNs) absolute
Description

give one of the two Polymorphonuclears (PMNs) units (percentage/absolute)

Data type

float

Measurement units
  • x 10^6/L
Alias
UMLS CUI [1,1]
C1168338
UMLS CUI [1,2]
C0007806
x 10^6/L
CSF: Mononuclear lymphocytes percentage
Description

record one of the two Mononuclear lymphocyte units (percentage/absolute)

Data type

float

Measurement units
  • % of total WBC
Alias
UMLS CUI [1,1]
C1513475
UMLS CUI [1,2]
C0200635
UMLS CUI [1,3]
C1549488
UMLS CUI [1,4]
C0007806
% of total WBC
CSF: Mononuclear lymphocytes absolute
Description

record one of the two Mononuclear lymphocyte units (percentage/absolute)

Data type

float

Measurement units
  • x 10^6/L
Alias
UMLS CUI [1,1]
C1513475
UMLS CUI [1,2]
C0200635
UMLS CUI [1,3]
C0007806
x 10^6/L
CSF: Total RBC count
Description

CSF: Total RBC count

Data type

float

Measurement units
  • x 10^6/L
Alias
UMLS CUI [1,1]
C0014772
UMLS CUI [1,2]
C0007806
x 10^6/L
CSF: Protein content
Description

CSF: Protein content

Data type

float

Measurement units
  • g/L
Alias
UMLS CUI [1,1]
C0555903
UMLS CUI [1,2]
C0007806
g/L
CSF Glucose content
Description

Record in mmol/L, g/L or percentage

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1,1]
C0337438
UMLS CUI [1,2]
C0007806
mmol/L
CSF Glucose content
Description

Record in mmol/L, g/L or percentage

Data type

float

Measurement units
  • g/L
Alias
UMLS CUI [1,1]
C0337438
UMLS CUI [1,2]
C0007806
g/L
CSF Glucose content
Description

Record in mmol/L, g/L or percentage

Data type

float

Measurement units
  • % plasma glucose concentration
Alias
UMLS CUI [1,1]
C0337438
UMLS CUI [1,2]
C0007806
% plasma glucose concentration
Plasma glucose concentration
Description

Record in g/L or mmol/L

Data type

float

Measurement units
  • g/L
Alias
UMLS CUI [1]
C0202042
g/L
Plasma glucose concentration
Description

Record in g/L or mmol/L

Data type

float

Measurement units
  • mmol/L
Alias
UMLS CUI [1]
C0202042
mmol/L
Gram stain result
Description

Gram stain result

Data type

text

Alias
UMLS CUI [1,1]
C0061856
UMLS CUI [1,2]
C1274040
CSF Culture: Species 1
Description

CSF Culture: Species 1

Data type

text

Alias
UMLS CUI [1,1]
C0007806
UMLS CUI [1,2]
C0430400
UMLS CUI [1,3]
C1705920
CSF Culture: Serotype/group 1
Description

CSF Culture: Serotype/group 1

Data type

text

Alias
UMLS CUI [1,1]
C0007806
UMLS CUI [1,2]
C0430400
UMLS CUI [1,3]
C0449943
CSF Culture: Species 2
Description

CSF Culture: Species 2

Data type

text

Alias
UMLS CUI [1,1]
C0007806
UMLS CUI [1,2]
C0430400
UMLS CUI [1,3]
C1705920
CSF Culture: Serotype/group 2
Description

CSF Culture: Serotype/group 2

Data type

text

Alias
UMLS CUI [1,1]
C0007806
UMLS CUI [1,2]
C0430400
UMLS CUI [1,3]
C0449943
CSF Latex agglutination test (LAT)
Description

CSF Latex agglutination test (LAT)

Data type

text

Alias
UMLS CUI [1]
C2026623
Other CSF antigen detection test
Description

(e.g. Binax Now)

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0729856
UMLS CUI [1,3]
C0007806
Other CSF antigen detection test result
Description

Other CSF antigen detection test result

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0729856
UMLS CUI [1,3]
C0007806
UMLS CUI [1,4]
C1274040
CSF PCR Result
Description

CSF PCR Result

Data type

text

Alias
UMLS CUI [1,1]
C2026647
UMLS CUI [1,2]
C1274040
Investigator's signature
Description

Investigator's signature

Alias
UMLS CUI-1
C2346576
Type of report
Description

Type of report

Data type

integer

Alias
UMLS CUI [1]
C0585733
Investigator's signature
Description

Please do not forget to complete a Serious Adverse Event Form

Data type

text

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

Printed Investigator's name

Data type

text

Alias
UMLS CUI [1]
C2826892
Date of investigator's signature
Description

Date of investigator's signature

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Meningitis Report

1 forms
  1. StudyEvent: ODM
    1. Meningitis Report
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])
Country
Item
Country
text
C0454664 (UMLS CUI [1])
Center Number
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Treatment Number
Item
Treatment Number
integer
C1522541 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Attached to SAE Report No
Item
Attached to SAE Report No
integer
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Meningitis Report No
Item
Meningitis Report No
integer
C0684224 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0025289 (UMLS CUI [1,3])
Sponsor receipt date
Item
Sponsor receipt date
date
C2985846 (UMLS CUI [1,1])
C2347796 (UMLS CUI [1,2])
Item
Type of report
integer
C0585733 (UMLS CUI [1])
Type of report
Code List
Type of report
CL Item
Initial report (1)
CL Item
First follow-up (2)
CL Item
Second follow-up (3)
CL Item
Third follow-up (4)
Date of first symptoms
Item
Date of first symptoms
date
C1457887 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Section 1: Clinical Symptoms
C1457887 (UMLS CUI-1)
Item
Signs and Symptoms
integer
C0037088 (UMLS CUI [1])
Signs and Symptoms
Code List
Signs and Symptoms
CL Item
Fever (1)
CL Item
Headache (2)
CL Item
Stiff neck or positive Kernig's or Brudzinski's signs  (3)
CL Item
Nausea (4)
CL Item
Vomiting (5)
CL Item
Photophobia (discomfort from bright light)  (6)
CL Item
Confusion (7)
CL Item
Sleepiness  (8)
CL Item
Seizure  (9)
CL Item
Tensing or bulging of fontanel (10)
CL Item
Rash  (11)
CL Item
Petechia or purpuric rash  (12)
CL Item
Refusing to feed  (13)
CL Item
Irritable when picked up, with high pitched or moaning cry (14)
CL Item
A stiff body with jerky movements (15)
CL Item
Floppy body and lifeless  (16)
Item
Was the symptom observed/present?
integer
C1441672 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
Signs and Symptoms
Code List
Was the symptom observed/present?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item Group
Section 2: Blood Test
C0005834 (UMLS CUI-1)
Date of blood test
Item
Date of blood test
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Was antibiotic treatment initiated prior to the blood culture?
integer
C0338237 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0200949 (UMLS CUI [1,3])
Antibiotic treatment initiated prior to blood culture
Code List
Was antibiotic treatment initiated prior to the blood culture?
CL Item
No (1)
CL Item
Yes  (2)
CL Item
Unknown (3)
Species in blood culture
Item
Species in blood culture
text
C0200949 (UMLS CUI [1,1])
C1705920 (UMLS CUI [1,2])
Serology results
Item
Serology results
text
C0036743 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Other blood tests
Item
Other blood tests
text
C0205394 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Item Group
Section 3: Lumbar Puncture
C0553794 (UMLS CUI-1)
Date of lumbar puncture
Item
Date of lumbar puncture
date
C0553794 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Was antibiotic treatment initiated prior to the lumbar puncture?
integer
C0338237 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0553794 (UMLS CUI [1,3])
Antibiotic treatment prior lumbar puncture
Code List
Was antibiotic treatment initiated prior to the lumbar puncture?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
CSF appearance: Clear
Item
CSF appearance: Clear
boolean
C0007806 (UMLS CUI [1,1])
C2963144 (UMLS CUI [1,2])
CSF appearance: Turbid
Item
CSF appearance: Turbid
boolean
C0007806 (UMLS CUI [1,1])
C0311420 (UMLS CUI [1,2])
CSF appearance: purulent
Item
CSF appearance: purulent
boolean
C0007806 (UMLS CUI [1,1])
C0439665 (UMLS CUI [1,2])
CSF appearance: Hematic
Item
CSF appearance: Hematic
boolean
C0007806 (UMLS CUI [1,1])
C0333275 (UMLS CUI [1,2])
CSF: Total WBC count
Item
CSF: Total WBC count
float
C0023508 (UMLS CUI [1,1])
C0007806 (UMLS CUI [1,2])
CSF: Polymorphonuclears (PMNs) percentage
Item
CSF: Polymorphonuclears (PMNs) percentage
float
C1168338 (UMLS CUI [1,1])
C1549488 (UMLS CUI [1,2])
C0007806 (UMLS CUI [1,3])
CSF: Polymorphonuclears (PMNs) absolute
Item
CSF: Polymorphonuclears (PMNs) absolute
float
C1168338 (UMLS CUI [1,1])
C0007806 (UMLS CUI [1,2])
CSF: Mononuclear lymphocytes percentage
Item
CSF: Mononuclear lymphocytes percentage
float
C1513475 (UMLS CUI [1,1])
C0200635 (UMLS CUI [1,2])
C1549488 (UMLS CUI [1,3])
C0007806 (UMLS CUI [1,4])
CSF: Mononuclear lymphocytes absolute
Item
CSF: Mononuclear lymphocytes absolute
float
C1513475 (UMLS CUI [1,1])
C0200635 (UMLS CUI [1,2])
C0007806 (UMLS CUI [1,3])
CSF: Total RBC count
Item
CSF: Total RBC count
float
C0014772 (UMLS CUI [1,1])
C0007806 (UMLS CUI [1,2])
CSF: Protein content
Item
CSF: Protein content
float
C0555903 (UMLS CUI [1,1])
C0007806 (UMLS CUI [1,2])
CSF Glucose content
Item
CSF Glucose content
float
C0337438 (UMLS CUI [1,1])
C0007806 (UMLS CUI [1,2])
CSF Glucose content
Item
CSF Glucose content
float
C0337438 (UMLS CUI [1,1])
C0007806 (UMLS CUI [1,2])
CSF Glucose content
Item
CSF Glucose content
float
C0337438 (UMLS CUI [1,1])
C0007806 (UMLS CUI [1,2])
Plasma glucose concentration
Item
Plasma glucose concentration
float
C0202042 (UMLS CUI [1])
Plasma glucose concentration
Item
Plasma glucose concentration
float
C0202042 (UMLS CUI [1])
Gram stain result
Item
Gram stain result
text
C0061856 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
CSF Culture: Species 1
Item
CSF Culture: Species 1
text
C0007806 (UMLS CUI [1,1])
C0430400 (UMLS CUI [1,2])
C1705920 (UMLS CUI [1,3])
CSF Culture: Serotype/group 1
Item
CSF Culture: Serotype/group 1
text
C0007806 (UMLS CUI [1,1])
C0430400 (UMLS CUI [1,2])
C0449943 (UMLS CUI [1,3])
CSF Culture: Species 2
Item
CSF Culture: Species 2
text
C0007806 (UMLS CUI [1,1])
C0430400 (UMLS CUI [1,2])
C1705920 (UMLS CUI [1,3])
CSF Culture: Serotype/group 2
Item
CSF Culture: Serotype/group 2
text
C0007806 (UMLS CUI [1,1])
C0430400 (UMLS CUI [1,2])
C0449943 (UMLS CUI [1,3])
CSF Latex agglutination test (LAT)
Item
CSF Latex agglutination test (LAT)
text
C2026623 (UMLS CUI [1])
Other CSF antigen detection test
Item
Other CSF antigen detection test
text
C0205394 (UMLS CUI [1,1])
C0729856 (UMLS CUI [1,2])
C0007806 (UMLS CUI [1,3])
Other CSF antigen detection test result
Item
Other CSF antigen detection test result
text
C0205394 (UMLS CUI [1,1])
C0729856 (UMLS CUI [1,2])
C0007806 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
CSF PCR Result
Item
CSF PCR Result
text
C2026647 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Item
Type of report
integer
C0585733 (UMLS CUI [1])
Type of report
Code List
Type of report
CL Item
Initial report (1)
CL Item
First follow-up (2)
CL Item
Second follow-up (3)
CL Item
Third follow-up (4)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Date of investigator's signature
Item
Date of investigator's signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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