ID

37885

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 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.

Keywords

Versions (2)
  1. 8/28/19 8/28/19 -
  2. 10/17/19 10/17/19 - Sarah Riepenhausen
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

Large Swelling Reaction

1 forms  
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
Cohort
Description

Cohort

Data type

integer

Alias
UMLS CUI [1]
C0599755
Visit Type
Description

Visit Type

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Large Swelling Reaction - Report of physical examination
Description

Large Swelling Reaction - Report of physical examination

Alias
UMLS CUI-1
C0038999
UMLS CUI-2
C0443286
UMLS CUI-3
C0031809
Date of physical examination
Description

Date of physical examination

Data type

date

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0011008
Was the examination performed by a member of study personnel during the large swelling reaction period
Description

Examination performed by study member during large swelling reaction period

Data type

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0025082
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0038999
UMLS CUI [1,5]
C0443286
UMLS CUI [1,6]
C1948053
Date when the swelling was first considered to be a large swelling reaction
Description

Date when swelling first considered a large swelling

Data type

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
If occurring within 24 hours after vaccination, please specify how long after vaccination
Description

Time after vaccination

Data type

integer

Measurement units
  • h
Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C1948053
UMLS CUI [1,3]
C0687676
UMLS CUI [1,4]
C0042196
h
Size of swelling
Description

Measurement of the greatest diameter

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Type of swelling
Description

Please specify in "Case description" section

Data type

integer

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0332307
Circumference of swollen limb
Description

at the site of maximum swelling

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0424682
UMLS CUI [1,2]
C0015385
UMLS CUI [1,3]
C0038999
mm
Circumference of the opposite limb
Description

at the same level

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0424682
UMLS CUI [1,2]
C0015385
UMLS CUI [1,3]
C1521805
mm
Associated signs: Temperature measurement
Description

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

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0886414
°C
Route of temperature measurement
Description

Route of temperature measurement

Data type

text

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0449444
Associated signs: Redness
Description

if yes, fill in size in next item

Data type

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0332575
Size of Redness
Description

largest diameter

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
mm
Associated signs: Induration
Description

if yes, fill in size in next item

Data type

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0332534
Size of induration
Description

largest diameter

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332534
UMLS CUI [1,2]
C0456389
mm
Associated signs: Pain
Description

if yes, record intensity in next item

Data type

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0030193
Intensity of pain at administration site
Description

Intensity of pain at administration site

Data type

integer

Alias
UMLS CUI [1,1]
C0521491
UMLS CUI [1,2]
C0518690
Associated signs: functional impairment
Description

if yes, record intensity in next item

Data type

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C4062321
Intensity of functional impairment
Description

Intensity of functional impairment

Data type

integer

Alias
UMLS CUI [1,1]
C4062321
UMLS CUI [1,2]
C0518690
Large swelling reaction - Clinical case desciption and outcome of the adverse event
Description

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
Case description
Description

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.

Data type

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C0868928
Last date when the swelling was still considered to be a large swelling reaction:
Description

Last date when the swelling was still considered to be a large swelling reaction

Data type

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
If swelling lasting for less than 24 hours, please specify duration (hours)
Description

If swelling lasting for less than 24 hours, please specify duration

Data type

integer

Measurement units
  • h
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0449238
h
Outcome of the large swellling reaction
Description

Outcome of the large swellling reaction

Data type

integer

Alias
UMLS CUI [1,1]
C0085565
UMLS CUI [1,2]
C0038999
Is there an alternative explanation for the swelling? (e.g.: allergy, infection, trauma, underlying conditions)
Description

If yes, specify in following item

Data type

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
Specify alternative explanation for the swelling.
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0681841
UMLS CUI [1,4]
C2348235
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Similar models

Large Swelling Reaction

1 forms
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])
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
HIV-pos. (1)
CL Item
HIV-neg. exposed (2)
CL Item
HIV-neg. unexposed, 3+1 schedule (3)
CL Item
HIV-neg. unexposed, 3+0 schedule (4)
CL Item
HIV-neg. unexposed, 2+1 schedule (5)
Item
Visit Type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Interim Analysis at/after Visit 6 (1)
CL Item
End of Study Analysis at/after Visit 10 (2)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Large Swelling Reaction - Report of physical examination
C0038999 (UMLS CUI-1)
C0443286 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Date of physical examination
Item
Date of physical examination
date
C0031809 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Examination performed by study member during large swelling reaction period
Item
Was the examination performed by a member of study personnel during the large swelling reaction period
boolean
C0031809 (UMLS CUI [1,1])
C0025082 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,4])
C0443286 (UMLS CUI [1,5])
C1948053 (UMLS CUI [1,6])
Date when swelling first considered a large swelling
Item
Date when the swelling was first considered to be a large swelling reaction
date
C0011008 (UMLS CUI [1,1])
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])
Time after vaccination
Item
If occurring within 24 hours after vaccination, please specify how long after vaccination
integer
C2745955 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
Size of swelling
Item
Size of swelling
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Item
Type of swelling
integer
C0038999 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of swelling
Code List
Type of swelling
CL Item
Local swelling around injection site, not involving adjacent joint (1)
CL Item
Diffuse swelling, not involving adjacent joint (2)
CL Item
Swelling, involving adjacent joint (3)
Circumference of swollen limb
Item
Circumference of swollen limb
integer
C0424682 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
Circumference of the opposite limb
Item
Circumference of the opposite limb
integer
C0424682 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C1521805 (UMLS CUI [1,3])
Associated signs: Temperature measurement
Item
Associated signs: Temperature measurement
float
C0886414 (UMLS CUI [1])
Item
Route of temperature measurement
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Route of temperature measurement
Code List
Route of temperature measurement
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
Associated signs: Redness
Item
Associated signs: Redness
boolean
C0037088 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Size of Redness
Item
Size of Redness
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Associated signs: Induration
Item
Associated signs: Induration
boolean
C0037088 (UMLS CUI [1,1])
C0332534 (UMLS CUI [1,2])
Size of induration
Item
Size of induration
integer
C0332534 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Associated signs: Pain
Item
Associated signs: Pain
boolean
C0037088 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Item
Intensity of pain at administration site
integer
C0521491 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Intensity of pain at injection site
Code List
Intensity of pain at administration site
CL Item
Grade 1: Minor reaction to touch (1)
CL Item
Grade 2: Cries / protests on touch (2)
CL Item
Grade 3: Cries when limb is moved /spontaneously painful (3)
Associated signs: functional impairment
Item
Associated signs: functional impairment
boolean
C0037088 (UMLS CUI [1,1])
C4062321 (UMLS CUI [1,2])
Item
Intensity of functional impairment
integer
C4062321 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Intensity of functional impairment
Code List
Intensity of functional impairment
CL Item
Grade 1: Easily tolerated, causing minimal discomfort and not interfering with everyday activities (1)
CL Item
Grade 2: Sufficiently discomforting to interfere with normal everyday activities (2)
CL Item
Grade 3: Prevents normal everyday activities. (3)
Item Group
Large swelling reaction - Clinical case desciption and outcome of the adverse event
C0038999 (UMLS CUI-1)
C0443286 (UMLS CUI-2)
C0678257 (UMLS CUI-3)
C0205210 (UMLS CUI-4)
C1705586 (UMLS CUI-5)
Case description
Item
Case description
text
C0678257 (UMLS CUI [1,1])
C0868928 (UMLS CUI [1,2])
Last date when the swelling was still considered to be a large swelling reaction
Item
Last date when the swelling was still considered to be a large swelling reaction:
date
C0038999 (UMLS CUI [1,1])
C1698059 (UMLS CUI [1,2])
C0549177 (UMLS CUI [1,3])
C1698059 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
If swelling lasting for less than 24 hours, please specify duration
Item
If swelling lasting for less than 24 hours, please specify duration (hours)
integer
C0038999 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item
Outcome of the large swellling reaction
integer
C0085565 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
9. Outcome of the large swellling reaction
Code List
Outcome of the large swellling reaction
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered/ not resolved (please provide further follow-up data) (3)
CL Item
Recovered with sequelae / resolved with sequelae (please specify under "Case Description" section) (4)
Is there an alternative explanation for the swelling (e.g.: allergy, infection, trauma, underlying conditions)
Item
Is there an alternative explanation for the swelling? (e.g.: allergy, infection, trauma, underlying conditions)
boolean
C0038999 (UMLS CUI [1,1])
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])
Specify alternative explanation for the swelling
Item
Specify alternative explanation for the swelling.
text
C0038999 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0681841 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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