ID
38429
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 solicited adverse events (local and general symptoms ) in the first 3 days after the study vaccinations, as well as whether the subject has experienced unsolicited (serious) adverse events. Details of unsolicited adverse events are to be given in a different form. This form is to be filled in after the vaccination Visits, i.e. Visits 1, 2, 3 and 8 (all cohorts) and additionally Visit 5 for all cohorts except for the 3+0 schedule without the booster vaccination in HIV-negative subjects.
Keywords
Versions (2)
- 9/2/19 9/2/19 -
- 10/17/19 10/17/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
October 17, 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
Solicited and unsolicited adverse events
- StudyEvent: ODM
Description
Solicited Adverse Events - Local Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
Description
Fill in entire item group once per vaccine The 10Pn-PD-DiT vaccine is administered at Visits 1 (all cohorts), 2 (all cohorts except the 2+1 schedule HIV-neg. cohort), 3 (all cohorts) and 5 (all cohorts except the EPI/3+0 schedule HIV-neg. cohort). The DTPw-HBV/Hib vaccine is administered at Visits 1, 2, 3 and 8 (all cohorts).
Data type
integer
Alias
- UMLS CUI [1]
- C0042196
Description
Redness, Swelling, Pain
Data type
text
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C2700396
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C1948053
Description
Fill in entire item group once per symptom
Data type
integer
Alias
- UMLS CUI [1]
- C1457887
Description
If yes, give either Size on Days 0-3 for Redness and Swelling or Pain Intensity on Days 0-3 for Pain. In case of large swelling reaction at the injected limb, please fill in ALSO the Large Swelling Reaction forms.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0150312
Description
for Redness and Swelling
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0456389
Description
for Redness and Swelling
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0456389
Description
for Redness and Swelling
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0456389
Description
for Redness and Swelling
Data type
integer
Measurement units
- mm
Alias
- UMLS CUI [1]
- C0456389
Description
Intensity: 0 / 1 / 2 / 3
Data type
integer
Alias
- UMLS CUI [1]
- C1320357
Description
Intensity: 0 / 1 / 2 / 3
Data type
integer
Alias
- UMLS CUI [1]
- C1320357
Description
Intensity: 0 / 1 / 2 / 3
Data type
integer
Alias
- UMLS CUI [1]
- C1320357
Description
Intensity: 0 / 1 / 2 / 3
Data type
integer
Alias
- UMLS CUI [1]
- C1320357
Description
if yes, give last day of symptoms in next item
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0549178
Description
Last Day of Symptoms
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Description
Solicited Adverse Events - General Symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
Description
Fever, Irritability/Fussiness, Drowsiness, Loss of appetite; Diarrhoea, Vomiting (those two are only applicable after Visit 2 and 3, and only if the Rotavirus Vaccine has been administered)
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C1948053
Description
Fill in entire item group once per symptom Diarrhoea and Vomiting are only applicable if HRV has been administered (Visit 2 and 3)
Data type
integer
Alias
- UMLS CUI [1]
- C1457887
Description
If yes: For fever, selected route of measurement, answer whether fever has been measured on Days 0-3, and height of fever. For Irritability/Fussiness, Drowsiness and Loss of appetite, record symptom intensity on Days 0-3. For Vomiting and Diarrhoea (if appropriate), record number of vomiting/stool episodes per day on Days 0-3. Definition of fever: Axillary, Oral, Tympanic (oral conversion) >= 37.5 °C Rectal and Tympanic (rectal conversion) >= 38 °C
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0150312
Description
Fever, Site of measurement
Data type
text
Alias
- UMLS CUI [1,1]
- C0449687
- UMLS CUI [1,2]
- C0015967
Description
Temperature taken on Day 0?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C0884358
Description
if taken, please specify
Data type
float
Measurement units
- C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0015967
Description
Temperature taken on Day 1?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C0884358
Description
if taken, please specify
Data type
float
Measurement units
- C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0015967
Description
Temperature taken on Day 2?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C0884358
Description
if taken, please specify
Data type
float
Measurement units
- C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0015967
Description
Temperature taken on Day 3?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C0884358
Description
if taken, please specify
Data type
float
Measurement units
- C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0015967
Description
For Irritability/Fussiness: 0 = Behavior as usual 1 = Crying more than usual / no effect on normal activity 2 = Crying more than usual / interferes with normal activity 3 = Crying that cannot be comforted / prevents normal activity For Drowsiness: 0 = Behavior as usual 1 = Drowsiness easily tolerated 2 = Drowsiness that interferes with normal activity 3 = Drowsiness that prevents normal activity For Loss of appetite: 0 = Appetite as usual 1 = Eating less than usual / no effect on normal activity 2 = Eating less than usual / interferes with normal activity 3 = Not eating at all
Data type
integer
Alias
- UMLS CUI [1]
- C0518690
Description
For Irritability/Fussiness: 0 = Behavior as usual 1 = Crying more than usual / no effect on normal activity 2 = Crying more than usual / interferes with normal activity 3 = Crying that cannot be comforted / prevents normal activity For Drowsiness: 0 = Behavior as usual 1 = Drowsiness easily tolerated 2 = Drowsiness that interferes with normal activity 3 = Drowsiness that prevents normal activity For Loss of appetite: 0 = Appetite as usual 1 = Eating less than usual / no effect on normal activity 2 = Eating less than usual / interferes with normal activity 3 = Not eating at all
Data type
integer
Alias
- UMLS CUI [1]
- C0518690
Description
For Irritability/Fussiness: 0 = Behavior as usual 1 = Crying more than usual / no effect on normal activity 2 = Crying more than usual / interferes with normal activity 3 = Crying that cannot be comforted / prevents normal activity For Drowsiness: 0 = Behavior as usual 1 = Drowsiness easily tolerated 2 = Drowsiness that interferes with normal activity 3 = Drowsiness that prevents normal activity For Loss of appetite: 0 = Appetite as usual 1 = Eating less than usual / no effect on normal activity 2 = Eating less than usual / interferes with normal activity 3 = Not eating at all
Data type
integer
Alias
- UMLS CUI [1]
- C0518690
Description
For Irritability/Fussiness: 0 = Behavior as usual 1 = Crying more than usual / no effect on normal activity 2 = Crying more than usual / interferes with normal activity 3 = Crying that cannot be comforted / prevents normal activity For Drowsiness: 0 = Behavior as usual 1 = Drowsiness easily tolerated 2 = Drowsiness that interferes with normal activity 3 = Drowsiness that prevents normal activity For Loss of appetite: 0 = Appetite as usual 1 = Eating less than usual / no effect on normal activity 2 = Eating less than usual / interferes with normal activity 3 = Not eating at all
Data type
integer
Alias
- UMLS CUI [1]
- C0518690
Description
For Diarrhoae and Vomiting, record number of episodes per day
Data type
integer
Alias
- UMLS CUI [1,1]
- C0750480
- UMLS CUI [1,2]
- C0332189
- UMLS CUI [1,3]
- C0439505
Description
For Diarrhoae and Vomiting, record number of episodes per day
Data type
integer
Alias
- UMLS CUI [1,1]
- C0750480
- UMLS CUI [1,2]
- C0332189
- UMLS CUI [1,3]
- C0439505
Description
For Diarrhoae and Vomiting, record number of episodes per day
Data type
integer
Alias
- UMLS CUI [1,1]
- C0750480
- UMLS CUI [1,2]
- C0332189
- UMLS CUI [1,3]
- C0439505
Description
For Diarrhoae and Vomiting, record number of episodes per day
Data type
integer
Alias
- UMLS CUI [1,1]
- C0750480
- UMLS CUI [1,2]
- C0332189
- UMLS CUI [1,3]
- C0439505
Description
if yes, give last day of symptoms in next item
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0549178
Description
Last Day of Symptoms
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1517741
- UMLS CUI [1,3]
- C1457887
Description
NO: The adverse event is not causally related to administration of the study vaccine(s). There are other, more likely causes and administration of the study vaccine(s) is not suspected to have contributed to the adverse event. YES: There is a reasonable possibility that the vaccine contributed to the adverse event.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1457887
Description
Unsolicited Adverse Events
Alias
- UMLS CUI-1
- C0877248
Description
within one month (minimum 30 days)
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0042196
- UMLS CUI [1,3]
- C0687676
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C0042196
- UMLS CUI [2,3]
- C0687676
Similar models
Solicited and unsolicited adverse events
- StudyEvent: ODM
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C0220825 (UMLS CUI [1,3])
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C2700396 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C1948053 (UMLS CUI [1,4])
C0150312 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0347984 (UMLS CUI [1,2])
C1948053 (UMLS CUI [1,3])
C0150312 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
C0332189 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
C0332189 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
C0332189 (UMLS CUI [1,2])
C0439505 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])