ID

36002

Beschreibung

Study ID: 107007 Clinical Study ID: 107007 Study Title: A phase IIIb randomized, double-blind, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine compared to Prevenar™, when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines as a 3-dose primary immunization course during the first 6 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00344318 https://clinicaltrials.gov/ct2/show/NCT00344318 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal conjugate vaccine GSK1024850A Trade Name: Prevenar, Tritanrix-HepB, Hiberix, Polio Sabin., Poliorix Study Indication: Infections, Streptococcal This study consists of 2 groups of probands (Children of 6-10-14 weeks or 2-4-6 months of age are included): One group receive a 3-dose primary vaccination with the GSK Biologicals' (10-valent) pneumococcal conjugate vaccine. The other group r eceive a 3-dose primary vaccination with Prevenar™. All probands receive DTPw-HBV/Hib and OPV or IPV vaccines. Ths study consists of 3 workbooks (WB): WB 1: The WB 1 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 1; Age for 10 weeks scheduled Visit 3, Timing: Month 2; Age for 14 weeks scheduled Visit 4, Timing: Month 3; Age for +/- 4 months scheduled Intervals between the visits: Visit 1 to Visit 2: 28-42 days, Visit 2 to Visit 3: 28-42 days, Visit 3 to Visit 4: 30-42 days WB 2: The WB 2 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 2; Age for +/- 4 months scheduled Visit 3, Timing: Month 4; Age for +/- 6 months scheduled Visit 4, Timing: Month 5; Age for +/- 7 months scheduled Intervals between the visits: Visit 1 to Visit 2: 49-83 days, Visit 2 to Visit 3: 49-83 days, Visit 3 to Visit 4: 30-42 days WB 3: The WB 3 consists the phone contact (6 months safety follow-up), Timing: Month 8 or 10. This document contains the Solicited adverse events - local and general symptoms and Unsolicited AE form. It has to be filled in for WB 1 and WB 2 for Visit 1-3.

Link

https://clinicaltrials.gov/ct2/show/NCT00344318

Stichworte

Versionen (2)
  1. 09.04.19 09.04.19 -
  2. 15.04.19 15.04.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

9. April 2019

DOI

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Creative Commons BY-NC 3.0
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Safety, reactogenicity and immunogenicity 10-valent pneumococcal conjugate vaccine compared to Prevenar™, co-administration of DTPw-HBV/Hib and OPV or IPV vaccines in infants, NCT00344318

Englisch

Solicited adverse events - local and general symptoms, Unsolicited AE

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Workbook Number
Beschreibung

Workbook Number

Datentyp

integer

Alias
UMLS CUI [1]
C2986015
Visit type
Beschreibung

Visit type

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Visit date
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Solicited adverse events - local symptoms
Beschreibung

Solicited adverse events - local symptoms

Alias
UMLS CUI-1
C1517001
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
UMLS CUI-4
C0042196
Vaccine
Beschreibung

"IPV vaccine": Only to be filled in for Workbook 2

Datentyp

integer

For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Beschreibung

If you tick yes, please complete No/Yes for each symptom in the following Items. If you tick yes by the symptom please complete all other items too.

Datentyp

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C2368628
Local symptoms
Beschreibung

Local symptoms

Datentyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Presence of symptom
Beschreibung

Tick for each symptom

Datentyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0150312
Day after Vaccination
Beschreibung

Please give information for each symptom and day mentioned.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
If redness/swelling, please note size of symptom
Beschreibung

Fill in for each redness and swelling.

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0456389
UMLS CUI [1,2]
C0518690
mm
If pain, please note the intensity
Beschreibung

Pain at injection site, definition: Grade 0: Absent Grade 1: Minor reaction to touch Grade 2: Cries / protests on touch Grade 3: Cries when limb is moved / spontaneously painful

Datentyp

integer

Alias
UMLS CUI [1]
C1320357
Ongoing after Day 3?
Beschreibung

Symptom ongoing

Datentyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
If symptom is ongoing after Day 3, please specify the date of the last day of symptom
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
If medically attended visit, please specify
Beschreibung

Medically attended visit, specification

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Solicited adverse events - general symptoms
Beschreibung

Solicited adverse events - general symptoms

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
Has the subject experienced any of the following signs/symptoms during the solicited period ?
Beschreibung

If you tick yes, please complete No/Yes for each symptom in the following Items.

Datentyp

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C2368628
General symptom
Beschreibung

General symptom

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0159028
Presence of symptom
Beschreibung

If symptom is present, please complete all following items.

Datentyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0150312
Day after Vaccination
Beschreibung

Please give information for each symptom and day mentioned.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
If "Fever", please note the route of measurement.
Beschreibung

Body temperature, route of measurement

Datentyp

text

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0449444
Body temperature
Beschreibung

Fever is definied as: Axillary >= 37.5°C Oral >= 37.5°C Rectal >= 38.0°C Tympanic (oral conversion) >= 37.5°C Tympanic (rectal conversion) >= 38.0°C

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Intensity of symptom
Beschreibung

The intensity for each symptom is defined as: Irritability / fussiness Loss of appetite: 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 Drowsiness: 0: Behavior as usual 1: Drowsiness easily tolerated 2: Drowsiness that interferes with normal activity 3: Drowsiness that prevents normal activity Loss of appetit: 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

Datentyp

integer

Alias
UMLS CUI [1]
C0518690
Ongoing after Day 3?
Beschreibung

Symptom ongoing

Datentyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
If symptom is ongoing after Day 3, please specify the date of the last day of symptom
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Causality of symptom?
Beschreibung

Causality of symptom

Datentyp

text

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C1457887
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
If medically attended visit, please specify
Beschreibung

Medically attended visit, specification

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Unsolicited Adverse events
Beschreibung

Unsolicited Adverse events

Alias
UMLS CUI-1
C4055646
UMLS CUI-2
C0877248
UMLS CUI-3
C0042196
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
Beschreibung

If you tick yes, fill in the Non-Serious Adverse Event section or Serious Adverse Event report as necessary.

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4055646
UMLS CUI [1,3]
C0332282
UMLS CUI [1,4]
C0042196
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C4055646
UMLS CUI [2,3]
C0332282
UMLS CUI [2,4]
C0042196
Has the subject experienced any meningitis?
Beschreibung

If you tick yes, please complete an SAE form and the meningitis page.

Datentyp

text

Alias
UMLS CUI [1,1]
C0025289
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
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Ähnliche Modelle

Solicited adverse events - local and general symptoms, Unsolicited AE

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Workbook Number
integer
C2986015 (UMLS CUI [1])
Workbook Number
Code List
Workbook Number
CL Item
WB 1 (1)
CL Item
WB 2 (2)
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Visit 1 (1)
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Item Group
Solicited adverse events - local symptoms
C1517001 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C0042196 (UMLS CUI-4)
Item
Vaccine
integer
Vaccine
Code List
Vaccine
CL Item
10Pn-PD-DiT or Prevenar vaccine (1)
CL Item
DTPw-HBV/Hib vaccine (2)
CL Item
IPV vaccine (3)
Item
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C0037088 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
Signs and symptoms
Code List
For each vaccine, has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes (Y)
Item
Local symptoms
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Local symptoms: Redness
Code List
Local symptoms
CL Item
Redness (RE)
CL Item
Swelling (SW)
CL Item
Pain (PA)
Item
Presence of symptom
text
C1457887 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Presence of symptom
Code List
Presence of symptom
CL Item
Yes (Y)
CL Item
No (N)
Item
Day after Vaccination
integer
C0439228 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Day of symptom duration
Code List
Day after Vaccination
CL Item
Day 0 (0)
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3  (3)
Size of symptom
Item
If redness/swelling, please note size of symptom
integer
C0456389 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Item
If pain, please note the intensity
integer
C1320357 (UMLS CUI [1])
Local symptoms: Redness
Code List
If pain, please note the intensity
CL Item
Grade 0 (0)
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
Item
Ongoing after Day 3?
text
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Symptom ongoing
Code List
Ongoing after Day 3?
CL Item
Yes (Y)
CL Item
No (N)
Date of last Day of Symptoms
Item
If symptom is ongoing after Day 3, please specify the date of the last day of symptom
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Medically attended visit
Code List
Medically attended visit
CL Item
Yes (Y)
CL Item
No (N)
Item
If medically attended visit, please specify
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Medically attended visit
Code List
If medically attended visit, please specify
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Item Group
Solicited adverse events - general symptoms
C0159028 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period ?
text
C0037088 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
Signs and symptoms
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period ?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes (Y)
Item
General symptom
text
C0042196 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
General symptom
Code List
General symptom
CL Item
Fever (FE)
CL Item
Irritability/Fussiness (IR)
CL Item
Drowsiness (DR)
CL Item
Loss of appetite (LO)
Item
Presence of symptom
text
C1457887 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Presence of symptom
Code List
Presence of symptom
CL Item
Yes (Y)
CL Item
No (N)
Item
Day after Vaccination
integer
C0439228 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Day of symptom duration
Code List
Day after Vaccination
CL Item
Day 0 (0)
CL Item
Day 1 (1)
CL Item
Day 2 (2)
CL Item
Day 3  (3)
Item
If "Fever", please note the route of measurement.
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Body temperature, route of measurement
Code List
If "Fever", please note the route of measurement.
CL Item
Axillary (A)
CL Item
Oral  (O)
CL Item
Rectal (R)
CL Item
Tympanic oral (X)
CL Item
Tympanic rectal (Y)
CL Item
Not taken (NT)
Body temperature
Item
Body temperature
float
C0005903 (UMLS CUI [1])
Item
Intensity of symptom
integer
C0518690 (UMLS CUI [1])
Intensity of symptom
Code List
Intensity of symptom
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Ongoing after Day 3?
text
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Symptom ongoing
Code List
Ongoing after Day 3?
CL Item
Yes (Y)
CL Item
No (N)
Date of last Day of Symptoms
Item
If symptom is ongoing after Day 3, please specify the date of the last day of symptom
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item
Causality of symptom?
text
C0015127 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Causality of symptom
Code List
Causality of symptom?
CL Item
Yes (Y)
CL Item
No (N)
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Medically attended visit
Code List
Medically attended visit
CL Item
Yes (Y)
CL Item
No (N)
Item
If medically attended visit, please specify
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Medically attended visit
Code List
If medically attended visit, please specify
CL Item
Hospitalization (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
Item Group
Unsolicited Adverse events
C4055646 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
text
C0877248 (UMLS CUI [1,1])
C4055646 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
C1519255 (UMLS CUI [2,1])
C4055646 (UMLS CUI [2,2])
C0332282 (UMLS CUI [2,3])
C0042196 (UMLS CUI [2,4])
SAE/AE, chronic disease
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
CL Item
Information not available (U)
CL Item
No vaccine administered (NA)
CL Item
No (N)
CL Item
Yes (Y)
Item
Has the subject experienced any meningitis?
text
C0025289 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Meningitis after Vaccination
Code List
Has the subject experienced any meningitis?
CL Item
No (N)
CL Item
Yes (Y)
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