ID

36000

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 Non-serious AE form. It has to be filled in if the subject experience a non-serious AE during study.

Link

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

Stichworte

Versionen (1)
  1. 09.04.19 09.04.19 -
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GlaxoSmithKline

Hochgeladen am

9. April 2019

DOI

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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

Non-Serious Adverse Events (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
Non-Serious Adverse Events
Beschreibung

Non-Serious Adverse Events

Alias
UMLS CUI-1
C1518404
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Beschreibung

If you tick yes, please complete the following items.

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0042196
AE Number
Beschreibung

AE Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
AE Description
Beschreibung

AE Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0678257
AE Site
Beschreibung

AE Site

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0450429
Vaccine administered
Beschreibung

IPV vaccine: Only to fill in for WB 2

Datentyp

integer

Alias
UMLS CUI [1]
C2368628
Comment for GSK
Beschreibung

Comment for GSK

Datentyp

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0008961
Start Date of AE
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C2697888
Tick if AE start during immediate post-vaccination period (30 minutes)
Beschreibung

AE start immediate post-vaccination period

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0205253
UMLS CUI [1,3]
C0687676
UMLS CUI [1,4]
C0042196
Stop Date of AE
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0877248
AE Maximum Intensity
Beschreibung

Definition: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. Severe: An adverse event which prevents normal, everyday activities (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice).

Datentyp

integer

Alias
UMLS CUI [1,1]
C0806909
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0877248
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschreibung

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.

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0439849
Outcome of AE
Beschreibung

Definition: 1: Recovered / resolved. 2:Recovering / Resolving: Subject is recovering at the time she/he completes the study or at the time she/he withdraws from study. 3: Not recovered / Not resolved: AE is ongoing at the time the subject completes the study or becomes lost to follow-up; in case of death AEs that are not the cause of death. 4: Recovered with sequelae / Resolved with sequelae

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
Medically attended visit
Beschreibung

Medically attended visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
If medically attended visit, please specify type
Beschreibung

Type of medically attended visit

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [1,4]
C1518404
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Ähnliche Modelle

Non-Serious Adverse Events (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])
Visit type
Code List
Workbook Number
CL Item
WB 1 (1)
CL Item
WB 2 (2)
Item Group
Non-Serious Adverse Events
C1518404 (UMLS CUI-1)
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
text
C1518404 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Non-serious AE after vaccine dose
Code List
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
CL Item
No (N)
CL Item
Yes (Y)
AE Number
Item
AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Description
Item
AE Description
text
C0877248 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
AE Site
text
C0877248 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
AE Site
Code List
AE Site
CL Item
Administration site (L)
CL Item
Non-administration site (G)
Item
Vaccine administered
integer
C2368628 (UMLS CUI [1])
AE Site
Code List
Vaccine administered
CL Item
10Pn-PD-DiT or Prevenar vaccine (901)
CL Item
DTPw-HBV/Hib vaccine (94)
CL Item
IPV vaccine (10)
Comment for GSK
Item
Comment for GSK
text
C0947611 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Start Date of AE
Item
Start Date of AE
date
C2697888 (UMLS CUI [1])
AE start immediate post-vaccination period
Item
Tick if AE start during immediate post-vaccination period (30 minutes)
boolean
C0877248 (UMLS CUI [1,1])
C0205253 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
Stop Date of AE
Item
Stop Date of AE
date
C0806020 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
AE Maximum Intensity
integer
C0806909 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
AE Maximum Intensity
Code List
AE Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C1518404 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
AE Relationship to investigational products
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
No (N)
CL Item
Yes (Y)
Item
Outcome of AE
integer
C1705586 (UMLS CUI [1])
Outcome of AE
Code List
Outcome of AE
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / resolved with sequelae (4)
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medically attended visit
Code List
Medically attended visit
CL Item
No (N)
CL Item
Yes (Y)
Item
If medically attended visit, please specify type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,4])
Medically attended visit
Code List
If medically attended visit, please specify type
CL Item
Hospitalisation (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)
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