ID

15005

Description

This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553. Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization course in study 105553. The immune response to a booster dose of GSK Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not primed with GSK Biologicals' vaccine but with Prevenar™. The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib vaccine. NCT00370396 Part: Medical History

Mots-clés

Versions (3)
  1. 05/05/2016 05/05/2016 -
  2. 08/05/2016 08/05/2016 -
  3. 11/05/2016 11/05/2016 -
Téléchargé le

11 mai 2016

DOI

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Licence

Creative Commons BY-NC 3.0
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Medical History Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396

Anglais

Medical History "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

1 Formulaires  
Identification
Description

Identification

Alias
UMLS CUI-1
C1300638
Center number
Description

Center number

Type de données

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0805701
Subject ID
Description

Subject ID

Type de données

text

Alias
UMLS CUI [1]
C2348585
Treatment Number
Description

Treatment Number

Type de données

text

Alias
UMLS CUI [1]
C1522541
GENERAL MEDICAL HISTORY I PHYSICAL EXAMINATION
Description

GENERAL MEDICAL HISTORY I PHYSICAL EXAMINATION

Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
Description

Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?

Type de données

boolean

Alias
UMLS CUI [1]
C0521987
Medical History List
Description

Medical History List

MedDRA System Organ Class
Description

MedDRA System Organ Class

Type de données

integer

Alias
UMLS CUI [1]
C2347091
Diagnosis
Description

Diagnosis

Type de données

text

Alias
UMLS CUI [1]
C0011900
Past or current
Description

Past or current

Type de données

integer

Alias
UMLS CUI [1]
C0521116
Laboratory Tests
Description

Laboratory Tests

Has a bloodsample been taken?
Description

Bloodsample

Type de données

boolean

Alias
UMLS CUI [1]
C0005834
Date of Bloodsample
Description

answer if yes

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
Retour au début de la page

Similar models

Medical History "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Identification
C1300638 (UMLS CUI-1)
Center number
Item
Center number
integer
C1301943 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
text
C1522541 (UMLS CUI [1])
Item Group
GENERAL MEDICAL HISTORY I PHYSICAL EXAMINATION
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
Item
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
boolean
C0521987 (UMLS CUI [1])
Item Group
Medical History List
Item
MedDRA System Organ Class
integer
C2347091 (UMLS CUI [1])
MedDRA System Organ Class
Code List
MedDRA System Organ Class
CL Item
Skin and subcutaneous tissue (1)
CL Item
Musculoskeletal and connective tissue (2)
CL Item
Cardiac (3)
CL Item
Vascular (4)
CL Item
Respiratory, thoracic and mediastinal (5)
CL Item
Gastrointestinal (6)
CL Item
Hepatobiliary (7)
CL Item
Renal and urinary (8)
CL Item
Nervous system (9)
CL Item
Eye (10)
CL Item
Ear and labyrinth (11)
CL Item
Endocrine (12)
CL Item
Metabolism and nutrition (13)
CL Item
Blood and lymphatic system (14)
CL Item
Immune system (incl allergies, autoimmune disorders) (15)
CL Item
Infections and infestations (16)
CL Item
Neoplasms benign, malignantand unspecified (incl cysts. polyps) (17)
CL Item
Surgical and medicalprocedures (18)
CL Item
Other (99)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Past or current
integer
C0521116 (UMLS CUI [1])
Past or current
Code List
Past or current
CL Item
current  (1)
CL Item
past (2)
Bloodsample
Item
Has a bloodsample been taken?
boolean
C0005834 (UMLS CUI [1])
Date of Bloodsample
Item
Date of Bloodsample
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Retour au début de la page 

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