ID
14999
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: Large Swelling Reaction
Mots-clés
Versions (3)
- 09/05/2016 09/05/2016 -
- 10/05/2016 10/05/2016 - Julian Varghese
- 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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Large Swelling Reaction Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396
Large Swelling Reaction "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
Description
Report of physical examination
Alias
- UMLS CUI-1
- C0031809
Description
Date of physical examination
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0031809
Description
Was the examination performed by a member of study personnel during the large swelling reaction period:
Type de données
boolean
Alias
- UMLS CUI [1]
- C0025082
Description
If hospitalization is required, please also complete a Serious Adverse Event (SAE) Form and contact GlaxoSmithKline Biologicals within 24 hours after becoming aware of the SAE.
Type de données
date
Alias
- UMLS CUI [1]
- C2316983
Description
Hours after Event
Type de données
text
Alias
- UMLS CUI [1]
- C0040223
Description
Size of swelling
Type de données
text
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Description
Please specify in section 7
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0332307
Description
Circumference of affected site
Type de données
text
Alias
- UMLS CUI [1,1]
- C0332520
- UMLS CUI [1,2]
- C0449642
Description
Circumference of the opposite site
Type de données
text
Alias
- UMLS CUI [1,1]
- C0332520
- UMLS CUI [1,2]
- C1708335
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 box for each symptom occurring during the extensive swelling period. If other symptoms are associated lnduration with the large swelling reaction please specify under section
Type de données
text
Alias
- UMLS CUI [1]
- C0039476
Description
Route
Type de données
text
Alias
- UMLS CUI [1]
- C0013153
Description
If yes, please specify diameter below.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0332575
Description
Redness Diameter
Type de données
float
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Description
If yes, plase specify diameter below.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0332534
Description
Largest Diameter of Induration
Type de données
text
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332534
Description
Pain
Type de données
boolean
Alias
- UMLS CUI [1]
- C0030193
Description
Intensity of pain at injection site grade 1: Minor reaction to touch grade 2: Cries/protests on touch grade 3: Cries when limb is moved/spontaneously painful
Type de données
integer
Alias
- UMLS CUI [1]
- C1320357
Description
Functional impairment
Type de données
partialDatetime
Alias
- UMLS CUI [1]
- C0012605
Description
Intensity of functional impairment: Grade 1: Easily tolerated, causing minimal discomfort and not interfering with everyday activities Grade 2: Sufficiently discomforting to interfere with normal everyday activities Grade 3: Prevents normal everyday activities
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0012605
- UMLS CUI [1,2]
- C0439793
Description
Clinical case descri tion and outcome of the adverse event
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 diagnostic(s) procedures and thera eutic interventions.
Type de données
text
Alias
- UMLS CUI [1]
- C0449437
Description
Last date when the swelling was still considered to be large swellin reaction:
Type de données
date
Alias
- UMLS CUI [1]
- C0449238
Description
If lasting for less than 24 hours, please specify duration (hours)
Type de données
time
Alias
- UMLS CUI [1]
- C0449238
Description
If Not recovered / not resolved, please provide further follow-up data If Recovered with sequelae / resolved with sequelae, please specify under section 7
Type de données
integer
Alias
- UMLS CUI [1]
- C1705586
Description
(e.g.: allergy, infection, trauma, under/ in conditions) if yes, please specify below
Type de données
boolean
Alias
- UMLS CUI [1]
- C0681841
Description
Alternative Explanation: Specification
Type de données
text
Alias
- UMLS CUI [1]
- C0681841
Similar models
Large Swelling Reaction "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396
C0805701 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C0449642 (UMLS CUI [1,2])
C1708335 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,2])
C0332534 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])