ID
14999
Descrição
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
Palavras-chave
Versões (3)
- 09/05/2016 09/05/2016 -
- 10/05/2016 10/05/2016 - Julian Varghese
- 11/05/2016 11/05/2016 -
Transferido a
11 de maio de 2016
DOI
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Licença
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
Descrição
Report of physical examination
Alias
- UMLS CUI-1
- C0031809
Descrição
Date of physical examination
Tipo de dados
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0031809
Descrição
Was the examination performed by a member of study personnel during the large swelling reaction period:
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0025082
Descrição
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.
Tipo de dados
date
Alias
- UMLS CUI [1]
- C2316983
Descrição
Hours after Event
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0040223
Descrição
Size of swelling
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Descrição
Please specify in section 7
Tipo de dados
integer
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0332307
Descrição
Circumference of affected site
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0332520
- UMLS CUI [1,2]
- C0449642
Descrição
Circumference of the opposite site
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0332520
- UMLS CUI [1,2]
- C1708335
Descrição
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
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0039476
Descrição
Route
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0013153
Descrição
If yes, please specify diameter below.
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0332575
Descrição
Redness Diameter
Tipo de dados
float
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Descrição
If yes, plase specify diameter below.
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0332534
Descrição
Largest Diameter of Induration
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332534
Descrição
Pain
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0030193
Descrição
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
Tipo de dados
integer
Alias
- UMLS CUI [1]
- C1320357
Descrição
Functional impairment
Tipo de dados
partialDatetime
Alias
- UMLS CUI [1]
- C0012605
Descrição
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
Tipo de dados
integer
Alias
- UMLS CUI [1,1]
- C0012605
- UMLS CUI [1,2]
- C0439793
Descrição
Clinical case descri tion and outcome of the adverse event
Descrição
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.
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0449437
Descrição
Last date when the swelling was still considered to be large swellin reaction:
Tipo de dados
date
Alias
- UMLS CUI [1]
- C0449238
Descrição
If lasting for less than 24 hours, please specify duration (hours)
Tipo de dados
time
Alias
- UMLS CUI [1]
- C0449238
Descrição
If Not recovered / not resolved, please provide further follow-up data If Recovered with sequelae / resolved with sequelae, please specify under section 7
Tipo de dados
integer
Alias
- UMLS CUI [1]
- C1705586
Descrição
(e.g.: allergy, infection, trauma, under/ in conditions) if yes, please specify below
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0681841
Descrição
Alternative Explanation: Specification
Tipo de dados
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])