ID
14999
Beschreibung
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
Stichworte
Versionen (3)
- 09.05.16 09.05.16 -
- 10.05.16 10.05.16 - Julian Varghese
- 11.05.16 11.05.16 -
Hochgeladen am
11. Mai 2016
DOI
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Lizenz
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
Beschreibung
Report of physical examination
Alias
- UMLS CUI-1
- C0031809
Beschreibung
Date of physical examination
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0031809
Beschreibung
Was the examination performed by a member of study personnel during the large swelling reaction period:
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0025082
Beschreibung
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.
Datentyp
date
Alias
- UMLS CUI [1]
- C2316983
Beschreibung
Hours after Event
Datentyp
text
Alias
- UMLS CUI [1]
- C0040223
Beschreibung
Size of swelling
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
Beschreibung
Please specify in section 7
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0332307
Beschreibung
Circumference of affected site
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0332520
- UMLS CUI [1,2]
- C0449642
Beschreibung
Circumference of the opposite site
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0332520
- UMLS CUI [1,2]
- C1708335
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI [1]
- C0039476
Beschreibung
Route
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
If yes, please specify diameter below.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0332575
Beschreibung
Redness Diameter
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332575
Beschreibung
If yes, plase specify diameter below.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0332534
Beschreibung
Largest Diameter of Induration
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0456389
- UMLS CUI [1,2]
- C0332534
Beschreibung
Pain
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0030193
Beschreibung
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
Datentyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beschreibung
Functional impairment
Datentyp
partialDatetime
Alias
- UMLS CUI [1]
- C0012605
Beschreibung
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
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0012605
- UMLS CUI [1,2]
- C0439793
Beschreibung
Clinical case descri tion and outcome of the adverse event
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1]
- C0449437
Beschreibung
Last date when the swelling was still considered to be large swellin reaction:
Datentyp
date
Alias
- UMLS CUI [1]
- C0449238
Beschreibung
If lasting for less than 24 hours, please specify duration (hours)
Datentyp
time
Alias
- UMLS CUI [1]
- C0449238
Beschreibung
If Not recovered / not resolved, please provide further follow-up data If Recovered with sequelae / resolved with sequelae, please specify under section 7
Datentyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beschreibung
(e.g.: allergy, infection, trauma, under/ in conditions) if yes, please specify below
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0681841
Beschreibung
Alternative Explanation: Specification
Datentyp
text
Alias
- UMLS CUI [1]
- C0681841
Ähnliche Modelle
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])