ID

23891

Description

Study part: Adverse Events- Post- Vaccination Observation Booster Dose. A phase 2 study to assess safety, reactogenicity and immunogenicity of a booster dose of an investigational vaccination regimen and GSK Biologicals Hib-MenC vaccine (co-administered with Infanrix penta) compared to a booster dose of Menjugate (co-administered with Infanrix hexa).Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Study ID: 100381, Clinical Study ID: 100381

Keywords

Versions (1)
  1. 7/16/17 7/16/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 16, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Adverse Events- Post- Vaccination Observation Booster Dose Hib-MenCY-TT-004 BST 003 Neisseria Meningitidis-Haemophilus influenzae type b Vaccine 100381

English

Adverse Events- Post- Vaccination Observation Booster Dose

1 forms  
ADVERSE EVENTS – POST–VACCINATION OBSERVATION
Description

ADVERSE EVENTS – POST–VACCINATION OBSERVATION

Alias
UMLS CUI-1
C0877248
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
Description

Adverse Events

Data type

text

Alias
UMLS CUI [1]
C0877248
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Similar models

Adverse Events- Post- Vaccination Observation Booster Dose

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ADVERSE EVENTS – POST–VACCINATION OBSERVATION
C0877248 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
text
C0877248 (UMLS CUI [1])
Adverse Events
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
CL Item
Information not retrievable [U (Information not retrievable [U)
CL Item
No Vaccine administered [NA (No Vaccine administered [NA)
CL Item
No [N (No [N)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form [Y (Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form [Y)
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