ID

33323

Beschrijving

Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Trefwoorden

Versies (1)
  1. 05-12-18 05-12-18 -
Houder van rechten

GSK group of companies

Geüploaded op

5 december 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065

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Visit 1: Unsolicited Adverse Events

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Administrative data
Beschrijving

Administrative data

Subject Number
Beschrijving

Subject Number

Datatype

integer

Protocol Number
Beschrijving

Protocol Number

Datatype

integer

Unsolicited Adverse Events
Beschrijving

Unsolicited Adverse Events

Has the subject experienced any serious or non-serious adverse events within one month (minimum 30 days) post-vaccination?
Beschrijving

Has the subject experienced any serious or non-serious adverse events within one month (minimum 30 days) post-vaccination?

Datatype

text

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Visit 1: Unsolicited Adverse Events

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Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Protocol Number
Item
Protocol Number
integer
Item Group
Unsolicited Adverse Events
Item
Has the subject experienced any serious or non-serious adverse events within one month (minimum 30 days) post-vaccination?
text
Has the subject experienced any serious or non-serious adverse events within one month (minimum 30 days) post-vaccination?
Code List
Has the subject experienced any serious or non-serious adverse events within one month (minimum 30 days) post-vaccination?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form (4)
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