ID

33336

Description

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

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Versions (1)
  1. 06/12/2018 06/12/2018 -
Détendeur de droits

GSK group of companies

Téléchargé le

6 décembre 2018

DOI

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Licence

Creative Commons BY-NC 3.0
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mmune 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 2: Study Continuation Check

1 Formulaires  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Type de données

integer

Protocol Number
Description

Protocol Number

Type de données

integer

Check for Study Continuation
Description

Check for Study Continuation

Did the subject return for visit 2?
Description

Did the subject return for visit 2?

Type de données

boolean

If yes, please complete all forms for Visit 2
Description

If yes, please complete all forms for Visit 2

Type de données

text

If No, record ONE most appropriate reason and skip the following pages of this visit
Description

If No, record ONE most appropriate reason and skip the following pages of this visit

Type de données

text

If SAE, record the SAE number
Description

If SAE, record the SAE number

Type de données

integer

If Non-SAE, record the unsolicited AE number
Description

If Non-SAE, record the unsolicited AE number

Type de données

integer

If Other, specify
Description

e.g., consent withdrawal, protocol violation, etc.

Type de données

text

Who took the decision?
Description

Who took the decision?

Type de données

text

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Visit 2: Study Continuation Check

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Protocol Number
Item
Protocol Number
integer
Item Group
Check for Study Continuation
Did the subject return for visit 2?
Item
Did the subject return for visit 2?
boolean
If yes, please complete all forms for Visit 2
Item
If yes, please complete all forms for Visit 2
text
Item
If No, record ONE most appropriate reason and skip the following pages of this visit
text
If No, record ONE most appropriate reason and skip the following pages of this visit
Code List
If No, record ONE most appropriate reason and skip the following pages of this visit
CL Item
Serious Adverse Event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other (3)
If SAE, record the SAE number
Item
If SAE, record the SAE number
integer
If Non-SAE, record the unsolicited AE number
Item
If Non-SAE, record the unsolicited AE number
integer
If Other, specify
Item
If Other, specify
text
Item
Who took the decision?
text
Who took the decision?
Code List
Who took the decision?
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
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