ID

33346

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2018-12-06 2018-12-06 -
  2. 2018-12-10 2018-12-10 -
Rättsinnehavare

GSK group of companies

Uppladdad den

6 december 2018

DOI

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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

Engelsk

Visit 4: Study Continuation Check

1 Formulär  
Administrative data
Beskrivning

Administrative data

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Protocol Number
Beskrivning

Protocol Number

Datatyp

integer

Check for Study Continuation
Beskrivning

Check for Study Continuation

Did the subject come for Visit 4?
Beskrivning

Did the subject come for Visit 4?

Datatyp

boolean

If no, please choose the reason
Beskrivning

If no, please choose the reason

Datatyp

text

If Other, please specify
Beskrivning

If Other, please specify

Datatyp

text

If SAE, please record the number
Beskrivning

If SAE, please record the number

Datatyp

integer

If Non-SAE, please record the number
Beskrivning

If Non-SAE, please record the number

Datatyp

integer

Please tick who took the decision
Beskrivning

Please tick who took the decision

Datatyp

text

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Visit 4: Study Continuation Check

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Date of Visit
Item
Date of Visit
date
Protocol Number
Item
Protocol Number
integer
Item Group
Check for Study Continuation
Did the subject come for Visit 4?
Item
Did the subject come for Visit 4?
boolean
Item
If no, please choose the reason
text
If no, please choose the reason
Code List
If no, please choose the reason
CL Item
same reason or decision as previous visit (1)
CL Item
Serious Adverse Event (2)
CL Item
Non-Serious Adverse Event (3)
CL Item
Other (4)
If Other, please specify
Item
If Other, please specify
text
If SAE, please record the number
Item
If SAE, please record the number
integer
If Non-SAE, please record the number
Item
If Non-SAE, please record the number
integer
Item
Please tick who took the decision
text
Please tick who took the decision
Code List
Please tick who took the decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
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