ID

33469

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

Keywords

Versions (2)
  1. 12/6/18 12/6/18 -
  2. 12/10/18 12/10/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 10, 2018

DOI

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License

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

English

Visit 3: Study Continuation Check

1 forms  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Date of Visit
Description

Date of Visit

Data type

date

Protocol Number
Description

Protocol Number

Data type

integer

Check for Study Continuation
Description

Check for Study Continuation

Did the subject come for Visit 3?
Description

Did the subject come for Visit 3?

Data type

boolean

If no, please choose the reason
Description

If no, please choose the reason

Data type

text

If Other, please specify
Description

If Other, please specify

Data type

text

If SAE, please record the number
Description

If SAE, please record the number

Data type

integer

If Non-SAE, please record the number
Description

If Non-SAE, please record the number

Data type

integer

Please tick who took the decision
Description

Please tick who took the decision

Data type

text

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Visit 3: Study Continuation Check

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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 3?
Item
Did the subject come for Visit 3?
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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