ID

33322

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 (1)
  1. 12/5/18 12/5/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 5, 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 1: Vaccine Administration

1 forms  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Protocol number
Description

Protocol number

Data type

integer

Vaccine Administration
Description

Vaccine Administration

Date
Description

Date

Data type

date

Pre-Vaccination temperature
Description

Pre-Vaccination temperature

Data type

float

Measurement units
  • °C
°C
Route
Description

Route

Data type

text

Vaccine Administration
Description

Vaccine Administration

tick only one box:
Description

tick only one box:

Data type

text

Replacement vial number
Description

if applies

Data type

integer

Wrong vial number
Description

If applies

Data type

integer

Administration side/site/route
Description

Administration side/site/route

Side and site
Description

Side and site

Data type

text

Route
Description

Route

Data type

text

Administration according to protocol
Description

Administration according to protocol

Has the study vaccine been administered according to the Protocol?
Description

Has the study vaccine been administered according to the Protocol?

Data type

text

Side
Description

Side

Data type

text

Site
Description

Site

Data type

text

Route
Description

Route

Data type

text

Non-administration
Description

Non-administration

Why was vaccine not administered?
Description

please tick ONE most appropriate category for non admonistration

Data type

text

If Other, please specify
Description

e.g., consent withdrawal, protocol violation

Data type

text

If SAE, please specify SAE number
Description

If SAE, please specify SAE number

Data type

integer

If Non-SAE, please specify unsolicited AE number
Description

If Non-SAE, please specify unsolicited AE number

Data type

integer

Please tick who took the decision
Description

Please tick who took the decision

Data type

text

Immediate Post-Vaccination Observation
Description

Immediate Post-Vaccination Observation

If any AE occurred during the immediate post-vaccination time (30 min), please fill in the Solicited Adverse Events section, the Non-SAE section or a SAE section.
Description

If any AE occurred during the immediate post-vaccination time (30 min), please fill in the Solicited Adverse Events section, the Non-SAE section or a SAE section.

Data type

text

If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick "Prophylactic" box.
Description

If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick "Prophylactic" box.

Data type

text

Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section.
Description

Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section.

Data type

text

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Similar models

Visit 1: Vaccine Administration

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Protocol number
Item
Protocol number
integer
Item Group
Vaccine Administration
Date
Item
Date
date
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
Item
Route
text
Route
Code List
Route
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Tympanic (oral conversion) (3)
CL Item
Tympanic (rectal conversion) (4)
CL Item
Rectal (5)
Item Group
Vaccine Administration
Item
tick only one box:
text
tick only one box:
Code List
tick only one box:
CL Item
Plain PRP Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial number (3)
CL Item
Not administered (4)
Replacement vial number
Item
Replacement vial number
integer
Wrong vial number
Item
Wrong vial number
integer
Item Group
Administration side/site/route
Item
Side and site
text
Side and site
Code List
Side and site
CL Item
Upper right thigh (1)
Item
Route
text
Route
Code List
Route
CL Item
IM (1)
Item Group
Administration according to protocol
Item
Has the study vaccine been administered according to the Protocol?
text
Has the study vaccine been administered according to the Protocol?
Code List
Has the study vaccine been administered according to the Protocol?
CL Item
Yes (1)
CL Item
No -> please tick all below items that apply (2)
Item
Side
text
Side
Code List
Side
CL Item
Upper left (1)
CL Item
Lower left (2)
CL Item
Upper right (3)
CL Item
Lower right (4)
Item
Site
text
Site
Code List
Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
text
Route
Code List
Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Item Group
Non-administration
Item
Why was vaccine not administered?
text
Why was vaccine not administered?
Code List
Why was vaccine not administered?
CL Item
Serious Adverse Event (1)
CL Item
Non-Serious Adverse Event  (2)
CL Item
Other (3)
If Other, please specify
Item
If Other, please specify
text
If SAE, please specify SAE number
Item
If SAE, please specify SAE number
integer
If Non-SAE, please specify unsolicited AE number
Item
If Non-SAE, please specify unsolicited AE 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)
Item Group
Immediate Post-Vaccination Observation
If any AE occurred during the immediate post-vaccination time (30 min), please fill in the Solicited Adverse Events section, the Non-SAE section or a SAE section.
Item
If any AE occurred during the immediate post-vaccination time (30 min), please fill in the Solicited Adverse Events section, the Non-SAE section or a SAE section.
text
If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick "Prophylactic" box.
Item
If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick "Prophylactic" box.
text
Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section.
Item
Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section.
text
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