ID

33340

Beschreibung

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

Stichworte

Versionen (1)
  1. 06.12.18 06.12.18 -
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GSK group of companies

Hochgeladen am

6. Dezember 2018

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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

Englisch

Visit 3: Vaccine Administration

1 Formulare  
Administrative data
Beschreibung

Administrative data

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Protocol number
Beschreibung

Protocol number

Datentyp

integer

Vaccine Administration
Beschreibung

Vaccine Administration

Date
Beschreibung

Date

Datentyp

date

Pre-Vaccination temperature
Beschreibung

Pre-Vaccination temperature

Datentyp

float

Maßeinheiten
  • °C
°C
Route
Beschreibung

Route

Datentyp

text

Vaccine Administration
Beschreibung

Vaccine Administration

tick only one box:
Beschreibung

tick only one box:

Datentyp

text

Replacement vial number
Beschreibung

if applies

Datentyp

integer

Wrong vial number
Beschreibung

If applies

Datentyp

integer

Administration side/site/route
Beschreibung

Administration side/site/route

Side and site
Beschreibung

Side and site

Datentyp

text

Route
Beschreibung

Route

Datentyp

text

Administration according to protocol
Beschreibung

Administration according to protocol

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

Has the study vaccine been administered according to the Protocol?

Datentyp

text

Side
Beschreibung

Side

Datentyp

text

Site
Beschreibung

Site

Datentyp

text

Route
Beschreibung

Route

Datentyp

text

Non-administration
Beschreibung

Non-administration

Why was vaccine not administered?
Beschreibung

please tick ONE most appropriate category for non admonistration

Datentyp

text

If Other, please specify
Beschreibung

e.g., consent withdrawal, protocol violation

Datentyp

text

If SAE, please specify SAE number
Beschreibung

If SAE, please specify SAE number

Datentyp

integer

If Non-SAE, please specify unsolicited AE number
Beschreibung

If Non-SAE, please specify unsolicited AE number

Datentyp

integer

Please tick who took the decision
Beschreibung

Please tick who took the decision

Datentyp

text

Immediate Post-Vaccination Observation
Beschreibung

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.
Beschreibung

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.

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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Visit 3: Vaccine Administration

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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