ID

33340

Descrizione

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

versioni (1)
  1. 06/12/18 06/12/18 -
Titolare del copyright

GSK group of companies

Caricato su

6 dicembre 2018

DOI

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Licenza

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

Inglese

Visit 3: Vaccine Administration

1 moduli  
Administrative data
Descrizione

Administrative data

Subject Number
Descrizione

Subject Number

Tipo di dati

integer

Protocol number
Descrizione

Protocol number

Tipo di dati

integer

Vaccine Administration
Descrizione

Vaccine Administration

Date
Descrizione

Date

Tipo di dati

date

Pre-Vaccination temperature
Descrizione

Pre-Vaccination temperature

Tipo di dati

float

Unità di misura
  • °C
°C
Route
Descrizione

Route

Tipo di dati

text

Vaccine Administration
Descrizione

Vaccine Administration

tick only one box:
Descrizione

tick only one box:

Tipo di dati

text

Replacement vial number
Descrizione

if applies

Tipo di dati

integer

Wrong vial number
Descrizione

If applies

Tipo di dati

integer

Administration side/site/route
Descrizione

Administration side/site/route

Side and site
Descrizione

Side and site

Tipo di dati

text

Route
Descrizione

Route

Tipo di dati

text

Administration according to protocol
Descrizione

Administration according to protocol

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

Has the study vaccine been administered according to the Protocol?

Tipo di dati

text

Side
Descrizione

Side

Tipo di dati

text

Site
Descrizione

Site

Tipo di dati

text

Route
Descrizione

Route

Tipo di dati

text

Non-administration
Descrizione

Non-administration

Why was vaccine not administered?
Descrizione

please tick ONE most appropriate category for non admonistration

Tipo di dati

text

If Other, please specify
Descrizione

e.g., consent withdrawal, protocol violation

Tipo di dati

text

If SAE, please specify SAE number
Descrizione

If SAE, please specify SAE number

Tipo di dati

integer

If Non-SAE, please specify unsolicited AE number
Descrizione

If Non-SAE, please specify unsolicited AE number

Tipo di dati

integer

Please tick who took the decision
Descrizione

Please tick who took the decision

Tipo di dati

text

Immediate Post-Vaccination Observation
Descrizione

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.
Descrizione

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.

Tipo di dati

text

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

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

Tipo di dati

text

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

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

Tipo di dati

text

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Similar models

Visit 3: Vaccine Administration

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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