ID
35334
Description
Study ID: 101222 Clinical Study ID: 101222 Study Title: Study to demonstrate the non-inferiority of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine compared to GSK Biologicals' Tritanrix™-HepB/Hiberix™ vaccine and to separate administration of DTPw-HBV Kft. and Hiberix™ vaccines with respect to the immunogenicity of all antigens, when administered to healthy infants. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed 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)
- 2/27/19 2/27/19 -
- 2/28/19 2/28/19 -
Copyright Holder
GSK group of companies
Uploaded on
February 28, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Immunogenicity of TPw-HBV/Hib Kft. Vaccine in healthy infants - 101222
Visit 4 (Amendment, Month 3.5 28 – 42 days after Visit 3) Dose 3
- StudyEvent: ODM
Description
CHECK FOR STUDY CONTINUATION
Description
Study Continuation Question
Data type
boolean
Description
Reason For Discontinuation
Data type
text
Description
(e.g.: consent withdrawal, Protocol violation, …)
Data type
text
Description
Who made decision
Data type
text
Description
VACCINE ADMINISTRATION
Description
Vaccination Date
Data type
date
Description
HBV+DTPw-HBV Hib/Kft. and DTPw-HBV Hib/Kft. groups
Data type
float
Measurement units
- °C
Description
Temperature Route
Data type
text
Description
(only one box must be ticked by vaccine)
Data type
text
Description
Vial Number For Replacement Vial
Data type
integer
Description
Vial Number For Wrong Vial
Data type
integer
Description
Side
Data type
text
Description
Site
Data type
text
Description
Route
Data type
text
Description
Comment
Data type
text
Description
VACCINE ADMINISTRATION 2
Description
Vaccination Date
Data type
date
Description
DTPw-HBV Kft. + Hiberix™ group
Data type
float
Measurement units
- °C
Description
Temperature Route
Data type
text
Description
(only one box must be ticked by vaccine)
Data type
text
Description
Vial Number For Replacement Vial
Data type
integer
Description
Vial Number For Wrong Vial
Data type
integer
Description
Side
Data type
text
Description
Site
Data type
text
Description
Route
Data type
text
Description
(only one box must be ticked by vaccine)
Data type
text
Description
Vial Number For Replacement Vial
Data type
integer
Description
Vial Number For Wrong Vial
Data type
integer
Description
Side
Data type
text
Description
Site
Data type
text
Description
Route
Data type
text
Description
Comments
Data type
text
Description
VACCINE ADMINISTRATION 3
Description
Vaccination Date
Data type
date
Description
Tritanrix™-HepB/Hiberix™ group
Data type
float
Measurement units
- °C
Description
Temperature Route
Data type
text
Description
(only one box must be ticked by vaccine)
Data type
text
Description
Vial Number For Replacement Vial
Data type
integer
Description
Vial Number For Wrong Vial
Data type
integer
Description
Side
Data type
text
Description
Site
Data type
text
Description
Route
Data type
text
Description
Comments
Data type
text
Description
VACCINE NON-ADMINISTRATION
Description
Please tick the ONE most appropriate category for non administration:
Data type
text
Description
SAE Number
Data type
integer
Description
AE Number
Data type
integer
Description
(e.g.: consent withdrawal, protocol violation, …)
Data type
text
Description
Who Made Decision
Data type
text
Description
Post-Vaccination Observation Reminder
Data type
text
Description
ADVERSE EVENTS
Description
SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS
Description
If any of these adverse events are serious according to Protocol definition, please report event to GSK monitor by telephone or fax within 24 hours (see Protocol) and complete the Serious Adverse Event form.
Data type
text
Description
LOCAL SYMPTOMS
Description
Redness
Data type
boolean
Description
Day
Data type
text
Description
Redness Size
Data type
integer
Measurement units
- mm
Description
Status Ongoing
Data type
boolean
Description
Last Day Of Symptoms
Data type
date
Description
Medically Attended Visit
Data type
boolean
Description
Medical Involvement
Data type
text
Description
Swelling
Data type
boolean
Description
Day
Data type
text
Description
Swelling Size
Data type
integer
Measurement units
- mm
Description
Status Ongoing
Data type
boolean
Description
Last Day Of Symptoms
Data type
date
Description
Medically Attended Visit
Data type
boolean
Description
Medical Involvement
Data type
text
Description
Pain
Data type
boolean
Description
Pain Intensity
Data type
text
Description
Status Ongoing
Data type
boolean
Description
Last Day Of Symptoms
Data type
date
Description
Medically Attended Visit
Data type
boolean
Description
Medical Involvement
Data type
text
Description
SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS (vaccine specific)
Description
AE Local Symptoms Question
Data type
text
Description
Redness
Data type
boolean
Description
Day
Data type
text
Description
Redness Size
Data type
integer
Measurement units
- mm
Description
Status Ongoing
Data type
boolean
Description
Last Day Of Symptoms
Data type
date
Description
Medically Attended Visit
Data type
boolean
Description
Medical Involvement
Data type
text
Description
Swelling
Data type
boolean
Description
Day
Data type
text
Description
Swelling Size
Data type
integer
Measurement units
- mm
Description
Status Ongoing
Data type
boolean
Description
Last Day Of Symptoms
Data type
date
Description
Medically Attended Visit
Data type
boolean
Description
Medical Involvement
Data type
text
Description
Pain
Data type
boolean
Description
Day
Data type
text
Description
Pain Intensity
Data type
text
Description
Status Ongoing
Data type
boolean
Description
Last Day Of Symptoms
Data type
date
Description
Medically Attended Visit
Data type
boolean
Description
Medical Involvement
Data type
text
Description
DTPw-HBV Kft. vaccine
Description
Redness
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C2700396
Description
Day
Data type
integer
Description
size; please measure the greatest diameter
Data type
integer
Measurement units
- mm
Description
Status Ongoing
Data type
boolean
Description
Last Day Of Symptoms
Data type
date
Description
Medically Attended Visit
Data type
boolean
Description
Medical Involvement
Data type
text
Description
Swelling
Data type
boolean
Description
Day
Data type
text
Description
Swelling Size
Data type
integer
Measurement units
- mm
Description
Status Ongoing
Data type
boolean
Description
Last Day Of Symptoms
Data type
date
Description
Medically Attended Visit
Data type
boolean
Description
Medical Involvement
Data type
text
Description
Pain
Data type
boolean
Description
Day
Data type
text
Description
Pain Intensity
Data type
text
Description
Status Ongoing
Data type
boolean
Description
Last Day Of Symptoms
Data type
date
Description
Medically Attended Visit
Data type
boolean
Description
Medical Involvement
Data type
text
Description
Hiberix™ vaccine
Description
Redness
Data type
boolean
Description
Day
Data type
integer
Description
Redness Size
Data type
integer
Measurement units
- mm
Description
Status Ongoing
Data type
boolean
Description
Last Day Of Symptoms
Data type
date
Description
Medically Attended Visit
Data type
boolean
Description
Medical Involvement
Data type
text
Description
Swelling
Data type
boolean
Description
Day
Data type
text
Description
Swelling Size
Data type
integer
Measurement units
- mm
Description
Status Ongoing
Data type
boolean
Description
Last Day Of Symptoms
Data type
date
Description
Medically Attended Visit
Data type
boolean
Description
Medical Involvement
Data type
text
Description
Pain
Data type
boolean
Description
Day
Data type
text
Description
Pain Intensity
Data type
text
Description
Status Ongoing
Data type
boolean
Description
Last Day Of Symptoms
Data type
date
Description
Medically Attended Visit
Data type
boolean
Description
Medical Involvement
Data type
text
Description
SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS
Description
GENERAL SYMPTOMS
Description
Fever: Axillary > 37.5 °C Rectal > 38 °C
Data type
boolean
Description
Day
Data type
text
Description
temperature
Data type
float
Measurement units
- °C
Description
t° not taken
Data type
boolean
Description
Route
Data type
text
Description
Status Ongoing
Data type
boolean
Description
Last day of symptoms
Data type
date
Description
Causality
Data type
boolean
Description
Medically attended visit
Data type
text
Description
Irritability / Fussiness
Data type
boolean
Description
Day
Data type
text
Description
Irritability / Fussiness Intensity
Data type
text
Description
In case of severe intensity
Data type
boolean
Description
crying in case of severe intensity
Data type
boolean
Description
Status Ongoing
Data type
boolean
Description
Last day of symptoms
Data type
date
Description
Causality
Data type
boolean
Description
Medically attended visit
Data type
text
Description
Drowsiness
Data type
boolean
Description
Day
Data type
text
Description
Drowsiness Intensity
Data type
text
Description
Status Ongoing
Data type
boolean
Description
Causality
Data type
boolean
Description
Medically attended visit
Data type
text
Description
Loss of appetite
Data type
boolean
Description
Day
Data type
text
Description
Intensity
Data type
text
Description
Status Ongoing
Data type
boolean
Description
Last day of symptoms
Data type
date
Description
Causality
Data type
boolean
Description
Medically attended visit
Data type
text
Similar models
Visit 4 (Amendment, Month 3.5 28 – 42 days after Visit 3) Dose 3
- StudyEvent: ODM
C2700396 (UMLS CUI [1,2])