Informações:
Falhas:
ID
35331
Descrição
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
Palavras-chave
Versões (2)
- 26/02/2019 26/02/2019 -
- 28/02/2019 28/02/2019 -
Titular dos direitos
GSK group of companies
Transferido a
28 de fevereiro de 2019
DOI
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Licença
Creative Commons BY-NC 3.0
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Immunogenicity of TPw-HBV/Hib Kft. Vaccine in healthy infants - 101222
Visit 5 (Month 4.5 30 – 42 days after Visit 4) + Study Conclusion
Similar models
Visit 5 (Month 4.5 30 – 42 days after Visit 4) + Study Conclusion
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Visit Number
Item
Visit Number
integer
Subject Number
Item
Subject Number
integer
Study Continuation Question
Item
Did the subject come at visit 4?
boolean
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
text
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (complete the Serious Adverse Event form) (1)
CL Item
Other (2)
Other Specify
Item
If Other, please specify
text
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
LABORATORY TESTS (GROUPS DTPW-HBV Kft + Hiberix™)
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA - > Only for 100 subjects without BS (3)
BLOOD SAMPLE
Item
Has a blood sample been taken ?
boolean
Concomitant vaccinations
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
boolean
Trade / (Generic) Name
Item
Trade / (Generic) Name
text
CL Item
Intradermal (1)
CL Item
Inhalation (2)
CL Item
Intramuscular (3)
CL Item
Intravenous (4)
CL Item
Intranasal (5)
CL Item
Other (6)
CL Item
Parenteral (7)
CL Item
Oral (8)
CL Item
Subcutaneous (9)
CL Item
Sublingual (10)
CL Item
Transdermal (11)
CL Item
Unknown (12)
Administration date
Item
Administration date
date
Concomitant Medication
Item
Have any medications/treatments been administered during study period?
boolean
Trade / Generic Name
Item
Trade / Generic Name
text
Medical Indication
Item
Medical Indication
text
Medical Indication Prophylactic
Item
Was the medical indication prophylactic?
boolean
Total daily dose
Item
Total daily dose
text
Route
Item
Route
text
Start date
Item
Start date
date
End date
Item
End date
date
Ongoing
Item
Ongoing?
boolean
Non-SAE Question
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
boolean
AE Number
Item
AE Number
integer
Description
Item
Description
text
Administration sites Reaction
Item
Did the AE occur on administration site?
boolean
CL Item
DTPw-HBV/Hib Kft. vaccine (1)
CL Item
DTPw-HBV Kft. vaccine (2)
CL Item
Hiberix™ vaccine (3)
CL Item
Tritanrix™-HepB/Hiberix™ vaccine (4)
Start date
Item
Start date
date
End date
Item
End date
date
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Relationship to investigational products:
Item
Relationship to investigational products:
boolean
CL Item
Recovered / Resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / Resolved with sequelae (4)
Medically attended visit
Item
Medically attended visit
boolean
CL Item
Hospitalisation (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
FOLLOW-UP STUDIES
Item
Would the subject be willing to participate in a follow-up study?
boolean
CL Item
Adverse Events, or Serious Adverse Events (1)
CL Item
Other (2)
Specify
Item
Specify
text
SAE Occurrence
Item
Did the subject experience any Serious Adverse Event during the study period ?
boolean
total SAE number
Item
if Yes -> specify total number of SAE's below
integer
Elimination criteria applied?
Item
Did any elimination criteria become applicable during the study ?
boolean
Specify
Item
Specify
text
subject withdrawn from study?
Item
Was the subject withdrawn from study?
boolean
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Protocol violation (3)
CL Item
Consent withdrawal, not due to an adverse event. (4)
CL Item
Migrated / moved from the study area (5)
CL Item
Lost to follow-up (6)
CL Item
Other (7)
Date of last contact:
Item
Date of last contact:
date
Item
Was the subject in good condition at date of last contact?
text
Code List
Was the subject in good condition at date of last contact?
CL Item
No, please give details within the Adverse Events section. (1)
CL Item
Yes (2)
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Investigator's confirmation
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
date
Investigator's signature
Item
Investigator's signature:
text
Printed Investigator's name
Item
Printed Investigator's name:
text