ID

33192

Beschrijving

Study ID: 104021 Clinical Study ID: 104021 Study Title: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158756 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix B Study Indication: Hepatitis B

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Versies (1)
  1. 30-11-18 30-11-18 -
Houder van rechten

GSK group of companies

Geüploaded op

30 november 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Immunogenicity of co-administration of Tritanrix™-HepB and DTPw-HBV vaccines or Triple Antigen™ and Engerix™-B with HRV vaccine to infants (3, 4½ and 6 month) - 104021

Engels

Study Conclusion

1 Formulieren  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative data
Beschrijving

Administrative data

Subject Number
Beschrijving

Subject Number

Datatype

integer

Occurrence of Serious Adverse Event
Beschrijving

Occurrence of Serious Adverse Event

Did the subject experience any Serious Adverse Event during the study period?
Beschrijving

Did the subject experience any Serious Adverse Event during the study period?

Datatype

boolean

If Yes, specify total number of SAE's
Beschrijving

If Yes, specify total number of SAE's

Datatype

integer

Elimination Criteria
Beschrijving

Elimination Criteria

Did any elimination criteria become applicable during the study?
Beschrijving

Did any elimination criteria become applicable during the study?

Datatype

boolean

If Yes, specify
Beschrijving

If Yes, specify

Datatype

text

Withdrawal from Study
Beschrijving

Withdrawal from Study

Was the subject withdrawn from study?
Beschrijving

Was the subject withdrawn from study?

Datatype

boolean

If Yes, please tick the ONE most appropriate category for withdrawal
Beschrijving

If Yes, please tick the ONE most appropriate category for withdrawal

Datatype

text

If Other, please specify
Beschrijving

If Other, please specify

Datatype

text

Who took the decision to withdraw?
Beschrijving

Who took the decision to withdraw?

Datatype

text

Date of last contact
Beschrijving

Date of last contact

Datatype

date

Was the subject in good condition at the date of last contact?
Beschrijving

If No, please give details within the Adverse Events section

Datatype

boolean

Investigator's signature
Beschrijving

Investigator's signature

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.
Beschrijving

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.

Datatype

date

Investigator's signature
Beschrijving

Investigator's signature

Datatype

text

Investigator's name (in print)
Beschrijving

Investigator's name (in print)

Datatype

text

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Similar models

Study Conclusion

1 Formulieren
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Occurrence of Serious Adverse Event
Did the subject experience any Serious Adverse Event during the study period?
Item
Did the subject experience any Serious Adverse Event during the study period?
boolean
If Yes, specify total number of SAE's
Item
If Yes, specify total number of SAE's
integer
Item Group
Elimination Criteria
Did any elimination criteria become applicable during the study?
Item
Did any elimination criteria become applicable during the study?
boolean
If Yes, specify
Item
If Yes, specify
text
Item Group
Withdrawal from Study
Was the subject withdrawn from study?
Item
Was the subject withdrawn from study?
boolean
Item
If Yes, please tick the ONE most appropriate category for withdrawal
text
If Yes, please tick the ONE most appropriate category for withdrawal
Code List
If Yes, please tick the ONE most appropriate category for withdrawal
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)
If Other, please specify
Item
If Other, please specify
text
Item
Who took the decision to withdraw?
text
Who took the decision to withdraw?
Code List
Who took the decision to withdraw?
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Date of last contact
Item
Date of last contact
date
Was the subject in good condition at the date of last contact?
Item
Was the subject in good condition at the date of last contact?
boolean
Item Group
Investigator's signature
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.
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
Investigator's name (in print)
Item
Investigator's name (in print)
text
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