ID

33192

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2018-11-30 2018-11-30 -
Rättsinnehavare

GSK group of companies

Uppladdad den

30 november 2018

DOI

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Licens

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

Engelsk

Study Conclusion

1 Formulär  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative data
Beskrivning

Administrative data

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Occurrence of Serious Adverse Event
Beskrivning

Occurrence of Serious Adverse Event

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

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

Datatyp

boolean

If Yes, specify total number of SAE's
Beskrivning

If Yes, specify total number of SAE's

Datatyp

integer

Elimination Criteria
Beskrivning

Elimination Criteria

Did any elimination criteria become applicable during the study?
Beskrivning

Did any elimination criteria become applicable during the study?

Datatyp

boolean

If Yes, specify
Beskrivning

If Yes, specify

Datatyp

text

Withdrawal from Study
Beskrivning

Withdrawal from Study

Was the subject withdrawn from study?
Beskrivning

Was the subject withdrawn from study?

Datatyp

boolean

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

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

Datatyp

text

If Other, please specify
Beskrivning

If Other, please specify

Datatyp

text

Who took the decision to withdraw?
Beskrivning

Who took the decision to withdraw?

Datatyp

text

Date of last contact
Beskrivning

Date of last contact

Datatyp

date

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

If No, please give details within the Adverse Events section

Datatyp

boolean

Investigator's signature
Beskrivning

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.
Beskrivning

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.

Datatyp

date

Investigator's signature
Beskrivning

Investigator's signature

Datatyp

text

Investigator's name (in print)
Beskrivning

Investigator's name (in print)

Datatyp

text

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Similar models

Study Conclusion

1 Formulär
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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