ID

33192

Descrizione

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

Keywords

versioni (1)
  1. 30/11/18 30/11/18 -
Titolare del copyright

GSK group of companies

Caricato su

30 novembre 2018

DOI

Per favore, per richiedere un accesso.

Licenza

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

Inglese

Study Conclusion

1 moduli  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative data
Descrizione

Administrative data

Subject Number
Descrizione

Subject Number

Tipo di dati

integer

Occurrence of Serious Adverse Event
Descrizione

Occurrence of Serious Adverse Event

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

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

Tipo di dati

boolean

If Yes, specify total number of SAE's
Descrizione

If Yes, specify total number of SAE's

Tipo di dati

integer

Elimination Criteria
Descrizione

Elimination Criteria

Did any elimination criteria become applicable during the study?
Descrizione

Did any elimination criteria become applicable during the study?

Tipo di dati

boolean

If Yes, specify
Descrizione

If Yes, specify

Tipo di dati

text

Withdrawal from Study
Descrizione

Withdrawal from Study

Was the subject withdrawn from study?
Descrizione

Was the subject withdrawn from study?

Tipo di dati

boolean

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

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

Tipo di dati

text

If Other, please specify
Descrizione

If Other, please specify

Tipo di dati

text

Who took the decision to withdraw?
Descrizione

Who took the decision to withdraw?

Tipo di dati

text

Date of last contact
Descrizione

Date of last contact

Tipo di dati

date

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

If No, please give details within the Adverse Events section

Tipo di dati

boolean

Investigator's signature
Descrizione

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.
Descrizione

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.

Tipo di dati

date

Investigator's signature
Descrizione

Investigator's signature

Tipo di dati

text

Investigator's name (in print)
Descrizione

Investigator's name (in print)

Tipo di dati

text

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Similar models

Study Conclusion

1 moduli
  1. StudyEvent: ODM
    1. Study Conclusion
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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