ID

33084

Description

Study ID: 104020 Clinical Study ID: 104020 Study Title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00126997 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Combined Measles, Mumps, Rubella, Varicella Vaccine Trade Name: Priorix Tetra Study Indication: Measles; Mumps; Rubella; Varicella

Mots-clés

Versions (1)
  1. 26/11/2018 26/11/2018 -
Détendeur de droits

GSK group of companies

Téléchargé le

26 novembre 2018

DOI

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Licence

Creative Commons BY-NC 3.0
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Immunogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020

Anglais

Study Conclusion Form

1 Formulaires  
  1. StudyEvent: ODM
    1. Study Conclusion Form
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Type de données

integer

Occurrence of Serious Adverse Event
Description

Occurrence of Serious Adverse Event

Did the subject experience any Serious Adverse Events during the study period?
Description

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

Type de données

boolean

If Yes, please specify total number of SAE's
Description

If Yes, please specify total number of SAE's

Type de données

integer

Status of treatment blind
Description

Status of treatment blind

Was the treatment blind broken during this study?
Description

For the control group, please tick 'No'

Type de données

boolean

If Yes, please complete date
Description

If Yes, please complete date

Type de données

date

Check the reason of blind breach
Description

Check the reason of blind breach

Type de données

integer

If Other, specify
Description

complete Non-Serious Adverse Event section or Serious Adverse Event form as appropriate

Type de données

text

Elimination Criteria
Description

Elimination Criteria

Did any elimination criteria become applicable during the study?
Description

Did any elimination criteria become applicable during the study?

Type de données

boolean

If Yes, specify
Description

If Yes, specify

Type de données

text

Was the subject withdrawn from study?
Description

Was the subject withdrawn from study?

Type de données

boolean

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

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

Type de données

text

If SAE, please specify SAE Number
Description

If SAE, please specify SAE Number

Type de données

integer

If Non-SAE please specify unsolicited AE Number
Description

If Non-SAE please specify unsolicited AE Number

Type de données

integer

If Protocol violation, please specify
Description

If Protocol violation, please specify

Type de données

text

If Other, please specify
Description

If Other, please specify

Type de données

text

Please tick who took decision
Description

Please tick who took decision

Type de données

text

Date of last contact
Description

Date of last contact

Type de données

date

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

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

Type de données

text

Investigator's Signature
Description

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 collegues is, to the best of my knowledge, complete and accurate, as of the date below.
Description

I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my collegues is, to the best of my knowledge, complete and accurate, as of the date below.

Type de données

date

Investigator's signature
Description

Investigator's signature

Type de données

text

Printed Investigator's name
Description

Printed Investigator's name

Type de données

text

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Similar models

Study Conclusion Form

1 Formulaires
  1. StudyEvent: ODM
    1. Study Conclusion Form
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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 Events during the study period?
Item
Did the subject experience any Serious Adverse Events during the study period?
boolean
If Yes, please specify total number of SAE's
Item
If Yes, please specify total number of SAE's
integer
Item Group
Status of treatment blind
Was the treatment blind broken during this study?
Item
Was the treatment blind broken during this study?
boolean
If Yes, please complete date
Item
If Yes, please complete date
date
Item
Check the reason of blind breach
integer
Check the reason of blind breach
Code List
Check the reason of blind breach
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
Other (2)
If Other, specify
Item
If Other, specify
text
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
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 (check SAE number) (1)
CL Item
Non-Serious adverse events (check the Non-SAE) (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 SAE, please specify SAE Number
Item
If SAE, please specify SAE Number
integer
If Non-SAE please specify unsolicited AE Number
Item
If Non-SAE please specify unsolicited AE Number
integer
If Protocol violation, please specify
Item
If Protocol violation, please specify
text
If Other, please specify
Item
If Other, please specify
text
Item
Please tick who took decision
text
Please tick who took decision
Code List
Please tick who took decision
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Date of last contact
Item
Date of last contact
date
Item
Was the subject in good condition at date of last contact?
text
Was the subject in good condition at date of last contact?
Code List
Was the subject in good condition at date of last contact?
CL Item
Yes (1)
CL Item
No, please give details within the Adverse Events section (2)
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 collegues 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 collegues 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
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