ID

33511

Beschreibung

Study ID: 104297 Clinical Study ID: 104297 Study Title: An open study for a 2-year period to confirm the safety and immunogenicity of the candidate malaria vaccine RTS,S/AS02A in Mozambican children aged 1 to 4 years at the time of first vaccine dose. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00323622 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: SB257049 Study Indication: Malaria

Stichworte

Versionen (3)
  1. 11.12.18 11.12.18 -
  2. 06.06.19 06.06.19 -
  3. 12.06.19 12.06.19 -
Rechteinhaber

GSK group of companies

Hochgeladen am

11. Dezember 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Immunogenicity of malaria vaccine candidate in Mozambican children (1 to 4 y.o) - 104297 (Malaria039)

Englisch

Study Conclusion

1 Formulare  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative data
Beschreibung

Administrative data

Protocol Number
Beschreibung

Protocol Number

Datentyp

integer

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Occurrence of serious adverse event
Beschreibung

Occurrence of serious adverse event

Did the subject experience any Serious Adverse Event since Visit 7, Month 21 of Malaria-026 study?
Beschreibung

SAEs recorded up to Visit 7, Month 21 of Malaria-026 to be recorded in Malaria-026 SAE forms; SAEs recorded 1 day after Visit 7, Month 21 to be recorded in Malaria-039 SAE forms

Datentyp

boolean

If Yes, specify total number of SAE's for the Malaria-039 period only
Beschreibung

If Yes, specify total number of SAE's for the Malaria-039 period only

Datentyp

integer

Subject Withdrawal
Beschreibung

Subject Withdrawal

Is the subject withdrawn from the study?
Beschreibung

A subject is withdrawn from interim analysis if he/she did not come for the interim analysis timepoint visit

Datentyp

boolean

If Yes, choose one reason for withdrawal
Beschreibung

If Yes, choose one reason for withdrawal

Datentyp

text

If Death, please specify SAE number
Beschreibung

If Death, please specify SAE number

Datentyp

integer

Is Serious Adverse Event, please specify the SAE number
Beschreibung

Is Serious Adverse Event, please specify the SAE number

Datentyp

integer

If Protocol violation, please specify
Beschreibung

If Protocol violation, please specify

Datentyp

text

If Other, please specify
Beschreibung

If Other, please specify

Datentyp

text

Who made the decision?
Beschreibung

Who made the decision?

Datentyp

text

Date of last contact
Beschreibung

Date of last contact

Datentyp

date

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

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

Datentyp

boolean

If No, please give details in Adverse Event section.
Beschreibung

If No, please give details in Adverse Event section.

Datentyp

text

Investigator's Signature
Beschreibung

Investigator's Signature

I confirm that I have reviewed the data in this Case Report 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.
Beschreibung

Investigator's confirmation

Datentyp

date

Investigator's signature
Beschreibung

Investigator's signature

Datentyp

text

Investigator's name (in print)
Beschreibung

Investigator's name (in print)

Datentyp

text

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Ähnliche Modelle

Study Conclusion

1 Formulare
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
Protocol Number
Item
Protocol Number
integer
Subject Number
Item
Subject Number
integer
Item Group
Occurrence of serious adverse event
Did the subject experience any Serious Adverse Event since Visit 7, Month 21 of Malaria-026 study?
Item
Did the subject experience any Serious Adverse Event since Visit 7, Month 21 of Malaria-026 study?
boolean
If Yes, specify total number of SAE's for the Malaria-039 period only
Item
If Yes, specify total number of SAE's for the Malaria-039 period only
integer
Item Group
Subject Withdrawal
Is the subject withdrawn from the study?
Item
Is the subject withdrawn from the study?
boolean
Item
If Yes, choose one reason for withdrawal
text
If Yes, choose one reason for withdrawal
Code List
If Yes, choose one reason for withdrawal
CL Item
Death (1)
CL Item
Serious adverse event (2)
CL Item
Protocol violation, please specify (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 Death, please specify SAE number
Item
If Death, please specify SAE number
integer
Is Serious Adverse Event, please specify the SAE number
Item
Is Serious Adverse Event, please specify the SAE 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
Who made the decision?
text
Who made the decision?
Code List
Who made the decision?
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 date of last contact?
Item
Was the subject in good condition at date of last contact?
boolean
If No, please give details in Adverse Event section.
Item
If No, please give details in Adverse Event section.
text
Item Group
Investigator's Signature
Investigator's confirmation
Item
I confirm that I have reviewed the data in this Case Report 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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