ID

33511

Descripción

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

Palabras clave

Versiones (3)
  1. 11/12/18 11/12/18 -
  2. 6/6/19 6/6/19 -
  3. 12/6/19 12/6/19 -
Titular de derechos de autor

GSK group of companies

Subido en

11 de diciembre de 2018

DOI

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Licencia

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)

Inglés

Study Conclusion

1 formularios  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative data
Descripción

Administrative data

Protocol Number
Descripción

Protocol Number

Tipo de datos

integer

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Occurrence of serious adverse event
Descripción

Occurrence of serious adverse event

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

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

Tipo de datos

boolean

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

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

Tipo de datos

integer

Subject Withdrawal
Descripción

Subject Withdrawal

Is the subject withdrawn from the study?
Descripción

A subject is withdrawn from interim analysis if he/she did not come for the interim analysis timepoint visit

Tipo de datos

boolean

If Yes, choose one reason for withdrawal
Descripción

If Yes, choose one reason for withdrawal

Tipo de datos

text

If Death, please specify SAE number
Descripción

If Death, please specify SAE number

Tipo de datos

integer

Is Serious Adverse Event, please specify the SAE number
Descripción

Is Serious Adverse Event, please specify the SAE number

Tipo de datos

integer

If Protocol violation, please specify
Descripción

If Protocol violation, please specify

Tipo de datos

text

If Other, please specify
Descripción

If Other, please specify

Tipo de datos

text

Who made the decision?
Descripción

Who made the decision?

Tipo de datos

text

Date of last contact
Descripción

Date of last contact

Tipo de datos

date

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

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

Tipo de datos

boolean

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

If No, please give details in Adverse Event section.

Tipo de datos

text

Investigator's Signature
Descripción

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.
Descripción

Investigator's confirmation

Tipo de datos

date

Investigator's signature
Descripción

Investigator's signature

Tipo de datos

text

Investigator's name (in print)
Descripción

Investigator's name (in print)

Tipo de datos

text

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Similar models

Study Conclusion

1 formularios
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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